National Drug Policy

Prepared by:Ratan Bahadur Mahatara

Reshma ShakyaSajan MaharjanSanju Maharjan

With the core objective to upgrade the health standards of the majority of the rural population by extending basic primary health services and making modern medical facilities available at the village level, Nepal’s government introduced a National Health Policy in 1991.

It called for prioritising preventive, promotive and curative health services to reduce infant and child mortality.

The policy has 15 components ranging from preventive health services to blood transfusion services and miscellaneous issues.

Among them one of its issue was Drug supply which stated:In order to bring about improvements in the supply of drugs in government health organizations as well as those operated under the private sector, the domestic production of essential drugs will be increased. The quality of the drugs will be upgraded by revising the National Drug Policy.

Review of National Health Policy

In accordance with the objectives of the National Health Policy 1991,National Drug Policy was introduced in 1995.Main Policy: To maintain, safeguard and promote the health of people by

making the country self- reliant in drug production ensuring the availability of safe, effective, standard, and quality

drugs at affordable price in quantities sufficient to cover the need of every corner of the country

to manage effectively all the drugs-related activities including production, import, export, storage, sale, supply and distribution.

National Drug Policy

2. Objectives:a. To evolve a suitable mechanism to ensure availability of safe,

effective and quality medicines at reasonable price throughout the country.

b. To adopt a well-defined and effective mechanism for procurement, transportation, sale-distribution, storage and dispensing of drugs at various levels of governmental and non-governmental health institutions.

c. To supply adequate quantities of essential drugs at each level of Governmental health institutions.

d. To include drug industry as priority sector by all concerned Ministries of HMG in order to make the nation self-reliant in the production of essential drugs.

e. To develop pharmacy manpower for effective implementation of the policy.

f. To promote rational use of drugs and to establish a drug information system.

g. To set-up a well-equipped quality control laboratory with trained staff under the Ministry of Health to carry out testing, analysis and standardization of drugs.

h. To develop an appropriate system to administer and monitor uniformity in drug prices.

i. To define, promote and regulate the quality and standards of Ayurvedic, Homeopathic, Traditional and other system of medicine by adopting scientific approach.

j. To improve the existing infrastructure of the Department of Drug Administration and provide sufficient qualified and trained personnel for strengthening the drug administration mechanism and effective of the Drug Act.

k. To consolidate and amend the existing Drug Act, Rules and Regulation to facilitate effective implementation of the Drug Policy.

To strengthen Department of Drug Administration as National Medicine Regulatory Authority (NMRA) and National Medicines Laboratory as National Control Laboratory (NCL) for the effective enforcement of the Drug Act

To ensure proper monitoring and reporting of Adverse Drug Reactions (ADR) for implementation of Pharmacovigilance programme.

To encourage collaboration among universities, research institutes and manufactures for promoting research & development activities.

To encourage transfer of technology by allowing contract manufacturing by foreign manufacturers with the national companies.

National Medicines Policy – 2007 (Revised NDP)

Drug managementProcurement, storage and distribution of medicinesQuality assurance and regulatory measuresRational Drug use and its informationManpower developmentNational drug industry and Traditional medicines

Policy strategies

Progress achieved so far with NDP National List of Essential Drugs published in 1986 and revised in

1992, was revised in 1997 and 2002 and list was further classified for district, primary health care centre, health post, sub-health post and primary treatment level.

In order to ensure availability of required essential medicines at different health institutions, community drug programme (cost sharing schemes) was implemented in 47 districts Health post / Sub health posts.

Branch offices of Department of Drug Administration established in three regions of the country.

National Medicines Laboratory was developed as National Quality Control Laboratory.

Good Manufacturing Practices as per WHO guidelines was made compulsory for registration of medicine.

Eight custom points were identified for the importation of drugs.

Standard treatment schedule for Health Post and Sub Health Post was revised in 1999.

Training on Good Manufacturing Practices was conducted.Drug Information Network of Nepal was established and made

functional.Nepalese National Formulary was published in 1997.A Pharmaceutical Affairs Unit (named as Pharmaceutical / Quality

Standard Section) established at the Ministry of Health & Population.Bachelor level Pharmacy education started at four Universities and

Diploma (Certificate) level education started at twenty one institutes under Council for Technical Education and Vocational training (CTEVT)

Nepal Pharmacy Council Act promulgated in 2000 and registration of pharmacy personnel started.

The number of domestic modern medicines industries increased to 40 and are producing 215 essential drug items out of 493.

Three quality control laboratories were established in private sector.Number of industries for the production of traditional medicines

increased to 33.Evaluation of new formulations of traditional medicines on scientific

basis carried out by Department of Ayurveda.National Guidelines for Use of Pharmaceuticals for clinical trial

developed by Nepal Health Research Council.One industry established in joint venture and another has technical

collaboration with a foreign company.Monitoring and evaluation of progress made in implementation

National Drug Policy done twice.

Drug Procurement

Current situation: Loss in efficiency for the Essential Drugs procured by the districts

The estimated loss of efficiency is 10% for additional

transport costs 30 percent for higher prices

paid by the districts due to lower quantities to be tendered.

