GMP fixes questioned in India vax plant restarts

The closing of three state-run vaccine plants in India appears to have been both preceded and followed by hasty decision-making. The shuttering of the aging facilities followed the finding of violations of WHO manufacturing practices.

The plant licenses were revoked in January 2008, and a new report by a parliamentary panel says a rehab and reopening of the plants was "not envisaged by the government." Yet a health official last March asked the government to restart the facilities "immediately" and bring them up to quality standards, as reported. Two of the plants were in operation as of last month, as reported, with the third well on its way.

But the parliamentary report writers say the central government has no roadmap to revive the plants. And a local press report finds that, despite the restarts, the government is "still not serious" about resolving the GMP matters.

- see the article

Suggested Articles

A biotech that worked with a nutritional products maker on the API for its clinical-stage radiation drug, is buying all of the manufacturing know-how.

Merck KGaA is selling a manufacturing site and its Allergopharma allergy drug business as it focuses on newer meds.

In a first, the FDA and Indian oversight agencies worked together to block illegal drugs from entering the U.S.