More Indian drug firms fall under US FDA scanner this year

Out of the eleven warning letters issued so far by the Office of Manufacturing Quality of the US Food and Drug Administration's (US FDA) this year, six were issued to India-based drug companies.

While some of the units of major Indian drug companies such as Wockhardt and Sun Pharma have been struggling for a few years now to comply with the ever-increasing stringent current Good Manufacturing Practices (cGMP) norms of the US drug regulator, the warning letters issued this year were for relatively smaller-sized firms.

These include Mylan Laboratories' acquired facility Agila Specialties' units in Bangalore, Hyderabad-based contract testing laboratory Sipra Labs Limited, Ahmadabad-based active pharmaceutical ingredients maker Mahendra Chemicals, Ahmedabad-based Cadila Pharmaceuticals, Bangalore-based Micro Labs and Apotex Research Lab's facility in Bangalore.

In 2014, the Office of Manufacturing Quality had given only five warning letters to Indian companies out of a total of 19 issued. At the receiving end last year were firms like Cadila Pharmaceuticals, Marck Biosciences, Sun Pharma, Smruti Organics and USV Limited.

Normally the FDA issues a warning letter after detailed inspections and giving time to rectify the defects observed in its inspection report. In the case of most of the Indian firms, the violations are not so serious and are related to lack of proper data maintenance or issues with manufacturing processes at plant level.

Mylan CEO Heather Bresch recently told Business Today that Mylan was aware of the manufacturing quality lapses which had happened before its acquisition of Agila Specialties and the company was working closely with the FDA to resolve the issues.

Bresch also noted that more Indian drug companies were coming under the FDA lens because of the huge volume of drug production from the country. Presently the market size of the pharmaceutical industry in India stands at US$ 20 billion and as on March 2014, Indian pharmaceutical manufacturing facilities registered with the US Food and Drug Administration (FDA) stood at 523, highest for any country outside the US, according to the data of India Brand Equity Federation.

"Data management is an important issue for many drug companies worldwide which often attracts scrutiny from the regulators. The FDA does not discriminate against any particular company or a nation", Howard Sklamberg, the US FDA Deputy Commissioner for Global Regulatory Operations and Policy had told Business Today in March, while reacting to allegations that Indian drug companies were increasingly found guilty of poor data maintenance and in many cases falsified data.