Indian protests on data exclusivity

Indian pharmaceutical companies have represented to an official panel that domestic drumakers should be allowed to challenge multinational corporations' marketing approvals if the authority decides to grant data exclusivity because this is an automatic delay in the entry of cheaper local follow-on copies.

The Satwant Reddy Panel, headed by the Secretary of the Chemicals Ministry, may soon pass its verdict on MNCs' demand for banning the use of their data for approving similar formulations from domestic companies. Pharmaceutical majors are required to submit clinical data to the drug registrar that are currently being used in approving local compounds made through short-cut processes, say industry sources.

Indian firms, the sources note, need to show their products are similar to the pioneer drug. "Domestic companies should be given a chance to question the marketing approval if it means a monopoly for the pioneer drug," said Indian Drug Manufacturers Association executive director Gajanan Wakankar. "The most ideal situation is not to allow data exclusivity to MNCs but, if political considerations prevail over economic wisdom, then the safeguard should be added to the ones already included," Mr Wakankar added.