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International journal of Applied Pharmaceutical and Biological Research, 2017; 2(6):24-28

Review Article ISSN : 2456-0189

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ABBRIVIATED NEW DRUG APPLICATION PROCESS IN INDIA

*1 Hitesh Chaturvedi, 2Ayush Garg, 3Dileep Kumar, 4Udai Bhan Singh Rathore

1,2 Department of Pharmaceutics, Pacific College of Pharmacy, Udaipur

3 Department of Pharmacology, Pacific College of Pharmacy, Udaipur 4 Department of Pharmaceutical Chemistry, Pacific College of Pharmacy, Udaipur

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ABSTRACT

The main focus of regulatory authorities is on product’s quality, safety and efficacy with their respective

country. It does not only involve the process of regulating and monitoring the drugs product but also the

process of manufacturing, distribution, and promotion of drug product. One of the foremost challenges or

goals for regulatory is to ensure the pharmaceutical products are developed as per the regulatory

requirement of that respective country. All new or generic drug products must be approved, by the respective

regulatory agency governing the respective market before a particular product can be introduce into the

market. Every country has its own regulatory authority. This regulatory authority is responsible to enforce

the rules and regulations and issue the guidelines to regulate the marketing of the drugs. In this review

article we mentioned & thoroughly study about the rule & regulations regarding ANDA registration which

are followed process in America Europe and India.

KEY WORDS- ANDA, Registration, Generic, Clinical, NDA

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INTRODUCTION

1. ANDA :

The word “ANDA” which means An Abbreviated New Drug Application (ANDA).IT contains all data which

is submitted to FDA's, Centre for Drug Evaluation and Research (CDER), at Office of Generic Drugs (OGD),

the data provides for the thoroughly review and final approval of a generic drug product.

After approval, an applicant may manufacture the generic drug product to provide a safe, effective, low

cost alternative dosage form to the public.

A generic drug product is one of that is comparable to an innovator drug product in dosage form,

strength, route of administration, quality, performance characteristics and intended use.

Important Facts about Generics And Generics Drug Application:

• Generic drug applications are termed "abbreviated" because they are generally not required to

perform preclinical (animal) and clinical (human) data to establish safety and effectiveness.

• Generic applicants must scientifically demonstrate that their product is bioequivalent with respect to

innovator drug (i.e., performs in the same manner as the innovator drug).

• Bioequivalence is generally determined by measuring the time taken for generic drug to reach the

bloodstream in 24 to 36 healthy volunteers. This gives the idea about the rate of absorption, and

bioavailability, of the generic drug which can be compared to that of the innovator drug.

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• The generic version must deliver the same amount of active ingredients into a patient's bloodstream

in the same amount of time as well as the innovator drug.

• The basis for approving generic copies of drug products was established by the "Drug Price

Competition and Patent Term Restoration Act of 1984," also known as the "Hatch -Waxman Act".

This is an application made for generic medicine production. In this process ,the sponsor does not need

any type of clinical studies and test. A person who manufactured generic drug must demonstrate that

their product is same as like and bioequivalent to, previously approved brand product.

The procedure of ANDA approval has been depicted.

Fig: 1 The basic regulation needed in ANDA approval

2. IND:

The word “IND” which means “Investigational New Drug” It’s an application filed to the FDA in order to

start clinical trials in humans. If the drug was found to be safe from the reports of Preclinical trials

(Animals). A firm or institution, called a Sponsor, Who is responsible for submitting the IND application.

Fig: 2 Flow Chart of Investigational New Drug Application

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3. NDA :

The word “NDA” which means “new drug application”. If clinical studies confirm that a new drug is

relatively safe and effective, and it will not pose unreasonable risks & interaction to patients, the

manufacturer files a New Drug Application (NDA), the actual request to manufacture and sell the drug in

that country.

Fig: 3 Flow Chart of New Drug Application

APPROVAL OF NEW DRUG IN INDIA:

When an any company in India want to manufacture or import a new drug it has to apply to seek

permission from the licensing authority (Drug Controller general of india) by filling in form 44 also

submitting the data as given in schedule Y of drug and cosmetics act 1940 and rules 1945.

