The national survey on spurious and not-of-standard (NSQ) quality drugs should be conducted at least once in two years, said Dr BR Jagashetty, former National Advisor (drugs control) to ministry of health & family welfare, and former Karnataka drugs controller.
The recently concluded national survey held between April 6 and 10, 2015, where drug samples were picked up at random from pharmacy outlets across the country, would have its test reports to indicate the correct the quantum of spurious and NSQs. The national survey model was actually provided by Dr. Jagashetty when he was nominated as chairman of such a committee to frame a model to detect the extent of spurious and NSQs drugs.
Pharmabiz had earlier reported that the National Institute of Biologicals (NIB) had issued a circular for the constitution of two Core Groups to conduct a scientific study on the extent of problems on spurious drugs and NSQs. For the core group to plan and devise the survey plan, NIB identified Terms of Reference (ToR) to develop statistical drug sampling and a methodology in consultation with Indian Statistical Institute, New Delhi.
The meeting convened on November 15, 2013 discussed the design and modalities to be adopted for such a study at the national level as per the circular issued by Dr Surinder Singh, director, NIB and nodal officer of the project who was the former Drugs Controller General of India (DCGI).
The circular issued via No. N1-26/2013 NIB Drugs, stated that first core committee for planning and designing the survey plan and its implementation was chaired by Dr B R Jagashetty, former Karnataka drugs controller.
In Karnataka, a drive to detect spurious and NSQs drugs was being implemented under Dr. Jagashetty’s supervision. This project involved the non governmental organizations (NGOs) who could identify any chemist and druggist outlet to pick up samples and also to nominate their choice of lab to undertake the testing of drugs. This ensured constant surveillance of spurious and NSQ drugs in the market. It was conducted once in six months during his tenure.
Under the recently concluded national survey on spurious and NSQs held last week, officers from across the CDSCO and state drugs control departments were trained.
From the Karnataka drugs control office, Dr N Vadivelu, deputy drugs controller was posted as observer for the Kashmir region.
The target for samples in 15 drug categories was estimated at 45,000. “We feel that such a national survey needs to be mandated once in two years if not annually to keep poor quality drugs at bay. Further, it would also keep the pharma industry on guard to ensure putting in place quality tests and processes to prevent circulation of NSQs. The intent is to ensure zero defect in final drug samples, Dr. Jagashetty told Pharmabiz.
As per the previous survey conducted by CDSCO, it is estimated NSQ drugs in India is between 5 and 8 per cent and presence of spurious drugs is a mere 0.03 per cent.