Govt may tighten labelling norms for generic drugs

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In a bid to promote low-cost generic medicines, the health ministry plans to make it mandatory for pharma firms to carry the generic names of drugs in letters that are two font sizes larger than the brand name.

A notification to this effect is likely to come out soon. Once notified under the Drugs and Cosmetics Act, any violation will be punishable under the law.

Fixed dose combinations (FDCs) of vitamins and other drugs containing three or more drugs, will be exempted from the new labelling rules.

“For vitamins and FDCs containing three or more drugs, the brand name or the trade name shall be written in brackets below or after the proper name. The rest of the packs of drugs shall carry the proper name of the drug or fixed dose combination drug at least two fonts larger than the brand name or the trade name,” said a person with direct knowledge of the matter on condition of anonymity.

Earlier, the Drug Technical Advisory Board (DTAB), the advisory body on drugs, approved an amendment to Rule 96 of the Drugs and Cosmetics Act that sought changes in the labelling of drugs to boost generic drugs. Rule 96 deals with the manner of labelling drugs.

The government wants doctors to prescribe drugs by their chemical names in an effort to break the ‘doctor-big pharma’ nexus that often leads to an increase in the cost of healthcare.

The Indian Drug Manufacturers Association (IDMA), a pharmaceuticals lobby group, feels that part of the proposal is unlikely to serve any purpose from a consumer perspective. In a presentation to the health ministry earlier last year, it said that putting the brand name or trade name in brackets on packs will only add to confusion.

“The brand name or trade name to be written in brackets below or after the proper name does not seem to be necessary as it only adds to confusion in interpretation. We are of the view that the requirement of displaying brand name in brackets is not likely to bring in any qualitative change and is not likely to serve any purpose from the consumer perspective,” IDMA said. Minthas reviewed a copy of the presentation.

The government has been pushing for generic drugs for a while now and its efforts gained momentum with Prime Minister Narendra Modi announcing plans to put in place a legal framework in April last year to ensure doctors prescribe generic medicines.

The Medical Council of India (MCI) had also issued orders in 2016 to all central and state government hospitals asking them to ensure that doctors write out prescriptions with generic names of medicines.

“The change in label is another effort in the same direction. Not only are we encouraging doctors to write their prescriptions with generic names, consumers will be benefited if the generic name is legible and easy to be read on the packs,” said another person in direct knowledge of matter, also requesting anonymity.

The move assumes significance as, according to the World Health Organization, India features among the countries with the highest out-of-pocket expenditure on healthcare. Even the National Health Policy admits that 63 million people are pushed into poverty annually owing to healthcare expenses.

“Medicines account for 70-75% of a household’s out-of-pocket expenditure on health. While generic medicines are also good quality medicines and cost much less, the doctor-chemist nexus often pushes people into buying more expensive alternatives,” added the second person cited above.

To push the use of low-cost generic medicines, even the draft pharmaceutical policy last year had proposed that public procurement and dispensing of medicines should be of generic drugs bearing names of salts. The draft suggested a major shift where only the name of salts (active ingredients) would be displayed on the package.

“Branded generic drugs are currently sold like other patented medicines, with their brand names displayed on the packaging. A manufacturer will only be allowed to stamp the company name and the generic name on the packaging and not the brand name,” the draft had proposed.livemint