Following completion of sampling of spurious and not-of-standard quality (NSQ) drugs as part of a nationwide survey, the National Institute of Biologicals (NIB) has sent 43,000 molecules 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.
This 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 common man.
According to an official, "All studies till date have been done only for spurious drugs. No 100 per cent testing for NSQ has been done till date. The new pan-India study will therefore not do any partial testing but complete testing for the first time in the history of India."
Collection of 43,000 samples has been 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.
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. Around 1500 drug survey seals with unique ID numbers were also developed to be able to track the respective drug inspector with a respective assigned seal number.
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.
Dr Surinder Singh, director, NIB, Noida, is the chairman of the committee conducting the survey. This broad-based survey would help in identifying the geographical areas where spurious drugs are available so that a focused monitoring is done by the concerned authorities in these areas for eliminating the menace of spurious drugs.
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.
The CDSCO formulated the survey plan in consultation with NIB for conducting a scientific study on the extent of problems of spurious drugs and drugs not of standard quality. Through this initiative between the state and the Centre, India will now be able to project a clear statistics on spurious drugs, thus clarifying the country’s stand on the same with scientific evidence.