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INDIAN INSTITUTE OF PUBLIC ADMINISTRATION

The Indian Institute of Public Administration, established as an autonomous body under the Registration of Societies Act, was inaugurated on March 29, 1954 by Shri Jawaharlal Nehru who was also the first President of the Society. The basic purpose of establishing this Institute was to undertake such academic activities as would enhance the leadership qualities and managerial capabilities of the executives in the government and other public service organization. The activities of the Institute are organized in four inter-related areas of Research, Training, Advisory and Consultancy Services and Dissemination of Information.

CENTRE FOR CONSUMER STUDIES

CCS is dedicated to consumer studies and is sponsored by DCA, GoI. The objective of the CCS is to perform, facilitate and promote better protection of consumers’ rights and interests with special reference to rural India. The broad areas of focus of the Centre comprise capacity building, advocacy, policy analysis, research, advisory and consultative services, and networking.

The Centre seeks to network with national and international agencies and interface with other stakeholders by serving as a bridging “think tank” with an intensive advocacy role. The Centre provides a forum for creating dialogue among policy-makers, service-providers, representatives of various business establishments and their associations, professional bodies/associations, civil society organizations, educational/research institutions, economic and social development organizations as well as leading NGOs.

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Centre for Consumer StudiesINDIAN INSTITUTE OF PUBLIC ADMINISTRATION

Indraprastha Estate, Ring Road, New Delhi-110002

Consumer Education Monograph Series- 25

Consumer Education Monograph Series-25

GENERIC MEDICINE AND CONSUMERS

Sreekumaran G. N.Mamta Pathania

Centre for Consumer StudiesIndian Institute of Public Administration

Indraprastha Estate, Ring Road, New Delhi

First Edition 2019

` 50/-

Sponsored by: Department of Consumer Affairs, Ministry of Consumer Affairs, Food and Public Distribution, Government of India.

Published by Centre for Consumer Studies, Indian Institute of Public Administration, New Delhi.

Printed at New United Process, A-26, Naraina Industrial Area, Ph-II, New Delhi 110028, Ph. 9811426024

FOREWORD

According to WHO (World Health Organisation), “A generic drug is a pharmaceutical product, usually intended to be interchangeable with an innovator product that is manufactured without a license from the innovator company and marketed after the expiry date of the patent or other exclusive rights.” A generic medicine is the same as a brand-name medicine in dosage, safety, effectiveness, strength, stability, and quality, as well as in the way it is taken and the way it should be used. Generic medicines use the same active ingredients as brand-name medicines and work the same way, so they have the same risks and benefits as the brand-name medicines.

Any generic medicine modeled after a brand-name medicine must perform the same in the body as the brand-name medicine. This standard applies to all generic medicines. In India, the issue of generic drugs vs branded drugs is grounded on the basis of larger societal good i.e. affordable healthcare. Branded drugs tend to be more expensive, and given the fact that a huge part of the population lives below the poverty line. Affordable medicines take the centre stage in policy discourse. The larger issue that unfolds over here is not of pricing, but of the status of the quality of generic drugs.

The issue of compulsory prescription of generic drugs instead of branded counterparts has been a contentious issue among the medical fraternity. Generic drugs have been in the limelight after Prime Minister announced that the government will make it compulsory for doctors to prescribe generic drugs. The policy concerning compulsory prescription of generic drugs is a well-intentioned policy for larger public good, but there are a number of issues that need to be addressed before making generic medicines compulsory. They need to undergo the test of quality . A number of reports have revealed anomalies and substandard qualities of generic drugs at several hospitals. Therefore it is equally important to ensure that consumers get standard generic medicines.

I am sure readers will find this monograph on Generic Medicine and Consumer very informative and useful. I compliment the authors for this timely publication.

Prof. Suresh MisraChair Professor & Coordinator

Centre for Consumer StudiesIndian Institute of Public Administration

PREFACE

Indian pharmaceutical sector is estimated to account for 3.1-3.6 percent of the global pharmaceutical industry in value terms and it is expected to grow to US $ 100 billion by 2025. Increase in the size of middle class households coupled with the improvement in medical infrastructure and increase in the penetration of health insurance in the country will also influence the growth of pharmaceutical sector. It is known fact that India is a global leader in the generic drugs market, exporting drugs to Africa and other emerging markets on October 02, 2012, the Union Health Ministry and the Medical Council of India issued a directive that generics drugs in India would not be sold under branded names but only by their generic names and all doctors and physicians in the Central and State Governments run hospitals should prescribe only medicines with generic names.

Generic medicines in India have received a new impetus with Prime Minister Shri Narendra Modi himself advocating the usage of these medicines. The perception of medicines by generic names will be mandatory thus bringing down drug prices and expand access to affordable health solutions. The promotion of generic drug consumption by government safeguards the health of its generic drug manufacturing industry. In India, the approval, production and marketing of quality drugs at reasonable prices is ensured by the Central Drug Standards and Control Organization (CDSCO) and the National Pharmaceutical Pricing Authority (NPPA) functioning under the Department of Chemical and Petrochemicals which fixes or revises the prices of decontrolled bulk drugs and periodically updates the list under price control, monitors the shortage of medicines, apart from other list of functions.

The present monograph will help the readers to understand the concept of Generic Medicines, process, manufacturing and various aspects dealing with the origin and development of Generic drugs both in India and abroad. It describes the formation and functions of regulatory bodies responsible for ensuring approval, production and marketing of quality drugs at reasonable prices in India.

We would like to thank Prof. Suresh Misra, Chair Professor and Coordinator, Centre for Consumer Studies, Indian Institute of Public Administration, New Delhi for his continued support and guidance without which it would not have been possible to bring out this monograph. We are also thankful to the Department of Consumer

vi

Affairs, Government of India for their support. Thanks are also due to the Publication Division, IIPA especially Shri Anil Kumar Gupta for bringing out this publication in its present form.

New Delhi Sreekumaran G.N.Dated: March, 2019 Mamta Pathania

ContentsPage

Foreword iiiPreface v

1. Introduction 12. Definitions 23. Generic vs Branded Drugs 44. Drug Development Process 55. History of Generic Drugs 66. International Practices 107. Genric Drugs—India Policy 278. Drugs Regulation in India 359. Acts and Rules 3710. Government Initiatives 4011. Challenges 4312. India-Advantage 4613. Generic Drugs-Advantages to Consumers-

Public Awareness52

14. Availability of Generic Drugs in India 5415. Indian System of Medicine and Generic Drugs 5616. Medical Fraternity- Stand on Generic Drugs 5817. Way Forward 6018. Conclusion 6319. Frequently Asked Questions? 64

GENERIC MEDICINES AND CONSUMERS

“We will bring in a legal framework by which if a doctor writes a prescription, he has to write in it that it will be enough for patients to buy generic medicines and he need not buy any other medicines”.1

INTRODUCTION

The World Health Organization (WHO), during the World Health Assembly in 1975, published a resolution to develop means to assist Member States in formulating national drug policies. Since then, and following the recommendations of the WHO, many countries have developed their own national drug policies. The framework of these recommendations is often considered to be built around improving access to “essential drugs” that in most cases mirror the Essential Medicines List from the WHO, currently in its 18th edition. According to the WHO, this list includes the most efficacious, safe and cost-effective medicines for priority conditions. Most of the drugs included are off-patent and available as generic products, which are often offered at lower prices than the innovator branded product, potentially reducing costs for patients and the healthcare system.

The use of generic pharmaceutical products is promoted, in order to reduce costs and increase access to healthcare. But, despite highlighting the need for rigorous quality and safety assessments for pharmaceutical products in order to achieve these goals, the quality of pharmaceutical products available in the market in many developing countries varies, in part because of the lack of clear and specific requirements for generic pharmaceutical products.

Currently, the use of generic pharmaceutical products represents over half of the total volume of pharmaceutical products used worldwide but only 18 percent of the total value of the pharmaceutical market. These proportions vary by region and country, but the consumption of generic pharmaceutical products is consistently higher than that of branded drugs in most countries, being one of the most used healthcare technologies around the world.

2 Generic Medicines Consumers

DEFINITIONS

• GenericDrugsAccording to WHO, “ A generic drug is a pharmaceutical product,

usually intended to be interchangeable with an innovator product that is manufactured without a license from the innovator company and marketed after the expiry date of the patent or other exclusive rights”2.

In USA, the Food and Drug Administration (FDA) has stated that, “A generic drug is identical—or bioequivalent—to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use”.

The European Medicines Agency (EMA), the main regulatory body for pharmaceutical products in the EU, defines a generic medicinal product as a “product which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product, and whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies”.3

These definitions are critical when regulatory agencies in each country determine the requirements and standards that pharmaceutical products must follow in order to obtain approval and reach the market. Minor differences in wording may have a great impact on how these products are assessed and the standards that must be followed. For example, using words such as “interchangeable”, “identical” or “bioequivalent”, which are used by the WHO, FDA and EMA, respectively, have important connotations with regard to determining the evidence required from a manufacturer of generic products in order to obtain approval from regulatory agencies and reach the market in specific countries. The concepts of bioequivalence and interchangeability are of particular importance in these definitions.

In theory, a generic drug is considered interchangeable with a branded drug or a reference pharmaceutical product when there is evidence demonstrating that it can be as effective and safe for patients in the specific indication. That evidence is often but not always obtained through bioavailability and bioequivalence studies comparing the

Generic Medicines and Consumers 3

generic to the branded as the reference product. A generic drug is a pharmaceutical drug that is equivalent to a brand-name product in dosage, strength, route of administration, quality, performance, and intended use, but does not carry the brand name.The generic drug has thus the same active pharmaceutical ingredient (API) as the original, but may differ in characteristics such as manufacturing process, formulation, excipients, color, taste, and packaging. In most cases, generic products become available after the patent protections afforded to a drug's original developer expires.

• BrandedGenericsGeneric drugs sold under a trade name or brand name given by the

manufacturer are called branded generics.

• BrandedDrugsThe brand name to a drug is chosen by the manufacturer, usually

on the basis that it can be recognized, pronounced and remembered by health professionals and members of the public. A brand name, is thus the trade name, the manufacturer gives to the medicine.

• BrandedGenericsandGenericGenericsThe difference is in the name. One is sold under a brand name and

the other is sold under a generic name. But both are generic drugs whose patent has expired. Generic drugs are sold by the non-proprietary name or generic name instead of a brand name.

The international non-proprietory name (INN) is a unique name given to identify pharmaceutical substances or active pharmaceutical ingredients. INN is globally recognised and is public property unlike a brand name that belongs to a particular company. A non -proprietary name, also known as generic name, is the simplified name for a chemical product, since it is impossible to remember the chemical name for most people. So, this chemical can be sold by its INN or generic name and sold as a branded generic.

• BioequivalenceThere are differing legal requirements in different jurisdictions

that define the specifics of what a generic medicine is. However, one of the main principles underpinning the safe and effective use of generic medicines is the concept of bioequivalence. Bioequivalence has been defined as follows: “ two pharmaceutical products are bioequivalent if they are pharmaceutically equivalent and their bioavailability’s (rate and


extent of availability) after administration in the same molar dose are similar to such a degree that their effects, with respect to both efficacy and safety, can be expected to be essentially the same”. 4

• PharmaceuticalEquivalenceImplies the same amount of the same active substance(s), in the same

dosage form, for the same route of administration and meeting the same or comparable standards. The purpose of establishing bioequivalence is to demonstrate equivalence between the generic medicine and the originator medicine in order to allow bridging of the pre-clinical and clinical testing performed on the originator drug.

GENERICvsBRANDEDDRUGSA generic drug is the same as a brand-name drug in dosage, safety,

strength, quality, the way it works, the way it is taken and the way it should be used. Not every brand-name drug has a generic drug. When new drugs are first made they have drug patents. Most drug patents are protected for 20 years. The patent, which protects the company that made the drug first, doesn't allow anyone else to make and sell the drug. When the patent expires, other drug companies can start selling a generic version of the drug. But, first, they must test the drug and the concerned authority must approve it.

Creating a drug costs lots of money. Since generic drug makers do not develop a drug from scratch, the costs to bring the drug to market are less; therefore, generic drugs are usually less expensive than brand-name drugs. But, generic drug makers must show that their product performs in the same way as the brand-name drug.

A generic drug is approved only after it has met rigorous standards established by the FDA with respect to identity, strength, quality, purity, and potency. All generic manufacturing, packaging, and testing sites must pass the same quality standards as those of brand name drugs.The generic drug manufacturer must prove its drug is the same as (bioequivalent) to the brand name drug.

For example, after the patient takes the generic drug, the amount of drug in the bloodstream is measured. If the levels of the drug in the bloodstream are the same as the levels found when the brand name drug is used, the generic drug will work the same.

In the developed countries, brand names are given to researched and patented first-in-market innovator drugs.After the expiry of patent period, other companies launch generics of the innovator drug with just


the pharmaceutical salt name at a hugely discounted price. So, the only difference between a brand name drug and its generic version is the price.

Once generic drugs enter the market, competition often leads to substantially lower prices for both the original brand-name product and its generic equivalents. Generic drug names are constructed using standardized affixes that distinguish drugs between and within classes and suggest their action.

DRUGDEVELOPMENTPROCESSWhenever a new potential pharmaceutical product is identified, the

inventor (individual or company) files for protection of their intellectual property. This pharmaceutical product is now patent protected and no one can produce it without permission (or license) from a patent holder. Patents are transferable following a legal process involving payment of royalty. Innovator Company is the first one to identify or develop and market the pharmaceutical product. Once the duration of patent protection expires (usually 20 years unless specified), any company can manufacture and market the drug without the permission of the innovator company, as long as it shows bioequivalence, that is, prove to the drug regulator that the copy releases the same amount of the active ingredient and is absorbed by the body in the same way as the original or innovator drug. Such a proven copy of a drug is called its generic version.

When a pharmaceutical company first markets a drug, it is usually under a patent that, until it expires, the company can use to exclude competitors by suing them for patent infringement. Pharmaceutical companies that develop new drugs generally only invest in drug candidates with strong patent protection as a strategy to recoup their costs to develop the drug (including the costs of the drug candidates that fail) and to make a profit.

In medicines development, the drug candidate is the molecule among several that has been shown to have sufficient target selectivity and potency, and favourable medicine-like properties and justifies further development. It will then be subjected to a new series of tests, and non-clinical studies and clinical trials. At this stage it is not yet a medicine.

For as long as a drug patent lasts, a brand-name company enjoys a period of market exclusivity, or monopoly, in which the company is able to set the price of the drug at a level that maximizes profit. This profit


often greatly exceeds the development and production costs of the drug, allowing the company to offset the cost of research and development of other drugs that are not profitable or do not pass clinical trials.

Large pharmaceutical companies often spend millions of dollars protecting their patents from generic competition. Apart from litigation, they may reformulate a drug or license a subsidiary (or another company) to sell generics under the original patent. Generics sold under license from the patent holder are known as authorized generics.

Generic drugs are usually sold for significantly lower prices than their branded equivalents and at lower profit margins. One reason for this is that competition increases among producers when a drug is no longer protected by patents. Generic companies incur fewer costs in creating generic drugs—only the cost of manufacturing, without the costs of drug discovery and drug development—and are therefore able to maintain profitability at a lower price. The prices are often low enough for users in less-prosperous countries to afford them.

HISTORY OF GENERIC DRUGSDespite the benefits associated with the use of a more cost-effective

drug, the generic drug industry has had its share of challenges. To understand these challenges and what the industry faces, it is important to examine the modest history of generic drug products and review the approval process.

The generic drug industry has been soaked in controversy since the establishment of the pharmacy and medical communities in the U.S. In 1888, the American Pharmaceutical Association (APhA) published the National Formulary to help prevent counterfeiting of branded products. US Congress in 1906 with the passage of the Federal Food and Drugs Act. This law, signed by President Theodore Roosevelt, was the first to require product labeling in an effort to prevent misbranding and adulteration, and it enabled the government to take action if a product caused substantial injury or death. This was the beginning of pharmaceutical regulation by what was soon to become the FDA.

Concern arose in 1928 regarding the substitution of generic drugs for brand-name products. A well-accepted pharmacy magazine published articles commenting on the appropriateness of this practice and voiced its concern that generic substitution might be deceptive. This came at a time when many mainstream drugs were beginning to enter the market.

Then, in 1938 Congress passed the Federal Food, Drug, and Cosmetic Act (FDCA). The FDCA designated products introduced after 1938 as


new drugs and required them to be proven safe through manufacturer testing and FDA clearance before they could be marketed. While the FDCA was an important step in improving the drug-regulation system, guidelines were not always followed when an identical or similar product was introduced after a patent on a pioneer drug expired. Because the drug was not always considered to be a new drug by the FDA, the same rigorous testing for safety and efficacy was not performed, resulting in a variety of original and derivative products of varying integrity.

The Durham-Humphrey Amendment of 1951 established two distinct categories of drugs: those that are unsafe to use without medical supervision and must be prescribed, and those that can be sold without a prescription. Despite the differentiation, multiple products continued to appear on the market, which potentiated difficulties with inventory and drug counterfeiting. While these laws helped prevent substitution of low-quality products, it limited opportunities for the manufacture of generic products of sufficient quality.

In 1962, the Kefauver-Harris Drug Amendments were mandated. These amendments were the first to require drug manufacturers to prove a product's safety and efficacy to the FDA prior to marketing it. Also at that time, all products on the market that had been released between 1938 and 1962 were declared once again to be new drugs, and pioneer products had to submit efficacy data for evaluation by active ingredient. If a product was found to be ineffective, all related products, in addition to the pioneer product, were removed from the market.

The Kefauver-Harris Drug Amendments also required all manufacturers of related products to submit an Abbreviated New Drug Application (ANDA) for products manufactured between 1938 and 1962. ANDAs contained information similar to that found in a pioneer drug application, with the exception of safety and efficacy. After 1962, the FDA established a new mechanism of proving safety and efficacy by allowing the "literature-based" New Drug Application. This meant that submission of published data regarding a branded product's safety and efficacy by a generic product's manufacturer was permitted. Over the next several years, the Kefauver-Harris Drug Amendments were challenged, most notably in Upjohn v. Finch in 1970, in which the courts upheld the amendments by ruling that evidence of drug safety and efficacy cannot be substantiated by commercial success alone.

The Medicaid and Medicare amendments to the Social Security Act (enacted in 1965) and additional legislation passed in 1967 helped move generic drug products into the forefront. After a cost-


effectiveness analysis of drug products conducted by Congress, the use of generic products by federal health and welfare programs was strongly encouraged to safeguard against inflated pricing arising from lack of competition.