In order to prove its efficacy and safety in India population it has to conduct clinical trial accordance with

guidelines specified schedule Y and submit the report of such clinical trial in specified format.

But a provision is there in rule-122A of D & C Act 1940 and 1945 that he licensing authority may waive

certain trails if he considers that in the interest of public health he may grant permission for import of

new drugs basing on the data of the trail done in the other countries. Similarly there is another provision

in rule-122A which say that the clinical trial may be waived in the case of new drug which are approved

and being used for several years in other countries.

Section 2.4 (a) of schedule Y –Drug and Cosmetics Act 1940 and Rules 1945 says for those;

Drug substances which are discovered in India all phase of clinical trial are required.

Drug substance which is discovered in other countries other than India; the applicant should

submit the data available from other countries and the licensing authority may require him to repeat all

the studies or permit him to proceed from phase III clinical trial. The Process of approval of new drug in

India is a very complicated process, which should meet necessary requirement along with NDA to FDA.

NEW DRUG APPROVAL APPLICATION:

To possess this permission a sponsor submits preclinical and clinical test data to NDA for analyzing the

drug manufacturing, description of manufacturing procedures.

After NDA received by the agency, it undergoes for technical screening and evaluation to ensure that

sufficient data and information.

At the conclusion of FDA review of an NDA, there are 3 possible actions that can send to sponsor:

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Not Approvable- In this latter list of deficiencies and explain the reason.

Approvable- It means that the drug can be approved but minor deficiencies that can be corrected like

labeling changes and possible request commitment to do post approval.

Approval- It means that the drug is approved.

If the action is taken is either an approvable or a not approvable, then FDA provides applicant with an

opportunity to meet with agency and discuss the deficiencies.

DRUG APPROVAL PROCESS IN INDIA:

Fig: 4 Drug approval process in India

RESULT AND DISCUSSION:

Table: 1 Principle of India

REQUIRMENT INDIA

Agency One Agency DGCI

Registration Process One Registration Process

TSE/BSE Study data TSE/BSE Study data Required

Braille Code Braille code is not required on labeling

Post approval change Post approval changes; Major quality changes

Moderates quality changes

Table: 2 Administrative Requirements

REQUIRMENT INDIA

Application MAA Required

Debarment Classification Not Required

Number of copies 1

Approval Timelines 12-18 Months

Fees 50,000 INR

Presentation Paper

Table: 3 Finished Product Control Requirement

REQUIRMENT INDIA

Justification ICH Q6A

Assay 90-110%

Disintegration Required

Colour Identification Required

Water Content Required

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Table: 4 Manufacturing & Control Requirement

REQUIRMENT INDIA

Number of Batches 1

Packaging Not addressed

Process Validation Required

Batch Size Pilot scale batch

Table: 5 Stability Requirements

REQUIRMENT INDIA

Number of batches 2 pilot scale/ Production Scale (If API stable)

3 Primary batches (If API unstable)

Condition: Long Term Stability, Accelerated stability Long Term: 300C/70%RH

Accelerated: 400C/75%RH

(0,3,6 month)

Minimum time period at Submission 6 Month Accelerate & 6 Month long term

Container orientation Upright & Inverted

Clause ICH Q1F

QP Certificate Required

Table: 6 Bioequivalence Requirements

REQUIRMENT INDIA

CRO(Audit) CDSCO

Reserve Sample -

Fasted/Fed As CDSCO recommendation

Retention of sample 3 years from date of filing the application

BE study for generic

drugs

Against US/EU Australia RLD in any country except Thailand where BE to be done locally against local

reference product

CONCLUSION

The approval of drug in India is the most demanding and new current trend in the world. The primary

objective of the regulation governing pharmaceutical product in India is to make safeguard for public

health. It is role and responsibility of public regulatory authorities to ensure that pharmaceutical

companies comply with regulations. There are legislation that require drugs to be developed, tested,

trailed and manufactured in accordance to the guidelines so that they are safe and patient’s well being is

protected.

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