The Indian pharma industry has seen its reputation and sales slip in the face of FDA actions against some of the biggest drugmakers and a barrage of criticism of its regulators. The government and industry have already responded with a PR campaign, and now India says it will spend more than $500 million to double its inspection staff and upgrade capabilities.
The Indian system works on two levels, with the central government approving and overseeing manufacturing facilities for the first 4 years, at which point oversight transfers to state authorities. The 30 billion rupees ($511 million) will be spent over three years to increase the number of inspectors in the central government to 1,000 from 500 today, and as many as 3,000 at the state level, Drugs Controller General of India G.N. Singh said Wednesday, The Economic Times reports.
"While following a zero tolerance policy for any laxity, the government will more than double the number of regulators in three years and set up state-of-the-art testing labs at ports to ensure the pharmaceuticals and drugs exports shipments meet global quality standards," Singh told reporters.
The top regulator was speaking at iPHEX 2014, an event organized by the industry with government support to promote its capabilities. Regulators from around the world were invited to attend and visit production plants in the country to see for themselves that things are better than reports suggest. The newspaper said Singh and his cohorts were meeting with regulators from about 40 other countries.
The iPHEX meeting is being used to try to counter the impression that India's generic drug industry is not meeting high standards. That impression has grown among some U.S. physicians this year in the wake of highly publicized FDA actions against a number of India's largest drugmakers. The FDA banned four of Ranbaxy Laboratories' 5 FDA-approved plants from shipping to the U.S., including two in the last year, over quality concerns. In fact, its long-running problems have led the company to agree to be sold for $3.2 billion to Indian drugmaker Sun Pharmaceutical, which also had a plant banned. Wockhardt, another big producer, had two plants banned in the last year.
During a trip to India in February, FDA Commissioner Margaret Hamburg met with Singh and other top leaders in government and the industry. She pledged cooperation from the FDA and urged the government to do more to ensure that all of its drugmakers were adhering to quality manufacturing standards.
- read the Economic Times story