Karnataka drugs control department has not yet received the order from the DCGI on the ban of phenformin formulations. But the Bangalore District Druggist and Chemists Association is withdrawing all stocks from the 3,000 chemists in the city and the sales were stopped from Wednesday, October 29 2003 following reports of the ban in the media.
According to Dr. Suresh Kunhi Muhammed, drugs controller of Karnataka, the intimation from the DCGI was expected in the next two to three days. Only then the department could spring into action to ensure that the products are no longer manufactured, sold or distributed in the state.
The ban of drugs usually comes under the purview of the Ministry of Health and Family Welfare, and it takes a longer time for the state drugs control departments to be intimated. Usually when a drug is banned a time period is given for phasing out the product. "Only after receiving an official communication, we would be able to plan our method of tackling the situation", said Dr. Suresh Muhammed.
All the drug inspectors will be asked to take immediate steps to ensure that no manufacture or sale are taking place in the state once the order is received, he added.
V Hari Krishnan, president, Bangalore District Druggists and Chemists Association stated that the sale of the product was not that high in Karnataka as most physicians prescribed Metformin and other formulations. For Bangalore alone we were able to inform the chemists over phone. For the 15,000 chemists in Karnataka, intimations will be made by the Federation of Druggists and Chemists, Karnataka, and the State drugs control department.
There are no major companies engaged in the manufacture of Phenformin in Karnataka and most companies preferred Metformin, Gliclazide and Glipizide formulations. Yet, there could be a few loan licensees engaged in the production of Phenformin for US Vitamins, said Krishnan.
It was difficult to identify the actual users of Phenformin at least in the last two years, said a trade source in south Bangalore. Only very few doctors prescribed the drug in Bangalore and they are mostly general practitioners in the outskirts of the city, sources said.
According to a panel of diabetologists from Bangalore Hospital, Manipal Hospital, Bowring and Lady Curzon Hospital, Baptist Hospital, there were prescriptions by doctors in the rural areas who were unaware of the adverse effects in the last three years. There are instances of patients from the districts in Karnataka who were referred to these hospitals with complications and Phenformin was discontinued, informed the doctors.