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Spurious drugs survey data evaluation reaches final stages of testing and compilation
Shardul Nautiyal, Mumbai | Friday, March 4, 2016, 08:00 Hrs  [IST]

The spurious drugs survey data of 47,000 samples collected as part of mammoth pan-India drugs survey involving around 1000 drug inspectors have reached its last leg and most likely to be submitted to the Union health ministry and the Parliament in a couple of months time for its final release.

Said Drugs Controller General of India (DCGI) Dr G N Singh, “Test reports sent to 10 drug testing labs across the country are likely to release its final report in a couple of months time as most of the test reports have reached its final destination. There would not be much of deviation as far as the quality of drugs under analysis is concerned which is based on a scientific evaluation and is likely to dispel a lot of myth regarding spurious drugs in the country.”

The analysis and testing is facilitated through a specialised AKS software which helps in offering field data on spurious and not-of-standard quality (NSQ) drugs online on a consistent basis in a seamless and flawless manner.

Earlier, a survey to assess the extent of spurious drugs conducted in 2009 revealed that the extent of drugs found spurious was 0.046 per cent only.

The survey is significant as all studies till date have been done only for spurious drugs and no 100 per cent testing for NSQ drugs 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 in 2009.

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.

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 pan-India drugs survey covered 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, 3 state drug testing labs and one autonomous lab in the country for testing to accomplish for the first time complete testing of NSQ drugs.

For facilitating the process of analysis and testing through a specialised software the analysis of field data on spurious and NSQ drugs was done online on a consistent basis. The survey, was being done in collaboration with Indian Statistical Institute (ISI), Kolkata and Hyderabad and National Sample Survey Organisation (NSSO).

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.

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