Hyderabad: The Drugs Controller General of India (DCGI) Dr Surinder Singh said they are mulling to introduce mobile drug testing vans as part of their drug testing methodologies.
He said they are in touch with their counterparts in the USA-the USFDA, and would soon launch a pilot project. According to him currently, about 40,000 drug samples from across the country are collected for verification. The DCGI is targeting to increase this to about two lakh by next year.
"Drugs that were sold in pharmacies and manufacturing sites would be considered as part of the random testing procedures. Within minutes we will get to know the drug analysis," Singh told media persons on the sidelines of national seminar on `Indian Pharma ndustry- Challenges and Opportunities.`
He said as far as India is concerned spurious drugs were not much of a concern, however standard and quality of drugs is. "Of the 40,000 drugs tested, spurious drug comprise a
mere 0.01 per cent. But about 5-6 per cent of these drugs are those that do not have standard quality and that`s a significant challenge," he said. The Drug controller would issue guidelines for regulation of clinical trials ethics committee 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 be dividing the country into zones to conduct audits of all sites where trials would be
conducted," Singh said.
Currently, only 1-2 per cent of the global clinical trials are done in India as opposed to the US, which takes up more than 50 per cent trials. The DCGI said it would initiate overseas inspection of drugs in countries including China and Europe early next year.
It was awaiting approval from the Union Government that would allow it to conduct audits and certify the manufacturing quality of the pharmaceutical products, it said. Currently, India imports about 12,000-13,000 crore drugs, of which 60-70 per cent are from China.
PTI
