The Union health ministry last week came out with a gazette notification banning manufacture and sale of 344 fixed dose combinations which have been in the market for last several years. The FDCs are banned under the Rule 26-A of the Drugs & Cosmetics Act on the ground that these products are likely to cause serious risk to the patients. The ban comes into immediate effect and the affected pharmaceutical companies are expected to stop manufacturing and withdraw the stocks from the market. The wholesalers and retailers are advised to not to sell the banned products. The ministry’s action is based on the recommendations of an expert committee which has found that these drugs are not having adequate therapeutic rationale to be in the market. The products include several commonly used cough syrups, analgesics and antibiotic combinations and many of them are being sold over the counter. The list of these 344 products also has combinations of drugs like nimesulide, cisapride and PPA which have been a cause of concern for long for health experts in India as they were banned in many countries several years ago. Three of the top selling brands affected by the ban order are phensydyl of Abbott, Corex of Pfizer and Vicks Action 500 of Proctor & Gamble.

The ban order is certainly going to hit the revenues and profitability of pharmaceutical companies and trade as these products are widely prescribed, promoted and often purchased without prescriptions for more than 20 years. Opposition to this government action is already visible with the obtaining of stay orders by at least 14 pharmaceutical companies against banning of some of their fast moving products within two days of the ban order. Some of the industry bodies like IDMA and OPPI have already objected to the government decision although they have not gone to the court yet. A druggists & chemists association from Bangalore has, however, urged the government to withdraw the order and reconsider the recommendations of expert committee in the interest of the public and pharma trade. Marketing of thousands of fixed dose drug combinations is perhaps unique in India and does not exist in most of the countries. This has been happening in India as there are independent drug licensing authorities in every state and Union Territories. In a bid to push up the sales, most pharmaceutical companies come up with new products by combining two or more drugs claiming all kinds of therapeutic properties. In most such cases neither the company nor the state licensing authorities assess the therapeutic rationale, efficacy and safety of the combinations. Once manufacturing license is obtained from one state authority, the company can market the product all over the country. DCGI has been advising state drug controllers for several years that the combination of two or more drugs should be treated as a new drug and marketing approval of DCGI needs to be obtained after clinical trials. Therefore for the current situation, both pharmaceutical companies and state regulatory authorities are responsible. Weeding out of bulk of these irrational and harmful combinations was found to be a necessity in the interest of public health and that exercise started by the DCGI some years ago by appointing an expert committee. Here also the cooperation of the pharma companies has been very poor by failing to submit adequate data to prove the efficacy and safety of each combination. The decision of the DCGI now is after a long wait and is justified.