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LATEST NEWS UPDATES | What's in a generic name? -George Thomas & S Srinivasan

What's in a generic name? -George Thomas & S Srinivasan

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published Published on May 12, 2017   modified Modified on May 12, 2017
-The Hindu

The core issues are affordable access to medicines and their rational prescription and use

The Medical Council of India (MCI) issued a circular on April 21 drawing attention to clause 1.5 of its regulations regarding the professional conduct of doctors: “Every physician should prescribe drugs with generic names legibly and preferably in capital letters and he/she shall ensure that there is a rational prescription of drugs.” Further, the circular said, “For any doctor found violating clause 1.5 of Ethics Regulation, suitable disciplinary action would be taken by the concerned SMC/MCI.”

This has caused considerable unease among medical professionals. It appears that the MCI has responded to the statement by the Prime Minister on April 17 that the government intended to ensure that doctors prescribe medicines by generic names only.

Nearly all drugs have three types of names, the International Union of Pure and Applied Chemistry (IUPAC), the non-proprietary or generic, most commonly the International Non-proprietary Name (INN) administered by the World Health Organisation (WHO), and the brand name. Some countries, such as the U.S., Britain and Japan, have their own generic names or approved names.

Once patents have expired, companies other than the original manufacturer can produce and sell the drug. This usually results in significant reduction in costs. These off-patent drugs are called generics internationally. However, the term ‘generic’ has a different meaning in India’s pharma trade. Medicines marketed exclusively with INN names are called generics or generic medicine.

The WHO advocates generic prescribing as part of an overall strategy to ensure rational medical treatment and prescribing tailored to local conditions. In India, there are many barriers to rational prescribing. For example, there are a bewildering number of fixed-dose combinations (FDCs), the vast majority of which have no therapeutic justification. These FDCs account for about 45% of the market (about Rs. 45,000 crore). The British National Formulary lists very few FDCs whereas in India there are thousands.

Of the total domestic pharmaceutical formulations, a market of over Rs. 1 lakh crore, generic medicines, as understood by the pharma trade, account for not more than 10%, or Rs. 10,000 crore. Therefore, even if a doctor prescribes a drug by generic name, the patient will generally end up buying a branded product.

A misinformed debate

It simply shifts the focus of promotional activities to the pharmacists. It is well known that different companies offer different trade margins. There is the moral hazard that pharmacists will dispense the brand which offers them the biggest margin. The current diktat by the MCI therefore will not reduce prices for the consumer.

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The Hindu, 12 May, 2017, http://www.thehindu.com/opinion/op-ed/whats-in-a-generic-name/article18429047.ece?homepage=true


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