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Wednesday, February 24, 1999

Drug board okays export of molecules covered under global patent 

Anju Ghangurde  
Mumbai, Feb 23: The Drug Technical Advisory Board (DTAB) is believed to have cleared a proposal allowing domestic drug firms to export molecules covered under international patents, subject to 16 broad conditions.

The DTAB proposal comes at a time when legal experts have raised doubts over the jurisdiction of its decision-making authority given that the Drugs and Cosmetics Act covers only sale of medicines in the domestic market.

Ministry sources indicate that the DTAB, which met in the capital on Tuesday, has decided to allowe such exports subject to a host of conditions like validating the quality of the export product in government-approved laboratories and providing the details of a marketing approval for the export product from each country where the consignment is headed.

Other conditions believed to be stipulated include a stage-by-stage approval from the Drugs Controller General of India (DCGI), though this could not be officially confirmed. The DTAB's recommendations will now be forwarded to the ministry of health for its consideration and approval, though this is usually a mere formality.

While the DTAB's approval may seem a victory of sorts for the domestic pharmaceutical industry, indications are that the riders attached to receive an approval for such exports may, in effect, be a major dampner.

"If industry has to seek bureaucratic approvals at various stages for exports orders, besides undertaking to test such products in government labs (it could take as many as three to five months), it could be extremely time-consuming. Overseas buyers are rather strict about export schedules," an official of a Delhi-based drug firm said.

Industry also claims that the pre-requisite of a marketing approval from the country of import will, in effect, seal the fate of exports of new molecules for research and development purposes as well as those made to traders in international markets.

The local drug industry has already been suffering following an "unwritten ban" imposed by the health ministry on exports of new drug molecules not registered in the country since the second half of 1998. The domestic industry has, all along, alleged that the ministry's move has no legal sanctity.

Significantly, the DTAB itself may be headed for a revamp, in what is being viewed as an attempt to widen its representation. Currently the 18-member DTAB (of which the term of around 10 members has expired) has been reduced to an eight member team. The board currently includes an ex-official from the Central Drug Research Institute (CDRI) and a management official of a mid-sized Mumbai-based pharmaceutical firm, besides the Drugs Controller General of India (DCGI).

Copyright © 1999 Indian Express Newspapers (Bombay) Ltd.


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