NEW DELHI: The Ayush drug licensing authority in Kerala has warned a drug company for not complying with Rule 170 of the Drugs and Cosmetics Act meant to prevent misleading advertisements. Kerala drug controller (Ayurveda) issued a warning to Pankajakasthuri Herbals India Pvt Ltd for publishing an ad without submitting it to the licensing authority for approval as stipulated by the rule.
In January 2025, Pankajakasthuri advertised tablets and an oil for leg pain and reduced mobility featuring a former woman panchayat member, saying that it worked for her. “The wordings of the ad are misleading. Pain in the legs could be due to any reason or conditions such as varicose vein, deep vein thrombosis, inflammations or any infection. Patients with leg pain could be misled that the advertised drug can be used for any purpose,” said Dr Babu KV, an ophthalmologist and RTI activist who complained to the drug controller and asked if the ad had been submitted for approval before being issued.
In response to Dr Babu’s RTI query, the drug controller’s office confirmed that the company had not submitted the ad for approval and added that a warning against engaging in such illegal activities in future was issued to the company. Dr Babu said that a mere warning was not a sufficient deterrent and sought exemplary punishment citing a violation despite the restoration of Rule 170 being widely reported.
Though Rule 170 was inserted into the Drugs and Cosmetics Act in December 2018, it was stayed by the Mumbai high court in February 2019 on a petition filed by ayurvedic drug manufacturers. In May 2023, the Ayurveda, Siddha, Unani Drugs Technical Advisory Board (ASUDTAB) of the central Ayush ministry recommended the omission of Rule 170 and a notification dated July 1, 2024, was issued omitting it. However, on August 27, 2024 the Supreme Court stayed the July 2024 notification and restored Rule 170 saying that “till further order passed rule 170 shall remain on statute book and in force”.
Under Rule 170, advertisement of ayurvedic, siddha and unani drugs have to be cleared by the licensing authority of the state where the manufacturer of the medicine is located or where the corporate office is located, in case the manufacturing is happening in more than one state. It was brought in through an amendment to the rules after consultations with ASUDTAB in response to an increasing number of misleading advertisements of Ayush products.