National Drug Policy May 5, 2005
MINISTRY OF HEALTH AND FAMILY WELFARE
PUBLIC HEALTH SECTION-1
Dated, the 18th April, 2005
No. Public Health-1/Drug-22/2004/154-Ministry of Health and Family Welfare has promulgated the following “National Drug Policy 2005” which is duly approved by the Cabinet.
In order to remedy the deplorable situation that existed in the drug and health sector of the country at the time of independence and thereafter and to ensure adequate supply and availability of good quality essential drugs at affordable prices, National Drug Policy (NDP) was formulated in 1982. Following the guidelines of this NDP, the Drugs (Control) Ordinance, 1982 was also promulgated in the same year by the then Government. These two national documents, which were highly applauded all over the world, produced tremendous positive effect on rapid development of the local Pharmaceutical industries and gradual improvement and gains in the drug sector of the country, which are evident from the following facts:
· local production of both allopathic, traditional and complimentary alternative drugs increased substantially.
· availability of essential drugs also increased remarkably with the increase in the volume of local production of all types of recognized drugs, the monetary value of which grew from Taka 1,730 million in 1981 to about Taka 41,000 million in 2002.
· local companies increased their share of production from 30% in 1970 to more than 80% in 2002.
· drug prices stabilized, increasing (practically a drop in place in real terms) by only 20%, compared to an increase of 179% in the consumer price index. This made drugs more affordable to consumers.
· quality of products improved and the proportion of substandard drugs fell from 36% in 1970 to only about 2% in 2002.
· volume of import of drugs and medicine in the country reduced drastically.
· commendable progress occurred in the research, education and manufacturing of Unani, Ayurvedic and Homeopathic-Biochemic systems of medicine.
· less dependency on imports and prioritization of useful drugs saved the country approximately US$ 600milion every year.
· a drug-importing country, Bangladesh turned into a drug-exporting country.
Pursuance of the NDP objectives to procure raw materials of acceptable quality at the most competitive prices led to a sharp decrease in the prices of raw materials and, in turn, to a fall in Maximum Retail Prices (MRP) of finished drugs.
Drug manufactures total profits have also gone up, because of the increased volume of production, while the unit profit has gone down, to the benefit of the consumers. The NDP and the Drugs (Control) Ordinance, 1982 effectively brought to an end to transfer pricing and over-invoicing for imports of capital machinery, raw materials and packaging materials, which were common practices before 1982.
While these spectacular achievements of the Drug Policy and the Drugs (Control) Ordinance of 1982 were well appreciated, these national documents were not reviewed or updated regularly to keep pace with time and the remarkable developments that were taking place in the medicine world.
Since the introduction of the Drug Policy, in the last two decades, there have been spectacular changes in the socio-economic sectors nationality and internationally. Beside, the world has witnessed remarkable achievements in the areas of pharmaceutical industry, medical science and also in the usage of medicines. Under the umbrella of WTO the global free trade policies are in the offing. To keep pace with the changed circumstances, it has become imperative to modernize and expand our pharmaceutical sector aiming beyond national horizon to the international export markets and also to attract the foreign investment in this sector. The aforesaid perspectives have made it inevitable to update and modernize the present national Drug Policy.
Although the successive Governments strongly felt than an updated Drug Policy should be formulated and the Drugs (control) Ordinance of 1982 should be amended to keep pace with time in order to regulate the drug sector of the country, no effective steps were taken before the present Government came to power in 2001.
Immediately after formation of the Government in October 2001, the Ministry of Health & Family Welfare realized the pressing need for reviewing the Drug Policy of the country and updating the Drugs (Control) Ordinance of 1982. The process got momentum when the Honorable Prime Minister reiterated the Government’s determination to review and update the policy and the Ordinance in various meetings with the experts and the professionals related to pharmaceutical industries in different times. The Ministry of Health and Family Welfare was given the responsibility to take immediate necessary measures to review and update the Drug Policy and to amend the Drugs (Control) Ordinance of 1982 accordingly.
The Ministry then constituted a National Drug Policy Review Committee with members from all relevant sectors. After a thorough discussion over a period of about two years the National Drug Policy Review Committee decided that an updated policy should be formulated including all the relevant and useful elements of the 1982 Policy and incorporating necessary changes, updated information and new elements in the new Policy and the Drugs (Control) Ordinance be amended accordingly in order to properly deal with the changes and developments that have taken place in the drug sector over this long period of time. The National Drug Policy 2005, which has been formulated now to meet the requirements of the current needs of the country, is thus an updated version of the National Drug Policy of 1982. The present Policy has been formulated.
i) to make it more applicable, effective and adaptive to the remarkable technological advancements that have been made in the medicine world.
ii) to guide the Drug Sector of the country to perform better in the competitive world market.
iii) to make the country a producer and exporter of good quality drugs in the world.
