Around 5000 samples of fixed dose combinations (FDCs) collected as a part of the survey on spurious and not-of-standard quality (NSQ) drugs have been sent to the lab of Indian Pharmacopoeia Commission (IPC) based in Ghaziabad for final testing and analysis. This is a part of national drugs survey which involves 224 molecules under 15 therapeutic categories.
Apart from the FDCs sent to the IPC, sampling of formulations and APIs imported into the country through its 9 notified ports which got recently started by National Institute of Biologicals (NIB) will take three months time to conclude. This is a part of drug sampling done at ports in Delhi, Hyderabad, Ahmedabad, Chennai, Mumbai, Kolkata in collaboration with Indian Statistical Institute (ISI), Hyderabad. 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 with the target of around 1000 drug samples.
Around 43000 samples have been collected encompassing all the retail drug stores including government medical stores, CHCs and PHCs as part of the pan-India drugs survey. These samples have already been sent for testing at drug testing labs across the country. As a part of the survey, field data or samples were 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.
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.