Legislation to expedite the availability of generic drug products was passed in 1984. The Drug Price Competition and Patent Term Restoration Act, more commonly known as the Hatch-Waxman Act, allowed the FDA to approve applications to market generic versions of brand-name drugs released after 1962 without repeating efficacy and safety research. This legislation also allowed brand-name manufacturers to extend their patent protection for up to 5 years for new products. This meant that these manufacturers could make up for time lost while their products were going through the FDA approval process. Despite the increase in patent protection, the Hatch-Waxman Act is considered to be one of the most pivotal legislative moves on behalf of the generic drug industry.

In 1994, through the passage of the Uruguay Rounds Agreements Act, the patent term of drugs manufactured in the U.S. was extended from 17 to 20 years after original filing. In particular, the approval process, issues of bioequivalence, and corruption have been at the forefront of the disputes.

In response to this corruption, the Generic Drug Enforcement Act of 1992 imposed penalties for illegal acts related to abbreviated drug applications and required generic drug manufacturers to include more scientific data concerning quality and bioequivalence. Fortunately, this legislation brought needed change and credibility to the generic drug industry and was a timely move towards restoring the integrity of the industry in a time of greatly rising health care costs.

TheApprovalProcessofGenericDrugsunderFDA

Unlike the approval process for new chemical entities, that for generic drugs allows use of the ANDA, which does not require the submission of clinical data regarding safety and efficacy since this information was already provided for the pioneer product. Since the original active ingredient was already proven safe and effective, the manufacturer must now prove bioequivalence for the pharmaceutically equivalent generic drug product.

In order to receive approval for marketing, a generic drug must meet the same batch requirements for identity, strength, purity, and quality and be therapeutically equivalent to the branded product.


Additionally, the drug must be manufactured according to the same Good Manufacturing Practice regulations required by the FDA. For the generic drug to be therapeutically equivalent, two clinical characteristics must apply: It must be pharmaceutically equivalent as well as bioequivalent. Pharmaceutical equivalence means that the active ingredient(s), dose form, route of administration, and strength are the same for both the branded product and the generic product. Bioequivalence is when both products have comparable bioavailability when studied under similar conditions.

Bioequivalence is determined by evaluation of the AUC and the maximum concentration of drug (Cmax). A generic product is considered to be bioequivalent to the pioneer product if the 90 percent confidence interval (CI) of the mean AUC and the relative mean Cmax is 80 percent to 125percent. This criterion is the same standard used for testing the bioequivalence of branded products with reformulation or manufacturing changes. Bioequivalence is determined by conducting crossover studies of at least 12 patients in which half of the patients receive the generic drug first and then the pioneer drug, with a washout period in between. The remaining patients receive the pioneer drug first, followed by a washout period and then the generic drug. The Cmax, time to reach Cmax, and AUC are determined by taking multiple blood samples from individual patients. Based on the 90 percent CI, if drug levels vary by more than 10 percent, failure to reach FDA criteria disqualifies a drug for a bioequivalence rating. According to data for bioequivalence testing performed on 224 drugs after 1962, the mean variation in bioavailability between branded and generic drug products was approximately 3.5 percent.5

Despite determinations of statistical bioequivalence, some health care providers still have concerns about interchangeability between narrow-therapeutic-index (NTI) branded and generic drugs. Currently, however, no data suggest that the bioequivalence criteria for NTI drugs should be more rigorous. Opponents of generic substitution have raised questions about changes in efficacy and toxicity in drugs such as antiepileptics and have voiced concerns about receiving consistent product with routine refills. In addition, it has been difficult to determine bioequivalence in products with timed-release properties.

A common misconception in the evaluation of generic substitution relates to therapeutic equivalence. While a generic drug may be AB-rated to a branded drug, there is no testing to determine whether generic products are bioequivalent to each other, although it is expected that their efficacy would not differ significantly.


INTERNATIONALPRACTICES

• USAGeneric Drug Approval Process in USA: Generic drugs play an

important role in the US system of health care. To stimulate generic drug entry, the FDA currently offers a period of marketing exclusivity to the first firm that gains approval for a generic version of a branded drug. During this 180-day period, only two firm can sell version of the drug: the original, branded drug maker and the first approved generic firm. After the period of exclusivity expires, other generic firms are free to enter the market.

There are two ways that a drug can gain FDA approval and brought to the market. First, if the drug is novel product, the developer must submit it to the FDA using new drug application (NDA). Second, if the drug is a generic version of an existing drug, the generic drug maker can submit an Abbreviated New Drug Application (ANDA). To gain FDA approval, a generic medicine must :

• Contain the same active ingredient as the originator medicine (inactive ingredients may vary)

• Be identical in strength, dosage form, and route of administration should have the same use indications

• Should be bioequivalent • Should meet the same batch requirements for identity, strength,

purity, and quality • Should be manufactured under the same strict standards of

FDA's good manufacturing practice regulations required for originator products.

Enacted in 1984, the US Drug Price Competition and Patent Term Act, informally known as the: “Hatch Waxman Act” standardized US procedure for the recognition of generic drug. The Waxman Hatch Act of 1984, among the other things, allowed the generic firm to submit ANDAs for drugs approved. The application is known as “abbreviated” because the generic manufacturer is no longer to repeat the tests showing the substance is safe and effective since the innovator had already done so. A generic drug manufacturer can be file as per given regulations:

(i) That no patent information on that brand name drug has been submitted to the FDA.

(ii) That the listed patent has expired.


(iii) That the listed patent will expire on a certain date, before which time the generic will not enter the market; or

(iv) That the patent is invalid or will not be infringed by manufacturer, use, or sale of the new drug for which the ANDA was submitted.6

Generic drugs play an important role in the US system of health care. To stimulate generic drug entry, the FDA currently offers a period of marketing exclusivity to the first firm that gains approval for a generic version of a branded drug.

• UKThe National Health Service (NHS) is the publicly funded national

healthcare system for England and one of the four National Health Services for each constituent country of the United Kingdom. It is the largest single-payer healthcare system in the world. Primarily funded through the general taxation system and overseen by the Department of Health, NHS England provides healthcare to all legal English residents, with most services free at the point of use. Some services, such as emergency treatment and treatment of infectious diseases are free for everyone, including visitors.

The Pharmaceutical Price Regulation Scheme (PPRS) is the mechanism used by the UK Department of Health to ensure that the NHS has access to good quality branded medicines at reasonable prices. It involves a non-contractual agreement between the UK Department of Health and The Association of the British Pharmaceutical Industry (ABPI). The scheme applies to all branded, licensed medicines available on the NHS. The purpose of the scheme is to achieve a balance between reasonable prices for the NHS and a fair return for the pharmaceutical industry.The current PPRS scheme, using a value-based pricing mechanism, came into effect on 1 January 2014, to run for no less than five years. It replaced an earlier scheme running from 2009 to 2013.

BrandedMedicinesCurrently, the PPRS covers approximately 80 percent of branded

medicines sales to the NHS. It is a voluntary scheme negotiated between the Department of Health and the Association of the British Pharmaceutical Industry (ABPI), whereby the industry agrees to a variety of measures to control prices and spend. Chief among these is the PPRS payment mechanism, whereby members make payments ‘back’ to the NHS if growth in NHS spend on branded medicines


supplied by PPRS members exceeds an agreed percentage. Despite this, the PPRS has not been as successful as the Government hoped in delivering savings to the NHS, thought to be partly because some companies have chosen to move their products out of the PPRS into the alternative statutory scheme, which does not include such payments back, resulting in lower savings for the NHS.

The new Act will enable the Government to introduce a payment back into the statutory scheme, with the intention of levelling the playing field between the two schemes and discouraging movement out of the PPRS.

GenericMedicinesUnbranded, generic medicines fall outside the PPRS and statutory

schemes. Reimbursement prices for generics (i.e. the price at which pharmacists dispensing on NHS prescriptions are reimbursed) under the NHS Drug Tariff are generally set by reference to market prices. However, this relies on there being competition in the market.

Recently, the media has highlighted a number of instances where, in the absence of competition, the price of an old generic drug has been increased dramatically. Examples include the anti-epilepsy drug phenytoin sodium, the price of which was reportedly increased by up to 2600 percent, and hydrocortisone tablets where the price of generic 10 mg tablets are reported to have been increased by more than 12,000 percent. Both have been subject to investigation by the Competition and Markets Authority (CMA).

The new Act gives the Government broad power to control the price of unbranded generics and should enable it to step in when an unreasonable price is being charged. This closes a ‘loophole’ in the existing legislation that barred it from controlling the prices of unbranded generics supplied by companies that were members of the voluntary PPRS. The circumstances and manner in which the Government will intervene, and what will be regarded as an unreasonable or excessive price, will be consulted on.

ComprehensiveInformationRequirementsThe Act provides extensive statutory powers to require

manufacturers, distributors and suppliers of branded and unbranded products to record and supply pricing and sales information. An issue here is that much of the information on generic prices used in setting the reimbursement price is currently provided on a voluntary basis, and


not all manufacturers and suppliers participate. The Government’s view is that collection of accurate and comprehensive pricing information, including in relation to discounts, should enable a more accurate reimbursement price to be set. It may also result in the Department of Health becoming aware of any unfair pricing practices at an earlier stage.

TheStatutoryPharmaceuticalPriceRegulationScheme

The Statutory Pharmaceutical Price Regulation Scheme runs in parallel to the better-known Pharmaceutical Pricing Regulation Scheme (PPRS). Both schemes relate to the regulation of branded medicines supplied to the health service, but whereas the PPRS is a voluntary scheme agreed between the Government and the pharmaceutical industry, the statutory scheme is for those manufacturers and suppliers which choose not to participate in the PPRS. These manufacturers and suppliers are obliged to comply with the statutory scheme. The regulations governing the statutory scheme are set out in the Health Service Medicines (Control of Prices and Supply of Information) (No 2) Regulations 2008/3258.

The statutory scheme currently provides for a fixed 15 percent cut on list price coupled with a price freeze based on sales prices as at 01.12.2013. Exclusions. The 15 percent cut does not apply to manufacturers and suppliers with sales of branded health service medicines of less than £5 million in the previous calendar year or to products supplied under certain framework agreements under the Public Contracts Regulations 2006.7

GenericDrugPrices

The prices of branded medicines supplied to the National Health Service are specifically regulated under the voluntary Pharmaceutical Price Regulation Scheme (PPRS) and the parallel statutory scheme.

Generic medicines (other than ‘branded generics’) are not included in these schemes. The price paid by the NHS for generic medicines under the NHS Drug Tariff is usually set by reference to market prices for the drug in question. Pharmacists dispensing these medicines to fulfil NHS prescriptions buy them in the market and are reimbursed under the Drug Tariff. This results in price competition as pharmacists look for the best price. The Department relies on this market competition to keep generic prices down.


UKintroducesnewlawtocontrolgenericdrugpricesA new law introduced in the UK is seeking to clarify and extend

the government’s powers to regulate the cost of medicines and medical supplies and to collect sales and pricing information from pharmaceutical companies.

The Health Service Medical Supplies (Costs) Act 2017 (c 23) is an Act of the Parliament of the UK. It provides that pharmaceutical companies can be compelled to reduce the price of a generic medicine or introduce other controls on brand-name drugs in cases where charges are ‘unreasonable’. It received Royal Assent on 27 April 2017.

TheActhasthreekeyaims:1. It will give extra powers to the Secretary of State to require a

payment mechanism in the statutory scheme to limit the cost of medicines and bring it into line with savings made through the Pharmaceutical Price Regulation Scheme (PPRS). The statutory scheme is used for pharma companies that do not join the PPRS.

2. It will enable the UK Government to step in to control dramatic price increases in unbranded generics. The government currently relies on competition to reduce prices. However, in cases where there is no competition there have been cases of large price increases.

3. It will create a comprehensive statutory power, allowing the Secretary of State to demand information on sales and purchases of health service medicines and other medical supplies from all parts of the supply chain, from manufacturer to pharmacy.

However, not everything in the new law is clearly defined, and there have been questions raised as to how the balance between the statutory and voluntary pricing schemes for brand-name drugs will evolve and on the approach the government will take to control excessive generics prices, in particular how it will determine what is an excessive or unfair price.

• EUROPEANUNIONThe European Medicines Agency (EMA) is a European Union

agency for the evaluation of medicinal products. From 1995 to 2004, the European Medicines Agency was known as European Agency for the evaluation of medicinal products. Roughly parallel to US Food and Drug Administration (FDA), but without FDA-style centralization, the


European Medicines Agency was setup in1995 with funding from the European Union and the pharmaceutical industry, as well as indirect subsidy from member states, in an attempt to harmonize.

MarketingAuthorizationTo place a medicine on the market in the European Economic Area

(EEA) a “Marketing Authorization” has been issued by the competent authority of a Member State (or EEA country) for its own territory (national authorization) or when an authorization has been granted in accordance with Regulation (EC) No 726/2004 for the entire Community (a Community authorization). The marketing authorization holder must be established within the EEA.

(i) Marketing authorization procedures in EU (ii) Mutual Recognition Procedure (MRP) (iii) Decentralized Procedure (DCP)

Procedure for submissionofmarketingauthorizationapplication toEMA

When preparing the submission of a MAA, applicants have the opportunity to meet the EMA to discuss any procedural or regulatory issues on the proposed submission. Requests for Pre-Submission Meetings should be sent to the EMA using the “Pre-Submission Meeting Request Form” which is included in the “EMEA Pre-Submission guidance document”. At least seven months before submission, applicants should notify the EMA of their intention to submit an application. In that notification applicants should include:

• A draft summary of product characteristics • A justification of the product’s eligibility for evaluation under CP. • An indication on the number of strengths / pharmaceutical

forms / pack sizes (if already known).

• CanadaThe Food and Drug Regulations under the Food and Drugs Act

apply to all drugs, including generic drugs. A generic drug must be approved by Health Canada before it can be sold.

Health Canada has written many guidance documents to explain the data that should be submitted before a drug can be approved. These are used by both manufacturers and Health Canada scientists so that generic drugs are safe, effective, and of high quality.


There are other laws and regulations which also apply to generic drugs. One example is the Narcotic Control Regulations under the Controlled Drugs and Substances Act. These regulations apply to any narcotic, whether it is in a brand name drug or a generic.

The length of time before a generic drug can be sold in Canada depends on several factors. Generic drug manufacturers have to:

• conduct studies to design and test their new generic drug• respect national and international patent and data protection

requirements• file a drug submission to Health Canada, and receive approval

Designing and testing a new generic drug can take several months or even years. Then, a new generic drug must be approved by Health Canada. In 2016-17, the average time for approval was approximately fifteen months.

Health Canada cannot approve a drug until patent and data protection requirements have been met. Brand name drugs are usually protected by patents. The generic drug manufacturer has to either challenge the patents in court, or wait until the patents expire.

Many new brand name drugs are innovative drugs and also have 'data protection', which means there are regulations that give them a period of market exclusivity. Health Canada cannot approve a generic copy of innovative drugs for at least 8 years.

The Canada-European Union Comprehensive Economic and Trade Agreement (CETA) has introduced another protection, called a Certificate of Supplementary Protection. This provides up to two years of additional protection to a drug product, after the patent expires.

• AustraliaA generic medicine is an additional brand of an existing medicine. It

contains the same 'active ingredient' as the existing medicine; the 'active ingredient' is the chemical that is biologically active in the body and makes the medicine work. Active ingredients can be manufactured and sold by other sponsors once the patent for the existing brand medicine has expired.Apart from containing the same active ingredient, generic medicines must also be 'bioequivalent'. This means that the same amount of active ingredient is absorbed by the body over the same period of time for the same dose of generic or existing medicine.

A 'first generic' medicine is the first registration approved by


TGA which permits a sponsor to market a generic drug product in Australia that contains a particular active ingredient. First generics are significant because they have the potential to create more affordable treatment options for patients by triggering a price reduction under the Pharmaceutical Benefits Scheme (PBS). Because the first generic registered by TGA may not necessarily be the first that is PBS listed, please consult the PBS website for further information.

GenericPharmaceuticalSuppliersAustralia has a relatively small but active competitive landscape for

generic pharmaceuticals with five major suppliers to the PBS. Whilst a growing market for generic sales, Australia represents a logistical issue for the world's biggest generic players. The relatively small size of the market and high cost of entry make Australia a difficult investment opportunity for multi-national generic companies that are structured for high volume markets. But there is genuine competition in the market place, with active sales forces encouraging generic supplier loyalty and encouraging efficient, timely stock purchasing, either directly from the supplier or through a short line or full line wholesaler.

The actual supply of generics is a critical issue. The cost of storage and distribution is a real cost and is part of the obligation of wholesalers to offer all PBS items to community pharmacy, in any part of Australia, within 24 hours. When a drug is supplied by a full line wholesaler (either Sigma, API or Symbion) the pharmacist can order and receive any quantity and that item will be delivered as part of their next (usually) daily order. If the pharmacist orders the drug from the generic supplier (direct supply) or a short line wholesaler (offering a limited range of stock, usually the top sellers) the order may be subject to a volume requirement, so that the delivery of the stock is cost effective.

Considerable effort is expended to entrench supplier loyalty as pharmacists are reluctant to change generic suppliers for short term gains. Despite the fact that the generic marketplace in Australia is dominated by two larger companies, Alphapharm and Sigma Pharmaceuticals, the smaller generic companies are vigorous and nimble competitors.

• ChinaState Food and Drug Administration (SFDA), China. The State

Food and Drug Administration (SFDA) is founded on the basis of the State Drug Administration. The State Food and Drug Administration is directly under the State Council of the People's Republic of China, which is in charge of comprehensive supervision on the safety management of


food, health food and cosmetics and is the competent authority of drug regulation in mainland, China.

BioequivalenceTestingThe Amended Regulation specifies that the generic drug shall

have the same active component, route of administration, dosage form, strength and therapeutic effect as the existing, approved drug. To the extentpossible, bioequivalence testing is an important aspect of the SFDA approval process for generic drug applications. Bioequivalence tests include human tests to determine if there is any statistical difference in absorption and absorption speed of the active component between the same or different dosage forms of the same drugs under the same test conditions, by using the methodology of a bioavailability study with pharmacokinetic parameters.

ClinicalTrailsA generic drug application, or so-called “abbreviated application,”

may omit preclinical and clinical test data on the basis that the drug is already on the market and its effectiveness and safety understood. The key aspects of the examination and approval process focus on the quality of the manufacturing process and conformity with the existing national drug standard. In certain circumstances, clinical trials are required for safety reasons.

According to the Annex to the Amended Regulation, for generic drugs based on Traditional Chinese Medicine (TCM), or natural drug injections, clinical trials on no less than 100 pairs of cases are required. For generic chemical drugs where the quality is controlled by defined processes and standards, clinical trials on 18-24 cases are typically required.

