India's biopharma woes grow with FDA Emcure plant ban

India's troubles with pharmaceutical manufacturing widened this week as the U.S. FDA issued an import alert for the Emcure Pharmaceuticals plant in Hinjawadi, citing deficiencies in good manufacturing practices at the site with no specifics immediately available.

A spokesman for Emcure declined to offer any comment when contacted by phone. The company makes and markets drugs used in cardiology and gynecology therapies, among others.

For India, the latest import alert builds on other quality woes in biopharma. Last week, Indian CRO Quest Life Sciences of Chennai saw the results of a clinical trial of HIV drugs rejected by the World Health Organization after an inspection found poor clinical practices on data and bioanalytical procedures that could not be remediated.

And in late June, India's Wockhardt voluntarily recalled 85,000 cartons of over-the-counter heartburn treatment famotidine tablets, its third product recall in as many months, which followed a U.S. FDA import ban on two manufacturing facilities in India, Chikalthana and Waluj.

Sun Pharma managing director Dilip Shanghvi

India's top drug firm, Sun Pharmaceutical Industries says it will focus on one plant at a time to restore the fortunes of four of the Ranbaxy manufacturing units it bought this year that were also banned by the U.S. FDA--as well as one of its own.

Ranbaxy's units Mohali and Toansa in Punjab, Dewas in Madhya Pradesh and Paonta Sahib in Himachal Pradesh are currently barred from exporting drugs to the U.S., and Sun says it is working to fix its own FDA-licensed facility at Halol in Gujarat.

The cumulative monetary effects of the regulatory crackdowns is not easily calculated, but anecdotally it boosts prices for related products sold in the U.S. and has directly prompted the FDA to increase the number of investigators in the country to 19 from 12, according to Reuters.

Emcure's web site says the company runs nine manufacturing plants, including one in the U.S., and exports to Europe, Brazil and Japan and also markets products with multinationals such as Roche ($RHHBY), Pfizer ($PFE), Novartis ($NVS) and Sanofi ($SNY).

- here's the story from Reuters
- and the FDA notice
- get FiercePharmaManufacturing's take