Ministry Of Ayush Notifies Omission Of Rule 170 That Regulate Ads Of ASU Drugs

New Delhi: Even as the matter of alleged misleading advertisements related to Ayurveda and herbal products are subject to various litigations in Courts including the Supreme Court of India, the Ministry of Ayush has issued the final notification omitting Rule 170 and related Forms in the Drugs Rules, 1945.

The Rule 170, which was incorporated in the Drugs Rules in 2018, made the permission of the state drug regulators mandatory for publishing advertisements of Ayurvedic, Siddha and Unani drugs.

The final notification follows the Ministry’s affidavit in April, 2024 – in the Supreme Court in a matter related to the Indian Medical Association’s petition against Union of India, Patanjali Ayurved and Divya Yoga Pharmacy promoted by Yoga Guru Ramdev – backing the decision to omit the Rule.

In a final notification dated July 1, 2024, the Ministry said that the Drugs (Fourth Amendment) Rules, 2024 shall come into force on the date of its publication in the Official Gazette. A draft notification seeking suggestions and objections on the amendment was issued on February, 2024, along with various other amendments.

Along with the omission of the Rule 170, related to prohibition of advertisements of Ayurvedic, Siddha or Unani drugs, the final notification also omits the Form 26 E4 and Form 26 E5 under the Schedule A of the Rules, which are application form for advertisement of ayurvedic, Siddha and Unani drugs and the form for the State Licensing Authority to approve such an application.

The Rule 170, included in the Drugs Rules, 1945 through a notification in December 24, 2018, stipulated that the manufacturer or his agent of ayurvedic, Siddha or Unani drugs shall not participate in publication of any advertisement relating to any drug for the use of diagnosis, cure, mitigation, treatment or prevention of any disease, disorder, syndrome or condition and these drugs shall be advertised for the purpose other than those mentioned, after the allotment of a Unique Identification Number (UIN), and after getting permission from the drug regulator.

It also detailed the provisions under which such an application for advertisement may get rejected by the State Licensing Authority (SLA), the procedures for the SLA to follow while considering such an application, the appeal process, and the actions to be taken if the directions of the SLA are not complied with.

However, the Ministry later said that the Rule 170 was challenged in proceedings before various High Courts and some of them have issued interim order directing the regulators not to take coercive action against the companies.

The Ayurveda, Siddha, Unani Drugs Technical Advisory Board (ASUDTAB), following recommendation of expert committee to revisit Rule 170, considered a draft gazette notification for omission of the Rule in March 15, 2021 and recommended for omission of the Rule.

This was considering the fact that whatever action is to be taken with respect to misleading advertisements of ASU drugs will be considered under the Drugs & Magic Remedies (Objectionable Advertisement) Act, 1954. The draft rule for omission of the Rule was initially published in the Gazette on July 2, 2021 for the objections or suggestions by the stakeholders.

In a twist to the progress of the decision, the Drugs Controller General of India (DCGI), who is a member of ASUDTAB, observed that it may not be appropriate to omit the Rule, in anticipation of its inclusion of similar provisions in the Drugs and Magic Remedies Act. However, in a later meeting held on May 25, 2023, the ASUDTAB reconsidered the matter and recommended to proceed with final notification for omission of the Rule and its related forms.

The Ministry, in its affidavit with the Supreme Court, also justified its communication in August, 2023, directing the SLAs not to initiate or take any action under the Rule, since the final notification for omission of the Rule and its related provisions will take some time. The Ministry informed the Court that this was in order to avoid confusion among various State and Union Territory SLAs and to prevent avoidable litigations.

The Ministry also informed that it has constituted an expert committee to examine the comments of various stakeholders of the draft notification and the report will be placed before ASUDTAB in its upcoming meeting.

It has also taken efforts in collaboration with the Advertising Standards Council of India (ASCI) and under the National Pharmacovigilance Coordination Centre against misleading advertisements, said the Ministry.

The matter of misleading advertisement was included under the umbrella of pharmacovigilance in addition to compiling and reporting of Adverse Drug Reaction (ADR) and the National Pharmacovigilance Coordination Centre (NPCC), was established at the All India Institute of Ayurveda (AIIA), New Delhi along with five intermediary Pharmacovigilance Centres – one each at National Institutes in the cities of Jamnagar, Jaipur, Chennai, Bengaluru and Kolkata, and 99 Peripheral Pharmacovigilance Centres (PPvCs) established and functioning across the country, to deal with the matter, it added.

The Ministry informed the Court that from 2018, a total of 36,040 cases of misleading advertisements were reported across the country, as reported with the NPCC, including 2091 in the year 2024. Action has been taken by SLAs in 354 cases upto March, 2024, in six states, it added.

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