The Union Chemicals and Fertiliser minister Ram Vilas Paswan's eagerness to mandate bi-lingual labels on drugs is unlikely to materialise in near future as the move could be sabotaged by the Drug Technical Advisory Board (DTAB), according to informed industry sources.
They note that changes in Drugs & Cosmetics Act requires approval of the DTAB and the Health Ministry will have to bring the issue before this expert group to make amendments to the Act. The health ministry is not much enthusiastic about the Chemical minister's move and has pointed out the technical issues that could crop up by the decision. The DCGI's office is more considerate about the manufacturers' practical difficulties in implementing the rules and is in the process of seeking legal opinion on the issue, said sources.
As pointed out by Pharmabiz, the chemical ministry's move is not to have any legal sanctity as the Health Ministry, the administrative ministry for the purpose, is yet to take a view on the whole issue. Despite this, the Department of Chemicals and Petrochemicals has instructed all pharma associations that the process of bi-lingual labelling on drugs should begin from April 18, 2006 and the transition should be completed by October 2, 2006.
Meanwhile, the pharmaceutical industry has demanded the Drug Controller General of India (DCGI) to clarify on the practical difficulties cited by them for printing bi-lingual labels on drugs. They also informed the government that it is impossible for any manufacturer to print the name of the medicine, the cost, the manufacturing and expiry date in English as well as in Hindi on drug labels.
Suresh G Kare, president, Indian Drugs Manufacturers Association (IDMA), in a letter to the DCGI noted that as per Rule 96 of the Drugs and Cosmetics Act related to 'Manner of Labelling', it is necessary to give the generic name in the label. In that case, the DCGI should clarify that whether the generic name of the drug in Hindi should also be carried on the label. "We would like to know whether the generic name in Hindi should be more conspicuous than the trade name on the innermost container and every other covering in which drug is packed as per 'Rule 96 (1) I(A)," said Kare.
Dara Patel, secretary general, IDMA said the association is awaiting response from the DCGI on the issue for further action and has informed him about the apprehensions of the industry.
The Organisation of Pharmaceutical Producers of India (OPPI) has also taken a similar stand on the issue. "The move is neither to benefit the consumer nor the manufacturer. Our reality is that 300 million Indians do not know how to read and write. Though Hindi is our national language, most of the people in many states lack knowledge on Hindi. More than that, our doctors write prescription in English. I think these are politically motivated populist announcements than any effort to better our healthcare delivery system," Ajit Dangi, secretary general, OPPI, told Pharmabiz.
He noted that the import of life saving medicines is increasing and it is impossible to ask manufacturers in different locations around the world to print drug labels in Hindi. Further, many imported drugs have to be kept in the cold chain and potency could be affected when these medicines are taken out for adding new labels.