Parenteral medicines are administered by routes other than the mouth or digestive system. The survey was titled Survey on the extent of problems with non-essential quality non-standard medicines in the country.
The Ministry of Health had asked the National Institute of Biological Sciences (NIB) to conduct the survey, in which a total of 47,954 samples were taken by drug inspectors from mid-2014 to mid-2016. A two-year national survey conducted under the supervision of the central government revealed that approximately 10% of government supply chain drugs are not of standard quality (NSQ).
However, the estimated percentage of NSQ drugs in the retail supply chain was only 3 per cent. State drug monitors served as nodal agents and coordinated the collection of samples and sent them to NIB.
Of the 47 954 samples taken, 98.03% were tested and analyzed in the laboratory. Of these 33,656 were retail outlets, 8,369 were from government sources and the rest of the samples came from ports. 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.
“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.
“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.
Understanding the gravity of the issue, the National Drug Survey recommended: "It is necessary for government procurement agencies to review their procurement guidelines with respect to manufacturers' qualification requirements. Should develop and implement risk-based pre-inspection standards for the selection of quality drug manufacturers and adopt quality testing of each shipment from NABL accredited laboratories (National Accreditation Board for Laboratories Testing and Calibration 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.