Objectives and Elements of the Policy:
While the above mentioned achievements are impressively by themselves, there are certain areas in the drug sector of the country. Which need immediate attention. Although many pharmaceutical manufactures of the country have commendable records of adherence to the current Good Manufacturing Practices (CGMP), there are still ample scope and needs for further improvement in many of them. Connected efforts of all the manufactures to adopt CGMP will ensure availability of adequate quantities of safe, efficacious and useful drugs in the country at affordable prices. The present Drug Policy is thus formulated in order to achieve the following objectives.
a) to ensure that the common people have easy access to useful, effective, safe and good quality essential and other drugs at affordable prices.
b) to strengthen the Directorate of Drug Administration by raising its status to that of a Directorate General of Drug Administration with corresponding increase in its manpower and intra-structure faculties to make it more effective as a Drug Regulatory Authority (DRA)
c) to update, from time to time, the criteria of restriction for import of all systems of medicine in line with the quality guidelines followed in developed countries to ensure safety, efficiency and usefulness of such medicines.
d) to provide, on a priority basis, required services and facilities to local drug manufacturing industries of all the recognized system of drugs so that self-sufficiency is attained in the manufacture of both drugs and pharmaceutical raw materials.
e) to exercise government control over advertisement so that common people are not hood-winked by commercial advertisement on drugs and health matters.
f) to encourage all local and foreign companies to manufacture good quality essential drugs in adequate quantities in the country.
g) to ban the manufacture, sale and distribution of counterfeit, adulterated and sub-standard drugs and to award exemplary punishment to persons guilty of such actions.
h) to strengthen the system of procurement, storage and distribution of drugs and medicines so that these are accessible to people in all areas of the country.
i) to allow manufactures to manufacture, distribute and sell drugs by their Generic or Formulary names and Trade or Brand names (except in Homeopathic Medicines) as appropriate for best identify of the product.
j) to continue the current system of controlling prices of the commonly used essential drugs as listed and updated from time to time by the Government.
k) to encourage foreign manufacturing to invest, manufacture and sell drugs in Bangladesh with corresponding assurance of transfer of new technology and technical knowledge in the country.
l) to ensure that no discrimination is made between the local and multinational companies, which have manufacturing plants in Bangladesh while applying the principles of this policy.
m) to encourage both local and multinational manufactures to establish full-fledged research & Development (R&D) facilities in the country.
n) to encourage investors to set up facilities for manufacturing pharmaceutical raw materials in the country.
o) to encourage collaboration between universities, research institutes and manufactures for undertaking basic and applied research in medicine, pharmacy, biotechnology, genetic engineering and biomedical science.
p) to ensure rational use of drugs (RUD) by proper counseling and motivation of both the prescribers and the ender users.
q) to ensure proper monitoring of Adverse Drug Reactions (ADR) in the country by motivating the physicians and the patients to report cases of adverse reactions of drugs.
r) to put emphasis on training of the people working in the Directorate of Drug Administration and in the quality Control and Production departments of the manufacturing units.
1. Laws and Regulations:
Relevant Laws and Regulations commensurate with the prevailing circumstances usually control and regulate production, distribution, sale and use of drugs in a country and ensure that they are of good quality, efficacious and safe. Currently, the Drugs Act, 1940 (XXIII of 1940) and the Drugs (Control) Ordinance, 1982 (Ordinance No. VIII of 1982) regulate the process of registration, manufacture, distribution, sale, import and export of drugs in Bangladesh. These drug regulatory legal instruments of the country are now quite old. They should be updated through necessary amendments to keep pace with newer developments in the drug sector. Similarly, the Rules made under the above Act and Ordinance should also be updated and integrated into one set of Rules.
if the functioning of these laws and regulations and their compatibility with other laws, either under the responsibility of the Ministry of Health & Family Welfare or other Ministries and Departments, affect implementation of the different aspects of the NDP, they should be amended accordingly.
2. Drug Regulatory Authority (DRA):
A strong administrative set-up is essential for effective management of the various aspects of the drug sector of a country. The Directorate of Drug Administration of Bangladesh has a very limited number of qualified technical personnel and totally insufficient infrastructure facilities to effectively perform the various functions of the regulatory authority.
