Compiled in 400 pages of well documented evidence based study - the national drugs survey which tested 47,012 samples revealed 13 samples (0.0245%) were spurious and 1,850 samples (3.16%) were NSQ.
To accomplish for the first time complete testing of NSQ drugs as per Indian pharmacopoeia and other pharmacopoeias, the Union health ministry had entrusted the job of National Drugs Survey in July 28, 2014 to Noida based National Institute of Biologicals (NIB). Dr Surinder Singh, director, NIB, Noida, is the chairman of the committee which conducted the survey.
Done at an estimated cost of Rs.8.5 crore, the survey was done in collaboration with Indian Statistical Institute (ISI), Kolkata and Hyderabad and National Sample Survey Office (NSSO) to assess the quality of drugs available to the patients.
The States/UTs provided the lists of 424,525 registered retail outlets in 572 districts out of 676 districts in the country. The survey deployed 936 Sample Drawing Officers (SDOs) for drawing samples from retail outlets and Government sources. Samples from Ports were drawn by 9 SDOs. Out of the 47,954 samples drawn under the survey, 47,012 samples drawn from 1,421 Government sources and 5,717 retail outlets were subjected to laboratory test and analysis. Of these 33,656 were from retail outlets, 8,369 were from Government sources and 4,987 were from Ports.
Total 1,011 samples out of the 33,656 samples tested from Retail Outlets were found to be NSQ and 8 samples were found to be Spurious. The estimated percentage of NSQ formulations from Retail Outlets in India is 3% and is not expected to be more than 3.19% (the upper 95% confidence limit), and the estimated percentage of Spurious drugs from retail outlets is 0.0237%.
State wise, NSQ percentage estimates for retail outlets varied from 0 to 8.82% percent (with the exception of Lakshadweep); Three States/UTs i.e. Andaman and Nicobar Islands, Dadra and Nagar Haveli, Goa had 0% NSQ. Fourteen States/UTs had NSQ percentage below the national average of 3% for Retail Outlets. Eighteen States had NSQ percentage above the national average of 3% for Retail Outlets.
The total number of non-compliance out of all tests of all samples from Retail Outlets was 1,251. Out of 69 tests performed on these samples, they failed in 28 tests, of which, Dissolution and Assay accounted for 56.4% of the non-compliance.
Total 839 samples out of the 8,369 samples tested from Government sources were found to be NSQ and 5 samples were found to be Spurious. The estimated percentage of NSQ formulations from Government sources in India is 10.02% and the 95% confidence interval for the same is 9.38% to 10.68% and the estimated percentage of spurious drugs from government sources is 0.0597%. State wise, NSQ percentage estimates varied from 0 to 17.39% with the exception of Sikkim.
Four UTs i.e. Chandigarh, Dadra and Nagar Haveli, Daman and Diu and Lakshadweep had 0%NSQ. Eighteen States/UTs had NSQ Percentage below national average of 10.02% for Government sources. Thirteen States had NSQ percentage above national average of 10.02% for Government sources.
The total number of non-compliance out of all tests of all samples from Government sources was 1,177. Out of 69 tests performed on these samples, they failed in 27 tests, of which, Assay and Dissolution accounted for 46.1% of the non-compliance.
Samples were drawn from 8 Ports from 1708 consignments. 97% of the samples came from Mumbai and Chennai Ports. None of the samples were found to be NSQ or Spurious.
The sampled data after field collection was sent online to 10 drug testing labs across the country for final analysis and testing. Only 10 per cent of the samples were tested during the pan-India study done in 2009.
The analysis and testing was facilitated through a specialised AKS software which offers field data on spurious and NSQ drugs online on a consistent basis in a seamless and flawless manner. This field data on drugs was 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.
A similar survey in 2009 had revealed that the extent of drugs found spurious was 0.046 per cent.