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

Karnataka Health Department developing state drug recall policy to address spurious drugs issue, ensuring patient safety.

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.

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.