India is second only behind Canada as a supplier of drugs exported to the U.S, so it's key to this country's drug supplies. But a string of recent plant infractions show it's also a country where many drugmakers, including the largest, have shown a total lack of competence in manufacturing products to FDA standards. That is the "rather daunting challenge" facing Altaf Ahmed Lal, an Indian-born Ph.D., as he takes over FDA operations in that country.
Born in Kashmir, Lal left India for the U.S. in 1980 but said he helped establish the FDA in his native country as health attaché for the U.S. embassy there. In his new role, he says collaboration will underpin his plans. He intends to work with India's drug industry so that drugmakers who are not passing inspections understand exactly what procedures are essential to producing safe and effective products the U.S. will accept. In a post on the FDA blog, he said he sees his mission as threefold: to create trust by working closely with the FDA's Indian counterparts, to conduct prompt plant inspections and to "help industry and regulators understand that protecting the quality, safety and effectiveness of every product is essential." He said he wants drugmakers to ask themselves what specific controls must be in place 24/7 in order to pass their next FDA inspection.
Many Indian companies have not been passing lately. Ranbaxy Laboratories just had a third Indian plant banned from shipping to the U.S. only four months after it pleaded guilty to felony charges and agreed to pay $500 million to settle regulatory actions that have been going on for years. Wockhardt, another big generics producer, also had one of its plants banned recently. There have been multiple warning letters sent to Indian facilities that laid out how plants have been manipulating data so it appears drugs have met specifications, then tried to hide the deceptions from regulators. Employees at Fresenius Kabi's oncolytic API plant in Kalyani, India, fessed up that computers and drug testing equipment were removed from the plant ahead of FDA visits to keep inspectors from learning the truth.
The FDA is hiring 7 new employees for the India office, bringing its staff to 19 to handle pharma concerns, as well as device and food oversight. It will now have 10 staff members dedicated to the pharma side. Lal's arrival also comes at a time when the country's top drug regulator, Drug Controller General of India G. N. Singh, has indicated an interest in meeting with his counterparts from other countries in an effort to fully understand their expectations for Indian drugmakers.
Lal said he realizes he faces a mountain of issues in India. In fact, he said a colleague likened his new responsibilities to "scaling Mount Everest." But he said he views it as both a challenge and an adventure, and he's "eager to be part of it."
- read the FDA blog post