DrugApprovalProcessinChinaGeneric drug applications must be filed by the drug manufacturer in

the provincial FDA (PFDA), where the applicant is located. The PFDA serves as the receiving office for the generic application and determines whether the application dossier is in proper order. If the requirements are met, the PFDA provides notification of acceptance of the drug registration application. If the requirements are not met, the applicant is provided with an explanation of the reasons for rejection, and the opportunity to reapply. Within five days of acceptance of the application, the PFDA will conduct an on-site inspection of the production site, as well as the original drug research data, and take samples of three consecutive batches to send to the Drug Control Institute for inspection.


The sample products are required to be manufactured in a facility with Good Manufacturing Practice (GMP) certification.

After completing examination of the application dossier, the PFDA will submit the dossier along with its examination recommendation, verification report and results of its inspection of the production site to the SFDA Center for Drug Evaluation (CDE) within 30 days. CDE will organize pharmaceutical, medical and other technical staff to examine the verification recommendation and the application dossier, and may request that the applicant provide supplemental information if necessary. At the same time, the Drug Control Institute tests the sample products and provides its sample test report to CDE, the PFDA and the applicant. CDE prepares a general examination recommendation based on the technical examination recommendation, production site inspection information and sample test report, and then submits to SFDA along with related data. SFDA then makes its approval decision based on the general recommendation and issues a Drug Approval Number (if no clinical trials are needed), or a Clinical Trial Approval (if clinical trials are needed). Upon completion of clinical trials, the applicant must then submit the clinical trials data to SFDA for issuance of a Drug Approval Number. For drugs that do not meet safety requirements, the Amended Regulation grants SFDA authority to suspend acceptance or approval of the generic drug application.

• SingaporeA generic product must have the same qualitative and quantitative

composition in active substances and be of the same pharmaceutical form as a currently registered product in Singapore (known as the ‘Singapore Reference Product’). A generic product must demonstrate bioequivalence to the Singapore reference product via appropriate bioequivalence studies.

The generic product must fulfil the following criteria: (a) the generic product is the same pharmaceutical dosage form as the

Singapore Reference Product. However, different conventional oral immediate-release dosage forms (i.e. tablets and capsules) are considered to be the same pharmaceutical form;

(b) the route of administration of the generic product is the same as the Singapore reference product;

(c) the conditions of use for the generic product fall within the directions for use (including indication(s), dosing regimen(s) and patient group(s)) for the Singapore reference product; and


(d) the generic product is bioequivalent with the Singapore reference product.

SingaporeReferenceProductThe Singapore Reference Product must be a currently registered

product that has been granted market authorisation based on the evaluation of the product’s quality, efficacy and safety – i.e. a dossier with chemical, biological, pharmaceutical, pharmacological-toxicological and clinical data. If such a reference product is not registered in Singapore, then an alternate registered comparator product may be used if adequately justified (e.g. a registered generic therapeutic product widely used by local hospitals) by the applicant and agreed upon by HSA.

The generic product should contain the same active substance(s) and strength(s) and be the same pharmaceutical dosage form as the Singapore reference product.

For generic products containing a different salt, ester, ether, isomer, mixture of isomer, complex or derivative of the active substance compared to the Singapore reference product, applicants are required to submit data to demonstrate that the different form does not differ from the active substance in the Singapore reference product in terms of safety and/or efficacy.

• SouthAfricaApplicants are advised to search HSA’s Register of Therapeutic

Products to identify the Singapore reference product. Applicants are encouraged to contact HSA to discuss the acceptability of a GDA if the generic product does not have a registered Singapore reference product of the same strength. In these instances, applicants should provide scientific justifications for HSA’s consideration.

TheMedicinesControlCouncil(MCC)The Medicines Control Council (MCC) is a statutory body that

regulates the performance of clinical trials and registration of medicines and medical devices for use in specific diseases. The MCC is responsible to ensure that all clinical trials of both non-registered medicines and new indications of registered medicines comply with the necessary requirements for safety, quality and efficacy.

Applications for clinical trials and for registration of medicines and medical devices are reviewed by an MCC expert committee, which considers amongst other issues the scientific, medical and ethical issues


of the applications. Reports on the progress of the study are sent to the MCC on a regular basis. Proof of safety, quality and efficacy must be submitted when applying to the MCC for approval and registration of a medicine for use in South Africa.

MedicineapprovalprocessinSouthAfrica Once the application for registration has been compiled, a specified

number of copies together with the applicable application fee, and a sample of the product appropriately labeled, must be submitted to the MCC Secretariat in Pretoria with the required fee. MCC will not accept partial submissions with further data to follow at a later stage.

The MCC evaluates the submission and will usually respond with questions or requests for further data. Once this is submitted and accepted, registration of the product will be “approved” or “not approved”. The time taken for evaluation varies depending on the workload but should be approximately 24 months for innovative products and 12 months for generic medicines, although backlogs have frequently developed in practice so that approval can take much longer. During this time there can be several interchanges between the MCC and the applicant company.

The time taken for approval of variations to registered product dossiers depends on the nature of the changes required but would usually take from 2-4 months for pharmaceutical changes and 6-12 months for changes involving clinical data. Again backlogs frequently develop in practice so approval can take much longer.

RegistrationandlicensingrequirementsforthemanufactureandsaleofPharmaceuticals

All medicines sold in South Africa must be registered by the Medicines Control Council, [MCC], the Medicines Regulatory Authority set up under the Medicines and Related Substances Control Act [Act 101 of 1965] as amended, to control all aspects of the manufacture and sale of medicines.

Requirements1. The Company must be registered under the Company’s Act and

then with the South African Pharmacy Council, and must have an operating license from the Medicines Control Council.

2. A “responsible pharmacist” must be appointed as the person legally responsible for compliance with all laws and regulations, codes of good practice and ethical obligations.


3. An application for registration must be compiled in a specified format by a pharmaceutical company registered and operating in South Africa

4 The applicant company must compile an Applicant Master File with details about the company, its physical address in South Africa, its organogram including the skills and experience of the staff responsible for the production, testing, storage and distribution of its medicinal products.

5. The product dossier compiled by the applicant company must be submitted to and approved by the MCC and is regarded as a legal contract. The Certificate of Registration of a medicine confirms this and is the license to sell the medicine. Any amendment made by the company after registration must be approved by the MCC.

GuidelinesforboththeregistrationandthecontrolofmedicinesbyMCC-includes:1. The claims made for the medicine with regard to the indications

for its use. These must appear on the package insert which must accompany each pack of a medicine.

2. Registration approval is based on these claims after MCC evaluation of the scientific and clinical data provided to support the claims. In addition, a Patient Information Leaflet to be made available to the patient taking the medicine, must also be compiled by the company and approved by the MCC.

3. Specifications and quality control procedures for all raw materials and packing materials, as well as the final dosage form in its final sales pack. These must be described in detail with exact specifications and control procedures described.

4. Manufacturing processes and in-process quality controls.

5. A validation program to ensure that all components and processes produce products of a consistent quality every time. This includes a stability testing program top ensure that the product retains all its quality parameters for the full shelf life of the product.

6. A Site Master File with specified details of the actual factory where the medicine is made.

7. For innovative medicines, details of the results of all pharmaceutical (laboratory), animal and human testing must be supplied. These include data generated throughout the product development from


the initial tests done to determine the absorption, distribution, metabolism and excretion of the drug in animals and healthy human volunteers (pharmacodynamic data) to the results obtained in clinical trials in sick patients.

8. The studies may be done in South Africa or in other countries but the data must be evaluated and approved by the MCC for registration of the medicine to be granted.

9. For generic medicines, the applicant must provide proof that the product has a comparable therapeutic effect to that of the originator’s product. This can be done by conducting comparative clinical trials, or by providing proof of bioequivalence or in some cases by laboratory testing.

10. All advertising must be based on the approved claims for the medicine i.e., those which appear on the approved package insert. Advertising does not require prior approval by the MCC but the MCC Inspectorate does deal with any infringement as a contravention of the regulations.

11. Generally the industry controls infringement of advertising and promotional practices by self-regulation e.g. PIASA has a Code of Practice for the Marketing of Medicines to healthcare professionals. This is aligned with the IFPMA Code of Practice and the Perverse Incentives Policy applicable to South African Healthcare professionals.

12. The manufacturing facility where a medicine is made, tested and packed is subject to inspections and approval by the MCC which may also test specific products and audit the product dossiers to ensure that these have been kept updated.

• JapanGeneric drug is defined as a drug with the same active pharmaceutical

ingredient (API), dosage form, strength, quality, indication, effect, direction, and dose as the original proprietary drug. In Japan, the drug product containing an API that has the different hydrate form or crystalline form from the original drug can essentially apply for as a generic drug, because they have basically the same chemical structure.

The drug product containing an API that has different salts, esters, and ethers from the original drug can apply for as a new drug, not a generic drug. The original drugs are given the re-examination period of 8 years at the time of approval.


The applicant can apply for the generic drugs after the re-examination period of original drugs. Because generic drugs are approved after the patent expiration of the original drugs and a re-examination period in Japan, the generic drugs have a reduced development cost, as compared to the original drugs. Therefore, the generic drug price is cheaper than the original drug. For example, in Japan, the price of a generic drug is usually 60 percent of the original drug price. Recently, demand has increased for reduced medical expenses in many countries including Japan, the USA, and Europe. Over 20 percent of Japan’s population is over the age of 65 years, and it is estimated that it will reach nearly 40 per cent by 2050. This is a key factor for healthcare cost expansion in Japan.

The Ministry of Health, Labour, and Welfare (MHLW) proposed the use of generic drugs to reduce healthcare costs in 2007. In particular, the generic drug market share in Japan was lower than in other developed countries, as the market share of generic drugs in Japan was 18.7 percent in 2007. In contrast, the market share of generic drugs was 72 percent in the USA, 65 percent in England, and 63 percent in Germany. One of the reasons for the low generic drug market share in Japan is that there was no substitution right for the pharmacists. The physicians had the decision right of the generic drug substitution before 2006.

In 2006, one important change of public health insurance was that the pharmacists were given right to substitute generic drugs for original drugs if the physicians explicitly allow substitution on their prescription format. The prescription format before 2008 was the format that the pharmacists could not change to generic drugs unless the physicians signed in the “substitution” space on the prescription. The change of the prescription format was carried out in 2008, and it was changed to “No substitutions“ from “substitutions.” If there is no checkmark in the “No substitutions” space on the prescription, the pharmacists were given right to substitute to generic drugs. In this prescription format, a space was provided for “a signature in case all prescription drugs cannot be changed to generic drugs.” With the signature of physicians, all prescription drugs could not be substituted.

In 2012, the prescription format was modified to one that allowed generic substitution for individual drug, making it easier to substitute to generic drugs. Many actions including the prescription format change are carried out in Japan to promote the generic drugs usage. Additionally, in 2013, the MHLW announced a 5-year plan to expand the use of generic drugs to over 60 percent by 2018. In order to promote the use of generic drugs, accelerated approval review for generic drugs is indispensable.


The Office of Generic Drugs, part of the Pharmaceuticals and Medical Devices Agency (PMDA), is responsible for the approval review of generic drugs in Japan.The PMDA reviews the equivalence of generic and original drugs from the viewpoint of quality, efficacy, and safety, based on a document submitted by generic drug applicants.

Recent consultations have evaluated generic drug development for dry powdered inhaler drug products. In Europe and the USA, guidelines for dry powder inhalers have already been published. Therefore, the Office of Generic Drugs of the PMDA is going to initiate studies to develop dry powder inhaled drug guidelines in the future.

GenericDrugApprovalinJapanThe Ministry for Health Labor and Welfare (MHLW) is the

regulatory body in Japan responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in Japan and makes the decision on approval of drugs.

Since 1 April 2007, all companies marketing originator drugs in Japan must perform post marketing surveys on new drugs so that efficacy and safety can be reconfirmed by re-examination by the MHLW for a specified period of eight years. Applications for generic drugs cannot be filed until completion of the re-examination and expiration of patents— which last for 20 years in Japan. Brand-name products are protected from generics during this period. Equivalency of generic drugs—that are supposed to be equivalent to new drugs—are examined by the MHLW through its Pharmaceutical and Medical Devices Agency based on the drug organization’s research on equivalency to already approved items. The Japanese government has set a target to raise the share of generic medicines by volume to 30 percent or more by 2012.

The MHLW established the ‘Action Programs for Promoting Safe Use of Generic Medicine’ in October 2007 and efforts have been made in accordance with this programme to gain the trust of patients and medical professionals with regard to generic medicines. Marketing Approval: Formal approvals and licenses are required to marketing drugs in Japan, and formal approval and/or licenses must first be obtained from the Minister of the MHLW or prefectural governor.The approval and licensing system has been revised in the amended Law and manufacturing (Import) approval became marketing approval from April 2005. Product licenses have been abolished and GMP compliance for each product has been specified as an approval condition (Japan Pharmaceutical Manufacturers Association, 2007). Marketing


approval require a review to determine whether or not the product in the application is suitable as a drug to be marketed by a person who has obtained a marketing business license (marketing authorization holder) for the type of drug concerned and confirmation that the product has been manufactured in a plant compliant with GMP (Japan Pharmaceutical Manufacturers Association, 2007).

The PMDA covers the entire range of work from clinical trial consultations to reviews. Application forms for approval to market drugs are usually submitted to the PMDA. When application forms for new drugs are received by the PMDA (KIKO), a compliance review of the application data (certification from source data), GCP on-site inspection, and detailed review report (Japan Pharmaceutical Manufacturers Association,2007). The approval review process consists of expert meeting of review team members and experts to discuss important problems. A general review conference attended by team members, experts and representatives of the applicant is held after the expert meeting.

The evaluation process followed by the PMDA is as follows :1. Interview (presentation, inquires and replies)2. Team review 3. Inquiries and replies 4. Review report 5. Expert meeting (include at least three clinical specialists as

experts) 6. General review conference (main agenda items and names of

participating experts made available 2 weeks prior to meeting; presentation)

7. Follow up expert meeting 8. Review report 9. Report to the evaluation and licensing division. Across most regional pharmaceutical markets, generics are

emerging as strong challengers to branded medications. The demand of generic drugs is also set to increase following the imminent loss of patent protection for several blockbuster drugs.

Japan is a large market but it is one of less penetrable market. Japan and India also has its own guidelines for approval of generic drugs. Indian generic players are seen as a major threat by European generic companies.


GENERICDRUGS—INDIAPOLICY

PharmaceuticalIndustryinIndia—TradeAnalyticsThe generics market stood at US$ 26.1 billion in 2016. India’s

generics market has immense potential for growth. Indian pharmaceutical companies received record 300 generic drug approvals in USA during 2017 where the generic market is expected to reach US$ 88 billion by 2021. India became the third largest global generic API merchant market in 2016, with a 7.2 per cent market share. With 70 per cent of market share (in terms of revenues), generic drugs form the largest segment of the Indian pharmaceutical sector. India supplies 20 per cent of global generic medicines market exports, in terms of volume, making the country the largest provider of generic medicines globally and expected to expand even further in coming years. Over the Counter (OTC) medicines and patented drugs constitute 21 per cent and 9 per cent, respectively, of total market revenues of US$ 20 billion.8 Indian pharma drug manufacturer Aurobindo Pharma has received the USFDA approval to manufacture oral suspension, which is used for controlling serum phosphorus in patients with chronic kidney disease on dialysis. This drug is a therapeutic equivalent generic version of Genzyme's Renvela oral suspension.

The share of generic drugs is expected to continue increasing; domestic generic drug market is expected to reach US$ 27.9 billion in 2020. Due to their competence in generic drugs, growth in this market offers a great opportunity for Indian firms. Generic drug market is expected to grow in the next few years, with many drugs going off-patent in the US and other countries. Domestic generic drug market has reached US$ 26.1 billion in 2016. India’s pharmaceutical export market is thriving due to strong presence in the generics space. Pharmaceuticals exports from India stood at US$ 16.84 billion in FY 2016-17.

The Indian pharmaceuticals market witnessed growth at a CAGR of 5.64 per cent, during FY11-16, with the market increasing from US$ 20.95 billion in FY11 to US$ 27.57 billion in FY16. The industry’s revenues are estimated to have grown by 7.4 per cent in FY17.Indian pharmaceutical market grew 5.5 per cent in CY2017 in terms of moving annual turnover. In March 2018, the market grew at 9.5 per cent year-on-year with sales of Rs 10,029 crore (US$ 1.56 billion).By 2020, India is likely to be among the top three pharmaceutical markets by incremental growth and 6th largest market globally in absolute size.9

Increase in the size of middle class households coupled with the


improvement in medical infrastructure and increase in the penetration of health insurance in the country will also influence in the growth of pharmaceuticals sector. Indian pharmaceutical sector is estimated to account for 3.1-3.6 per cent of the global pharmaceutical industry in value terms and 10 per cent in volume terms. It is expected to grow to US$100 billion by 2025. The market is expected to grow to US$ 55 billion by 2020, thereby emerging as the sixth largest pharmaceutical market globally by absolute size. Branded generics dominate the pharmaceuticals market, constituting nearly 80 per cent of the market share (in terms of revenues). The sector is expected to generate 58,000 additional job opportunities by the year 2025.

India’s pharmaceutical exports stood at US$ 16.8 billion in 2016-17 and are expected to grow by 30 per cent over the next three years to reach US$ 20 billion by 2020, according to the Pharmaceuticals Export Promotion Council of India (PHARMEXCIL).Export of pharmaceutical items reached Rs. 696.84 billion (US$ 10.76 billion) during April 2017 – January 2018.

Indian companies received 304 Abbreviated New Drug Application (ANDA) approvals from the US Food and Drug Administration (USFDA) in 2017. The country accounts for around 30 per cent (by volume) and about 10 per cent (value) in the US$ 70-80 billion US generics market.

India's biotechnology industry comprising bio-pharmaceuticals, bio-services, bio-agriculture, bio-industry and bioinformatics is expected grow at an average growth rate of around 30 per cent a year and reach US$ 100 billion by 2025. Biopharma, comprising vaccines, therapeutics and diagnostics, is the largest sub-sector contributing nearly 62 per cent of the total revenues at Rs 12,600 crore (US$ 1.89 billion).10 The pharmaceutical industry in India ranks 3rd in the world terms of volume and 14th in terms of value. India is the largest provider of generic drugs globally with the Indian generics accounting for 20 per cent of global exports in terms of volume. Of late, consolidation has become an important characteristic of the Indian pharmaceutical market as the industry is highly fragmented.11

India enjoys an important position in the global pharmaceuticals sector. The country also has a large pool of scientists and engineers who have the potential to steer the industry ahead to an even higher level. Presently over 80 per cent of the antiretroviral drugs used globally to combat AIDS (Acquired Immuno Deficiency Syndrome) are supplied by Indian pharmaceutical firms.

