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Licence renewal of drug firms: CAG slams FDA


Licence renewal of drug firms: CAG slams FDA

Mumbai: The country’s apex auditor CAG has slammed the Food and Drug Administration (FDA), an agency of the Maharashtra government, over the shortage of drug inspectors in the department and a host of other issues.

The Comptroller and Auditor General (CAG), in its report tabled in the state legislature, also noted that only 20 percent Assistant Commissioners (Food) and 18 percent Food Safety Officers (FSOs) were on the rolls as against the requirement assessed by the FDA Commissioner.

“The Drugs Division offices were functioning by giving additional charge to Assistant Commissioners. Drug inspectors were also given additional charge of Assistant Commissioners. There was a shortfall of 37 percent in the post of Drug Inspectors,” the report stated.

It said the health regulator had failed to cancel the licenses of 1,535 drug selling units whose licenses had expired. A possible sale of drugs by such units pose a risk to public health.

The CAG report said in some cases renewal of licenses was done without inspecting the premises of drugs selling units.

Also, there were serious shortfalls in the inspection of Food Business Operators (FBOs), drugs manufacturing and selling units.

“The shortfall was to the extent of 35 percent in the case of drugs manufacturing units and 63 percent in case of selling units,” the report stated.

The CAG recommended that the state government conduct a survey and create a database of FBOs which should be updated periodically so as to bring maximum FBOs within the ambit of the Food Safety and Standards Regulations Act.

The auditor asked the government to address the issue of staff shortage on priority and streamline the procedure of licensing and registration.

The CAG recommended the government establish additional food testing laboratories to meet the requirements of the entire state and ensure non-functioning ones are made operational with requisite equipment, infrastructure, and manpower.



Source: PTI
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