Option: Centre Procures All ED, Budgets Remain at Respective Districts

At the Level of Guiding Principles• Free health service policy should be supported by a sound procurement and

supply system to ensure round-the-year availability of ED.• Centre may take over the responsibility of quality assurance of drugs.

At the Level of Implementation• At centre and district level: Re-directing budget and procurement responsibilities

to the centre, at least for the main ED.• Central bidding, and price negotiation and local purchasing of the ED.

For Future Follow-up Activities• A study on the ED-prescribing behaviour of the health workers particularly after

the implementation of FHCP should be conducted.• A national level study should be conducted on pricing of all ED

Recommendations

Include drug industry as priority sectorMajor objective: to produce 80 per cent of the essential drug formulations in the coming ten years.After ten years, we have achieved only 45 per cent of the total target.

The domestic sector at present claims a-three billion rupees worth of market, which is around 35 per cent of the total eight billion rupees pharmaceutical market in Nepal.Foreign companies occupy almost 65 per cent of the drug market. Even among the foreign brands, Indian companies are dominant.

Other problems in the Nepali pharmaceutical sector VAT and extra taxes. Smuggling of drugs through the porous Indo-Nepal border. Too many players and lingering doubts over the quality of the medicines produced.( 40 Nepali companies alongwith 201 foreign companies, they are offering 7,299 brands) Unlike other products where more brands usually mean more choice for consumers, the

large number of brands in the pharmaceutical sector is only encouraging unhealthy practice.

Possible Solutions There should be no VAT and extra tax on raw materials, packaging material and

machines. Reducing the number of brands to control unhealthy practices.  The practice of giving incentives is unethical in pharma business and should be

controlled Some foreign companies, which were inspected long time back need re-

inspection. Government should have a well-equipped body for quality control. The quality

is tested once when a foreign company registers its products. Further checking is done every year or on specific complaints. This practice should be discouraged. Instead Medicines entering Nepal should be regularly tested at the customs points by the authorities.

All the domestic companies start producing at least one essential and one life-saving drug.

http://businessjournalist.blogspot.com/2007/05/nepali-pharmaceutical-industry-needs.html

Rational Use of drugs The requirements for rational drug use are that the right drugs shall be used for the right

indications in the right dose and dosage form for the right duration. Nearly 42% of the health budget is spent on drugs and international donors spend another

three times, 80% of medicinal products are imported to Nepal however, the availability of drugs in the health posts and clinics are sporadic resulting into the prevalence of  inappropriate drug use.

Concerted efforts shall be made by government at all levels to promote rational drug use through:

Rational Prescribing:The objective is to ensure that drugs are prescribed rationally• Up-to-date Standard Treatment Guidelines and a National Formulary shall be made

available to all prescribers according to the level of care;• Prescribing shall be by International Non-Proprietary Names (INN) or generic names

Rational DispensingThe objective of rational dispensing shall be to ensure that patients receive adequateinformation on the use of dispensed drugs in order to derive the desired benefitsto them. In this regard the following shall be put in place:i. Dispensing shall only be carried out on duly licensed premises;ii. The minimum information requirement on the label of a dispensed medicine shall be the following:• Name of patient,• Generic name of dispensed drug,• Strength of the drug,• Dosage instruction in symbols or words as may be appropriate,• Duration of treatment• Date of dispensing, and• The name of the institution where the drug was dispensed;iii. The patient shall be counselled on the use of dispensed drugs, in a conduciveenvironment suitable for effective communication; andiv. Dispensing shall be carried out in a suitable container that will be child proofand ensure the stability of the drug dispensed.

Drugs and Therapeutics Committees (DTCs) shall be established in all health care institutions which will be responsible for:

· the selection of drugs for use in the institution, based on the National Essential Drug List,· the accurate estimation of pharmaceutical requirements for thehospital,· monitoring of the use of therapeutic guidelines and overall drugutilisation, and· monitoring of the rational use of drugs in the institution

In drug Act 2035If it is deemed necessary , the department with taking approval of His Majesty's Government may fix the price of any drug.Till date, the price of drugs fixed are

Uniformity in drug price

In India, retail price of drug formulations is fixed as per Drug Price control order (DPCO) act, 1998.

R.P. = ( M.C.+C.C.+P.M.+P.C. ) * ( 1+ MAPE / 100 ) + ED.WHERE, R.P. = RETAIL PRICE M.C.= MATERIAL COST C.C.= CONVERSION COST P.M.= PACKAGING MATERIAL COST P.C.= PACKING CHARGES ED = EXCISE DUTY MAPE= MAXIMUM ALLOWABLE POST MANUFACTURING EXPENSES FROM DATE OF RECEIPT OF COMPLETE INFORMATION GOVT. FIX RETAIL PRICE WITHIN 2 MONTHS.FOR PRICE REVISION OF SUCH FORMULATION MANUFACTURER SHOULD APPLY WITHIN 30 DAYS.WITHOUT APPROVAL OF GOVERNMENT, MANUFACTURER CAN NOT INCREASE RETAIL PRICE OF DRUG.