The UN-backed Medicines Patent Pool has signed six sub-


licences with Aurobindo, Cipla, Desano, Emcure, Hetero Labs and Laurus Labs, allowing them to make generic anti-AIDS medicine TenofovirAlafenamide (TAF) for 112 developing countries.

The government started to encourage the growth of drug manufacturing by Indian companies in the early 1960s, and with the Patents Act in 1970. However, economic liberalization in 90s enabled the industry to become what it is today. The patent act removed composition patents from food and drugs, and though it kept process patents, these were shortened to a period of five to seven years.

The lack of patent protection made the Indian market undesirable to the multinational companies that had dominated the market. Whilst the multinationals streamed out, Indian companies carved a niche in both the Indian and world markets with their expertise in reverse-engineering new processes for manufacturing drugs at low costs. Although some of the larger companies have taken baby steps towards drug innovation, the industry as a whole has been following this business model until the present.

The number of purely Indian pharma companies is fairly low. Indian pharma industry is mainly operated as well as controlled by dominant foreign companies having subsidiaries in India due to availability of cheap labor in India at low cost. In 2002, over 20,000 registered drug manufacturers in India sold $9 billion worth of formulations and bulk drugs. 85 percent of these formulations were sold in India while over 60 percent of the bulk drugs were exported, mostly to the United States and Russia. Most of the players in the market are small-to-medium enterprises; 250 of the largest companies control 70 percent of the Indian market.12

Thanks to the 1970 Patent Act, multinationals represent only 35 percent of the market, down from 70 percent thirty years ago.Most pharma companies operating in India, even the multinationals, employ Indians almost exclusively from the lowest ranks to high level management.Homegrown pharmaceuticals, like many other businesses in India, are often a mix of public and private enterprise.

In terms of the global market, India currently holds a modest 3.1-3.6 percent share, but it has been growing at approximately 10 percent per year. India gained its foothold on the global scene with its innovatively engineered generic drugs and active pharmaceutical ingredients (API), and it is now seeking to become a major player in outsourced clinical research as well as contract manufacturing and research.


There are 74 US FDA-approved manufacturing facilities in India, more than in any other country outside the U.S, and the United States Food and Drug Administration (USFDA) approved more Abbreviated New Drug Application (ANDA) in 2017 than any other year, according to its latest FY 2017 activities report.

An ANDA contains data which is submitted to FDA for the review and potential approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, lower cost alternative to the brand-name drug it references. A generic drug product is one that is comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics, and intended use.

The USFDA approved total 847 ANDA during 2017 which is the highest number of ANDA approvals during the last decade. Indian Pharmaceutical companies along with their combined global subsidiaries have received a totalof 314 final ANDA amounting to 37 percent of total approvals from the USFDA in the year 2017.13

Some of the initiatives taken by the government to promote the pharmaceutical sector in India are as follows:

• In March 2018, the Drug Controller General of India (DCGI) announced its plans to start a single-window facility to provide consents, approvals and other information. The move is aimed at giving a push to the Make in India initiative.

• The Government of India is planning to set up an electronic platform to regulate online pharmacies under a new policy, in order to stop any misuse due to easy availability.

• The Government of India unveiled 'Pharma Vision 2020' aimed at making India a global leader in end-to-end drug manufacture. Approval time for new facilities has been reduced to boost investments.

• The government introduced mechanisms such as the Drug Price Control Order and the National Pharmaceutical Pricing Authority to deal with the issue of affordability and availability of medicines.

PatentsA significant change in intellectual property protection in India

was the 1 January 2005 enactment of an amendment to India’s patent law that reinstated product patents for the first time since 1972. The


legislation took effect on the deadline set by the WTO’s Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, which mandated patent protection on both products and processes for a period of 20 years. Under this new law, India was forced to recognise not only new patents but also any patents filed after 1 January 1995. Indian companies achieved their status in the domestic market by breaking these product patents, and it is estimated that within the next few years, they will lose $650 million of the local generics market to patent-holders.

In the domestic market, this new patent legislation has resulted in fairly clear segmentation. The multinationals narrowed their focus onto high-end patents who make up only 12 percent of the market, taking advantage of their newly bestowed patent protection. Meanwhile, Indian firms have chosen to take their existing product portfolios and target semi-urban and rural populations.

AnanalysisofGenericMedicinesinIndiaGeneric medicines in India have received a new impetus with Prime

Minister Modi himself advocating the usage of these medicines. Doctors will now be required to prescribe generic formulations of medicines, as opposed to specific brands. The Prime Minister has announced that prescription of medicines by their generic names will be mandatory.This is expected to bring down drug prices and expand access to affordable health solutions. As per the latest National Sample Survey Office survey on healthcare, in 2014, medicines emerged as a principal component of total health expenses-72 percent in rural areas and 68 percent in urban areas. For a country with one of the highest per capita out-of-pocket expenditures on health, even a modest drop in drug prices will free hundreds of households from the widespread phenomenon of a medical poverty trap. In addition to the social benefits, the generics-only policy also makes economic sense. By promoting generic drug consumption, the government safeguards the health of its generic drug manufacturing industry-one of the largest suppliers of low-cost medicines in the world.


With increasing pressure from the “Big Pharma” companies in developed countries, Indian generic manufacturers must now operate under a markedly restrictive intellectual property rights (IPR) regime. The new policy can ensure that—at least in the Indian market—generic manufacturers retain an advantage. Big Pharma’s access to Indian consumers will have to be routed through generic companies using channels such as voluntary licensing.Low-cost medicines, apart from their attribute as a commercial commodity, have far-reaching implications on public health and international human rights. India has unambiguously subscribed to the pro-public health argument, and has articulated its position several times at home and in international forums.

RegistrationThe regulation of manufacture, sale and distribution of drugs is

primarily the concern of state authorities while central authorities are responsible for approval of new drugs and clinical trials, laying down the standards for drugs, control over the quality of imported drugs, coordination of the activities of State Drug Control Organizations providing expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act.

Central Drugs Standard Control Organization (CDSCO) under Ministry of Health and Family Welfare is the pivotal agency dealing with all drug related issues. This organization deals with all new drug approvals, review of new safety information regarding approved drugs, approval and safety review of fixed-dose combinations, medical devices, and implants. All endocrine and metabolic drugs are covered by these organizations and acts. Food supplements (including many herbal products) are regulated by separate laws since they are legally not considered drugs.

PricingandtaxpoliciesthroughDPCOandNPPAPrice control on medicines was first introduced in India in 1962

and has subsequently undergone evolution through the Drug Price Control Order (DPCO). As per the directive of NPPA, the criterion for price regulation is based on the nature of the drug in terms of whether it enjoys mass consumption and in terms of whether there is lack of adequate competition for the drug.

In 1978 selective price controls based on disease burden and prevalence was brought about by the Government. Thereafter, the list of


prices under DPCO underwent a gradual decrease over a period of time. Around 80% of the market, with 342 drugs, was under price control in 1979. The number of drugs under DPCO decreased from 142 drugs in 1987 to 74 in 1995.

The major objective of DPCO 1995 was to decrease monopoly in any given market segment, further decrease the number of drugs under price control to 74 and the inclusion of products manufactured by small scale producers under price control list.14

In 1997, the National Pharmaceutical Pricing Authority [NPPA] was constituted in order to administer DPCO and deal with issues related to price revision.The NPPA also regulates the prices of bulk drugs or pharmaceutical actives. The MRP excise on medicines was levied by the Finance ministry in 2005 with the objective of increasing revenue and lowering prices of medicines by using fiscal deterrent on MRP. This change may have had some impact in terms of magnifying the advantage to industries located in the excise free zones.

Drugs with high sales and a market share of more than 50 percent are part of the price regulation exercise. These drugs are referred to as scheduled drugs. Historically the NPPA would intervene only if the annual price increases were more than 20 percent. However, post-2007, the NPPA intervenes in cases where drugs have significant sales and where the annual price increases by 10 percent.

The National Pharmaceuticals Policy 2006, proposed various measures such as increasing the number of bulk drugs under regulation from 74 to 354, regulating trade margins and instituting a new framework for drug price negotiations so as to make drugs more affordable for the Indian masses, to name a few.

GoodManufacturingPracticesandPoliciesWorld Health Organization GMP guidelines were instituted in

1975 in order to assist regulatory authorities in different countries to ensure consistency in quality, safety and efficacy standards while importing and exporting drugs and related products. India is one of the signatories to the certification scheme. The WHO-GMP certification, which possesses two-year validity, may be granted both by CDSCO and state regulatory authorities after a thorough inspection of the manufacturing premises.

WHO defines Good manufacturing practice (GMP) as a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks


involved in any pharmaceutical production be it manufacturing, packaging, testing, labeling, distributing and importing, that cannot be eliminated through testing the final product – drug or device or any formulation. The GMP protocols are largely concerned with parameters such as drug quality, safety, efficacy and potency.

India has made progress in the domain of GMP through the enforcement of Schedule M Compliance. The requirements specified under the upgraded Schedule ‘M’ for GMP have become mandatory for pharmaceutical units in India from July 1, 2005. Schedule M classifies the various statutory requirements mandatory for drugs, medical devices and other categories of products as per the current Good Manufacturing Practices (cGMP). Schedule M contains various regulations for manufacturing, premises, waste disposal, and equipment.

Schedule M protocols have been revised to harmonize it along the lines of WHO and US-FDA protocols. These revised protocols include detailed specifications on infrastructure and premises, environmental safety and health measures, production and operation controls, quality control and assurance and stability and validation studies.

Schedule M compliance is the next thing, smaller pharmaceutical units may take longer to be compliant whereas large-scale firms have shown greater willingness to comply with the revised norms in order to increase their competitiveness in the global arena. According to state regulatory sources, units in states like Gujarat, Karnataka, Maharashtra and Andhra Pradesh have achieved a high percentage of Schedule M compliance in comparison to units in other states.

Export of drugs, devices, and formulations to developed countries from India requires that Regulators from these countries visit Indian manufacturers to carry out a thorough inspection of their manufacturing units before registering the concerned product.

A large number of domestic players are seeking international regulatory approvals from agencies like US-FDA, MHRA UK, TGA Australia and MCC South Africa in order to export their products, mostly generic medicines, in these markets. Indian drug makers have the largest number of FDA-approved plants outside the US and accounted for 39 per cent of all approvals for generic drugs during 2013.

The cost of production has been a leading source of India’s industry strength, as India is 60 percent cheaper than the U.S. and 50 percent cheaper than Europe in terms of drug production costs.


DRUGS REGULATION IN INDIA In India, the approval, production, and marketing of quality drugs

at reasonable prices is ensured by the following regulatory bodies:• TheCentralDrugStandardsandControlOrganization(CDSCO) CDSCO functions under the Ministry of Health and Family Welfare

prescribes standards and measures for ensuring the safety, efficacy, and quality of drugs, cosmetics, diagnostics and devices in the country; Regulates the market authorization of new drugs and clinical trials standards; Supervises drug imports and approves licenses to manufacture the above-mentioned products;

• TheNationalPharmaceuticalPricingAuthority(NPPA) The NPPA functions under the Department of Chemicals and

Petrochemicals fixes or revises the prices of decontrolled bulk drugs and formulations periodically updates the list under price control through inclusion and exclusion of drugs in line with prescribed guidelines priodically, maintains data on production, exports and imports and market share of pharmaceutical firms, monitors the shortage of medicines in addition to providing inputs to Parliament in issues pertaining to drug pricing.The Ministry of Health and Family Welfare examines pharmaceutical

issues within the larger context of public health while the focus of the Ministry of Chemicals and Fertilizers is on industrial policy.

A new department under Ministry of Chemicals and Fertilisers –gives greater focus and thrust on the development of Pharmaceutical Sector in India and regulate various complex issues related to pricing and availability of affordable medicines, research and development, protection of intellectual property rights and international commitments related to pharmaceutical sector which require integration of work with other ministries.

All the drugs and pharmaceuticals, unless specifically allotted to any other department, would come under the purview of the department of pharmaceuticals. The main functions and responsibilities of the department are as follows:• All matters relating to NPPA including its functions of price control

and monitoring.• Responsible for the drugs and pharmaceuticals, excluding those

specifically allotted to other departments, and for the development of infrastructure, manpower and skills for the pharmaceutical sector


• Work for the promotion and coordination of basic, applied and other research in areas related to the pharmaceutical sector and for international co-operation in pharmaceutical research.

• Entrusted with the task of maintaining inter-sectoral coordination between organizations and institutes, both under Central and State Governments, related to areas concerning the subject.

• To deal with all matters relating to planning, development, and control of, and assistance to, all industries in the pharmaceutical segment.

• Promotion of Public Private Partnership (PPP) in pharmaceutical related areas.

RolesofotherMinistriesintheRegulationProcessOther ministries that play a role in the regulation process are the

Ministry of Environment and Forests, Ministry of Finance, Ministry of Commerce and Industry and the Ministry of Science and Technology. The process for drug approval requires the coordination of different departments, in addition to the DCGI, depending on whether the application in question is a biological drug or one based on recombinant DNA technology.

The Department of Industrial Policy and Promotion and Directorate General of Foreign Trade, both under the aegis of Ministry of Commerce and Industry and the Ministry of Chemicals and Fertilizers, look into matters related to industrial policy such as the regulation of patents, drug exports, and government support to the industry.

Licensing, quality control issues, market authorization is regulated by the Central Drug Controller, Ministry of Health and Family Welfare, Department of Biotechnology, Ministry of Science and Technology (DST) and Department of Environment, Ministry of Environment and Forests.

State drug controllers have the authority to issue licenses for the manufacture of approved drugs and monitor quality control, along with the Central Drug Standards Control Organization (CDSCO)

The Department of Biotechnology (DBT) constituted under the Ministry of Science and Technology is the parent body for policy, promotion of R&D, international cooperation and manufacturing activities.

Together with DBT, Genetic Engineering and Approval Committee


(GEAC) constituted under Ministry of Environment and Forests (MoEF) is the key regulatory body in Biotechnology in India. Several committees have also been constituted under the said ministries to regulate the activities involving handling, manufacture, storage, testing, and release of genetic modified materials in India.

The Institutional Bio Safety Committee (IBSC), Review Committee on Genetic Manipulation (RCGM) and the Genetic Engineering Approval Committee (GEAC) to monitor rDNA research, product development and commercialization. The ISBC functions as the nodal point for interaction within the institution for the implementation of the rDNA Biosafety guidelines. The RCGM essentially monitors the safety related aspects of activities involving genetically engineering organisms or hazardous microorganisms.

The GEAC undertakes the responsibility of approval of activities involving large-scale use of genetically modified/hazardous microorganisms and products thereof in research and industrial production and their safety in terms of environmental protection. In addition, the DCGI and state drug controllers as per the Drugs and Cosmetics Act 1945 and its subsequent amendments regulate biologicals.

ACTS AND RULES

DrugsandCosmeticsActof1940andRules1945In India, drug manufacturing, quality and marketing is regulated in

accordance with the Drugs and Cosmetics Act of 1940 and Rules 1945. Over the last few decades, this act has undergone several amendments. The Drugs Controller General of India (DCGI), who heads the Central Drugs Standards Control Organization (CDSCO), assumes responsibility for the amendments to the Acts and Rules. Other major related Acts and Rules include,

• The Pharmacy Act of 1948, • The Drugs and Magic Remedies Act of 1954The Drug Prices Control Order (DPCO) 1995 and various other

policies instituted by the Department of Chemicals and Petrochemicals.Some of the important schedules of the Drugs and Cosmetic Acts

include:ScheduleD:dealing with exemption in drug imports,ScheduleM: to control spurious drugs, incorporated in 1995 that


lays down Good Manufacturing Practices(GMP) at par with WHO standards.involving premises and plants

ScheduleY: which, specifies guidelines for clinical trials, import and manufacture of new drugs

In accordance with the Act of 1940, there exists a system of dual regulatory control or control at both Central and State government levels. The Central Regulatory Authority undertakes approval of new drugs, clinical trials, standards setting, control over imported drugs and coordination of state bodies’ activities. State authorities assume responsibility for issuing licenses and monitoring manufacture, distribution and sale of drugs and other related products.

NarcoticDrugsandPsychotropicSubstancesActThe Narcotic Drugs and Psychotropic Substances Bill, 1985 was

introduced in the Lok Sabha in August 1985 and subsequently passed by both the Houses of Parliament.It came into force on 14 November 1985 as The Narcotic Drugs And Psychotropic Substances Act, 1985 (shortened to NDPS Act). Under the NDPS Act, it is illegal for a person to produce/manufacture/cultivate, possess, sell, purchase, transport, store, and/or consume any narcotic drug or psychotropic substance. Under one of the provisions of the act, the Narcotics Control Bureau was set up with effect from March 1986. The Act is designed to fulfill India’s treaty obligations under the Single Convention on Narcotic Drugs, Convention on Psychotropic Substances, and United Nations Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances. The Act has been amended three times – in 1988, 2001, and most recently in 2014.

Preventionof IllicitTrafficking inNarcoticDrugsandPsychotropicSubstancesAct

The Prevention of Illicit Trafficking in Narcotic Drugs and Psychotropic Substances Act is a drug control law passed in 1988 by the Parliament of India. It was established to enable the full implementation and enforcement of the Narcotic Drugs and Psychotropic Substances Act of 1985.

The Narcotics Control Bureau (NCB) is the chief law enforcement and intelligence agency of India responsible for fighting drug trafficking and the abuse of illegal substances. It was created on 17 March 1986 to enable the full implementation of the Narcotic Drugs and Psychotropic Substances Act (1985) and fight its violation through the Prevention of


Illicit Trafficking in Narcotic Drugs and Psychotropic Substances Act (1988).

There exists a published list that mentions the names of all substances banned or controlled in India under the NDPS Act – 237 line items. The list uses the International Nonproprietary Name (INN) of the drugs but in some cases mentions drugs by their chemical name also widely known drugs such as ganja, cocaine, heroin etc. are mentioned as such. Cultivation/production/manufacture, possession, sale, purchase, transport, storage, consumption or distribution of any of the following substances, except for medical and scientific purposes and as per the rules or orders and conditions of licenses that may be issued, is illegal and a punishable offense.

ThePatentsActThe Patent Act of 1970 recognized only process patents. The life

of the patent was also reduced significantly from 16 to 5 years from the date of sealing or 7 years from the date of filling a complete application, whichever is shorter; in other words, the maximum period of patent was 7 years. Further, in the amended Act an MNC could patent only one process.

The Patent Act of 1970 and the changes in domestic regulation virtually curbed the monopoly of MNCs. Adopting the flexible provisions of the amended patent act, indigenous companies started imitating the patented product and could eventually come out with better processes for the same product.The industry also embarked on the path of high growth during this period. The other significant outcomes were fall in the prices of the medicines and the introduction of a large number of generic versions of patented products.

