India to Withdraw Licenses of Irrational Combination Drugs

Based on a meeting of State drug controllers organized by the Drug Controller General of India (DCGI), over 30 combination drugs have been ordered for removal from the market. In addition, the review of over 1,000 other combinations drugs has also been proposed.

Combination drugs are considered new drugs in India and require prior marketing approval from the DCGI. The DCGI has issued lists outlining the banned drugs, which includes pain-killers, gastro-intestinal medicines, and central nervous system drugs. Manufacturing licenses would also be withdrawn for these banned products.

The DCGI has ordered immediate removal of these banned products without allowing companies the opportunity to establish “rationality” of their combination products. The Indian Pharmaceutical Alliance, an organization consisting of major pharmaceutical firms in India, has proposed an assessment system for these banned drugs. This way, companies would have the chance to present quantitative data and expert opinions to support their combination product. At this point, the DCGI has not made any comments on this assessment system.

The review of over 1,000 combinations would consist of those drugs approved by the State and not the main DCGI. The list includes drugs in various fields, from anti-microbials, cardiovascular, gastro-intestinal, cough and cold, and central nervous system. Many of the companies listed are Indian, though there are a few multinationals such as Merck and GlaxoSmithKline also under review. The Central Drugs Standard Control Organization (CDSCO) has said only irrational combinations would be removed after review.