Strengthening of the Drug Regulatory Authority (DRA)
The following measures should be taken for the strengthening of the DRA:
i) The status of the Directorate of Drug Administration (DDA) should be raised to that of the Directorate General of Drug Administration (DGDA) with corresponding increase in its manpower and infrastructure facilities.
ii) The organogram of the DGDA should accommodate all lawful systems of drugs and regulate them under unified control.
iii) The regulatory responsibilities should be delegated to different Directors under DGDA to expedite and facilitate the functional processes.
iv) The decision making processes should be guided by the objective, non-discriminatory and transparent guidelines and procedures.
v) The staff of the DGDA should be adequately trained, have clearly defined functions and powers, and be entrusted with responsibility in relation to all aspects of registration, manufacture, storage, distribution, sale, import, export and quality of drugs in order to ensure compliance with the laws, rules and regulations.
3. Drug Registration:
All drugs and medicine and other medicinal substances in finished. Dosage forms, which are manufactured imported, distributed, marketed or consumed in the country, must be registered with the Drug Regulatory Authority (DRA) of the country in the specific dosage form and strength as recommended by the Drug Control Committee (DCC).
However, the Licensing Authority may allow manufacture of any drug in any dosage form and strength for export purpose only as per the requirements of the importing country.
a) Selection of Drugs for Registration:
i) Selection of a drug either for manufacture or import is one of the important functions of the National Regulatory Authority (NRA). For this purpose the current system of having a drug registration advisory committee, i.e., Drug Control Committee (DCC) which comprises of experts and professionals from all lawful systems, should continue.
ii) Quality, safety efficacy and usefulness should always be the predetermining criteria for approval for sale of pharmaceutical product.
iii) The Directorate General of Drug Administration, in consultation with the experts committee formed by the government, will prepare a list of non-prescription (OTC) drugs that will be updated from time to time.
b) Registration Criteria:
i) As a general principle, registration for manufacture, import and sale of combination drugs other than those of Unani, Ayurvedic & other Herbal preparations, vitamins and nutritional preparations should not be allowed in the country.
However, combinations like vitamins, nutritional preparations and other drugs which are therapeutically useful and are registered in the developed countries could be considered for registration.
In case of the Homeopathic system also, registration for manufacture, import and sale of combination medicines shall be allowed according to the principles of Homeopathy.
ii) In case of imported allopathic drugs, the manufacturing site will be inspected for GMP validation by the inspectors of the drug regulatory authority of Bangladesh. The inspections will be schedule by the DRA and the concerned manufactures will bear the cost of any such inspections. However, the inspections will not be a bar to the consideration of a new drug application manufactured in a developed country included in the list of the Licensing Authority.
iii) Bioavailability and bioequivalence data will be considered as important criteria for the registration of any imported medicine.
iv) Any Unani, Ayurvedic or other Herbal drugs included in the official Formulary of other countries, if considered essential and useful by the National Unani, Ayurvedic & Herbal Formulary Committee, may be granted registration for manufacture and sale in the country. National Unani, Ayurvedic & other Herbnal Formulary Committee will be constituted by the government with the experts on Unani, Ayurvedic and Herbal drugs.
v) Registration for Mother Tinetures, Crude Triturations and 1 X potency of 12 Biochemic medicines will be required but no registration will be required for further potentization of the Homeopathic and Biochemic medicines.
vi) For th eregistration of Homeopathic and Biochemic medicines the quality standards, set in the Homeopathic and Biochemic pharmacopoeias accepted in the developed countries, will be followed. Products will be registrar by the Licensing Authority (Drugs) based on their safety, quality and usefulness.
vii) Liquid dosage forms of Unani, Ayurvedic and other Herbal drugs, that contain up to 50% (v/v) of 96% ethanol may be allowed to be registered, if useof such high proportion of ethanol is absolutely needed for their better efficacy and keeping quality. However, in exceptional cases, use of ethanol up to a maximum volume of 10% (v/v) may be allowed, if recommended by the DCC.
viii) Certain drugs, inspite of their known serious side-effects and possibility of being misused, may be registered for import, production and sale in limited quantities for restricted use.
c) Registration Procedure:
The current procedures adopted for registration of drugs of all the recognized systems, as specified in the existing laws, should continue after modifying or upgrading them as appropriate. But efforts should be made to develop methods for expediting the process of registration.
