Himachal: Drug Control Admn under scanner after samples of 68 firms found substandard

The working of the Drug Control Administration (DCA) has come under the scanner with an abrupt increase in the number of drug samples declared not of standard quality (NSQ) in the monthly alerts issued by the Central Drugs Standard Control Organisation (CDSCO).

As many as 146 drug samples were declared NSQ in May nationally. Fifty pertained to 38 drug firms of Himachal. This was a whopping 37 per cent of the total drugs.

In April, 24 per cent drugs in the national alert pertained to Himachal.

While steps such as conducting risk-based inspections of firms that repeatedly appear in this list have been undertaken by the DCA, several firms continue to err even after they face partial or total suspension of their manufacturing.

Highlighting their resolve to promote quality drug manufacturing, State Drugs Controller Dr Manish Kapoor asserted, “In a bid to ensure quality drug manufacturing the state DCA has acted against 68 drug firms after their samples were declared substandard by the national drugs regulator in the last two years.”

“This includes 23 drug firms, against whom the DCA had initiated action such as cancellation or partial/total stop on the manufacturing of orders, and 45 others, against whom similar action was taken after risk-based inspections were jointly conducted by the DCA and officials of the CDSCO,” added Dr Kapoor.

Expressing concern, he said, “The image of the state pharmaceutical industry has been severally tarnished due to emergence of 20 cases of spurious drugs in the past one year. Bogus firms outside Himachal were found manufacturing such drugs. While no such firm existed in the state, bogus firms in Uttar Pradesh, Punjab, Gujarat and Karnataka used labels of Himachali firms and brought disrepute to the state.”

Responding to large number of NSQ cases, Dr Kapoor said since various states and union territories were also displaying list of drugs declared NSQ, besides the CDSCO on their portal, the overall tally of NSQ drugs appears to have increased.

“If we add the state/UTs figures to the CDSCO figures during the five years, the increase in NSQ drugs is marginal,” claimed Dr Kapoor.

Officials claim they were strictly enforcing the Drugs and Cosmetics Act with audits and surprise inspections at the manufacturer, wholesale as well as level of retailer to ensure safety and quality of drugs.

With some firms reporting repeated failure of several batches of injection samples due to serious manufacturing defects, the regulatory framework needs to tighten noose around such erring firms to promote quality drug manufacturing in Himachal Pradesh.