Indian pharma makers wary of U.S. safety bill

Indian pharma makers wary of U.S. safety bill    Indian drug exporters are concerned over possible FDA legislation being proposed by three members of Congress, according to a report Monday in Mint.
   The Food and Drug Globalization Act 2009 would require drug makers to undergo more rigorous inspection procedures, an imposition that would add significant costs.
   “The proposed legislation has drawn a mixed response from Indian pharma manufacturers, some of whom believe that the law, if implemented, could trigger a consolidation in the industry as smaller firms would be unable to absorb the additional costs,” the report said.
   Even larger firms are wary of increased costs.
   “It will definitely impose a higher cost burden on the pharma industry, because of its stringent quality compliance requirements, particularly the new requirements to secure the entire supply chain,” P.V. Appaji, executive director of India’s Pharmaceutical Export Promotion Council, told the newspaper. “But it will also raise our competitiveness on the global stage.”
   A pharmaceutical producer said that if the law is fair, it could be a boon to the country’s industry.
   “As long as it is applied uniformly between Indian and foreign players, it is a welcome step,” said Amar Lulla, joint managing director of the manufacturer Cipla. “As the cost of inspections of manufacturing facilities will now need to be borne by drug makers, only serious players will remain in the field.”
   The bill was introduced Jan. 28 by three House democrats, John Dingell of Michigan, Frank Palone Jr. of New Jersey, and Bart Stupak of Michigan. It would essentially make safety requirements for drug manufacturers in the United States and abroad the same, including ensuring the safety of their supply chains.