Last week, the FDA launched its Drug Controller General of India workshops, during which a senior official argued that quality must be the top priority for Indian pharma companies—and indeed, for all international drug companies.
Drug manufacturers in India accounted for over half of warning letters sent out globally by the U.S. drug safety office in 2013 alone. This number has increased for India, considering the country only received a tenth of all warning letters from the U.S. drug safety office over the last three and a half years.
India is the second largest supplier of over-the-counter and prescription drugs to the United States. Not to mention, the country accounts for 40 percent of drug master files to date and 37 percent of Abbreviated New Drug Applications in 2012. The Economic Times also reported that the number of international firms named in FDA drug recalls, withdrawals, or safety alerts “almost doubled from 19 in 2010 to 36 in 2012 and there had been 32 in just the first six months of 2013.”
While the FDA says some Indian Pharma companies are maintaining cGMP (current good manufacturing practice), there are still some pharma manufacturers of all sizes that are not meeting the terms of cGMP compliance. While most noncompliance instances are inadvertent, there are still a number of reports of deliberate actions. Sun Pharma was one of the most recent cases, when FDA officials reported last November that employees lied about test data and deleted unfavorable results. However, not all FDA regulatory action has aimed at Indian pharma companies as of late. According to Financial Express,a number of large global pharma companies, including Pfizer, GlaxoSmithKline (GSK), Johnson & Johnson, Sanofi, and Amgen, have also been subject to FDA regulatory action in the past few years.
What solutions exist to improve drug quality?
Indian Pharmaceutical Alliance (IPA) secretary general DG Shah said the key to compliance could be peer pressure.
“We want peer pressure also to grow because one incident (import alert from drug regulatory agencies) impacts the entire industry,” he explained to the Business Standard.
When asked about the increased scrutiny of Indian pharma exports by the FDA, Shah said the agency is not only targeting India, but international drug companies as a whole.
In fact, under the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012, the FDA is required to perform the same inspectional schedule for both foreign and domestic drug manufacturers. FDASIA also requires the FDA “to clear the backlog of applications by the end of the first five-year user-fee authorization period.” These new regulations and additional resources will increase the risk-based generic drug inspections conducted domestically and worldwide.
“The US needs Indian pharma products as much as we want our exports to grow to that country,” Shah said. “The U.S. healthcare Bill has been kept within limits only because of the import of affordable medicines from India.”
"It's because of our commitment to protecting the health of the American public that we've been focused on increasing our collaborative efforts and risk-based inspectional activity in India for a number of years already,” FDA Commissioner Margaret Hamburg said in a previous visit.
Hamburg also added that the FDA’s India staff plans to work with Indian companies to identify problems and help them take the proper steps to correct them.