Large-sized generic namesJune 29, 2018
Generic names must be printed more prominently on the drug label than brand names, govt informs drug makers
The Union government has mooted a proposal to make it mandatory for all generic medicine manufacturers to print the generic names of drugs on the labels larger than the brand or trade names.
Ministry of Health and Family Welfare published a draft notification explaining that “the proper name of the drugs shall be printed in a conspicuous manner which shall be in the same font but at level two font size larger than the brand name or the trade name.’’
The draft notification vide GSR 302 (E) dated 30.03.2017 for amendment of Rule 96 had been published for public comments, Ashwini Kumar Choubey, the Minister of State (Health and Family Welfare), informed Lok Sabha through a written reply. Rule 96 deals with the manner of labelling drugs.
Earlier, the Drug Technical Advisory Board (DTAB), which advises government of technical aspects of medicines, approved an amendment to Rule 96 of the Drugs and Cosmetics Act that sought the labelling changes. The labelling norm for generic drugs is to ensure that the consumer is well informed about the generic medicine, Mr Choubey said.
The new regulation will come in to force after the completion of due formalities as per the provisions of the Drugs and Cosmetics Act, 1940.
Central Drugs Standard Control Organisation (CDSCO), India’s top drug regulatory agency, had met with the stakeholders to emerge a consensus on the issue in December last year.
The generic manufacturers, however, have different take on the issue. At least a section of drug makers are of the view that the proposed changes could hardly yield any benefits. Rather, the new norms can only add more confusion to the consumers, they say.
“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,” said a spokesperson representing an industry lobby group who doesn’t want to be identified.
Even though government has been pushing for generic prescription for a while, it gathered pace with Prime Minister Narendra Modi announcing plans to put it in place a legal framework in April last year to ensure doctors prescribe generic 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,” proposed the draft pharmaceutical policy last year.