The drug policy of 1978 was, however, revised in 1986 to dilute the mechanism of check and control with respect to the production of certain categories of drugs. NDP 1986 also regularized the production of a large number of drugs that were earlier questionable on regulatory grounds.The Patent Law was amended under the WTO compulsion to recognize product patent from 2005 onward. This was implemented in a staggered manner in three phases. The first phase of it was implemented in 1995 in which the ‘mail-box’ system was recognized.

On January 1, 2000, a Second Amendment was introduced where the salient features were re-defined patentable subject matter, extended the term of patent protection to 20 years and amended the compulsory licensing system.A third amendment of patent law was made on


January 1, 2005 to introduce product patent regime in areas, including pharmaceuticals that were hitherto covered by process patents only.

GOVERNMENT INITIATIVESIndia is the world’s third-largest pharmaceutical market globally

in terms of volume. The country is the largest supplier of cost-effective generic medicines to the world, accounting for 20 percent of global exports.Focus on generic drugs, presence of local players and intense competition is what makes the Indian Pharmaceutical Industry significant. The country is the world’s third-largest pharmaceutical market globally in terms of volume and thirteenth-largest by value. The Indian pharmaceutical industry registered a growth of 15.1 percent from USD 27 billion in the Financial Year (FY) 2014-15 to USD 31 billion in FY 2015-16. Much of this growth was attributed to rapid increase in exports – the country is the largest supplier of cost-effective generic medicines to the world, accounting for 20 percent of global exports in terms of volume. With the government’s thrust towards manufacturing under the ‘Make in India’ initiative, the industry recorded a 9.7 percent increase in exports in FY 2015-16.15

The pharmaceutical sector16 was valued at US$ 33 billion in 2017. The country’s pharmaceutical industry is expected to expand at a CAGR of 22.4 per cent over 2015–20 to reach US$ 55 billion. India’s pharmaceutical exports stood at US$ 17.27 billion in 2017-18 and are expected to reach US$ 20 billion by 2020.

To realise the vision of making India the largest global provider of quality medicines and encourage innovation, the Department of Pharmaceuticals under the Ministry of Chemicals and Fertilizers launched the Cluster Development Programme for Pharma Sector (CDP-PS) in December 2015.

The demand for pharmaceutical products is predicted to rise to meet the needs of a growing population. According to the United Nations, India’s population is set to touch 1.45 billion by 2028, making it the world’s most populous nation. With socio-economic changes, the society is more prone to lifestyle-related ailments, including diabetes, obesity, stroke and cancer and this is where the Pharma sector steps in. Income levels are rising and so is public health-care spending and healthcare financing: all of which implies a high growth trajectory in the years to come.

One of the key strengths of the sector is its strong export potential, with Indian Pharma companies making their presence felt around the


world. The high demand for generic medicines in India is being fulfilled by the country’s strong drug manufacturing infrastructure. A range of factors including competitive land rates, skilled labour, low costs of resources like water and electricity have contributed to the low cost of production in India. Additionally, the industry’s focus on innovation, Research and Development (R & D) and product diversity makes it a leader among the league of developing countries. India’s biologics capabilities and its human capital is an asset for this knowledge-led industry.

The Union Budget 2017-18 shows an increase of 23 percent in the health expenditure that is likely to give further impetus to the pharma sector. The government, as part of the Budget, has proposed amendments to the Drugs and Cosmetics Rules to ensure availability of generic drugs at reasonable prices and promote the use of generic medicines.The government has also introduced a range of fiscal incentives to promote domestic manufacturing, including the reduction of inverted duty structure and basic customs duty.

Drug patenting is significant to spur growth in the pharmaceutical sector. The National Intellectual Property Rights (IPR) Policy launched by Department of Industrial Policy and Promotion (DIPP) in May 2016 lays down processes to expedite IPR filings that are critical for the success of the sector.

Providing essential drugs and medicines at cost-effective prices is the key focus of Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers. Under the National Pharmaceutical Pricing Policy (NPPP), the National Pharma Pricing Authority regulates the prices of essential drugs. The Authority also monitors the availability of drugs and identifies shortages, if any. As on December 15, 2016, ceiling price of 853 formulations are under price control. The fixation of ceiling prices on medicines has resulted in a total saving of USD 392 million since May 2014.

Various notable steps have been taken by the government in a bid to boost sector growth. Pharma Jan Samadhan, a customer grievances redressal system was launched to address consumer complaints, a mobile application - Pharma Sahi Daam that provides real-time information to consumers on prices of Scheduled/Non-scheduled medicines has also been introduced and the Pharma Data Bank, an integrated pharmaceutical database management system was launched to facilitate online filling of mandatory returns as prescribed for Drugs.


To ease the process of doing business, the government introduced initiatives including Pharma Jan Samadhan, a customer grievances redressal system and Pharma Sahi Daam, a mobile application provides real-time information to consumers on prices of Scheduled/Non-Scheduled medicines, among others.

Healthcare is the fifth-largest employer among all sectors (both in terms of direct and indirect employment). Given the significance of highly educated and specialized scientists in the sector, skill development is a massive requirement. The National Institute of Pharmaceutical Education and Research (NIPER) imparts quality education in the areas of pharmaceutical sciences. 11 NIPERs were approved till 2015, while 3 new NIPERs at Chhattisgarh, Maharashtra and Rajasthan were announced in 2016.

Superior quality and technology coupled with an enormous variety of medicines ensure that India continues to be one of the most lucrative pharma markets in the world. The rapidly growing Indian pharmaceutical industry is predicted to become the sixth-largest market globally by 2020, with its value reaching USD 55 billion by absolute size.17

According to India Brand Equity Foundation, the Indian pharmaceutical market is likely to grow at a compound annual growth rate (CAGR) of 14-17 per cent in between 2012-16. India is now among the top five pharmaceutical emerging markets of the world.

The Government of India has unveiled 'Pharma Vision 2020' aimed at making India a global leader in end-to-end drug manufacture. It has reduced approval time for new facilities to boost investments. Further, the government has also put in place mechanisms such as the Drug Price Control Order and the National Pharmaceutical Pricing Authority to address the issue of affordability and availability of medicines.

Some of the major initiatives taken by the government to promote the pharmaceutical sector in India are as follows:

• The State government like; Andhra Pradesh will provide necessary infrastructure, incentives and skill up-gradation facilities for the pharmaceutical industry. A similar push has been initiated in states of Karnataka and Gujarat.

• The Government of India and the pharmaceutical industry will jointly float a trust to promote the brand image of Indian pharmaceutical globally and fight malicious campaigns.

• India plans to set up industrial parks in the pharmaceutical and


information technology (IT) sectors in China to strengthen India-China trade and investment ties.

• The National Health Protection Scheme is largest government funded healthcare programme in the world, which is expected to benefit 100 million poor families in the country by providing a cover of up to Rs 5 lakh (US$ 7,723.2) per family per year for secondary and tertiary care hospitalisation. The programme was announced in Union Budget 2018-19.

• In March 2018, the Drug Controller General of India (DCGI) announced its plans to start a single-window facility to provide consents, approvals and other information. The move is aimed at giving a push to the Make in India initiative.

• The Government of India is planning to set up an electronic platform to regulate online pharmacies under a new policy, in order to stop any misuse due to easy availability.

• The Government of India unveiled 'Pharma Vision 2020' aimed at making India a global leader in end-to-end drug manufacture. Approval time for new facilities has been reduced to boost investments.

• The government introduced mechanisms such as the Drug Price Control Order and the National Pharmaceutical Pricing Authority to deal with the issue of affordability and availability of medicines.

CHALLENGESThe lack of patent protection made the Indian market undesirable to

the multinational companies that had dominated the market. The Indian companies carved a niche in both the domestic arena and world markets with their expertise in reverse-engineering, new processes, technologies of drug formulations. The critical was manufacturing and supplying affordable drugs at low costs. Though some of the larger Indian players have taken baby steps towards drug innovation, the industry as a whole has been following the above stated business model till date.

India's bio-pharmaceutical industry clocked a 17 percent growth with revenues of ($3 billion) in the 2009–10 financial year over the previous fiscal. Bio-pharma was the biggest contributor generating 60 percent of the industry's growth at Re. 88.29 billion, followed by bio-services at Re. 26.39 billion and bio-agri at Re. 19.36 billion.

In 2013, there were over 4,655 pharmaceutical manufacturing plants all over the country.18


The pharmaceutical industry is one of the highly regulated industries, with many rules and regulations enforced by the government to protect the health and well-being of the public. Therefore, the aim of the pharmaceutical industry is to identify and develop a generic drug product which can be tailor made to meet the diverse market requirements. As per global market trend, it is estimated that approximately $150 billion worth of drugs will be offpatented during the period 2010 to 2017, which will serve as a platform for pharmaceutical companies to develop generic drugs. The pharmaceutical industry in India has shown a remarkable growth which in turn has risen the economy of India. After the introduction of the product patent regime in India, there was a need for pharmaceutical companies both in India and abroad to explore newer markets. Indian pharma majors are entering new markets with global ambitions, mergers and acquisitions. For sustained growth over the next few decades, firms have to concentrate on generic drug products.

However, there are three fundamental areas of concern:

• The first relates to the efficacy of Indian-made drugs. Oftentimes, such drugs have been found to contain less than the required amount of active pharmaceutical ingredient (API), rendering them ineffective.

• Closely linked to the issue of efficacy is the lack of data integrity. The poorly managed documentation practices of Indian generic firms featured as the primary criticism flagged by foreign regulatory authorities. The lack of reliable and complete data on the test results of specific drug batches, along with inconsistencies in the records presented, meant that inspection and verification of drug quality was extremely difficult.

• Another aspect relates to the hygiene standards of the manufacturing plants. Individuals suffering from illness are especially susceptible to infections, and inspections of generic drug plants reveal pest infestations and dilapidated infrastructure.

• Lower awareness and corruption have given rise nexus between Doctors chemists and pharma sector. So, public awareness via digital media along surveillance mechanism to curb nexus

• International pressure: Big western pharmaceutical lobbies may back stringent IPR rigme and compulsory licensing. They may blame India to breach TRIPS agreement and drag into WTO. But recent UN report has given precedence to human rights over patent


rights which support India's move for affordable generic price to improve health care

• Supply side challenge: India is import driven country for active pharmaceutical ingredient and already facing challenge of substandard quality of generic drugs. Along with this current move may reduce FDI inflow in pharm sector and slowdown research & development in domestic pharma companies. However, India has taken steps like ‘India Pharma & India Medical Device 2017’ and new IPR policy that offer incentive & ease of doing business in India. India should adopt stricter accreditation and inspection rules for generic drugs.

• At least 90 percent of the Indian domestic pharmaceutical market, of `1,00,000 crore and more, comprises drugs sold under brand names. There simply are not enough generic name equivalents of branded medicines sold.

• About half the market-`50,000 crore and more-is for fixed-dose combinations (FDCs) of drugs, a further half of them irrational.

• Many FDC drugs contain even eight or nine medicines. To write, and remember, the constituents of FDC drugs in generic names is impractical, considering that there would be thousands of FDC brands.

• A combination drug is a fixed-dose combination (FDC) that includes two or more active pharmaceutical ingredients (APIs) combined in a single dosage form, which is manufactured and distributed in fixed doses.

• Even if the doctor manages to write a prescription in generic names for single-ingredient drugs, pharmacists will sell the brand that maximises their commission and will in all likelihood not stock the less costlier but equivalent brand or generic medicine that is as good. This defeats the basic intention of making medicines affordable for consumers.

• Prescription by generic names merely shifts the focus of the pharmaceutical industry’s unethical drug promotion to the pharmacist; away from the prescriber, and resulting in business as usual.

• Medicines will continue to account for anything from 50 percent to 80 percent of treatment costs.


Stepstakeninthisregard• The Government of India has championed setting up Jan Aushadhis,

which are pharmacies selling only generic name medicines to the extent possible, giving preference to pharmaceutical public sector undertakings (PSUs) too.

• There are not enough Jan Aushadhis, possibly less than 3,000 against the more than eight lakh retail pharmacies in existence, with many rural areas still underserved.

• To facilitate Jan Aushadhis, the Drugs Technical Advisory Board (DTAB) in May 2016 considered amending Rule 65 (11A) of the Drugs and Cosmetics Act, 1940 so that pharmacists can dispense generic name medicines and/or equivalent brands against prescriptions in brand names.

• The DTAB rejected the idea citing that the bioavailability of a generic drug may not be as good as that of the prescribed brand.

• Bioavailability is a measurement of the extent of a therapeutically active medicine that reaches the systemic circulation and is therefore available at the site of action; whereas bioequivalence is the comparison of the bioavailability of two medicines, say the generic drug and the branded drug.

• This means that the government’s top decision-making body on medicine-related matters does not have confidence in the products manufactured by the government’s own PSUs.

• The DTAB, however, could have recommended bio waivers on bioavailability/bioequivalence (BA/BE) for certain classes of drugs based on their permeability and solubility, a practice followed in countries where healthcare is well regulated.

• BA/BE studies are essential for certain critical dose drugs and drugs of narrow therapeutic range, which are few in number.

• By implication, the DTAB has doubts that generic name medicines in general can have acceptable BA/BE at all. Probably, the DTAB is not confident that India’s regulatory agencies can strictly enforce quality requirements.

INDIA - ADVANTAGEIndia's drugs and pharmaceuticals industry is expected to grow

at a compound annual growth rate (CAGR) of 14 per cent to reach a turnover of (US$ 47.06 billion) by 2018. The domestic drugs industry,


which is valued at (US$ 25.87 billion) at present, according to Care Ratings, is also expected to grow in the local market with aggressive rural penetration by drug makers, increased government spending on health, Urbanization and growing health awareness among people.

India exports pharmaceutical products to more than 200 countries. Pharmaceutical exports are expected to cross the Rs 1 trillion (US$ 16.17 billion) mark this year. The share of formulations was 71 per cent and growing in percentage terms on annual basis.19

India currently exports drug intermediates, Active Pharmaceutical Ingredients (APIs), Finished Dosage Formulations (FDFs), bio-pharmaceuticals, CRAM and Clinical services across the globe. According to PricewaterhouseCoopers (PwC) in 2010, India joined among the league of top 10 global pharmaceuticals markets in terms of sales by 2020 with value reaching US$50 billion.

CompulsoryLicensingProvisioninIndiaThe compulsory licensing provision is permitted in the TRIPS

(Trade-Related Aspects of Intellectual Property Rights) agreement under Article 31. The agreement does not limit the grounds upon which compulsory license may be granted and only sets forth the conditions to be applied in the case of granting. This includes specification of grounds of compulsory licensing and reasonable rate of licensing fees to the patent holder. Grant of compulsory license (CL) is for the remaining term of the patent unless a shorter period looks reasonable and required in case to the controller. Further, it is to be noted that while granting the license the controller shall take into account the nature of invention, time elapsed, ability of applicant, his efforts for obtaining a license on reasonable terms. While granting CL reasonable royalty is also paid to the patentee, having regard to nature of invention, its utility, expenses incurred in maintaining patent grant in India and other factors.

PoliciesRelatingtoClinicalTrialsTill about a decade ago, there was little or no visibility with regard

to the conduct of quality clinical trials in India-compliant to regulatory standards and ethics. The Central Drugs Standards Control Organization (CDSCO) has played a critical role in bringing about a positive change in the clinical trials landscape for India.The progression towards Good Clinical Practice (GCP) has largely been a gradual and slow process.• In 1988 local clinical trials for new drug introductions were first

made mandatory in India. Along with the changeover to product


patents in January 2005, India also amended the schedule Y of the ‘‘Drugs and Cosmetics Rules’’ to allow drug trials without a phase lag in the country, that is, Phase II and Phase III trials were permitted only after these had been carried out elsewhere in the world.

• The new rule permitted conducting the concurrent trials of the same phase in India. Also Drugs Technical Advisory Board (DTAB) made GLP practices mandatory for all laboratories and in-house units of pharmaceutical firms and Contract Research Organizations (CROs).

• Reports of incidents of ethical violations related to informed consent and conduct of trials by multinational and domestic organizations were known prior to the year 2000. In 2000, the regulators – the Central Ethics Committee on Human Research (CECHR) and Indian Council of Medical Research (ICMR) took proactive initiative to conceptualize and issue the Ethical Guidelines for Biomedical Research on Human Subjects.

• The Good Clinical Practice (GCP) guidelines were developed in line with the latest WHO and ICH guidelines in 2001 by Central Expert Committee -set up for the purpose by Central Drugs Standards Control Organization (CDSCO)

• Subsequently in 2005, the requirements of data submission on animal testing for permission to undertake Phase I, Phase II and Phase III clinical trials were laid down in the revised Schedule Y of the Drugs and Cosmetics rules.

• Clear responsibilities for investigators; and sponsors were specified and notifying changes in the protocol were made mandatory. Expert clinicians and scientists from the industry assist the evaluation of the relevant data submitted to the Drugs Control General of India (DCGI)

• Similarly, for registration and approval of new drugs, which have already been registered and used in the country of origin, The DCGI mandates Phase II trials in about 100 prior to allowing such products to be marketed in India. Normally, new drug approval is usually granted for a period of about two years. The trials are conducted only after clearances are obtained from the Institutional Ethics Committees. Consent of patients for participation in such trials is an integral part of the regulatory framework.

However, there remains a need for the establishment of


pharmacovigilance centers at national, zonal and regional levels to monitor adverse drug reactions to be met.Recognizing the potential for growth, the Government of India

took up the initiative of developing the Indian Pharmaceuticals sector by creating a separate Department in July 2008. The Department is entrusted with the responsibility of policy, pIanning, development and regulation of Pharmaceutical Industries. An assessment of the Indian Pharmaceutical Industry's strength reveals the following key features:

StrongExportMarket India exported drugs worth US$ 15 billion to more than 200

countries including highly regulated markets in the US, Europe, Japan and Australia. Large Indian pharma companies have emerged as among the most competitive in the evolving generic space in North America and have created an unmatched platform in this space. Indian companies are also making their presence felt in the emerging markets around the world, particularly with a strong portfolio in anti-infective and antiretroviral.• Large domestic pharma companies have continued to grow, assuming

leadership position in many therapies and segments in the Indian market as well as creating a strong international exports back-bone.

• Competitive market with the emergence of a number of second-tier Indian companies with new and innovative business modules.

• Indian players have also developed expertise in significant biologics capabilities.

• Biologic portfolios while still nascent in India are being built with an eye on the future.

• Multinational companies have continued to invest significantly in India and are making their presence felt across most segments of the Indian pharma market. Companies have also begun to invest in increasing their presence in tier II cities and rural areas and making medical care more accessible to a large section of the Indian population.

