Indian drug regulator to conduct surprise inspections of foreign-owned plants

G N SINGHDrug Controller General of India (DCGI) will soon start conducting surprise inspections of foreign-owned drug plants. The announcement followed the detection of serious quality issues by foreign regulators.

DCGI G. N. Singh, India's top drug regulator, said if foreign regulators could make surprise inspections on Indian pharma companies, then Indian regulator could also conduct inspections on both domestic and foreign drug makers.

Announcing the decision, he said, "There has to be a level playing field. If foreign regulators can make surprise checks on Indian pharma companies, we can do the same for both domestic as well as foreign drugmakers."

A few days back, the U. S. Food & Drug Administration (FDA) banned a Ranbaxy Laboratories Ltd's active pharmaceutical ingredient (API) facility following a follow-up inspection earlier in January.

Earlier, the FDA banned drugs from Ranbaxy's Paonta Sahib, Dewas and Mohali-based plants, citing poor manufacturing practices. The increasing number of Indian drug makers that have gotten crosswise with foreign regulators agency in the recent past has become a matter of concern for India.

However, India isn't the only nation that has suffered due to foreign drug regulators' more intensified inspections in the past few years. The U. S. regulator is also adding in-country inspectors in China.

India is one of the world's biggest producers of generic drugs. This Asian country accounts for nearly 40 per cent of U. S. generic drug products.