Govt eases drug export norms

MUMBAI, MAR 17: The commerce and chemicals ministries are believed to have convinced the Drugs Technical Advisory Board DTAB to roll ba...

MUMBAI, MAR 17: The commerce and chemicals ministries are believed to have convinced the Drugs Technical Advisory Board DTAB to roll back several of the conditions laid down for the export of new drug molecules. The new norms, now down to around six from 16, are expected to re-open the gate for domestic drug exporters.

The diluted conditions for export of new drugs comes alongside a health ministry attempt to clear all pending export approval cases on a priority basis.

Industry sources in the capital said the six conditions stipulated include details of the export order/manufacturing premises, details on responsibility on quality aspects and maintenance of records on exports/manufacturing so that inspection could be done by the state drug authorities. Besides, exporters will also have to undertake not to divert export-bound drugs to the domestic market. No official confirmation was, however, available on the norms.

Sources say export permission will, however, be denied if the drug in question has beenbanned in the country of import. Most of these conditions, they say, are routine and more-or-less in line with the general requirements for any export consignment.

The commerce ministry had earlier expressed concern over the possible negative impact on drug exports in 1997-98 these stood at 1,370 million following 16 conditions laid down by DTAB. These included 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.

The local drug industry had been hit by an quot;unwritten banquot; imposed by the health ministry on exports of new drug molecules not registered in the country since the second half of 1998. Exports of a host of new molecules like pantaprazole an anti-ulcerant, carvedilol a cardiovascular drug, celecoxib for arthritis, trovafloxacin an anti-bacterial are believed to have been hit due to this diktat.