The Ministry of External Affairs is examining the powers available to the Indian drug regulatory agency, the Central Drugs Standard Control Organisation (CDSCO), to inspect the overseas facilities of drug manufacturers doing business in India.
The plan to inspect drug manufacturing plants located abroad that cater to the Indian market has been in the pipeline for a while now. “It is under active consideration,” Drugs Controller General of India, G.N. Singh, who heads the CDSCO, told Business Line .
Even as the US Food and Drugs Administration (FDA) has been monitoring the facilities of Indian drug manufacturers located in India to ensure compliance with current good manufacturing practices, the Indian regulator does not enjoy the same powers.
Following the recent crackdown by the FDA on Ranbaxy’s product, the issue of Indian regulator monitoring the drug business facilities abroad has once again come into the limelight.
CDSCO is likely to send its inspectors abroad to check the manufacturing facilities of Ranbaxy and other pharma firms. “We want to make sure that the products meet our quality standards as well. We are concerned about the medicines being manufactured abroad that are being imported into India,” Singh said.
Recently, the FDA banned Ranbaxy’s Toansa (Punjab) plant from manufacturing medical products for the US market.
Earlier, the US regulator had also banned three other Ranbaxy plants while also serving notices to other companies, such as Lupin Pharmaceuticals and Sun Pharmaceuticals.
Manpower shortageHowever, severe manpower shortage has been a hindrance in proper inspections by the CDSCO, which is responsible for monitoring drug safety, approving new drugs, inspecting manufacturing sites and monitoring clinical trials.
In December, Singh had told Business Line that CDSCO has forwarded a “detailed proposal” to the Central Government to increase the staff strength to at least 5,000 by the end of the Twelfth Five Year Plan.