Final report on spurious drugs survey likely to come by November 2016
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Shardul Nautiyal, Mumbai
August 30 , 2016
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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.
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