National Institute of Biologicals (NIB) sampled field data to the tune of 48,000 samples as part of national drugs survey which were sent to 10 drug testing labs across the country is likely to release its final report by November 2016.
This is for the first time that complete testing of NSQ drugs would be 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.
Said 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 expected to be submitted to the health ministry in couple of months time.”
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.
Around 1000 drug inspectors and an equal number of NGOs were trained to execute the sampling process to implement the study in the most meticulous and transparent manner. The analysis and testing is facilitated through a specialised AKS software which helps in offering field data on spurious and NSQ drugs online on a consistent basis in a seamless and flawless manner.
The survey which was done in collaboration with Indian Statistical Institute (ISI), Kolkata and Hyderabad and National Sample Survey Organisation (NSSO), is a pan-India project in which drug samples were drawn from healthcare institutions and retail pharmacies across the country to assess the quality of drugs available to the patients.
Central Drug Testing Labs (CDTL) in Chandigarh, Mumbai, Hyderabad, Chennai, Kolkata and Guwahati, state drugs testing labs at Gujarat, Karnataka Maharashtra and a lab at Indian Pharmacopoeia Commission (IPC), Ghaziabad are part of testing and analysis.
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.
Collection of samples was done covering all the retail drug stores including government medical stores, CHCs and PHCs as part of the pan-India survey. The exercise of pan-India drugs survey is a mammoth exercise as it covers 29 states and 7 Union territories. Around 1,000 drug inspectors from across the country have done sampling of drugs from retail pharmacies, CGHS dispensaries, ESI hospitals, Central Medical Stores Depots, PHCs and CHCs.
For facilitating the process of analysis and testing through a specialised software the analysis of field data on spurious and NSQ drugs is done online on a consistent basis. 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.