• Low cost of production.• Low R&D costs.• Innovative Scientific manpower.• Excellent and world-class national laboratories specializing in

process development and development of cost-effective technologies.


• Increasing balance of trade in Pharma sector.• An efficient and cost effective source for procuring generic drugs,

especially the drugs going off patent in the next few years.• An excellent center for clinical trials in view of the diversity in

population.

ExperienceandExpertiseIndia is the only country with largest number of US-FDA compliant

plants (more than 262 including APIs) outside of USA. Nearly 1400 WHO-GMP approved Pharma Plants, 253 European Directorate of Quality Medicines (EDQM) approved plants with modern state of the art Technology are in place in India.

Thus Indian pharma companies have a wide variety of experience in manufacturing as per global standards. Through intensive competition in the Indian market, Indian companies are experienced in the manufacturing of a variety of formulations that makes them efficient and competitive in their operations.

The Indian pharma market is mature with decades of experience in generics manufacturing, catering to the needs of the general population. These companies have the experience and know-how to produce quality drugs in an efficient, high-quality and cost-effective manner without compromising on any aspect. There are many companies manufacturing drugs for oncology, AIDS and other complex therapies.

LowCostofManufactureIndia is capable of manufacturing low-cost generic alternatives

due to a number of economic factors favoring the industry. Some of these include the competitive land rates, the cheap labor available, low resource costs like water, electricity etc., lower cost of production machinery. Importantly, the various drugs like, Intermediates, APIs and Formulation companies are seamlessly integrated while following international regulations of safety.

ResearchandDevelopmentThe Government has taken several policy initiatives for

strengthening Research & Development in Pharmaceuticals sector such as fiscal incentives to R&D units sector and streamlining of procedures concerning development of new drug molecules, clinical research and new drug delivery systems leading to new R&D set-ups with excellent infrastructure in the field of original drug discovery. India has a large


branded generics market which enables most companies to launch their version of a generic drug in the market place. Research and Development is an important aspect for development of generics that match the quality and cost targets.

India is now increasingly recognized as a strategic partner in the drug discovery value chain. Further, there are Indian companies which are investing in their R&D centers and are offering early stage discovery services as well as promising molecules. A large scientific pool in India is dedicated to Research and Development of patent non-infringing methodologies for drugs.

HighlyEducated,SpecializedScientists

India's rich human capital is the strongest asset for the Indian Pharmaceuticals Industry which is a knowledge-led industry. Various studies show that the scientific talent pool of Indians is the second largest English-speaking group worldwide, after the US. This enables easier access to qualifications that handle the basic work in a plant or an R&D set-up in India. National Institute of Pharmaceutical Education and Research (NIPER) at Mohali is a premier institute in the field of Pharmaceuticals. The Institute is a member of Association of Commonwealth Universities. NIPER Mohali is offering Masters level programs and PhD programs in 15 streams. The laboratories here are fully equipped with modern facilities and the available facilities are of international level and standards. Further, six new National Institutes of Pharmaceutical Education and Research (NIPER) were opened in 2007. Recently, three new NIPERs have been proposed in the states of Maharashtra, Rajasthan and Chattisgarh.

ExperienceinInternationalServicing

Many of the Indian pharmaceutical companies are experienced in servicing top multinational companies for their highly regulated markets, meeting their stringent quality expectations. The same experience enables Indian organizations to cater to the needs of the regulatory authorities of most nations across the world. Further, technical consultancy capability of NIPERs is contributing to the growth of the industry. Indian clinical trials industry has developed a complete gamut of clinical research services capabilities of global standards. From medical writing to site management, data management, regulatory submissions to patient recruitment the expertise meets the highest standards of stringent regulatory conditions internationally.


There is an effective control system to monitor the quality of pharmaceuticals at all the levels in India. There are various agencies/ bodies under Ministry of Health and Family Welfare and Department of Pharmaceuticals. They are responsible for standard of drugs, market authorizations, import licenses, cGMP, monitoring of quality of drugs and cosmetics manufactured, pre and post licensing inspection, and price control etc. The recent initiatives through new legislations and optimized processes are targeted towards regulating the industry better and effectively.

Drugs have to comply with stringent quality provisions under the Drugs and Cosmetic Act of India. Any drug including API confirms to the specifications of the prescribed pharmacopeias or those claimed on the label ensuring that all the products manufactured in India are of highest quality. All the pharmaceutical products are inspected at the customs port of the country by competent authorities before they are shipped out.

GENERIC DRUGS-ADVANTAGES TO CONSUMERS-PUBLICAWARENESS

The availability and utilization of generic alternatives to brand-name drugs have had a significant effect on cost savings for health care consumers. In 2008, generic drugs accounted for more than 63 percent of total prescriptions filled in the United States. Although generics are used to fill the majority of prescriptions, the actual costs associated with these medications are less than 13 percent compared with their branded counterparts. While direct cost savings are a significant advantage for generic drug products, studies have also shown improvements in indirect costs such as therapy adherence and compliance.• Since the economic crisis of 2008, most developed nations have

taken several measures to push the prescription of generic drugs. In 2013, generics accounted for more than three-quarters of the volume of pharmaceuticals sold in the US, UK, Chile, Germany and New Zealand. Generics accounted for well over one quarter of the market in Italy , France and Japan. Prescribing in INN is permitted in two thirds of OECD countries and mandatory in France, Spain, Portugal and Estonia. Many developed countries have also fixed price caps for generic drugs, either by bulk procurement through tenders or by fixing it as a certain percentage of the brand-name's price.

• The issue in India is not about expensive brand name drugs versus


cheaper generics, as in the West, but one of quality drugs versus suspect quality drugs. Branded generics are also generics with a brand name, plus the quality assurance from well-known companies like Cipla, Sun or Dr Reddy’s. Doctors have come to trust these companies and their brands over time. Indian pharma’s field force numbering nearly one million medical representatives have done a good job of building this trust in their companies and brands. It is simply not possible for doctors to transfer this trust to generics, manufactured by unknown companies. The entire issue of cheaper generics is based on the premise of measurable and enforceable assurance about quality through bioequivalence tests and other globally mandated parameters.

In the absence of an international standard drug regulatory mechanism like the USFDA, Indian doctors have to rely on the reputation of companies like Cipla, Sun and hundreds of others who have demonstrated their commitment to quality over time and become trusted names in the eyes of doctors and patients.Also, Indian branded generic companies have been innovative in terms of drug delivery systems to improve absorption, reduce side-effects, thereby increasing the efficacy of the drug. These novel drug delivery system (NDDS) drugs are available in all category of drugs from ordinary mouth dissolving pain-killers for quick results to complex diabetes drugs that are released into the blood in a steady stream to ensure better blood-sugar control with lesser chances of hyperglycemia – one of the dangerous complications of taking diabetes medicines.

One way is to reduce illicit medical practices. The Medical Council of India has already given strict instructions to doctors to prescribe generic medicines. But very few private practitioners usually do this. So strict measures should be adopted so that the doctors are compelled to prescribe generic medicines.More steps are needed to be taken to strengthen the Jan Ausadhi scheme.

• Measures should also be taken to end the doctor-big pharma nexus.• The MCI needs to provide more practical guidelines.• Also the Government should take measures to increase awareness

of generic drugs to the general public.• The Jan Aushadhi stores that are available today are either run by

the hospital’s administration or some NGOs in the Government hospitals and public healthcare centres. Steps should be taken to


encourage more and more private companies or individuals to open generic drug stores.

• The Government should control the MRP of drugs, generic or branded, so that benefits reach the common man.

• The IMA should also take measures to ensure quality, safe, affordable generic drugs.

AVAILABILITYOFGENERICDRUGSININDIA

JanAushadhiScheme• The Government has launched ‘Jan Aushadhi Scheme’ to make

available quality generic medicines at affordable prices to all, especially the poor, throughout the country, through outlets known as Jan Aushadhi Stores (JASs).

• Under the Jan Aushadhi Scheme, the State Governments are required to provide space in Government Hospital premises or any other suitable locations for the running of the Jan Aushadhi Stores (JAS).

• Bureau of Pharma PSUs of India (BPPI) is to provide one-time assistance of Rs.2.50 lakhs as furnishing and establishment costs, start up cost for setting up a Jan Aushadhi Outlet.

• Any NGO/Charitable Society/Institution/Self Help Group with experience of minimum 3 years of successful operation in welfare activities, can also open the Jan Aushadhi store outside the hospital premises. A margin of 16 percent on the sale price is built in the MRP of each drug.

• In addition, the JAS are eligible for incentive linked to sale of medicines @ 10 percent of monthly sales amount, subject to a ceiling of Rs.10,000 pm for a period of first 12 months. In case of Stores opened in North Eastern States and other difficult areas i.e., Naxal affected areas/Tribal areas etc., the rate of incentive is 15 percent of monthly sale amount, subject to a ceiling of Rs.15,000 per month.

• At present more than 175 Jan Aushadhi Stores have been


opened across various States/UTs. JAS are opened on the locations as requested by the entity intending to open. The steps are also taken to open Jan Aushadhi stores in all AIIMS, prominent Hospitals, Medical Colleges under the Ministry of Health and Family Welfare.The Public Health Foundation of India (PHFI) was asked to study

the Scheme and suggest remedial measures. PHFI in their report pointed out the following factors which were mainly responsible for the scheme not being successful:

(i) Over dependence on support from State Government.(ii) Poor Supply Chain management.(iii) Non-prescription of Generic Medicines by the doctors.(iv) State Governments launching free supply of drugs.(v) Lack of awareness among the publicAfter the report, the government has taken several remedial

measures to remove the problems associated with the scheme. Various steps taken by the government are mentioned below:(a) Increasing the number of products from 361 to 504 medicines and

161 surgical and consumable items. Recently 88 more drugs are added to the basket.

(b) Improving the supply chain mechanism through appointing Distributors and C&F agents in different States.

(c) Increasing the number of functional stores.(d) Strengthening the Operating Agency i.e., BPPI through augmenting

of manpower.(e) Relaxation in the eligibility criteria of Operating Agency for JAS.

However, there are three fundamental areas of concern.• The first relates to the efficacy of Indian-made drugs. Many a

times, such drugs have been found to contain less than the required amount of active pharmaceutical ingredient (API), rendering them ineffective.

• Closely linked to the issue of efficacy is the lack of data integrity. The poorly managed documentation practices of Indian generic firms featured as the primary criticism flagged by foreign regulatory authorities. The lack of reliable and complete data on the test results of specific drug batches, along with inconsistencies in the records


presented, meant that inspection and verification of drug quality was extremely difficult.

• Another aspect relates to the hygiene standards of the manufacturing plants. Individuals suffering from illness are especially susceptible to infections, and inspections of generic drug plants reveal pest infestations and dilapidated infrastructure

• The Patents Act removed composition patents for foods and drugs, and though it kept process patents, these were shortened to a period of five to seven years.

• The resulting lack of patent protection created a niche in both the Indian and global markets that Indian companies filled by reverse- engineering new processes for manufacturing low-cost drugs.

• The code of ethics issued by theMedical Council of India in 2002 calls for physicians to prescribe drugs by their generic names only.

INDIAN SYSTEM OF MEDICINE AND GENERIC DRUGSProgress in medicine and medical research goes hand in hand. There

have been phenomenal advances in medicine over the last fifty years; still there are many questions which remain unanswered in treatment methodology. Worldwide there is evidence of increased shift towards the use of traditional medicine. The peoples’ acceptance of traditional medicinal products may be attributed to growing appreciation of such products on account of being made up of organic and natural materials, their cost effectiveness and comparative safety, holistic use and disenchantment with chemical drugs. This phenomenon has equally touched the medicine of traditional Indian systems: Ayurveda, Siddha and Unani (ASU), which are explored for providing therapeutic solutions to the emerging health problems. Going by statutory provisions, there exist two types of ASU medicine, one being the classical medicine as mentioned in the authoritative books of Ayurveda, Siddha and Unani Medicine and the other category of Patent or Proprietary medicines. The former group of medicines is manufactured and named in accordance with the formulations described in the authoritative texts, whereas second group of medicine makes use of ingredients referred in the formulations of authoritative texts but with intellectual intervention, innovation or invention to manufacture products different from the classical medicine. Although the ASU systems are known for their long history of safe and effective use, yet validation of safety and efficacy using scientific and evidence-based methodologies is needed for the purpose of universal acceptability, gaining confidence of practitioners


and satisfaction of end users in the products. Adherence to standard protocol leads to generate quality data for international acceptance with reproducibility of findings.

In fact, quality of expected outcome depends upon quality of the way clinical trial is conducted, therefore conducting clinical trials with compliance to GCP helps to ensure that clinical research participants are not exposed to undue risk and the data generated are valid and accurate. The fundamental tenets of Good Clinical Practice guidelines for ASU medicine include protection of human rights as a subject in clinical trial. It also provides assurance of the safety and efficacy of the newly developed as well as conventionally used ASU formulations. These guidelines include standards of how clinical trials should be conducted; and define the roles and responsibilities of clinical trial sponsors, clinical research investigators, monitors etc. The objective is to inculcate the culture of conducting ASU intervention-based clinical studies in the country in accordance with requisite scientific standards and appropriately designed methodologies. It is also intended that results and findings of clinical trials are properly recorded, analyzed and reported. Sincere adherence to these guidelines will facilitate the acceptance of clinical data by national and international scientific fraternity. The guidelines on the whole adopt the basic principles outlined by the CDSCO for engaging in Good Clinical Practice albeit with necessary modifications to suit the ASU principles and treatment methodologies.

ClassicalAyurvedicDrugsDrugs having a reference in some Ayurvedic classical text were

considered classical Ayurvedic drugs. These drugs are prepared as per the methods and compositions described in Ayurvedic texts and are marketed with their original names (often followed by the name of the text in parenthesis from where the reference is taken). For the purpose of the study, these are also called as generic as these drugs are essentially marketed with same name and composition by all the pharmaceutical companies. These formulations are available in AFI. It should however be understood that using the word generic here is not in parallel to classical definition of generic drugs as is adopted in allopathy.

ProprietaryAyurvedicDrugsProprietary drugs in Ayurveda are defined as compound

formulations not described in classical Ayurvedic texts and are developed by pharmaceutical companies having a proprietary right


on the drug formulation and its marketing. These formulations are not available in AFI.

AyurvedicRasaDrugsAny prescribed drug having a suffix of rasa at the end of its name is

considered a rasa drug for the purpose of the study. These are usually the herbo-metallic preparations often containing mercury as one essential component.

ProceduresVarious bio-purificatory procedures (called as Pancha Karma

Procedures) recommended in the prescription are considered as procedures for the purpose of the study. These include a single or a set of multiple procedures recommended to the same patient in a single prescription. The Pancha Karma Procedure includes procedures classified as purva karma (preparatory procedures), Pradhanakarma (major procedures) and Paschata Karma (post procedures).

EDLofAyurvedaEDL of Ayurveda as recommended by the Ministry of AYUSH in

year 2013 is considered EDL for the purpose of this study. Instead of evaluating the use of generic drugs, antibiotics, and injections as per the WHO indicator list, classical Ayurvedic drugs, rasa drugs and procedures were evaluated in this study along with essential utilization of the same method as it is recommended in the WHO protocol.

Ayurvedic prescriptions have never been screened for their rationality on the pretext of individualization of the prescription based upon the knowledge of the prescriber and also the individual susceptibility and need of the medicine. It is however observed that Ayurvedic prescriptions are not free from anomalies and hence the corrective measures may be required. The biggest places where irrationality is found in Ayurvedic practice is the preferred use of proprietary drugs over generic drugs, rasa drugs over herbal drugs and procedures over medical management. Surprisingly, all these trends have a possibility to be caught by a simple observation of the trends of practice in a setting using WHO drug use indicators. Although such indicators have been developed for the allopathic drug usage, they can find an easy application in Ayurveda by making a simple modification.

MEDICAL FRATERNITY- STAND ON GENERIC DRUGSPrime Minister Narendra Modi’s resolve to ensure that doctors


prescribe only generic medicines is being undone by some creative interpretation of the Medical Council of India’s (MCI’s) “code” for doctors, which ostensibly makes it mandatory to prescribe using generic names. Reacting to the MCI injunction that doctors should prescribe generic drugs, the Indian Medical Association (IMA) said “should means may and may means optional or preferable”.

Meanwhile, doctors demanded that the PM ban companies from manufacturing any generic medicine with a trade name and ensure they produced only high-quality generics. Though the PM said he would bring a legal framework to prescribe generics, there is as yet no new law, either for the pharma industry or for doctors and chemists.

All that has happened after his announcement is that MCI has issued a notification reiterating an existing clause in its code of ethics regulations. The clause, which had earlier stated that “every physician should, as far as possible, prescribe drugs with generic names” was amended in October 2016 to “every physician should prescribe drugs with generic names”, indicating the intention to make it mandatory. However, the IMA has pounced on the fact that the letter of the clause uses “should” instead of “shall” to argue that it is not mandatory. IMA President K K Aggarwal’s statement on the issue further pointed out that the clause did not say doctors can prescribe “only” with generic names. So, IMA has advised doctors that they can write the generic name and add the name of the company that manufactures the drug.

PreferenceforGenericPrescriptionsCompanies spend huge amounts of money on promoting their

branded generics and that cost is added to the drug’s price, making them much more costly than generic named drugs. To bring down the cost of prescription drugs, most health systems opt for generic named drugs and ensure that the quality of generic drugs are maintained. Only generic names are used in medical and pharmacological textbooks. It is expected that the use of generic names will ensure production, sale, and dispensing of more rational, single ingredient drugs.

ObjectionstoPrescriptionusingGenericNamesDoctors are often influenced by the marketing practices of

pharmaceutical companies and believe that drugs being sold under trade names are of better quality. There are also genuine concerns about the quality of many of the branded generic drugs and the generic name drugs. With very high margins for retailers on generic drugs, both branded as


well as generic name drugs, doctors fear that their generic prescriptions will be used by pharmacists to push the products of companies that give them the highest margins. Doctors fear that while they are directly held responsible to the patient for treatment, the pharmacists would not be held liable for dispensing poor quality drugs.

WAY FORWARDThe Indian pharmaceutical market size is expected to grow to US$

100 billion by 2025, driven by increasing consumer spending, rapid urbanisation, and raising healthcare insurance among others. Pharma sector’s revenues are expected to grow by 9 per cent year-on-year through fiscal 2020. Going forward, better growth in domestic sales would also depend on the ability of companies to align their product portfolio towards chronic therapies for diseases such as cardiovascular, anti-diabetes, anti-depressants and anti-cancers that are on the rise.

The Indian government has taken many steps to reduce costs and bring down healthcare expenses. Speedy introduction of generic drugs into the market has remained in focus and is expected to benefit the Indian pharmaceutical companies. In addition, the thrust on rural health programmes, lifesaving drugs and preventive vaccines also augurs well for the pharmaceutical companies.

