India Drug Regulator Releases Steps To Improve Drug Manufacturing Quality

The Central Drugs Standard Control Organization (CDSC), which oversees drug approvals and clinical trials in India, released a letter last week outlining steps Indian drugmakers need to take to tighten inspection procedures, issue reports, and improve processes for qualifying inspectors. The regulator hopes its effort will increase confidence in the Indian pharmaceutical manufacturing industry globally as well as improve quality domestically, the Wall Street Journal reported.

“The letter is recognition of the inconsistent manner in which inspections of manufacturing facilities have been carried out in the country,” Vince Sunejga of TwoFour Insight, a consulting firm that specializes in the Indian pharmaceutical industry, said. “This inconsistency has resulted in sometimes arbitrary and unexplainable enforcement with consumers ultimately paying the price.”

Sunejga added that this letter could mean a more “hands on and transparent approach to inspections.” Currently there is no official documentation available to guide Indian inspectors. Because of this, inspections are extremely inconsistent and depend on the opinion of the individual inspector or regulator.

India has been racked with concerns about the manufacturing quality issues that have plagued some domestic companies as the FDA continues its crack down on Indian pharmaceutical manufacturing plants, the Wall street Journal reported.  It also has a lot to lose if quality doesn’t improve, considering over a quarter of its pharmaceutical products are exported to the U.S.

But it has been the FDA’s opinion that since the U.S. passed a law which enforced new levies on generic drug makers to help pay for plant inspections in 2012, not enough was being done to ensure quality was being achieved.

As a result, in 2013 the FDA:

• Conducted 111 inspections in India — nearly twice as many as they did in 2009
• Issued warning letters to a number of drug makers
• Issued 21 import alerts, which gives the FDA power to ban imports from certain companies 

In February 2014, FDA Commissioner Margaret Hamburg spent a week in India to meet with 16 drug companies and affiliated groups to address growing drug quality concerns. It was the agency’s opinion that not enough had changed, despite increased scrutiny.

In a subsequent blog, which discussed manufacturing quality issues both in the U.S. and worldwide, she said: "Consumers should be confident that the products they are using are safe and high quality and when companies sacrifice quality, putting consumers at risk, they must be held accountable."

Hamburg also announced that the FDA had plans to expand its inspection staff in India to 19 total to increase oversight in the country, and hoped to work more closely with Indian regulators.