The Central Government has retracted from its directive on mandating bi-lingual labels in English and Hindi with a deadline from October 2, 2006, and now says the decision is left to the manufacturers on a 'voluntary' basis.
The Drug Controller General of India (DCGI) is learnt to have instructed the pharma associations to clarify with their members that bi-lingual labelling is not a mandatory provision, citing that some of the Southern States are opposing the idea of printing labels in Hindi. "The requirements as appeared in the press or as circulated by the Department of Chemicals and Petrochemicals are voluntary in nature and there is no legal requirements for such bilingual labelling under the provisions of the Drugs & Cosmetics Act", clarified the DCGI.
Pharmabiz had earlier reported that Union Chemical Minister Ram Vilas Paswan's keenness to ensure drug labels in Hindi and English are unlikely to materialize as changes in Drugs & Cosmetics Act requires approval of the Drugs Technical Advisory Board (DTAB) and the Health Ministry will have to bring the issue before this expert group to make amendments to the Act.
The health ministry was not enthusiastic about the Chemical minister's initiative and had pointed out the technical issues that could crop up by the decision and the practical difficulties for the manufacturers. The Drug Controller General of India also understood the practical difficulties involved in the issues, sources said.
Industry sources said the move was then supported by some of the major pharma associations to impress the Minister and thus escape the proposed move on price control for all drugs under the National List of Essential Medicines (NLEM). Further the move was in the long run a business advantage for the companies focusing the Northern markets. A good percentage of the major drug manufacturers and medium companies have now switched over to the new regime, said sources.
The Pharmaceutical Manufacturers Association of Tamil Nadu, the Confederation of Indian Pharmaceutical Association (CIPI) etc. had vehemently opposed the move to mandate the bi-lingual labels.