Prescribing By Generic Names – Possible Problems In South Asia
Correspondence Address :
Dr. P. Ravi Shankar KIST Medical College
One of the central tenets of using medicines rationally is to prescribe by generic names. There are a number of advantages with generic prescribing, but there may also be certain problems. The authors aim to highlight some of these problems in a South Asian context.
India is a major medicine manufacturer in South Asia and the world. There is a significant Indian influence on the drug markets in Nepal, Sri Lanka, Maldives and Bhutan. Before 2005, in India, molecules marketed by one company could be manufactured by another using a different process without infringing on the patent(1). Drugs manufactured by this procedure may be correctly termed as â€˜branded genericsâ€™. They were marketed at a fraction of the cost of the innovator brand, drug prices were kept low and it was ensured that medicines were affordable. After 2005, India introduced product patents for new molecules in compliance with TRIPS guidelines. So, â€˜newâ€™ medicines cannot be â€˜reverse engineeredâ€™ and may not be cheap. Only a few manufacturers in India manufacture â€˜genericsâ€™ in the classical sense of the term, and in Nepal, â€˜genericsâ€™ are not being manufactured to the best of our knowledge. There is also significant variation in the cost of different brands of the same medicine(2).
The non- availability of generics may cause problems when doctors prescribe by the â€˜genericâ€™ name. We are of the opinion that doctors may prescribe using generic names in hospitals which run their own pharmacies, and have a functioning drug and therapeutics committee (DTC). The pharmacy can then dispense either generic medicines or brands which have been approved by the DTC. However, many hospitals do not have DTCs, and pharmacies are run by external agencies on contract. In this situation, if the doctor prescribes by the generic name, then the pharmacy (either inside or outside the hospital) will substitute a brand of the drug which gives them the maximum commission. The manufacturers of low quality medicines are able to offer a better commission because of the low input costs of raw materials. The bioavailability of certain medicines is dependent on the formulation. Use of alternate brands can alter bioavailability. Also, the formulation techniques practiced by certain companies may be suboptimal, leading to problems with the medicines.
Independent information on medicines is not easily available. Doctors and prescribers lack access to information on the prices of drugs (medicines) manufactured by various companies. Patients should also have access to cost and quality information of medicissnes. China and India are among the largest manufacturers of counterfeit medicines. Even well known brands are being counterfeited, and the risk would be much more if prescribing is done by generic names. With Good Manufacturing Practice (GMP) certification, quality of medicines has been assured to a certain extent. However, doubts remain. In this scenario, the classical advice to prescribe by generic names warrants a closer and more detailed look! Prescribing by generic names remains the gold standard but these problems should be resolved if maximum benefit is to be derived.
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