ScopeofGenericDrugsinIndiaIn today’s era, the scope of generic drugs is increasing day by day

specially in several ill health conditions such as diabetes, cardiovascular and in microbial diseases etc. When any patent expires, new generics are introduced into the market. Economic prosperity would improve affordability for generic drugs in the market and improve per capita sales of pharmaceuticals in India.

The scope is also increased due to Para IV filings and Bolar provisions. Recently, Para IV filing strategy has been adopted by leading Indian pharmaceutical companies to introduce generic drug of its own taking advantage of shortcoming in patent application of patent holders. According to this, a generic manufacturer challenges the original patented drug and claims that the generic version proposed to be launched by the manufacturer does not infringe the patent holder’s version. In case a patent challenge is won, it entitles the first to file Para IV generic manufacturer a 180 days exclusivity, if company comes up with an equivalent of the innovator’s branded formulation.

‘Bolar provision’ allows generic manufacturers to prepare and develop regulatory procedures before patent expires, so that, products


are ready for market as soon as the patent ends. With these provisions, in India, the scope of generic drug manufacturing has also increased.

The Medical Council of India (MCI), in an amendment to the Code of Conduct for doctors in October 2016, has recommended that every physician “should prescribe drugs with generic names legibly … and he/she shall ensure that there is a rational prescription and use of drugs.”• Rational use and prescription depends on the doctor, the pharmacist,

the regulator, and the consumer. How the MCI is going to ensure rational prescription and use, without a framework to measure the same, should be looked into seriously.

• Some minimum prerequisites for rational use are: prescription-only medicines (Schedules G, H, H1 and X) must not be available freely over the counter; doctors and their professional bodies along with regulators must ensure there is no misuse of antibiotics and critical drugs; and the removal of all irrational/harmful/useless medicines, both FDCs and unscientific single ingredients, must be ensured.

• Practical guidelines for rational use and prescription audit of medicines must be developed and implemented seriously by all doctors. Branding of off-patent drugs needs to be discouraged as is the practice in well-regulated countries.

• The Hathi Committee Report (1975) too had recommended debranding.

• Price control of an enlarged list of essential and life-saving drugs is a must as was mandated by the Supreme Court in 2003.

• The current market-based price mechanism of the Drug Price Control Order (DPCO) 2013 is a travesty and has resulted in ceiling prices that allow 2,000 percent to 3,000 percent (and in some cases, 10,000 percent) margins. This needs to be replaced by the cost-plus method of ceiling price fixation of the DPCO 1995.20

• The number one priority must, thus, be the replication of the Tamil Nadu/Rajasthan model of free medicines in all states, and pharmaceutical PSUs must be re-energised and reinvented instead of the government disinvesting in them.

• Since the issue is also about quality, the government must put in place reforms that will make it mandatory for drug manufacturers in India to adhere to globally accepted standards.

• The solution to the problem of branded versus generic lies in


strengthening the existing drug regulatory and quality control structure.

• The strategy can be two pronged with an increase in the capacity of existing testing laboratories and opening up of new laboratories in government colleges.

• A time bound plan to make generic prescriptions mandatory will also prepare Indian pharma’s vast supply chain of 800,000 wholesalers and retailers to get used to the new initiative progressively. India’s 800,000 retailers have thrived because it is a profitable high-margin business.

• Indian generic drug makers are exploring all options to get a foot in the door to Japan's lucrative but difficult-to-crack US$ 111 billion drug industry after its penetration in Europe and US. The penetration of generic drugs in Japan, the world's largest drug market after the US and Europe, is a little more than 30 per cent.

• The domestic market will also see a significant growth in sales on the back of increasing affluence, changing lifestyles resulting in higher incidence of lifestyle-related diseases, increasing government expenditure on healthcare through schemes like the Central Government Health Scheme (CGHS), National Programme for Healthcare of the Elderly (NPHCE), Rashtriya Arogya Nidhi (RAN) and Janani Suraksha Yojana (JSY) in the next three years, according to Care analysis.

• The rise of pharmaceutical outsourcing and investments by multinational companies (MNCs), allied with the country's growing economy, committed health insurance segment and improved healthcare facilities, is expected to drive the market's growth.

• Medicine spending in India is expected to increase at 9-12 per cent CAGR between 2018-22 to US$ 26-30 billion, driven by increasing consumer spending, rapid urbanisation, and raising healthcare insurance among others.

• Going forward, better growth in domestic sales would also depend on the ability of companies to align their product portfolio towards chronic therapies for diseases such as such as cardiovascular, anti-diabetes, anti-depressants and anti-cancers that are on the rise.The Indian government has taken many steps to reduce costs and

bring down healthcare expenses. Speedy introduction of generic drugs into the market has remained in focus and is expected to benefit the Indian pharmaceutical companies. In addition, the thrust on rural health


programmes, lifesaving drugs and preventive vaccines also augurs well for the pharmaceutical companies.

CONCLUSIONThe push towards generics in India is lauded by many stakeholders.

In a global economic environment that is turning increasingly hostile to generic drug production, this is a bold move-indicative of the government’s categorical support for one of its key industries.

While the push for a generics-only policy is a step in the right direction, it is important to assess and ensure that Indian generic companies are competent enough to take on the task before institutionalizing such a policy. Also, the policy must move beyond rhetoric-for in a sector such as health, faulty policy design will directly affect the country’s mortality statistics.

The story of generic drugs versus branded drugs being used to treat patients all over the world is not new. While it is acceptable that good quality generics can be compared to the branded drugs, the quality depends upon the processing and manufacturing of a research molecule.As per the rich experience of the doctors, the original molecules are more competent in curing the root of the disease as compared to the various molecules collected and collaborated to form medicines through dubious ways.

The drug control mechanisms in India have huge hurdles in terms of availability of manpower and technology. The other hurdles include non-availability of greater number of qualified pharmacists and dispensers on medical shops.

Regarding the drug pricing, the National Pharmaceutical Pricing Authority can always lessen the maximum retail price, and leave very little room for manipulation by the pharma companies.Government may also consider introducing static code of marketing for curbing the cost of medicines.

Brand INDIA, and Make in INDIA are critical progressive strategic goals to be achieved by cohesive working of Indian pharmaceutical Industry and Government. We need to position our capabilities and abilities and establish India as a Quality, Price Advantage Manufacturing Base for Domestic, Emerging and Regulated Nations.

The Indian Pharmaceutical Industry has witnessed a robust growth over the past few years moving on from a turnover of approx. US $ 1 billion in 1990 to over US $30 billion in 2015 of which the export


turnover is approximately US $ 15 billion. The country now ranks 3rd world wide by volume of production and 14th by value, thereby accounting for around 10 percent of world’s production by volume and 1.5 percent by value. Globally, it ranks 4th in terms of generic production and 17th in terms of export value of bulk actives and dosage forms. Indian exports are destined to more than 200 countries around the globe including highly regulated markets of US, West Europe, Japan and Australia. It has shown tremendous progress in terms of infrastructure development, technology base creation and a wide range of products. It has established its essence and determination to flourish in the changing environment. The industry now produces bulk drugs belonging to all major therapeutic groups requiring complicated manufacturing technologies. Formulations in various dosage forms are being produced in GMP compliant facilities. Strong scientific and technical manpower and pioneering work done in process development have made this possible.21

“Always laugh when you can; it is cheap medicine. Merriment is a philosophy not well understood. It is the sunny side of existence.” 22

FREQUENTLYASKEDQUESTIONS?

Whatisagenericdrug?

A generic drug is a medication that has exactly the same active ingredient as the brand-name drug and yields the same therapeutic effect. It is the same in dosing, safety, strength, quality, the way it works, the way it is taken, and the way it should be used. Generic drugs do not need to contain the same inactive ingredients as the brand name product. However, a generic drug can only be marketed after the brand-name drug's patent has expired, which may take up to 20 years after the patent holder’s drug is first filed with the U.S. Food and Drug Administration (FDA).

Generic drugs are usually much less expensive than brand name drugs once they reach the market. A drug company develops new drugs as brand-name drugs under patent protection. This protects their investment in drug research by giving the drug company the sole right to manufacture and sell the brand-name drug while the patent is in effect. When patents or other periods of exclusivity expire, other manufacturers can submit an abbreviated new drug application (ANDA) to the FDA for approval to market a generic version of the brand-name drug.


Aregenericdrugsassafeasbrandnamedrugs?Yes. The FDA must first approve all generic drugs. The FDA

requires that generic drugs must be as high in quality, and as strong, pure and stable as brand-name drugs. Generic drugs use the same active ingredients as brand-name drugs and work the same way. They have the same risks and the same benefits as the brand-name drugs.

Aregenericdrugsaseffectiveasbrand-namedrugs?Yes. A generic drug is the same as a brand-name drug in dosage,

safety, strength, quality, the way it works, the way it is taken and the way it should be used.

Not every brand-name drug has a generic drug. When new drugs are first made they have drug patents. Most drug patents are protected for 20 years. The patent, which protects the company that made the drug first, doesn't allow anyone else to make and sell the drug. When the patent expires, other drug companies can start selling a generic version of the drug. But, first, they must test the drug and the concerned authority must approve it.

Creating a drug costs lots of money. Since generic drug makers do not develop a drug from scratch, the costs to bring the drug to market are less; therefore, generic drugs are usually less expensive than brand-name drugs. But, generic drug makers must show that their product performs in the same way as the brand-name drug

Dogenericdrugshavetomeetstandards?Before marketing the drug, generic manufacturers need to obtain

permission from relevant drug regulatory authorities. First, any drug manufactured should follow good manufacturing

practices guidelines, the enforcement of which is the responsibility of drug regulators. The manufacturing units should obtain certification in this regard from drug regulators of the respective country.

Second, there is a requirement for in-vitro dissolution and in-vivo bio-availability and bio-equivalence (BA-BE) testing of new brand (from generic manufacturer) which compares the release of active pharmaceutical ingredient (API) on certain dissolution and liberation characteristics and pharmacokinetic parameters (Cmax, Tmax, and area-under-the-curve) with those from reference standard. If dissolution and BA-BE of API is within acceptable range only then, the new brand is approved for marketing. This ensures that the quality of drugs


marketed by generic manufacturers is as good as the one marketed by the innovators. In-vivo BA-BE studies are required only at the time of seeking approval for marketing and not after that while in-vitro studies can be performed anytime.

Health professionals and consumers can be assured that approved generic drugs have met the same rigid standards as the innovator drug.

• contain the same active ingredients as the innovator drug (inactive ingredients may vary)

• be identical in strength, dosage form, and route of administration• have the same use indications• be bioequivalent• meet the same batch requirements for identity, strength, purity,

and quality• be manufactured under the same strict standards of FDA's good

manufacturing practice regulations required for innovator products

AreGenericstheSameasBrand-NameDrugs?The law requires a generic drug to meet standards that ensure it's

the same basic product as the brand-name drug. That means the generic drug is safe and can be taken: • The same way as a brand-name drug • For the same reason as a brand-name drug

To approve a generic drug, it must be the same as the brand-name product in: • Active ingredient • Strength • Use and effect • How you take it (for example as a pill, inhaler, or liquid) • Ability to reach the required level in the bloodstream at the

right time and to the same extent • Testing standards

AreGenericsdifferentfromBrand-NameDrugs?Some differences between generics and brand-name drugs are


allowed. These may change the look of the drug. But they don’t affect how it works or its safety.

Generic drugs may differ in: • Shape • Color • Packaging • Labeling (minor differences)

Generic drugs are allowed to have different inactive ingredients than brand-name drugs. For example, they may have a different: • Flavoring • Preservative

The inactive ingredients in a generic, though, must be considered safe by the approving authority.

Generic drugs may also have a different expiration date than brand-name drugs. But even so, the generic must keep its effectiveness until its expiration date, just like a brand-name product.

AreGenericDrugsCheaperThanBrand-NameDrugs?A generic drug can be sold at a much lower price than a brand-

name drug. The difference in price has to do with the different costs drug makers have in bringing generics and brand-name drugs to the pharmacy shelf.

Whyaregenericdrugscheaper?Although generic drug active ingredients are chemically identical

to their branded counterparts, they are typically sold at a cheaper price than the brand-name drug. Generics are less expensive because the drug manufacturer does not have to duplicate the original clinical trials for effectiveness and safety, which lowers the cost to bring the drug to market. Generics are not less expensive because they are lower in quality.

Aregenericdrugsalwayscheaper?Usually. However, when a generic drug is first approved and

marketed, costs may remain high (although less than the brand name drug) for 6 months because the FDA will give the first generic manufacturer a “180-day exclusivity period”. The “180-day exclusivity”


is assigned to the generic manufacturer who is the first to file an ANDA and has done the additional work to get the generic drug to market.

This exclusivity allows the company to be the first - and possibly only - generic on the market for 6 months. Generic manufacturers may charge higher prices during this time because there is little to no other generic competition. Generic companies state that exclusivity allows them to recoup expenses related to being the first to bring a generic to market.If more than one generic manufacturer files their ANDA at the FDA on the same day, these companies would share the 180-day exclusivity, which might lead to somewhat lower prices during the 180-day period due to competition, but possibly not as low as when several generics enter the market.

Situations that require special consideration before choosing a Generic?

Some drugs -- known as NTI (Narrow Therapeutic Index) drugs -- may need special consideration if you are thinking of using the generic version. NTI drugs have a narrow margin between the amount that is safe and effective and the amount that is toxic.

These generic drugs include: • Warfarin (a blood thinner) • Digoxin (treats certain heart conditions) • Theophylline (treats asthma, COPD, and other lung diseases)

The doctor should tell you if you are taking an NTI drug and what type of monitoring one need.

ShouldYouBeTakingGenericMedication?Generics are not available for all medications. The best way to find

out if a generic is available for a medication one is taking and whether or not one should take it, is to ask ones doctor and pharmacist.

Some health insurance providers require that one should use a generic drug, if available. If one chooses to purchase the brand-name product, he/she may end up paying on his own or have a larger co-pay.

Generally, his pharmacist can substitute a generic drug for a brand-name drug. If a generic is available, but for some reason the doctor thinks one should still take the brand-name drug, he’ll write "Do Not Substitute" on the prescription.

If the pharmacist for some reason does not substitute a generic for a


brand-name drug, one can ask the doctor to indicate on the prescription that substitutions are acceptable. That way, one can get the same drug for a lot less money.

It can get confusing. Don't be afraid to ask the pharmacist if the medication one received is the generic form of the medicine one is used to taking.

Tell the doctor if one notices any change in the condition or have any unusual side effects when changing from a brand-name to a generic drug.

WhatareIndianlawsandpolicyonGenericDrugs?The regulation of manufacture, sale and distribution of drugs is

primarily the concern of state authorities while central authorities are responsible for approval of new drugs and clinical trials, laying down the standards for drugs, control over the quality of imported drugs, coordination of the activities of State Drug Control Organizations providing expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act. • Central Drugs Standard Control Organization (CDSCO) under

Ministry of Health and Family Welfare is the pivotal agency dealing with all drug related issues. This organization deals with all new drug approvals, review of new safety information regarding approved drugs, approval and safety review of fixed-dose combinations, medical devices, and implants. All endocrine and metabolic drugs are covered by these organizations and acts. Food supplements (including many herbal products) are regulated by separate laws since they are legally not considered as drug.

References1. PM Narendra Modi hints at rules for doctors to prescribe generic drugs, Indian Express

Published: 17th April 2017 05:00 PM 2. http://medind.nic.in/icd/t15/i5/icdt15i5p541.htm3. https://books.google.co.in/books?id=NEK8DAAAQBAJ&pg=PA123&lpg=PA123&dq4. https://books.google.co.in/books?id=FRREP4qhdDoC&pg=PA1239&lpg=PA1239&dq=5. http://stage.uspharmacist.com/article/generic-drugs-history-approval-process-and-cur-

rent-challenges6. https://www.researchgate.net/publication/261635737_MARKETING_AUTHORIZA-

TION_OF_GENERIC_DRUG_GLOBAL_ISSUE_AND_CHALLENGES7. https://www.stevens-bolton.com/cms/document/Spotlight_on_pharmaceutical_pricing_

regulation.pdf8. https://www.ibef.org/download/Pharmaceuticals-February-2018.pdf9. https://www.ibef.org/download/Pharmaceuticals-February-2018.pdf10. https://www.ibef.org/archives/detail/b3ZlcnZpZXcmMzc4OTQmOTA=11. https://www.ibef.org/industry/pharmaceutical-india.aspx


12. http://www.centurypharma.com/wp-content/uploads/2017/06/High-Growth-of-the-Indian-Pharma-Market-v1.2.pdf

13. http://www.mondaq.com/india/x/674750/Life+Sciences+Biotechnology/ Indian+Pharma-ceutical+Companies+Abbreviated+New+Drug+Application+Approvals+2017

14. https://blog.ipleaders.in/generic-drug/15. http://www.makeinindia.com/article/-/v/sector-survey-pharmaceuticals16. https://www.ibef.org/industry/pharmaceutical-india.aspx17. http://www.makeinindia.com/article/-/v/sector-survey-pharmaceuticals18. https://www.ibef.org/blogs/india-pharma-outlook-and-brand-india19. http://www.ijsr.net/archive/v4i7/SUB156513.pdf20. https://donttradeourlivesaway.wordpress.com/2017/05/01/prescribing-generic-medicines/21. http://pharmaceuticals.gov.in/pharma-industry-promotion22. George Gordon Byron (invariably known as Lord Byron), later Noel, 6th Baron Byron of

Rochdale FRS was a British poet and a leading figure in Romanticism. https://www.goodreads.com/author/show/44407.George_Gordon_Byron, accessed on

24th August, 2018.


Annexure - 1

LIST OF GENERIC EQUIVALENTS FOR BRAND NAME DRUGS

List of brand name drugs and their Generic Equivalents alphabetically by brand name followed by generic name (The list is not inclusive of all generic drugs or brand names)Source: List of Generic Equivalents for Brand Name Drugshttps://www.disabled-world.com/medical/pharmaceutical/generic-equivalents.php* For Statewise Janaushadhi Centers please see the link below http://janaushadhi.gov.in/store Details.

