Karnataka to draft drug recall policy to withdraw substandard, spurious medicines from the market

Health Minister Dinesh Gundu Rao had recently written to the Centre after nine injectable drugs manufactured outside the State failed the sterility test in Karnataka’s government labs between January 1, 2025, and February 16, 2025.
| Photo Credit: Special arrangement

In the absence of an effective centralised system to recall spurious drugs from the market, Karnataka’s Health Department is all set to come out with a State drug recall policy, said Health Minister Dinesh Gundu Rao on Friday (February 28, 2025).

The State had recently raised the issue with the Centre after nine injectable drugs manufactured outside the State failed the sterility test in Karnataka’s government labs between January 1, 2025, and February 16, 2025.

Addressing presspersons here, the Minister said the Health Department is working on developing a software with details of retailers, wholesalers, manufacturers and their authorised agents to trace the available stocks of ‘Not of Standard Quality’ (NSQ) drugs at every stage, which will be implemented very soon.

“Although the Health Department can immediately withdraw such contaminated drugs from its hospitals, there is no system in place as of now to recall it from the private sector. In the absence of a central drug recall policy, we are working on a State-level policy to ensure that any drug that fails the sterility test in government labs can be recalled from the market and returned to the company immediately. This will prevent instances of patients being administered substandard medicine in both government and private hospitals,” Mr. Gundu Rao said.

Not-of-standard quality drugs

Sharing the details of drugs that were tested in government laboratories and found to be NSQ, the Minister said a special drive was conducted and NSQ drugs worth over ₹17 lakh have been recalled from the market in the last two months. Besides, 75 cases have been filed under the violation of Drugs and Cosmetics Act, 1940.

Stating that a special drive was conducted in January 2025 to prevent misuse of ​​Narcotic Drugs and Psychotropic Substances (NDPS), Mr. Gundu Rao said, “Sale of such drugs in 488 medical stores was investigated and show-cause notices were issued to 400 stores for violating rules. While 231 licenses have been suspended, three licenses were cancelled,” he said.

Similarly, a two-day special drive conducted from February 17 to check the misuse and sale of antibiotics in medical stores revealed that 52 stores sold antibiotics without prescription.

Food safety

Of the total of 3,608 samples of food items collected by food safety officials for analysis in January, as many as 26 samples have been declared unsafe for human consumption and 28 samples have been found to be of poor quality.

Pointing out that there has been a reduction in the amount of artificial colours used in baking cakes after the Health Department sensitised and warned bakeries against the use of harmful chemicals and colouring agents, the Minister said, “In August 2024, 295 samples of cakes across the State were collected and analysed. Of these, 12 samples (4.06%) revealed the presence of artificial colours.” He said the colours included Allura Red, Sunset Yellow FCF, Ponceau 4R, Tartrazine, and Carmoisine in more than the prescribed limits.

“During a special campaign in January, officials found only seven cake samples unsafe for human consumption, indicating that there is more awareness now. In the coming days, we plan to sensitise bakery entrepreneurs to use natural and approved colouring agents. A follow-up analysis of more samples will be taken up after that,” the Minister said.

Bottled water

The Food Safety Department is also cracking down on bottled water units. Officials have collected samples of 288 brands of bottled water for analysis in February 2025. The laboratory analysis of the bottled water samples is under progress, Mr. Gundu Rao said.

“Likewise, as many as 106 samples of fried green peas had been collected to test the presence of artificial colours. Of the 31 samples for which testing has been completed, 26 samples are found to be unsafe for consumption,” the Minister added.