Sampled field data to the tune of 48,000 samples as part of national drugs survey compiled in the form of around 400 pages of well documented evidence based study submitted to the health ministry recently will be tabled in the winter session of parliament soon.
Done at an estimated cost of Rs.8.5 crore, the Union health ministry had entrusted the job of National Drugs Survey in July 28, 2014 to Noida based National Institute of Biologicals (NIB) to accomplish for the first time complete testing of NSQ drugs as per Indian pharmacopoeia and other pharmacopoeias.
NIB had further sent the data online to 10 drug testing labs across the country for final analysis and testing. This is for the first time that complete testing of NSQ drugs was done as per Indian pharmacopoeia and other pharmacopoeias. Only 10 per cent of the samples were tested during the pan-India study done in 2009.
Informed Dr G N Singh, drugs controller general of India, “Compilation of field data is currently being done and final report will be released by the Union health ministry in couple of months time.”
A similar survey in 2009 had revealed that the extent of drugs found spurious was 0.046 per cent. Only 10 per cent of the samples were tested during the pan-India study done in 2009.
Dr Surinder Singh, director, NIB, Noida, is the chairman of the committee which conducted the survey.
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 statistical design and not on their own.
The pan-India drugs survey is aimed at complete testing of drugs for the first time in the history of India. The survey is significant as all studies till date have been done only for spurious drugs and no 100 per cent testing for NSQ has been done till date. This is for the first time that complete testing of NSQ drugs would be done as per Indian pharmacopoeia and other pharmacopoeias.
The analysis and testing was facilitated through a specialised AKS software which offers field data on spurious and NSQ drugs online on a consistent basis in a seamless and flawless manner. This field data on drugs was being sent online 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.
As part of the national drug survey, samples 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.
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. 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 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.
The survey was done in collaboration with Indian Statistical Institute (ISI), Kolkata and Hyderabad and NSSO to assess the quality of drugs available to the patients.