The ban on export of new drug molecules had caused considerable hardship to the domestic drug industry which faced the threat of losing international business worth crores.

Industry sources said the committee's decision will mean that manufacture and export of new drug molecules would now, probably, only need the approval of the state FDA. At present, all such exports need a specific no-objection certificate (NOC) from the DCGI. Repeated efforts to contact the Drugs Controller General of India on the issue proved futile.

Officials at the DCGI office had earlier maintained that there was no "ban" on the export of new drug molecules, butthat the absence of a provision in the Drugs & Cosmetics Act had prompted them to refer the matter to the law ministry for a correct interpretation. They had also questioned the logic of domestic drug firms securing firm export orders for such drugs before receiving a proper NOC from the DCGI.

Experts here, however, said that the entire issue, even if resolved, had yet to be made official. "Each day matters and industry was still losing time as exports had yet to recommence," an official said.

Earlier, leading domestic drug bodies, the Indian Drug Manufacturers' Association (BDMA) and the Bulk Drug Manufacturers' Association (BDMA) had sought the intervention of the commerce ministry in lifting the "ban".

New drugs like pantoprazole (an anti-ulcerant), carvedilol (a cardiovascular drug), celecoxib (for arthritis), trovafloxacin (an anti-bacterial) and atervastatin and travastatin (both cholestrol reducers) had been hit by the "ban".

INSIGHT:

If the move to allow exports of new drug moleculesis eventually approved by Drug Controller of India (without an NOC), then Indian exports would, in effect, be more or less decentralised. With this the companies would probably be able to hit the export market faster. A host of companies like Ranbaxy, Dr Reddy's, Sun Pharma and Cipla are set to benefit, if the move goes through.