New Delhi: Labeling rules for generic drugs are going to become stringent on order to endorse low-cost generic medicines as the health ministry is soon going to come out with a notification, making it compulsory for pharma companies to carry the generic names of drugs in letters that are two font sizes larger than the brand name.
As per a recent Mint report ,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 labeling rules.
Speaking with Mint, a person having direct knowledge of the matter said, “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.”
A modification to Rule 96 of the Drugs and Cosmetics Act had been approved by the Drug Technical Advisory Board (DTAB) that sought changes in the labeling of drugs to boost generic drugs as Rule 96 deals with the manner of labeling drugs.
Last year, in its presentation to the health ministry, the Indian Drug Manufacturers Association (IDMA), a pharmaceuticals lobby group said that putting the brand name or trade name in brackets on packs will only add to the confusion and the part of the proposal is unlikely to serve any purpose from a consumer perspective.
IDMA said, “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.”
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.
“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.