Brand Name - A GenericACCOLATE zafirlukastACCUNEB albuterol solutionACCURETIC quinapril /hydrochlorothiazideACEON perindoprilACLOVATE alclometasoneACTIGALL ursodiolACTIQ fentanyl citrateADALAT CC nifedipine ext-relADDERALL amphetamine / dextroamphetamine mixed saltsADDERALL XR amphetamine / dextroamphetamine mixed salts ext-relADIPEX-P phentermine 37.5 mgAGRYLIN anagrelideALDACTAZIDE spironolactone / hydrochlorothiazideALDACTONE spironolactoneALDARA imiquimodALLEGRA fexofenadineALPHAGAN P brimonidineALTACE ramiprilAMARYL glimepirideAMBIEN zolpidem


AMBIEN CR zolpidem ext-relAMERGE naratriptanANAFRANIL clomipramineANAPROX naproxen sodiumANTIVERT meclizineARALEN chloroquine phosphateARAVA leflunomideARICEPT donepezilARICEPT ODT donepezil soluble tabASTELIN azelastineATIVAN lorazepamATROVENT Nasal Spray ipratropium bromide solution nasal sprayAUGMENTIN amoxicillin / potassium clavulanateAUGMENTIN XR amoxicillin / potassium clavulanate ext-relAXID nizatidineAYGESTIN norethindrone acetateAZULFIDINE sulfasalazineAZULFIDINE EN-TABS sulfasalazine delayed-rel

Brand Name - B GenericBACTROBAN mupirocinBENTYL dicyclomineBENZAC AC benzoyl peroxideBENZAMYCIN erythromycin / benzoyl peroxideBETAGAN levobunololBETAPACE AF sotalolBIAXIN clarithromycinBIAXIN XL clarithromycin ext-relBLEPH-10 sulfacetamide 10%BONTRIL phendimetrazineBRETHINE terbutalineBREVICON Necon 0.5 / 35 (norethindrone / EE)

Brand Name - C GenericCAFERGOT ergotamine / caffeineCALAN verapamilCALAN SR verapamil ext-relCARAFATE sucralfateCARDIZEM diltiazem


CARDIZEM CD diltiazem ext-relCARDIZEM LA diltiazem 24hr ext-relCARDURA doxazosinCATAFLAM diclofenac potassiumCATAPRES clonidineCEFTIN cefuroxime axetilCELLCEPT mycophenolate mofetilCILOXAN ciprofloxacinCIPRO ciprofloxacintabsCLARITIN loratadine (available OTC without a prescription)CLEOCIN clindamycinCLEOCIN T clindamycin gel / lotion / solutionCLEOCIN Vaginal Cream clindamycin creamCLIMARA estradiol transdermalCLINORIL sulindacCLOMID clomipheneCLOZARIL clozapineCOLAZAL balsalazideCOLESTID colestipolCONDYLOX podofiloxCOPEGUS ribavirin tabsCORDARONE amiodaroneCOREG carvedilolCORGARD nadololCORTEF hydrocortisoneCORZIDE nadolol/bendroflumethiazideCOSOPT timolol maleate / dorzolamide hclCOUMADIN warfarinCOZAAR losartanCUTIVATE fluticasonepropionatecrm0.05%, oint 0.005%CYCLOGYL cyclopentolateCYTOMEL liothyronineCYTOTEC misoprostolCYTOVENE ganciclovir

Brand Name - D GenericDANTRIUM dantrolene


DAYPRO oxaprozinDDAVP desmopressin inj / nasal / tabsDEMADEX torsemideDEMEROL meperidineDEPAKENE valproic acidDEPAKOTE divalproex sodium delayed-relDEPAKOTE ER divalproex sodium ext-relDEPAKOTE SPRINKLES divalproex sodium coated particlesDEPO-PROVERA medroxyprogesterone acetate 150 mg / mLDESOGEN Apri,Reclipsen,Solia (0.15 / 30 desogestrel / EE)DESOWEN desonide cream / lotion / oint 0.05%DEXEDRINE dextroamphetamineDEXEDRINE SPANSULE dextroamphetamine ext-relD.H.E. 45 dihydroergotamine mesylateDIABETA glyburideDIAMOX SEQUELS acetazolamide ext-relDIFFERIN adapaleneDIFLUCAN fluconazoleDILACOR XR diltiazem ext-relDILANTIN phenytoin sodium extendedDILAUDID hydromorphoneDIPROLENE AF betamethasone dipropionate crm 0.05%DIPROLENE gel / lotion / oint betamethasone diproprionate augmented gel / lotion / oint 0.05%DITROPAN XL oxybutynin ext-relDONNATAL atropine / hyoscyamine / scopolamine / phenobarbitalDRISDOL ergocalciferol (D2)DUONEB ipratropium / albuterol solutionDURAGESIC fentanyl transdermalDYAZIDE triamterene / hydrochlorothiazide 37.5 / 25 caps

Brand Name - E GenericEC-NAPROSYN naproxen delayed-relEFFEXOR XR venlafaxine ext-rel caps


EFUDEX fluorouracilsolutionELDEPRYL selegiline capsELDOPAQUE FORTE Melpaque HP (hydroquinone)ELOCON mometasone furoate crm / oint 0.1%EMLA lidocaine / prilocaineESGIC butalbital / acetaminophen / caffeineESGIC-PLUS butalbital / acetaminophen / caffeineESTRACE estradiolESTROSTEPFE Tri-LegestFE,TiliaFE,norethindrone acetate / EE / ironEXELON rivastigmine

Brand Name - F GenericFAMVIR famciclovirFELDENE piroxicamFIORICET butalbital / acetaminophen / caffeineFIORINAL butalbital / aspirin / caffeineFLAGYL metronidazoleFLAGYL 375 metronidazole 375 mgFLAGYL ER metronidazole ext-relFLAREX fluorometholoneFLEXERIL cyclobenzaprineFLOMAX tamsulosinFLONASE fluticasoneFLUMADINE rimantadineFML fluorometholoneFOCALIN dexmethylphenidateFOLTX folic acid / vitamin B6 / vitamin B12FOSAMAX alendronate

Brand Name - G GenericGLUCOPHAGE metforminGLUCOPHAGE XR metformin ext-relGLUCOTROL glipizideGLUCOVANCE glyburide / metforminGLYNASE glyburide micronized

Brand Name - H GenericHALCION triazolam


HYDREA hydroxyureaHYZAAR losartan / hydrochlorothiazide

Brand Name - I GenericIMDUR isosorbide mononitrate ext-relIMITREX sumatriptan succinateIMURAN azathioprineINDERAL LA propranolol ext-relINSPRA eplerenoneISOPTIN SR verapamil ext-relISORDIL isosorbidedinitrate,oral

Brand Name - K GenericKEFLEX cephalexinKEPPRA levetiracetamKERLONE betaxololKLARON sulfacetamideKLONOPIN clonazepamK-LOR 20 potassium chloride 20 mEqK-TAB potassium chloride ext-rel tabs 10 mEqKYTRIL granisetron

Brand Name - L GenericLAC-HYDRIN ammonium lactate 12%LAMICTAL lamotrigineLAMISIL terbinafinetabsLANOXIN digoxinLASIX furosemideLEVBID hyoscyamine sulfate ext-relLEVSIN hyoscyamine sulfateLITHOBID lithium carbonate ext-relLO/OVRAL Cryselle,Low-Ogestrel (0.3 / 30 norgestrel / EE)LOCOID hydrocortisone butyrateLOESTRIN1/20 Junel,Microgestin1/20 (norethindrone acetate / EE)LOESTRIN1.5/30 Junel,Microgestin1.5/30 (norethindrone acetate / EE)LOESTRINFE1/20 JunelFE,MicrogestinFE1/20 (norethindrone acetate / EE / iron)


LOESTRINFE1.5/30 JunelFE,MicrogestinFE1.5/30 (norethindrone acetate / EE / iron)LOMOTIL diphenoxylate / atropineLOPID gemfibrozilLOPRESSOR metoprolol tartrateLOPROX ciclopiroxLORCET hydrocodone / acetaminophenLORTAB hydrocodone / acetaminophenLOTENSIN benazeprilLOTENSIN HCT benazepril / hydrochlorothiazideLOTREL amlodipine / benazeprilLOXITANE loxapineLURIDE fluoridedropsLURIDELOZI-TABS fluoridetabletsLUSTRAMelquinHP, hydroquinone

Brand Name - M GenericMACROBID nitrofurantoin ext-relMACRODANTIN nitrofurantoin macrocrystalsMAVIK trandolaprilMAXIDONE hydrocodone / acetaminophenMAXITROL neomycin / polymyxin B / dexamethasoneMAXZIDE triamterene / hydrochlorothiazide 75 / 50MAXZIDE-25 triamterene / hydrochlorothiazide 37.5 / 25 tabsMEDROL methylprednisoloneMEGACE megestrol acetateMESTINON pyridostigmineMETADATE ER methylphenidate ext-relMETAGLIP glipizide / metforminMETROCREAM metronidazole crm 0.75%METROLOTION metronidazole lotion 0.75%METROGEL-VAGINAL metronidazoleMEVACOR lovastatinMIACALCIN nasal spray calcitonin-salmon nasal sprayMIDRIN acetaminophen / dichloralphenazone / isometheptene


MINIPRESS prazosinMINOCIN minocyclineMIRALAX polyethylene glycol 3350MIRAPEX pramipexoleMIRCETTE Azurette,Kariva(desogestrel/EE)MOBIC meloxicamMODICON Necon0.5/35(norethindrone/EE), Nortrel 0.5 / 35MONODOX doxycycline monohydrateMOTRIN ibuprofenMS CONTIN morphine ext-relMYAMBUTOL ethambutolMYCELEX clotrimazole trochesMYSOLINE primidone

Brand Name - N GenericNAPROSYN naproxenNAVANE thiothixeneNEO-SYNEPHRINE phenylephrineNEORAL cyclosporine(modified)NEOSPORIN neomycin / polymyxin B / gramicidinNEURONTIN gabapentinNIMOTOP nimodipineNIRAVAM alprazolam soluble tabNITRO-DUR nitroglycerin transdermalNIZORAL SHAMPOO ketoconazole shampoo 2%NORDETTE Levora,Portia(0.15/30levonorgestrel/ EE)NORINYL1+35 Necon1/35,Nortrel1/35 (norethindrone / EE)NORINYL 1+50 Necon 1 / 50 (norethindrone / ME)NORPACE disopyramideNORPRAMIN desipramineNOR-QD Camila,Nora-BENORVASC amlodipineNULYTELY peg 3350 / sodium bicarbonate / sodium chloride / potassium chloride


Brand Name - O GenericOCUFLOX ofloxacinOLUX clobetasol propionate foam 0.05%OPANA oxymorphoneOPTIPRANOLOL metipranololORAPRED prednisolone sodium phosphateORTHO-CEPT Apri,Reclipsen,Solia (0.15 / 30 desogestrel / EE)ORTHO-CYCLEN Mononessa,Previfem,Sprintec (0.25 / 35 norgestimate / EE)ORTHOMICRONOR Errin,JolivetteORTHO-NOVUM1/35 Necon1/35,Nortrel1/35 (norethindrone / EE)ORTHO-NOVUM7/7/7 Necon7/7/7,Nortrel7/7/7ORTHOTRI-CYCLEN Trinessa,Tri-Previfem,Tri-SprintecOVCON35 Balziva,ZenchentOVIDE malathionOXANDRIN oxandrolone

Brand Name - P GenericPACERONE amiodaronePAMELOR nortriptylinePAMINE scopolamine methylbromidePAMINE FORTE scopolamine methylbromidePARAFON FORTE DSC chlorzoxazonePARCOPA carbidopa / levodopa orally disintegrating tabsPARLODEL bromocriptinePARNATE tranylcyprominePAXIL paroxetine hclPAXIL CR paroxetine hcl controlled relPEDIAPRED prednisolone sodium phosphatePEPCID famotidinePERCOCET oxycodone / acetaminophenPERCODAN oxycodone / aspirinPERIDEX chlorhexidine gluconatePERIOSTAT doxycycline hyclatePERSANTINE dipyridamole


PHOSLO calcium acetatePLAQUENIL hydroxychloroquinePLEXION sulfacetamide / sulfurPOLYTRIM polymyxin B / trimethoprimPONSTEL mefenamic acidPRAVACHOL pravastatinPRED FORTE prednisolone acetate 1%PRELONE prednisolone syrupPREVACID lansoprazole delayed-relPREVACID SOLUTABS lansoprazole soluble tabsPRILOSEC omeprazole delayed-relPRINIVIL lisinoprilPRINZIDE lisinopril / hydrochlorothiazidePROCARDIA XL nifedipine ext-relPROCTOCORT hydrocortisonesupp,rectalPROCTOCREAM-HC 2.5% hydrocortisone cream 2.5%PROSCAR finasteridePROSOM estazolamPROTONIX pantoprazole delayed-relPROVERA medroxyprogesterone acetatePROZAC fluoxetinePROZACWEEKLY fluoxetinedelayed-relPULMICORT RESPULES budesonide nebulizer suspPYRIDIUM phenazopyridine

Brand Name - Q GenericQUESTRAN / cholestyramine cans / pktQUESTRAN LIGHT

Brand Name - R GenericRAZADYNE galantamineRAZADYNE ER galantamine ext-relREBETOL ribavirin capsREGLAN metoclopramideREMERON mirtazapineREMERON SOLTAB mirtazapine orally disintegrating tabsREQUIP ropinirole hclRESTORIL temazepam


RETIN-A tretinoinRETROVIR zidovudinesyrup,tabsREVIA naltrexoneRIFADIN rifampinRISPERDAL risperidoneRISPERDAL M-TAB risperidone soluble tabRITALIN methylphenidateRITALIN-SR methylphenidate ext-rel 20 mgROBAXIN methocarbamolROCALTROL calcitriol(1,25-D3)ROWASA mesalamine rectal suppROXICODONE oxycodoneRYTHMOL propafenoneRYTHMOL SR propafenone ext-rel

Brand Name - S GenericSALAGEN pilocarpineSANCTURA trospiumSEASONALE Jolessa,QuasenseSECTRAL acebutololSELSUN selenium sulf shampoo 2.5%SEPTRA sulfamethoxazole / trimethoprimSEPTRA DS sulfamethoxazole / trimethoprimSILVADENE silver sulfadiazineSINEMET carbidopa / levodopaSINEMET CR carbidopa / levodopa ext-relSKELAXIN metaxaloneSOMA carisoprodolSONATA zaleplonSPORANOX itraconazoleSTARLIX nateglinideSULAR nisoldipine ext-relSYNTHROID levothyroxine

Brand Name - T GenericTAMBOCOR flecainideTAPAZOLE methimazoleTARKA trandolapril / verapamil ext-rel


TEGRETOL carbamazepineTEGRETOL XR carbamazepine ext-relTEMOVATE clobetasol propionate crm / oint / gel / lotion 0.05%TENEX guanfacineTENORETIC atenolol / chlorthalidoneTENORMIN atenololTENUATE diethylpropionTERAZOL 3 terconazole 0.8% crm / suppTERAZOL 7 terconazole 0.4% crmTESSALON benzonatateTIAZAC Taztia XTTIGAN caps trimethobenzamide capsTIMOPTIC timolol maleateTIMOPTIC OCUDOSE timolol maleateTIMOPTIC-XE timolol maleate gelTOBRADEX tobramycin / dexamethasoneTOBREX tobramycinTOFRANIL imipramine hclTOFRANIL PM imipramine pamoateTOLECTIN tolmetin sodiumTOPAMAX topiramateTOPICORT desoximetasone crm / oint 0.25% / gel 0.05%TOPROL-XL metoprolol succinate ext-relTRANXENE T-TAB clorazepateTRIAZ benzoylperoxidelot,OscionTRILEPTAL oxcarbazepineTRI-NORINYL Aranelle,Leena(norethindrone/EE)TRUSOPT dorzolamide hclTUSSIONEX hydrocodone polistirex / chlorpheniramine polistirex ext-rel suspTYLENOL WITH CODEINE codeine / acetaminophenTYLOX oxycodone / acetaminophen

Brand Name - U GenericULTRAM tramadolULTRAVATE halobetasol


UNIRETIC moexipril / hydrochlorothiazideUNIVASC moexiprilURSO ursodiol

Brand Name - V GenericVALIUM diazepamVALTREX valacyclovirVASERETIC enalapril / hydrochlorothiazideVASOTEC enalaprilVENLAFAXINE ER venlafaxine ext-rel tabsVERELAN PM verapamil ext-relVIBRAMYCIN doxycycline hyclateVICODIN hydrocodone / acetaminophenVICODIN ES hydrocodone / acetaminophenVICOPROFEN hydrocodone / ibuprofenVIDEX EC didanosine delayed-relVIROPTIC trifluridineVISTARIL hydroxyzine pamoateVIVACTIL protriptylineVOLTAREN OPHTHALMIC diclofenac sodium ophthalmicVOLTAREN-XR diclofenac sodium ext-relVOSPIRE ER albuterol ext-rel

Brand Name - W GenericWELLBUTRIN bupropionWELLBUTRIN SR bupropion ext-relWELLBUTRIN XL bupropion ext-relWESTCORT hydrocortisone valerate crm / oint 0.2%

Brand Name - X GenericXANAX alprazolamXANAX XR alprazolam ext-relXYZAL levocetirizine

Brand Name - Y GenericYASMIN Ocella (drospirenone / EE)YAZ Gianvi (EE / drospirenone)

Brand Name - Z GenericZANAFLEX tizanidine


ZANTAC ranitidineZARONTIN ethosuximideZAROXOLYN metolazoneZEGERID omeprazole / sodium bicarbonateZERIT stavudineZESTORETIC lisinopril / hydrochlorothiazideZESTRIL lisinoprilZIAC bisoprolol / hydrochlorothiazideZITHROMAX azithromycinZOCOR simvastatinZOFRAN ondansetronZOLOFT sertralineZONEGRAN zonisamideZOVIRAX acyclovirZYBAN bupropion ext-relZYLOPRIM allopurinolZYRTEC cetirizine (OTC)

INDIAN INSTITUTE OF PUBLIC ADMINISTRATION

The Indian Institute of Public Administration, established as an autonomous body under the Registration of Societies Act, was inaugurated on March 29, 1954 by Shri Jawaharlal Nehru who was also the first President of the Society. The basic purpose of establishing this Institute was to undertake such academic activities as would enhance the leadership qualities and managerial capabilities of the executives in the government and other public service organization. The activities of the Institute are organized in four inter-related areas of Research, Training, Advisory and Consultancy Services and Dissemination of Information.

CENTRE FOR CONSUMER STUDIES

CCS is dedicated to consumer studies and is sponsored by DCA, GoI. The objective of the CCS is to perform, facilitate and promote better protection of consumers’ rights and interests with special reference to rural India. The broad areas of focus of the Centre comprise capacity building, advocacy, policy analysis, research, advisory and consultative services, and networking.

The Centre seeks to network with national and international agencies and interface with other stakeholders by serving as a bridging “think tank” with an intensive advocacy role. The Centre provides a forum for creating dialogue among policy-makers, service-providers, representatives of various business establishments and their associations, professional bodies/associations, civil society organizations, educational/research institutions, economic and social development organizations as well as leading NGOs.

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