Prescription drugs made in India are coming under increased surveillance from the Food and Drug Administration (FDA), citing safety concerns.
Officials from the FDA recently de-certified the last approved factory operated by one of India's largest drug manufacturers. The agency is banning the sale of many Indian drugs that do not meet standards required of U.S. manufacturers. Most of these are generic copies of brand-name prescriptions. Workhardt Limited and Ranbaxy Laboratories were forbidden from American sales of prescription drugss produced in some Indian plants.
Margaret Hamburg, FDA commissioner, visited India, where she was met with a mixed welcome. While on the subcontinent, Hamburg participated in a roundtable discussion with food and drug manufacturers and exporters. The talk was sponsored by Federation of Indian Chambers of Commerce and Industries. During the discussions, Indian business leaders expressed concern over long approval times for new drugs.
"I told them that every company supplying the U.S. market has the responsibility of ensuring that their products are safe, effective and of high-quality. In my talks with regulators and companies here in India I have placed a great deal of emphasis on why quality matters. As I explained, quality is linked to product safety and without a direct focus on quality, the potential for patient harm increases significantly," Hamburg said.
During the talks, the two sides agreed American inspections of Indian drug manufacturers would be announced ahead of time, and partly paid for by the factories. These companies may also send manufacturing records to the FDA, in place of hosting inspections.
An Office of Pharmaceutical Quality has recently been established by the FDA, as part of a renewed drive to ensure the purity of medicine.
Loss of confidence in Indian drugs is the latest blow to the country to come from federal regulators. The Federal Aviation Administration (FAA) recently downgraded their assessment of the agency regulating commercial flights in India. This led to financial losses for two airlines. Tata Nano, a small and cheap automobile, popular among Indian drivers, does not meet international standards for safety. India is currently struggling, as the nation attempts to balance economic progress with safety concerns. Traffic regulations are routinely ignored around the country, lending an air of chaos to the society. Some observers within the world's second-most-populous country say the west has gone too far with regulations.
Some Indian producers, desiring trade with other nations, began producing goods manufactured to one standard for export, and another for domestic sales. As India trades more on the international market, this idea is no longer proving feasible.
In the short term, recent decisions by the FDA may cost Indian corporations money. By adopting international standards, these corporations may find they are investing in increased trade.
