Around 350 drug samples collected from 9 ports as a part of the survey on spurious and not-of-standard quality (NSQ) drugs are in the process of being sent to the lab of Indian Pharmacopoeia Commission (IPC) based in Ghaziabad for final testing.
Sampling of formulations and APIs imported into the country through its 9 notified ports recently being started by National Institute of Biologicals (NIB) will take three months time. Drug sampling done at ports in Delhi, Hyderabad, Ahmedabad, Chennai, Mumbai, Kolkata in collaboration with Indian Statistical Institute (ISI), Hyderabad will cover 224 molecules under 15 therapeutic categories.
Earlier sampling of drugs imported into the country was to be done based on a one month survey but got further extended to 3 months to collect more drug samples from the ports expected to hit the target of around 1000 drug samples.
As a part of the survey, field data or samples have been collected from 665 of the total 676 districts of the country based on a statistical design till date. Drug samples have been drawn from healthcare institutions and retail pharmacies from across the country to assess the quality of drugs available to the common man. Collection of 43000 samples have been done successfully encompassing all the retail drug stores including government medical stores, CHCs and PHCs as part of the pan-India survey.
Around 36,000 samples have already been sent for testing at drug testing labs across the country. There are 7 central drug testing labs and 3 state drug testing labs at Maharashtra, Vadodara and Karnataka. Around 1000 drug inspectors from across the country were trained for the pan-India initiative. This broad-based survey would help in identifying the geographical areas where spurious drugs are available so that a focused monitoring is done by the concerned authorities in these areas for eliminating the menace of spurious drugs.
Earlier, a survey to assess the extent of spurious drugs in the country was conducted in the year 2009 by the ministry of health, which revealed that the extent of drugs found spurious was 0.046 per cent only.
The NSSO had asked the state governments to provide information to arrive at a statistical design for the survey like information such as the number of retail outlets (district-wise); information regarding the maximum prescription of drugs under each of the 15 categories including their trade name district wise; number of civil hospital stores (district-wise); number of central medical store (state-wise); and number of Central Government Health Scheme (CGHS) dispensaries throughout the country.
The CDSCO formulated the survey plan in consultation with NIB for conducting a scientific study on the extent of problems of spurious drugs and drugs not of standard quality. Through this initiative between the state and the centre, India will now be able to project a clear statistics on spurious drugs, thus clarifying India’s stand on the same with scientific evidence.