Field data to the tune of 47,000 samples as part of national drugs survey which has been sent to 10 drug testing labs across the country is likely to release its final report by April 2016. Testing and analysis on the same may conclude by December end this year, according to reliable sources.
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.
According to an official, "The pan-India drugs survey will not do any partial testing but complete testing 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." Only 10 per cent of the samples were tested during the pan-India study done in 2009.
Collection of 47,000 samples was done successfully 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 1000 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.
Following completion of sampling of spurious and not-of-standard quality (NSQ) drugs, the National Institute of Biologicals (NIB) under the Union health ministry had sent samples to each of the seven central drug testing labs across the country for testing to accomplish for the first time complete testing of NSQ drugs. Only 10 per cent of the samples were tested during the pan-India study done in 2009. This is for the first time that complete testing of NSQ drugs would be done as per Indian pharmacopoeia and other pharmacopoeias.
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. The survey, being 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.
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 ensures 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.
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.