Criteria for recommended withdrawl of products from the Bangladesh market.
The Expert Committee constituted by government Order No.S-DA/D-D-20/82/74 dated 27 April 1982 met at 10.00 a.m. on 28/April 1982 in the office of the Director, IPGMR, Dacca, under the Chairmanship of Professor Nurul Islam for evaluation of the Pharmaceutical products available in the country and to draft a National Drug Policy, keeping in view the health needs of the country.
Consistent with the declared guidelines of Government to provide basic needs of life to the majority of the people through austerity, and to improve the economy of the country and prevent wastage of foreign exchange, the production and/or importation of unnecessary drugs or drugs of marginal value have to be stopped.
Almost any drug may produce unwanted or adverse reactions. The combination of two or more active ingredients not only makes the product constlier, it also increases the possibility of adverse reaction without increasing the efficacy over a single ingredient product. Hence, as a general rule, combinations of similar or dissimilar drugs will be prohibited.
Combination drugs could be approved if the drug company can give definitive, approved scientific proof (ie WHO publications, British national formulary, British Pharmacopeia, European Pharamacopeia, USA or other authoritative guidelines like Goodman’s and Gilman’s. The Pharamcological Basis of Therapeutics’, ‘Current Medical Diagnosis and Treatment’, etc.) of the drugs synergistic action and increased efficacy. They also have to prove conclusively that combining the elements creates no increase of toxicity or side effects nor instability of the compound or shortening of the life of the product.
One of the great sources of drainage of the country’s financial resources is the irresponsible prescribing and marketing and inappropriate self-use of vitamins. Another great wastage of meagre resources is cough mixtures, gripe water, alkali preparations, and digestive enxymes which are of little or no therapeutic value.
It is unanimously decided that the following criteria will serve as the guidelines in evaluating all the registered / licensed pharmaceutical products manufactured and/or imported in Bangladesh.
- The combination of an antibiotic with another antibiotic or antibiotics with corticosteroids or other active substances will be prohibited.
Antibiotics harmful to children (eg Tetracycline) will not be allowed to be manufactured in liquid form.
- The combination of analgesics in any form is not allowed as there is no therapeutic advantage and it only increases toxicity, especially in the case of kidney damage. The combination of analgesics with iron, vitamins or alcohol is also not allowed.
- The use of codeine in any combination form is not allowed as it causes addiction.
- In general, no combination drugs will be used unless there is absolutely no alternative single drug available for treatment or if no alternative single drug is cost effective for the purpose.
Certain exceptions will be made in the cases of eye, skin, respiratory and haemorrhoidal preparations, co-trimoxazole, oral rehydration salts, antimalarial, iron-folic, etc. as well as certain vitamin preparations, allowing combinations of more than one active ingredient in a product.
- Vitamins should be prepared as single ingredient products with the exception of B complex. Members of vitamin B complex with the exception of B12 may be combined into one product. B12 always has to be produced as a single ingredient injectable product. Other members of B complex may also be produced as single ingredient products (eg B1, b2, B6 etc.) Vitamins will not be allowed to be combined with any other ingredient such as minetals, glycerophosphate, etc. It will be allowed to produce vitamins in tablets, capsules and injectable form only.
No liquid forms will be permited because of wastage of financial resources and the tremendous misuse involved. However, paediatric liquid multivitamin (with no B12, E, K and/or minerals) will be allowed to be manufactured in bottles of up to 15 ml size and droppers. Paediatric liquid preparations of single ingredient vitamins will also be allowed to be manufactured in bottles of upto 15 ml. with droppers.
- No cough mixtures, throat lozenges, gripe water, alkalies, etc. will be allowed to be manufactured or imported as these are of little therapeutic value and amount to great wastage of our meagre resources.
- The sale of tonics, enzyme mixtures/preparations and so-called restorative products flourish on consumer ignorance. Most are habit-forming and with the exception of pancreatin and lactase these are of no therapeutic value. Henceforth local manufacture or importation of such products will be discontinued. However, pancreation and lactase will be allowed to be manufactured and/or imported as single ingredient products.
- Some drugs are being manufactured with only a slight difference in composition from another product but having similar action. This only confuses both patients and doctors. This will not be allowed.
- Products of doubtful, little or no therapeutic value and rather sometimes harmful, are subject to misuse and will be banned.
- All prescription chemicals and galenical preparations not included in the latest edition of British Pharmacopeia or British Pharmaceutical Codex will be prohibited.
- Certain drugs, in spite of known serious side-effects and possibility of mixuse, having favourable risk-benefit ration may be allowed to be produced in limited quantity for restricted use. These will be prescribed by specialists only.
- The same or close substitutes of a drug which is being produced in the country will not be allowed to be imported, as a measure of protection for the local industry. However, if local production is far short of needs, this condition may be relaxed.
- A basic pharmaceutical raw material which is locally manufactured will be given protection by disallowing it or its substitute to be imported if efficient quantity is available in the country.
- The role of multinationals in providing medicines for this country is acknowledged with appreciation. In view of the calibre of machinery and technical know-how which lies in their hands for producing important and innovtive drugs for the country, the task of producing important and innovative drugs for the country, the task of producing antacids and vitamins will lie solely with the National Companies, leaving the Multinationals free to concentrate their efforts and resources on those eitems not so easily produced by smaller National Companies. Multinationals will, however, be allowed to produce injectable vitamins as single ingredient products.
- No foreign brands will be allowed to be manufactured under license in any factory in Bangladesh as this leads to unnecessary high prices and payment of royalties. In the light of this policy, all existing licensing agreements should be reviewed.
- No Multinational Company without their own factory in Bangladesh will be allowed to market their products after manufacturing them in another factory in Bangladesh on toll basis.
After approval of these recommendations by Government, the licensing authority for drugs (Director, Drug Administration) will have to issue necessary orders withdrawing/cancelling the licensing/registration of the products, with the provision of a maximum period of six months grace for using up the present stock of corresponding raw materials. Henceforth no raw material should be allowed to be imported for the manufacture of these products. All future licensing registration should be given after evaluation of the products on the basis of the above criteria.