India’s big drugmakers will need at least five more years to improve their manufacturing standards and data reliability to a level demanded by international regulators, said a senior industry official. The lengthy timeline is a concern not only in India but around the world, as India’s pharmaceutical firms supply a third of the drugs sold in the United States and a large percentage in other countries.
US and European Union regulators have called on India’s $16 billion pharmaceutical industry to step up their efforts if it wants to continue to dominate the generic drugs sector.”When you go plant by plant and want to assess whether something is working or not, this is a time consuming process,” D. Shah, secretary general of the Indian Pharmaceutical Association (IPA), told Reuters late Tuesday. “It may go beyond 5 years as well.”
The IPA, which counts 20 of the country’s largest drugmakers as its members, has formulated a five-year quality improvement plan that includes training employees and automating procedures. Shah said the plan was currently being implemented at six of the country’s top drugmakers, and that it would eventually be rolled out to the rest of the industry.
“We have to train every employee in both manufacturing and quality,” said Shah, noting that it means training 40,000-50,000 employees at just the top six drug companies.
STRUGGLING TO IMPROVE
The industry has struggled to improve their factory processes and train staff since 2013, when major violations were found at India’s then-largest drugmaker Ranbaxy Laboratories . Complaints from regulators have ranged from issues over hygiene and maintenance to concerns over falsifying manufacturing-related test results and data. Dr Reddy’s Laboratories, India’s No. 2 drugmaker, continues to work on resolving data integrity problems found by the FDA in November 2015 at a key plant to produce cancer drugs. While its larger rival, Sun Pharmaceutical Industries, has not been able to get a clearance on two plants sanctioned by the FDA in 2013 and 2014 despite remediation efforts. So far this year, 14 Indian companies have received safety notices from the U.S. Food and Drug Administration, the regulator that has issued the majority of sanctions against its industry.
Shah said IPA was working to ensure “companies do not get faulted on the same thing again and again,” and reach a compliance level that appeases the FDA. Some in the industry say the severity of the issues the FDA has been finding in India has been increasing and that the five-year timeline laid out was too long.
“If companies follow all procedures, they should be able to resolve their issues soon,” said Bharat Celly, an analyst with Equirus Securities. “But if they think they can still get away with altering data and being dishonest with the FDA, they are aggravating their problems.”