The government has acted promptly to do away with a rule to regulate advertisement of Ayush drugs just three months after this was recommended by a technical committee. However, the amendments to the Drugs and Magic Remedies (DMR) Act meant to strengthen regulation of drug advertisements, drafted three years back, remain in limbo.
The omission of Rule 170, which was supposed to regulate advertisements for Ayush drugs, was recommended in May this year.
It has been operationalised though the final notification of the omission has not happened yet. In response to a right to information query, Ayush ministry wrote that while “the final notification for omission of Rule 170 and its related provisions mentioned in the Drugs and Cosmetics Rules, 1945 will take some time”, all licensing authorities in states and union territories have been “directed not to initiate/take any action under Rule 170”. The letter to states and union territories from the Ayush ministry was sent on August 29.
Rule 170 had been brought in through an amendment to the rules after consultations with ASUDTAB (Ayurvedic, Siddha, Unani Drugs Technical Advisory Board) in response to an increasing number of misleading advertisements of Ayush products. The rule mandated that all advertisements for Ayush drugs would have to be previewed and cleared by the regulator before being publicised.
In 2018, the Ayush minister revealed that the ministry had come across 804 instances of misleading advertisements or claims between April 2015 and January 2018. Pharmacovigilance centres of Ayush reported 1,127 cases of misleading advertisements from August 2018 to March 2019. However, less than a month after the new Rule 170 was gazetted, several manufacturers went to court against it and in January 2019 the Delhi high court stayed its operation.
ASUDTAB took up the issue of omission of Rule 170. However, in its meeting in June 2022, according to the minutes of the meeting obtained through RTI, then DCGI, Dr VG Somani “suggested that, it is not ethical to omit the existing Rule in anticipation of its inclusion in the proposed amendment of DMR Act”. However, file notings given as part of an RTI response from the health ministry show that the proposed amendments to strengthen the DMR Act have been in limbo since November last year.
“Drugs and Magic Remedies Act or the Consumer Protection Act can be invoked only after a misleading ad has appeared. Hardly any action gets taken when such complaints are filed and the cases drag on for years, by which time the intent of publishing such an ad will be met. Rule 170 was meant to be preventive. It would have prevented misleading ads from being published as these ads would first have to be cleared by the concerned state licensing authority. It is unfortunate that the government is buying the industry argument instead of working to protect public interest,” said Dr KV Babu, ophthalmologist and RTI activist.
The Ayush ministry’s letter to the state licensing authorities shows that it has decided to go ahead with the recommendation of ASUDTAB following the meeting held on May 25 to proceed with final notification for omission of Rule 170.