The Commerce Department has come out in strong support of the Indian pharmaceutical industry facing criticism from the media on quality issues following a series of action taken by the US drug controller against top Indian companies.

Debunking media reports on the suspect quality of drugs manufactured in India for exports, the Department has said that the pharmaceutical sector is a highly regulated one and the US continues to be a top buyer of Indian generic or off-patent medicines.

"Statistics reported by Pharmexcil (drugs export council) indicates strong presence of Indian industry in the US and the reports of US FDA penalising Indian companies are only a small aberration," an official release of the Commerce Department said.

Last month, Indian generic pharmaceutical manufacturer Ranbaxy was fined by the US Food and Drugs Administration (USFDA) for selling adulterated drugs in the US. Later in the month, the FDA issued an import alert against Indian drugmaker Wockhardt for violating manufacturing processes in its Aurangabad plant.

Close on its heels, another Indian pharmaceutical major Hospira got a warning letter from the FDA following concerns about contamination of finished drugs at its manufacturing plant in Tamil Nadu.

This led to a series of media reports, both in the country and abroad, raising questions on the quality of low-priced generic drugs being produced in India.

The Commerce Department, in its release, said the allegations were not supported by facts. India is the fourth largest producer of drugs by volume in the world and continues to account for 15 per cent of generics sold in the US in volume terms.

"The pharmaceutical sector is a highly regulated one and exports are heavily guided by various regulatory regimes of the importing countries. There is also a requirement for continuous monitoring of quality related aspects including complaints of sub-standard / falsified drugs from various countries," the release said.

All organisations concerned in the Government are constantly interacting to ensure that India's image as a safe exporter is protected from all angles, the release said, adding that the Government is working with the industry on a "trace and track" mechanism which would enable monitoring of the supply chain possible at the tertiary, secondary and primary levels.

amiti.sen@thehindu.co.in

Related Topics
comment COMMENT NOW