Indian regulator lays down new standards for its inspectors

FDA Commissioner Margaret Hamburg earlier this year urged India regulators to pick up their game when it came to oversight of Indian drugmakers, noting that the country has become a significant piece of the global supply chain. Some recent indications show that they are taking her suggestions to heart.

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. In May, the Drugs Controller General of India, G.N. Singh, said the government would spend 30 billion rupees ($511 million) 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. Now, India's Central Drugs Standard Control Organization (CDSCO) has issued new guidelines for state inspectors on how to prepare for and handle inspections of drug manufacturing facilities, Regulatory Focus points out.

Among the CDSCO suggestions is that inspections last two to 5 days, depending on the number and complexity of the products manufactured. That compares with the one- to two-week inspections that the FDA usually does at Indian manufacturing plants. CDSCO also said that state inspectors must carry out a minimum of 5 inspections a year.

India's regulations focus on whether drugs work efficiently and are less focused than the FDA on meeting global good manufacturing standards. And most of India's drugmakers don't sell into the U.S. market. But those that do have become substantial players. The FDA says about 40% of the generic and over-the-counter drugs sold in the U.S. now come from India.

The problem is that the FDA has been finding that some of India's largest drugmakers have been playing loose with the rules, particularly when it comes to meeting specifications. A significant number of manufacturers have received warning letters, or even had plants banned by the FDA in recent years after they were found to be faking or manipulating required tests on active pharmaceutical ingredients, or finished products.

Ranbaxy Laboratories pleaded guilty last year to criminal charges admitting that it had done as much at two Indian plants that were shipping drugs to the U.S. It agreed to pay $500 million in penalties to settle charges by the federal regulators here. Those two plants have been banned since 2008 from shipping products here, but since the settlement in May 2013, the FDA has issued import alerts against two more Ranbaxy plants for many of the same problems. The issues have been so troublesome to Daiichi Sankyo, which owns controlling interest in the Indian drugmaker, that it agreed in April to sell Ranbaxy to India's Sun Pharmaceutical.

India's Wockhardt has also had two plants banned in the last year for faking data and this week reported that its earnings for the quarter had plunged nearly 95% compared to the same time last year before the two bans were in place, blocking much of its sales to the U.S.

When Hamburg went to India this year, she pointed out that many of India's drugmakers do have modern facilities that meet cGMP standards but said that those who don't meet the standards have been hurting the reputation of the entire industry.

- here's the Regulatory Focus item
- here are the new guidelines (PDF)
- get more from Pharmalot