CAG raps FDA over substandard drugs

The laxity of Maharashtra’s Food and Drugs Administration (FDA) exposed people to inferior quality drugs between 2012 and 2017. A Comptroller and Auditor General (CAG) of India report revealed that delay in recalling 25 per cent of drugs marked Not of Standard Quality (NSQ) exposed public to health risk. About 1,006 cases of sub-standard drugs were reported between 2012 and 2017, but FDA failed to recall most of these drugs

CAG raps FDA over substandard drugs

The country’s top auditor has found the state’s food and drug watchdog slacking on the job as it thoroughly neglected its basic responsibility of checking consumables and cosmetics for quality through regular tests and inspections.

A report tabled by the CAG in the state legislature on Wednesday revealed that the Food and Drug Administration (FDA) allowed pharmacies and wholesalers to operate on expired licences for a year.

The report states that licences were renewed for shops that were not inspected, so it is not known if these premises met the requisite standards at the time they were permitted to stay in business.

These grave lapses took place against a backdrop of an immense shortage of drug inspectors.

The report states that since drug control laboratories in Aurangabad and Nagpur did not have facilities to test for microbes on drugs and cosmetics, their samples were sent to the Mumbai lab, where the staff strength proved unequal to the influx of the volume of work.

Speaking in regards with this to My Medical Mantra, RTI activist, Yajurvedi Rao said, “In Food and Drug Administration (FDA) there is a shortage of manpower, that’s why there is a delay in work. The drug controller does not pay due attention and thereby the substandard drugs pass through. Basically there is no supervision by the commissioner. And this is the reason such cases happen.”

The CAG report findings state:

  • FDA had failed to take action to cancel the licenses of 1,535 drug selling units whose licenses had expired, thereby posing a risk to public health by the possible sale of drugs by such units.
  • 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/survey was not done to verify that the drug selling/manufacturing units were not involved in any activities during the suspension period.
  • The delay in recalling Not of Standard Quality (NSQ) drugs resulted in consumption of the NSQ drugs by the public. In 95 (25 per cent) out of 375 cases scrutinised in audit, more than 50 per cent of the NSQ drugs were already consumed before they were recalled. Of this, in 61 cases, the entire stocks of NSQ drugs were consumed and therefore could not be recalled.
  • The deficiencies identified above clearly indicate the failure of the Medical Education and Drugs Department in ensuring that the food consumed by the public is of standard quality.
  • Further, even the quality of drugs supplied is not ensured due to inadequate testing and failure to follow-up effectively.

Total not inspected 20,851 drug stores between one to ten years.

  • 5,280 selling units in Thane
  • 4,493 in Pune
  • 4,086 in Mumbai

These districts were not inspected for more than one year as on March 2017. The FDA did not fix any internal targets for inspection of the manufacturing/selling units by the drug inspectors after considering the risk profile of the licensing units and manpower available.