4. Drug Production:
i) One of the main objectives of the NDP is to produce good quality drugs in the country. The Current Good Manufacturing Practice (CGMP) guidelines of WHO should thus be strictly followed in the manufacture of drugs in the country. In order to ensure strict compliance with the requirements of CGMP, all drug production units should be subject to regular inspection by the Inspectors of the Directorate General of Drug Administration. The manufactures will also be expected to conduct periodic internal CGMP audit following the standard check-list of the Directorate General of Drug Administration.
ii) Another main objective of the NDP is to ensure self-sufficiency in all types of drugs. Therefore, all necessary measures should be undertaken to ensure that the current trend of increased rate of local production of drugs is sustained and further improved.
iii) Priority should be given to production of adequate quantity of essential drugs. Efforts would be made to ensure that all the essential drugs and non-prescription (OTC) drugs (lists of which are appended to this policy) are manufactured in the country in sufficient quantities and they are available at affordable prices.
iv) Foreign and multinational companies will be allowed to invest and manufacture drugs in Bangladesh as long as they have at least three of their original research drug products registered in at least two of the following countries; USA, UK, Switzerland, Germany, France, Japan and Australia.
v) Manufacture of drugs that are not included in the last five editions of the British Pharmacopoeia (BP) or United States Pharmacopoeia (USP) or International Pharmacopoeia (IP) or the British Pharmaceutical Codex (BPC) or in the WHO lists of the International Non-proprietary Names (INN), will be prohibited.
vi) In order to encourage transfer of technology and availability of the newly developed drugs, foreign companies, with or without having manufacturing plants in Bangladesh, will be allowed to manufacture drugs in the country under licensing agreements with any partners of their choice if the drug in the same brand name is registered and marketed in at least two of the following developed countries; USA, UK, Switzerland, Germany, France, Japan and Australia.
vii) Only for marketing outside Bangladesh, foreign companies without having manufacturing units in Bangladesh will be allowed to manufacture drugs in the country under toll/licensing agreement with any partner of their choice.
viii) The task of producing Unani, Ayurvedic and other Herbal drugs will lie solely with national manufactures with a view to attaining self-sufficiency in respect of local resource based drugs.
ix) Both local and foreign companies having manufacturing plants in Bangladesh will be allowed to manufacture drugs under toll/contract manufacturing arrangements at any other manufacturing plants of their choice.
x) For the purpose of export only, any drug may be allowed to be produced in the country in accordance with the specific requirements of the importing country.
5. Drug Procurement:
i) Drugs and pharmaceutical may be procured by government by local purchase or import, and by receiving as donation or gift. Unregistered drugs and pharmaceuticals should be avoided in case of import, donation and gift received by the Government in emergency situation. However, in emergency situation these types of drugs and pharmaceuticals can be received with the prior approval of DGDA.
ii) Drugs for personal use of individual patients or to meet any national emergency situation or for the purpose of research and clinical trials or for any other specific use, which are not registered may be imported with prior approval of the Licensing Authority (Drugs) for specific quantity and for non-commercial purpose.
iii) All procurements by the public sector should normally be made directly from the manufactures through open tenders in generic names.
iv) To reduce dependence on imported drugs, the local pharmaceutical manufactures will be offered necessary cooperation to produce quality medicines in adequate quantities. The drugs registered for import in Bangladesh may be imported subject to prior approval of the Drug Regulatory Authority. The recently innovated life-saving drugs will be preferred while considering registration of drugs for import. The application for registration of a drug for import will be taken into consideration only if the drug is registered under the same brand name in at least one of the following developed countries: USA, UK, Switzerland, Germany, France, Japan and Australia.
v) To reduce the cost of procurement of drugs produced locally, the production of active pharmaceutical ingredients will be encouraged through offering various facilities including setting up of a dedicated industrial park.
vi) To encourage transfer of technology the foreign investors will be encouraged to produce locally the active pharmaceutical ingredients of their innovative life savings drugs.
6. Drug Distribution, Sale and Storage:
Prompt and safe distribution and ethical sale of drugs from public/private storage facilities to the end-users should be ensured so that the quality of the products is maintained throughout the whole process and good quality essential drugs are always available to those who need them.
i) Only the drugs, which are registered in Bangladesh should be allowed to be distributed and sold in the country.
ii) No person without having professional qualification or holding valid professional licence should be allowed to stock, distribute or sell drugs and medicines.
iii) No drugs or medicines, other than non-prescription (OTC) drugs, should be sold or dispensed without prescriptions.
iv) Maintenance of quality and safety of drugs in retail outlets and in storage should be ensured by carrying out regular checks by Inspectors of drugs on the quality of stored drugs at all levels.
[Note: Please download the pdf to view the full document]