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Karnataka FDA concerned over lack of guidelines for tattoo ink which causes skin diseases, viral & bacterial infections
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Nandita Vijayasimha, Bengaluru
March 05 , 2025
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The Karnataka Food Safety and Drug Administration (FDA) is concerned over the lack of dedicated guidelines for tattoo inks which are tested and found to have heavy metals detected which cause skin diseases, viral and bacterial infections.
There are no Bureau of Indian Standards (BIS) for this tattoo ink and it is not covered under the rules of the Drugs and Cosmetics Act. When these heavy metals and micro-organisms enter the body through this tattoo ink, it can lead to many skin disease, bacterial, viral, fungal infections, and many other diseases, stated Karnataka FDA commissioner Srinivas K.
The state’s FDA officers had drawn tattoo Ink samples for analysis from the market. According to the analytical report, about 22 heavy metals like selenium, chromium, platinum, arsenic, etc are found in the ink.
Since the Central government has the authority to formulate the rules, the Central government has to take action to bring standards under the Bureau of Indian Standards (BIS), he added.
Further, we are implementing strict control and vigilance over drugs marketed across all 31 districts. This initiative aims to ensure the availability of high-quality, safe, and effective medicines while cracking down on non-compliance and illegal drug sales, he said in his communication note.
By exercising strict control and vigilance on the drugs marketed in the state, the department eradicates the menace of spurious and substandard drugs, ensure safety of drugs and their availability on the controlled prices to the public, he noted.
The drug enforcement officers have drawn early this year 1,133 medicine samples in the interest of the public health and analysed in Drugs Testing Laboratories. Among them 938 samples are declared as standard quality and 106 are confirmed as a not-of-standard quality (NSQ).
Last month alone, 1,841 drug samples were drawn for analysis. So far, 58 are declared as NSQ. In December 2024, of the 262 cosmetics samples drawn for analysis, 120 were NSQs. The rest of the samples are under analysis, he said.
In December 2024 and January 2025, 75 cases have been permitted to file under the violation of Drugs and Cosmetic Act, 1940 and Rules thereunder. A special drive has been conducted to recall. Approximately Rs. 17 lakh worth of NSQs were recalled from the market. A special drive was conducted in the month of January 2025 to prevent the misuse of drugs (NDPS).
In the month of January 2025, a total of 1,983 drugs samples were drawn by the enforcement officers. 259 drug licenses were suspended and 07 drug licenses were cancelled. 1,608 drug samples are drawn for analysis. In the case of Ringer lactate solution, 113 samples have been declared as Not of Standard Quality. Nine prosecutions have been filed in various honourable courts.
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