Following completion of sampling of spurious and not-of-standard quality (NSQ) drugs as a part of a nationwide survey, the Central Drugs Standard Control Organisation (CDSCO) in association with National Institute of Biologicals (NIB) is in the process of testing for the first time all drug samples for assessing the proportion of drugs which are NSQ.

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. Only 10 per cent of the samples were being 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."

Collection of 43000 samples have been done successfully covering all the retail drug stores including government medical stores, CHCs and PHCs as part of the pan-India survey. Around 36,000 samples have already been sent for testing at drug testing labs across the country. The exercise of pan-India survey is a mammoth exercise as it covers 36 states and 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.

The exercise of sampling has been very transparent as drug inspectors were assisted by NGOs or a person from the Pharmacy Council of India (PCI) to guide them with which medical shop to go for sampling in each of the 676 districts of the country on the basis of statistical design.

When drug inspectors were drawing samples, 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 is done through a specialised software which helps in offering field data on spurious and NSQ drugs online on a consistent basis for facilitating the process of analysis and testing. This field data on drugs is 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.

Dr Surinder Singh, director, National Institute of Biologicals (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 India’s stand on the same with scientific evidence.