Indian regulators punch up standards as FDA action takes a toll on the industry

The FDA has come down hard on some top Indian generic drugmakers in the last couple of years after realizing that they were cutting serious corners to get drugs to market. And while the infractions have piled up, some, including FDA Commissioner Margaret Hamburg, have wondered where India's inspection overseers have been. Until very recently, there had been no serious consequences dealt out by India's Central Drugs Standard Control Organization (CDSCO), even for Ranbaxy Laboratories, which last year pled guilty to criminal charges in the U.S. for selling subpar drugs. But CDSCO appears to be turning over a new leaf--at least a little.

Vince Suneja

The agency has now issued new guidelines for state inspectors on how to prepare for and handle inspections of drug manufacturing facilities, Regulatory Focus points out. For example, it says that inspections should last two to 5 days, depending on the number and complexity of the products manufactured. That's compared with the one- to two-week inspections that the FDA usually does in India. It says that state inspectors must carry out a minimum of 5 inspections a year.

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

The move comes two months after India Drugs Controller General of India G.N. Singh said the county would invest more than half a billion dollars over three years to make improvements in its inspection process. And that came after Hamburg went to India to meet with top government and industry officials. She stressed the need for them to work more closely with the FDA and other global regulators to improve India's manufacturing standards, given its importance in the world market.

Part of the problem has been that India only approves drugs for sale within the country, and it has a different attitude about what constitutes safety and quality. Former Pfizer ($PFE) employee and pharma entrepreneur Praful Akeli explained those difference earlier this year. He said the fact that Ranbaxy facilities have failed to meet FDA standards does not necessarily mean the company's drugs are ineffective. "The DCGI standards are lower but can we as a nation invest on each facility at par with USFDA standards?" he asked rhetorically. "The almost doubling of costs is something we need to factor in."

But with some of India's biggest drugmakers seeing their sales ravaged by bans that the FDA has imposed on their plants, India's industry is taking note. Some are even said to be looking to building plants in the U.S. to separate themselves from the taint that manufacturing in India has gotten in recent years. The impact of FDA bans were on full display this week, when Wockhardt, which had two plants banned last year, reported that its last quarter profits were off nearly 95%, as access to the U.S. market was sharply curtailed by the bans.

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