Hamburg: Checks & balances
Mumbai, Feb. 9: Margaret A. Hamburg, Commissioner of the US Food and Drug Administration (USFDA), is likely to ask domestic pharma companies to step up their manufacturing and quality control vigilance as she embarks on her maiden, week-long visit to India, which is the second-largest supplier of generic drugs to the US.
Hamburg’s visit is significant: At stake is not only nearly Rs 21,000 crore of pharma exports from the country but also its reputation of being a reliable supplier of generic drugs.
India prides itself on the fact that it houses the most number of plants approved by the FDA outside the US – roughly 150 FDA-approved medical product plants.
But her arrival comes at a difficult time when several pharma companies in India have come under fire from the USFDA because of serious shortcomings in their production and quality standards.
Recently, the USFDA had barred drug imports from Ranbaxy Laboratories’ Toansa facility, citing violations in good manufacturing practices. This is Ranbaxy’s fourth unit that has been barred from exporting to the US.
In November last year, the drug regulator had imposed an import alert against Wockhardt’s manufacturing unit at Chikalthana plant and followed it up with similar action against its Waluj plant in May 2013.
Other firms have also received warning letters regarding manufacturing practices at their units, leading to concerns in some circles that Indian companies are being singled out by the regulator as it supplies low-cost drugs to the developed markets.
Industry circles aver that during her visit, Hamburg is likely to reiterate the USFDA’s agenda in that it will continue to ensure that drugs and other food products exported from India are safe and of good quality.
During the trip, Hamburg will visit New Delhi, Mumbai and Kochi, and meet Indian policy makers and government regulators. She is scheduled to meet India’s drug controller general G.N. Singh.
The Federation of Indian Chambers of Commerce and Industry (Ficci) will host a roundtable discussion with Hamburg on February 11 that Ranbaxy’s chief executive officer Arun Sawhney is scheduled to attend.
Ahead of her visit, Hamburg told Bloomberg in an interview that she was looking to build partnerships in India.
“We cannot possibly screen all the stuff as it comes across our borders,” Hamburg said.
“We cannot even inspect every single facility that’s involved in the manufacture of products or components of products. So, we really need to build new partnerships,” she said.
“We expect the USFDA Commissioner to provide some clarity on what it expects from the domestic companies and point out the areas or gaps that our industry needs to work on. Hopefully, this visit will help in bridging the gap between the two,” said a senior official with a leading pharmaceutical company.
The official, however, admitted that it was wrong to assume that the regulator was singling out Indian companies.
“It (the USFDA) is taking actions against other overseas companies as well. Moreover, one must remember that the stringent practices followed by the USFDA are also beneficial for our industry in the long run as it will improve our manufacturing practices. There are several examples of Indian companies that have successfully adopted corrective actions after they received a warning letter from the USFDA.”
Sarabjit Kaur Nangra, vice-president (research) at Angel Broking, said India is a big exporter of low-cost generic drugs and it will be beneficial for the country if more drug units conform to the stringent FDA standards and do not face penal action.
Nangra adds that Hamburg’s visit could also see domestic drug companies seeking faster approvals for their generic drug applications. “There are issues on both sides that could be discussed. The Indian industry wants quicker approvals from the USFDA. Approvals from the regulator take time (12 to 18 months in some cases) as it is short-staffed,” she added.
She added that many pharma companies have now started employing consultants and conducting regular audits to ensure they meet the tough standards set by the US regulator.
Hamburg isn’t going to visit any drug facilities on her first visit but she is expected to tour a spice firm and a seafood-processing plant.
A study carried out last October that examined dry spice shipments from 2007 to 2009 showed that about 9 per cent of spice imports from India were contaminated with salmonella. In 2010, India was the biggest spice exporter to the US, accounting for about 16 per cent of its spice imports.