Karnataka Health Minister Dinesh Gundu Rao on Friday said the state government will soon write to the Union Drug Controller General of India, seeking regulation and the issuance of guidelines for tattooing as per Bureau of Indian Standards, after 22 heavy metals were found in tattoo ink samples collected and analysed in the state.

Based on complaints, the Karnataka Food Safety and Drug Administration department collected these samples for testing.

According to Rao, the analytical report of these tested samples revealed the presence of heavy metals such as selenium, chromium, platinum, and arsenic, which could cause various skin diseases, including bacterial, viral, and fungal infections.

"So, unfortunately, what we found is that there is currently no law in place to regulate this. There are no Bureau of Indian Standards for tattoo ink, and it is not covered under the Drugs and Cosmetics Act. There are no regulations on the quantity of ink and metals that can be used, or how they should be used. There has to be a proper protocol for this, which is currently lacking in the country," Rao told reporters during a press briefing.

Noting that this is a serious issue, the Minister said the government will raise the matter with the Centre.

"Our Food Safety and Drugs Commissioner will soon write a letter to the Drug Controller General of India, urging them to address this issue and establish standards as per BIS. This will help determine what is safe and what is unsafe, ensuring proper regulation under the law," he stressed.

Explaining how heavy metals and microorganisms can enter the body through tattoo ink, Rao said, "Some remain on the surface, while others get injected into the skin, potentially causing harm. Since these are heavy metals, this issue needs to be closely monitored." Listing the recent drives conducted by the Karnataka Food Safety and Drug Administration Department, the Health Minister stated that in January, out of 1,133 drug samples collected and analysed, 106 samples were declared "not of standard quality," while the remaining were found to be of "standard quality." In February, out of 1,841 drug samples analyzed, 58 were declared "not of standard quality." "So far, 75 cases have been booked under the Drugs and Cosmetics Act, 1940, for violations related to poor quality and substandard drugs," Rao said.

He also noted that in January, a special drive was conducted to remove drugs from the market that were previously declared to be of substandard quality. As a result, approximately Rs 17 lakh worth of such drugs were recalled.

According to Rao, in December 2024, out of 262 cosmetic samples analyzed, 120 were declared of "standard quality," while the remaining samples are still under analysis.

Additionally, a special drive was conducted in January to prevent the misuse of drugs under the Narcotic Drugs and Psychotropic Substances (NDPS) Act, during which 488 medical shops were investigated.

"We found violations in 400 out of the 488 medical shops inspected, and showcase notices were issued to these firms. A total of 231 licenses were suspended, and three licenses were cancelled," he said.

During a special drive conducted across the state from February 17 to 19 to monitor the misuse and sale of antibiotics, authorities found that 52 medical shops sold antibiotic drugs without valid prescriptions. "Investigations are ongoing, and prosecutions will be filed if necessary," Rao added.

Regarding the Ringer Lactate Solution case, he stated that 113 samples were declared "not of standard quality." "Nine prosecutions have been filed in various courts, and permission has been granted to file cases against 36 companies that supplied the substandard solution," he said.

Calling for the need to reform and regulate the industry, the Health Minister said the department is introducing a new computerized system to tackle the issue of poor-quality drugs, which will be implemented soon.

"We (Drugs Control Department) are developing a new system that will integrate all stakeholders in the drugs and cosmetics business—suppliers, wholesalers, distributors, medical shops, pharmacists, and chemists—under one platform. We aim to create a computerized system and a web application that will ensure the seamless flow of information among all stakeholders," Rao added.

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