Indian plan to link patents and generic approval stirs controversy

India’s Drugs Controller General (DCGI), Surinder Singh, said that he did not intend to approve marketing applications for cut-price generic versions of drugs that have a patent in India. The DCGI’s plan, which is yet to be finalized, is expected to help the innovator companies with valid Indian patents to launch a product without having to take on cheaper generic versions from domestic firms that have previously challenged the innovator’s patent.

Although the Organisation of Pharmaceutical Producers of India (OPPI), which represents several multinational firms, welcomed the DCGI’s initiative, the Indian industry has voiced its reservations on the issue. The Indian pharma industry contended that the system of patent linkage would require enormous resources and has been rarely adopted in the world. It also questioned the need for the patent linkage system as it is also not one of TRIPS obligations.