State regulators asked to boost efforts to monitor drug quality

India's drug regulator has asked state-level watchdogs to increase efforts aimed at monitoring the quality of medicines sold in the country, a top official has said.

"We have told the state drug controllers to keep a close watch on the quality of medicines being made and marketed in India," G.N. Singh, the Drugs Controller General of India (DCGI), told Business Today recently. "They (the state drug controllers) are taking extra care and I am in touch with them on this on a regular basis."

Singh, who heads the Central Drugs Standard Control Organization, said that efforts were being made to increase monitoring across the country and wherever required, the DCGI would get involved and support state regulators. He said that 2014 will be dedicated to "patient and animal safety". He added that all drug manufacturers have been told that if at any time, a watchdog in a highly regulated market like the US flags any concern over the practices of a company, the manufacturer should bring it to the notice of the concerned state drug controller and the central regulator.

The remarks gain significance in the light of some leading Indian drug companies such as Wockhardt and Ranbaxy coming under the scanner of the US Food and Drug Administration over manufacturing practices at several factories. FDA Commissioner Margaret A. Hamburg, in her recent visit to India, had also announced plans to work closely with Indian drug regulatory authorities.

Meanwhile, the Food and Drug Administration of Maharashtra has issued three show-cause notices to Wockhardt between February 11 and March 14. The notices relate to issues such as handling and storage of raw material, data integrity and possible violation of some provisions of the Indian Drugs and Cosmetics Act and licencing conditions, Viraj T. Paunikar, Joint Commissioner at the state regulatory agency, told BT. 

The notices were issued to the company's three units in Aurangabad-two at Waluj and one at Chikalthana. Wockhardt Chairman Habil Khorakiwala, when contacted over the phone, said he was not aware of any such development, though Paunikar pointed out that the company had responded to some of the earlier notices, which were being examined.

R.L. Meena, the drug controller in Andhra Pradesh, said that, six months ago, a committee on good manufacturing practices had been formed under the initiative of the DCGI with some drug controllers like those in Orissa, Chandigarh and Hyderabad as its members. This committee, he said, had last month submitted its recommendations to the DCGI.