Aimed at getting an authentic scenario of spurious and NSQ drugs in the Indian healthcare system, the much awaited national spurious drugs survey has finally been submitted to the Union health ministry for further approval and release.
Samples during the pan-India exercise were 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 in collaboration with Indian Statistical Institute (ISI), Kolkata and Hyderabad and National Sample Survey Organisation (NSSO).
The draft report submitted is the culmination of a pan-India sampling exercise done by the National Institute of Biologicals (NIB) of nearly 48, 000 samples and chemical analysis involving 10 drug testing labs from across the country.
In order to assess the extent of spurious drugs and NSQ drugs in a comprehensive manner, Central Drugs Standard Control Organisation (CDSCO) formulated the survey plan in consultation with NIB for conducting the study to help project a clear statistics on spurious drugs, thus clarifying India’s stand on the same with scientific evidence. Only 10 per cent of the samples were tested during the pan-India study done in 2009.
Samples were being sent online through a specialised AKS software to Central Drug Testing Labs (CDTL) in Chandigarh, Mumbai, Hyderabad, Chennai, Kolkata and Guwahati for analysis and final report. Other State Drugs Testing Labs at Vadodara, Karnataka and at IPC, Ghaziabad are also a part of testing and analysis.
The Union health ministry had entrusted the job of National Drugs Survey in July 28, 2014 to Noida based National Institute of Biologicals to accomplish the study in a scientific manner as per Indian pharmacopoeia and other pharmacopoeias.
Done at an estimated cost of Rs. 8.5 crore, the survey is the first of its kind study to have concluded complete testing of NSQ and spurious drugs. Dr Surinder Singh, director, NIB is the chairman of the committee which conducted the survey.
Aimed at identifying geographical areas where spurious drugs are available, around 1000 drug inspectors from across the country were trained for the pan-India initiative.
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.
In order to facilitate effective sampling of drugs by the drugs inspectors, all the 224 molecules covering 15 therapeutic drug categories were assigned a unique sequence in the format developed through a statistical design which ensured that the drug inspector can pick up samples only on the basis of the statistical design and not on his own will.