Karnataka pushes for regulating tattoo ink sales after heavy metals found in samples

Bengaluru: The Food Safety and Drug Administration (FDA) of the state health department has written to the Drugs Controller General of India requesting regulations and guidelines for tattoo ink as it found the presence of 22 heavy metals after testing some samples recently.

DH accessed a copy of the letter, which notes that there are no standards under the Bureau of Indian Standards (BIS) for tattoo ink and they are unregulated. The letter calls on the DCGI to include tattoo ink under Schedule M-II of the Drugs and Cosmetics Act, 1940, and notes that the sale of tattoo ink "should be prohibited until the BIS standards are made and guidelines (are) prepared".

The FDA's analysis found heavy metals such as Selenium, Chromium, Platinum, and Arsenic after analysing samples of eight different tattoo ink colours, noted state health minister Dinesh Gundu Rao on Friday. These pigments and heavy metals may be transported to organs such as the liver, lungs or kidneys.

"We have got to know of bacterial and fungal infections from some places; these occur in the short-term but we need to check for any long-term-impact. We don't have full information regarding this yet," Rao said.

Besides this, the department has issued show cause notices to nearly 400 medical stores for violating the Narcotic Drugs and Psychotropic Substances Act, 1985, in a special drive conducted in January.

This is a part of their work to prevent the misuse of narcotics and psychotropic drugs. Of the 488 medical shops that were investigated, 400 were found violating the Act. Licences of 231 shops were suspended and three licences were cancelled.

Additionally, the department conducted a special drive to check the misuse and sale of antibiotic drugs without prescriptions in medical stores across the state between February 17 and 19. Officers found 52 medical shops selling antibiotics without a valid prescription and launched investigations against them, said state health minister Dinesh Gundu Rao.

Nearly 113 of the 246 samples of Ringer's lactate (RL) IV solution by the Paschim Banga Pharmaceuticals have been found Not-of-Standard Quality (NSQ). Nine cases have been filed in various courts. "As of today (Friday), we have given permission to file 36 more cases," said Rao.

Cases have been filed against 75 drugs manufacturers and sellers for violating the Drugs and Cosmetics Act, 1940. The department is also recalling NSQ drugs worth nearly Rs 17 Lakh from the market.

In January, 1,133 drug samples were drawn and tested, 106 of which were declared NSQ. In February, of the 1,841 drug samples drawn for testing, 58 samples were declared NSQ.

The department is also developing a software and application to better trace NSQ drugs in the market and aid their recall in a more effective manner. The software will have the complete details about retailers, wholesalers, manufacturers and their authorised agents to "trace available stocks of Not-of-Standard-Quality Drugs at every stage", read an official release by the department. "We will bring in a drug recall policy for the in the state," said the minister.