On March 10, the office of Drug Controller General of India came out with the notification banning manufacturing and marketing of 344 fixed dose combinations as it was found to be harmful or irrational drugs. The ban was expected to take immediate effect and the affected companies were to stop manufacturing and sale of these products in the market. The pharmaceutical trade consisting of 7 lakhs of wholesalers and retailers was directed not to sell these products and return them to the respective pharmaceutical companies. After this notification, there were reports that more FDCs are under scrutiny of the DCGI and they will also be banned later. The ministry’s action is based on the recommendations of an expert committee which has found that these drugs are not safe and not having adequate therapeutic rationale to be in the market. The banned products included several commonly used cough syrups, analgesics and antibiotic combinations manufactured by MNCs and many leading Indian companies. The list of these 344 products also has combinations of drugs like nimesulide, cisapride and PPA which have been banned in many countries several years ago.
As the unexpected ban order can seriously affect the sales of several high turnover products of leading pharma companies, challenging that order was not at all unexpected. And within a few days time, 30 companies obtained stay orders from the Delhi High Court against the ban order of their products. This was followed by a petition by the Indian Drug Manufacturers Association against the order on behalf of its members. Probably industry has a reason to oppose the ban order as many of the FDCs were cleared for marketing by DCGI himself a few months back. Such an oversight should not have occurred in matters like this. By obtaining stay orders by the pharma companies and IDMA, a major confusion has been created among the trade and physicians with regard to the sale and prescription of these products. The exercise of returning the banned products by the trade channels to the pharmaceutical companies seems to have come to a halt in many parts of the country. And many members of the trade think that they can continue freely selling the products covered under the ban order. At the same time, no further directions came from the DCGI to the pharma trade after obtaining of stay orders. A large number of the combinations are cough syrups and other OTC products requiring no prescriptions. Medical practitioners who rarely take note of periodical regulatory reviews of the authorities continue to prescribe these controversial products to their patients even now. Until these cases are heard and settled by the Delhi HC, the ban order may not be operative. Considering the ban covers a huge number of fast moving products of several top companies, the office of DCGI should have anticipated legal hurdles before issuing such an order and took appropriate steps to avoid this confusion.