CAG Report Reveals 63 percent Shortfall In Inspections In Manufacturing Units By Maha FDA

CAG Report Reveals 63 percent Shortfall In Inspections In Manufacturing Units By Maha FDA

Mumbai, 24 Dec 2018:  Performance audit of Maharashtra Food and Drug Administration (FDA) done by Comptroller and Auditor General (CAG) for the period from March, 2012 to April 2017 has revealed shortfall in inspections to the extent of 35 per cent in case of drug manufacturing units and 63 per cent in case of drug retail units. 

The audit revealed that there was shortfall of 37 per cent in the post of drug inspectors who are key personnel for effective enforcement of provisions made under different acts for drugs control.  There was wide variation in the workload of the drug inspectors due to uneven distribution of drug inspectors among the seven divisions in the state.

Joint Commissioner (JC) at division level and Assistant Commissioner (AC) at the district level are designated as Licensing Authority for manufacturing and selling units respectively who are responsible for issuance and renewal of licenses to drugs manufacturers and sellers, inspecting units and initiating action for violation of norms. 

Audit observed that in all the seven Division offices, JCs were not posted and their work was being done by giving additional charge to ACs. In Ratnagiri and Wardha District office and Greater Mumbai Zones (2, 3 and 4) Drug Inspectors (DIs) were given the additional charge of ACs. This adversely affected regulatory functions. 

DIs are key personnel for effective enforcement of provisions made under different Acts for drugs control. They are responsible for inspections of licensee units, investigation of complaints and collecting drug samples for testing. They are also responsible for follow-up action for not of standard quality (NSQ) drugs and for initiating prosecutions for breach of the acts and rules. 

An expert committee under the Chairmanship of Dr R A Mashelkar appointed by union health ministry had recommended one DI per 50 manufacturing units and one DI per 200 sales/distribution outlets. However, the process for filling up of vacant posts and review of sanctioned strength was still stated in September 2017 to be in progress.

Against the requirement of 413 DIs as per Dr. Mashelkar Committee report, the sanctioned strength was 161 DIs. Only 101 DIs (63 per cent) were posted.

There was no action to cancel the licenses of 1,535 drug retail units whose licenses had expired, thereby posing a risk to public health by the possible sale of drugs by such units, as per the CAG report.

The renewal of drug licenses was done without inspection of the premises of the drug selling units and thereby the requirement of adequate physical infrastructure was not ensured before grant of licenses. Inspection or survey was not done to verify that the drug selling or manufacturing units were not involved in any activities during the suspension period.

The drug testing labs at Aurangabad and Mumbai issued 2,026 test reports during 2012 to 2017, without expressing any opinion on the samples of drugs tested. Test reports on the drugs tested were issued after 90 days from the date of receipt of sample in the lbs, in 10,501 (40 per cent) samples tested.

Labs in Aurangabad and Nagpur did not have facilities to conduct microbiological test on drugs and cosmetics and as a result all the samples were being sent to the lab in Mumbai, where they were unable to cope with the volume of work. 

Opportunity to strengthen and upgrade the testing labs by purchasing various modern equipment was lost despite availability of funds due to non-receipt of approvals from medical education and drugs department (MEDD) or Finance Department to the purchase proposals of the FDA. Pharmabiz