February 21, 2017 1:06:56 am
A two-year-long nation-wide survey, conducted under the supervision of the Central government, has found that around 10 per cent of the drugs in the government supply chain are not of standard quality (NSQ).
However, the estimated percentage of NSQ drugs in retail supply chain was found to be 3 per cent only. The health ministry had asked the National Institute of Biologicals (NIB) to conduct the survey, wherein a total of 47,954 samples were drawn by drug inspectors from mid-2014 to mid-2016. State drug controllers served as nodal officers and coordinated the sample collection and their dispatch to NIB.
“The fact that the NSQ (drugs) from government sources are 3.17 times higher than in the retail highlights that there is something amiss in the existing procurement processes, especially in states where the NSQ is much higher than the national average. Further, lack of uniform levels of enforcement may be leading to difference in the extent of NSQ in retail outlets and government supply chain in different States/UTs(union territories). The NSQs are much higher in case of parenterals as compared with oral dosage forms and this area therefore needs special attention,” the survey commented.
Parenteral drugs are administered through routes other than mouth or digestive system. The survey was titled ‘Survey of Extent of Problems of Spurious and Not of Standard Quality Drugs in The Country’. Out of the 47,954 samples drawn, 98.03 per cent were subjected to laboratory test and analysis. Of these 33,656 were from retail outlets, 8,369 were from government sources and the rest of the samples were from ports.
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“The estimated percentage of NSQ drugs from government sources in India was 10.02 per cent and for spurious drugs was 0.059 per cent.
During analysis of samples declared NSQ from government supply chain, the following trend was observed: civil hospital stores: 11.03 per cent, state government medical store depots: 10.44 per cent, ESI (Employee State Insurance) dispensaries: 9.01 per cent, CGHS (Central Government Health Scheme) dispensaries: 4.11 per cent,” the survey noted.
Of all the samples, sourced from the government supply chain and found to be NSQ, 23.96 per cent and 22.18 per cent failed assay test and dissolution test, respectively. Among states, the government supply samples from Meghalaya, Mizoram, Arunachal Pradesh, Nagaland, Telangana, Uttarakhand, Uttar Pradesh and Punjab were on the higher side of NSQ (11.39-17.39 per cent). On the other hand, Chandigarh, Delhi, Odisha, Tamil Nadu and West Bengal were on the lower side of NSQ (0 – 7.93 per cent).
Understanding the gravity of the matter, the national drug survey recommended: “There is a need for government procurement agencies to revisit their procurement guidelines with respect to criteria for qualifying the manufacturers. The agencies should develop and implement risk-based pre-inspection norms for selection of manufacturers of quality drugs and adopt quality testing of each consignment from NABL (National Accreditation Board for Testing and Calibration Laboratories) accredited laboratories.”
It further added that government warehouses, medical store depots and pharmacies should have adequate storage facilities and provision for temperature and humidity control, sufficient air conditioned space, refrigerators, deep freezers etc. along with their annual maintenance contracts. “These facilities, should be inspected at least once a year by a joint team of CDSCO (Central Drugs Standard Control Organization) and State Licensing Authorities (SLA). Alternatively, third party inspections by accredited bodies could be considered, however, this will not be a substitute for regulatory inspections,” the survey noted.
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