Even most samples to be tested and certified by state’s drug inspectors for quality and safety for sale expired in laboratory before they could be put to test
People of West Bengal may well be consuming expired and unsafe drugs, as the state’s drug quality and control department runs with just 23 per cent of its approved strength. In fact such is the human resource shortage that most samples to be tested and certified by the state’s drug inspectors for quality and safety for sale also expired in laboratory before they could be put to test.
The latest Comptroller and Auditor General (CAG) of India’s audit report of the state’s Directorate of Drug Control, State Drugs Control & Research Laboratory (SDCRL), Central Medical Store, Kolkata and assistant directors of drugs control in five out of the state's 20 districts in the state brings out a sorry state of drug quality control in the state. The audit report recently tabled in the state Assembly covered 2012-2017.
The state needs an adequate number of drug inspectors to test and certify drugs both at manufacturing and retail outlets. This is a critical quality-monitoring step, given the high level of sale of spurious drugs — also labelled ‘Not of Standard Quality (NSQ)’ — their.
“The test results of the Laboratory were doubtful as it often did not run all the mandatory tests on the samples. There was also delay in generation of test results by the laboratory by which time the NSQ drugs had been consumed by the patients,” according to the audit report.
Expectedly, the state has registered a significant growth in drug manufacturing units as well as retail outlets. But, the number of government-sanctioned strength of drug inspectors has remained the same since 2000. Also, most positions have not been filled up.
The CAG audit found 77 per cent of such positions vacant: “Acute shortage in the post of key functionaries like Drug Inspectors / Sr Drug Inspectors affected activities like issue and renewal of licences, inspections, statutory sampling and consequently drug control in general.”
The lack of hands has grave ramifications for public health. Many drug manufacturers and sellers have not applied for renewing their licenses. Strangely, the CAG found no record of licenses of 5,191 such operators.
“The renewal process could only be initiated after submission of renewal application. But, the drug business was being continued even in case of those who did not apply for renewal. This indicated that DDC was not watching the expiry of licences,” the report claimed. Even in cases of license renewal, it has been just 24 per cent of the manufacturing applicants and 3 per cent of the drug selling applicants.
When the CAG examined renewal status of 13 (out of 180 firms) operators, it found major deficiencies in manufacturing and quality control process. Despite irregularities and non-adherence of procedures, the state department renewed their certificates. “Moreover, products of 12 out of such 13 manufacturing firms were found ‘Not of Standard Quality (NSQ)’ multiple times by different Drug Testing Laboratories,” noted the audit report.
In another critical lapse due to non-availability of adequate manpower, many blood banks are functioning without valid licenses. “Out of 125 blood banks in the State, 48 (38 per cent) were functioning without valid licences as of March 2017.” Out of these 36 have been operating without licenses for the last 15-20 years.
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