RAMESH KUMAR VERMA (pursuing company secretary course) 18 September 2010

Drug Controller General of India to Scan Foreign Drug Facili

Drug Controller General of India to Scan Foreign Drug Facilities.

Hyderabad: As part of its proposal to inspect manufacturing facilities in countries from where drugs are imported, the Drug Controller General of India (DCGI) has started discussions with the ministry to send drug inspectors to those countries to verify quality parameters. The immediate trigger seems to be the recent cancellation of over 100 import licences due to poor drug quality.

As the first step, the regulator is expected to send inspectors to China and Europe by early next year. Large quantities of drugs are imported into the country from China. For better monitoring of over 8,000 pharma companies, the regulator is also increasing the number of drug inspectors from the current 55 to 327.

According to DCGI estimates, the country imports drugs worth Rs 12,000 crore. “With increasing volumes, we have decided to send our drug inspectors before we grant registration to import bulk drugs. Though there was a provision in the Drugs and Cosmetics Act (DCA) earlier too, it required a lot of budgetary support. But in the current scenario, we are serious in conducting audits before allowing imports and have taken up the issue with the ministry,” Dr Surinder Singh, Drugs Controller General (India) said. “We are awaiting ministry approval for the step and bring more transparency into the system,” he added.

The irony is that Indian inspectors have not checked overseas manufacturing facilities so far while inspectors from the US, European Union, Nepal, Nigeria, Brazil and South Africa regularly visit Indian facilities.

The drug regulator is talking to the government to introduce mobile drug testing vans to speed up drug testing. A pilot DCGI project is on the cards, which would be on the lines of mobile vans in China and the US.

“These are high-tech vans, costing about Rs 4 crore each, which would screen a large number of drugs,” Dr Singh said. He added that drugs sold in pharmacies and manufacturing sites would be considered as part of the random testing procedures. Currently, only about 40,000 drug samples are collected and tested across the country. However, DCGI is planning to increase this to about two lakh samples by next year.DCGI also plans to issue guidelines for regulation of clinical trials, approve ethics committees and lay down norms for sites where clinical trials would be conducted. “We want to establish a robust and dynamic mechanism for clinical trials. Soon, we will dividing the...