IGMPI India



FDA brings up the Safety and GMP Issues for Indian Drugs and increasing drug inspectors in India

An alert has been raised by US FDA over the drugs manufactured in India by many Indian and multinational pharmaceutical companies. With around 40 % of generic drugs export, India is one of the largest exporters of drugs in US market. USFDA have inspected many local pharmaceutical companies in India to ensure the safety of the drugs exported from the country.

Over last couple of years, FDA has raised the issues of GMP compliance not being followed by the manufacturing units of Indian industries including Ranbaxy Laboratories and Wockhardt. Among 21 warning letters issued by USFDA in 2013, 10 were sent to Indian companies which are much more as compare to only 1 warning letter among 23 in 2012.

The condition has not improved for Ranbaxy laboratories after being in control of Daiichi Sankyo few years back. The company has seen ban by USFDA on its three facilities in last couple of years and one more plant in this year. Wockhardt limited has also been banned from export of drugs to US market from one of its manufacturing plant.

Evidently, there is a need of improvement in quality standards of Indian drug makers else to face the issue with US regulators. Many Indian drug makers do not agree with the ban imposed by USFDA. FDA head during her visit to India said that If Indian pharmaceutical companies want to sell in the US, they need to comply with our standards, practices and expectations. By working together we can enhance the quality and better ensure the health of public. And FDA experts stressed that the quality of drugs exported to US market will be checked regularly against the stringent manufacturing practices, for the safety of US consumers.

FDA is contriving to recruit seven new drug inspectors in India after the visit of FDA commissioner. During her recent visit to India, main focus was on the quality of drugs and ingredients manufactured in the country for export to the states, especially in light of several US suppliers including Ranbaxy and Wockhardt, having recently been pulled up on a number of GMP violations.