The report stated that the FDA failed to recall drugs of the ‘Not of Standard Quality’ (NSQ) category. “This resulted in consumption of NSQ drugs.
As per an audit report tabled by the Comptroller and Auditor General (CAG) in the state legislature earlier this week, the Maharashtra Food and Drug Administration (FDA) Department allowed sale of low quality drugs in the market by failing to carry out inspections. As per this report, between 2012 and 2017, 25 per cent of low quality drugs were sold in the market in the state.
The report stated that the FDA failed to recall drugs of the ‘Not of Standard Quality’ (NSQ) category. “This resulted in consumption of NSQ drugs. In 95 (25 per cent) of the 375 cases scrutinised in the audit, over 50 per cent were already consumed before they were recalled. Of this, in 61 cases, the entire stock of NSQ drugs was consumed and therefore could not be recalled,” said the report.
The report stated that as many as seven lakh food business operators (FBOs) in the state were working without a valid licence. The number is about 44 per cent of the total number of FBOs in the state.
It also pointed out at the serious lapses in the inspection of FBOs, and drugs manufacturing and selling units. The lapses were to the extent of 35 per cent in the case of drug manufacturing units and 63 per cent in selling units.
“We have also found that samples of infant food, instant milk substitutes, meat and fish products, and fruits and vegetables, were not taken for tests in thousands of cases,” the report said, which conducted a performance audit of the FDA test-check of records for 2012-17.
“The Drugs Division offices were functioning by giving additional charge to assistant commissioners. Drug inspectors were also given an additional charge of assistant commissioners. There was a shortfall of 37 per cent in the post of drug inspectors,” it stated.
It added that the health regulator had failed to cancel the licences of 1,535 drug selling units whose licences had expired. Possible sale of drugs by such units poses a risk to public health, the report stated.
The FDA functions under the administrative control of the Medical Education and Drugs Department in Maharashtra. It is responsible for implementation of the Food Safety and Standards Act, the Drugs and Cosmetics Act, and other acts to safeguard public health and to ensure quality of drugs, cosmetics, and food. The FDA also grants and renews licences for drugs issued to manufacturers/sellers, and maintains quality.
In the absence of adequate manpower, the FDA failed to carry out its duties, stated the report. The CAG pointed out microbiological tests for food samples were not carried out as there was no microbiological division, and thus, pathogenic bacteria, yeast, and mould could not be tested, raising serious food safety concerns.
“Tests to analyse the contents of metals, toxic substance, and insecticides were also not being done due to non-availability of requisite equipment,” the report added. A case in point was the way Mumbai and Aurangabad laboratories issued 2,026 test reports between 2012 and 2017, without any opinion on the samples of drugs tested. Reports were issued 90 days after the receipt of samples. —(with PTI inputs)