Sampling of drugs imported into the country through its 9 notified ports which concluded on September 30, 2015 has collected 5000 samples under the national survey on spurious and not-of-standard quality (NSQ) drugs.
Drug samplings done at ports in Delhi, Hyderabad, Ahmedabad, Chennai, Mumbai, Kolkata in collaboration with Indian Statistical Institute (ISI), Hyderabad covers 224 molecules under 15 therapeutic categories.
Conducted by National Institute of Biologicals (NIB) as per a statistical design, APIs and formulations collected during the survey at ports are in the process of being sent to IPC, Ghaziabad for final testing and analysis. The sampling at ports which was earlier scheduled to be a one-month exercise got further extended to 3 months to accomplish collection of more drug samples in a comprehensive manner.
As part of the national drug survey, around 43000 field data or samples have already been collected from 665 of the total 676 districts of the country based on a statistical design encompassing all the retail drug stores including government medical stores, CHCs and PHCs. These 43000 samples have also further been sent to 7 central drug testing labs and 3 state drug testing labs of the country. Around 1000 drug inspectors from across the country were trained for the pan-India initiative.
Based on this broad-based survey, a focused monitoring can be done by the concerned authorities in these geographical areas for eliminating the menace of spurious drugs. A similar survey in 2009 had revealed that the extent of drugs found spurious was 0.046 per cent only.
In order to assess the extent of spurious drugs and NSQ drugs in a comprehensive manner, the drug regulatory authority - Central Drugs Standard Control Organisation (CDSCO) formulated the survey plan in consultation with NIB for conducting the study. The survey which is a part of the co-ordinated efforts between Centre and the states will help project a clear statistics on spurious drugs, thus clarifying India’s stand on the same with scientific evidence.
The National Sample Survey Office (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. NSSO is an organisation under the ministry of statistics of the government of India which conducts regular socio-economic surveys in the country.