NEW DELHI, Feb 22:
Over 10 per cent of drugs in the Government supply chain were found to be ‘Not of Standard Quality’ (NSQ), three times higher than substandard drugs found in retail outlets, a Health Ministry survey has found.
Claimed by the Ministry to be the largest ever survey in the world to determine the quality of drugs, it found the estimated percentage of NSQ drugs from samples taken from retail outlets across the country was just three per cent while 0.023 per cent were found to be spurious.
Following this, the autonomous body under the Health Ministry which conducted the survey has recommended that the Government procurement agencies should “revisit” their procurement guidelines with respect to criteria for qualifying the manufacturers.
The extent of NSQ and spurious drugs for both retail outlets as well as Government sources in the country together was estimated to be 3.16 per cent and 0.0245 per cent respectively, the survey found.
The statistical design of the drug survey included as many as 224 drug molecules belonging to 15 different therapeutic categories of the National List of Essential Medicines (NLEM) 2011.
As part of the survey, 47,954 drug samples relating to 23 dosage forms were drawn from 654 districts of 36 states and UTs from supply chains including retail outlets, Government sources and from eight airports and seaports, an official statement said.
“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 NSQ, state Government medical store depots: 10.44 per cent NSQ, ESI dispensaries 9.01 per cent NSQ and CGHS dispensaries – 4.11 per cent NSQ,” said the survey done by National Institute of Biologicals (NIB), Noida.
In terms of Government supply chain, states like Meghalaya, Mizoram, Arunachal Pradesh, Nagaland, Telangana, Uttarakhand, Uttar Pradesh and Punjab were on the higher side of NSQ (11.39 – 17.39 per cent) whereas Chandigarh, Delhi, Odisha, Tamil Nadu and West Bengal were on the lower side (0 – 7.93 per cent).
The estimated percentage of NSQ and spurious drugs from retail outlets in the country was 3 per cent and 0.023 per cent respectively.
Out of 69 tests performed on the samples from retail outlets, they failed in 28 tests, said the ‘Survey of the extent of Problems of Spurious and Not of Standard Quality Drugs’.
In terms of retail outlets, states/UTs like Mizoram, Nagaland, Meghalaya, Manipur, Tripura, Puducherry, Gujarat, and Punjab were on the higher side of NSQ (4.20 – 8.82 per cent) whereas, Andaman and Nicobar Islands, Dadra and Nagar Haveli, Goa, West Bengal, Delhi, Jharkhand and Kerala were on the lower side (0 – 1.97 per cent), the report said.
“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- accredited laboratories,” the body recommended in the survey.
It also recommended 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 and others along with their annual maintenance contracts.
“These facilities, should be inspected at least once a year by a joint team of CDSCO 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,” it said.
The agencies should conduct regular skill development training for the medical store officers, pharmacists and other staff members for handling of drugs, inventory control, good storage and warehousing, it added.
The survey said that none of the samples drawn from airports or seaports were found to be NSQ or spurious.
“All the samples were subjected to test/analysis as per pharmacopoeial requirements in the Central and State Drug Testing Laboratories that have been accredited by National Accreditation Board for Testing and Calibration Laboratories (NABL).
“This is the largest ever scientifically designed and professionally executed drug survey undertaken in the world for determining the quality of drugs,” the Health Ministry statement said.
A nationwide training in drug survey methodology was imparted at 28 centres across the country to over 1,800 sample drawing officers (SDOs) and representatives of civil society and Pharmacy Council of India (PCI).
A budgetary allocation of Rs 8.5 crores was given by the Health Ministry.
“The methodology of the study covered all major therapeutic categories, highest ever number of drug molecules in any study, entire range of dosage forms dispensed through Government as well as retail sources, sampled from the length and breadth of the country using a statistically designed three-stage sampling plan prepared by Indian Statistical Institute, Hyderabad,” the study said. (PTI)