Amidst the ongoing litigation in various courts, including the Supreme Court of India, over alleged misleading advertisements of Ayurvedic and herbal products, the Ministry of Health of India has issued a final notification omitting Rule 170 of the Drugs Rules, 1945 and related forms.
Rule 170, incorporated into the Drugs Rules in 2018, has made permission from state drug regulators mandatory for advertising Ayurvedic, Siddha and Unani drugs.
The final notification follows an affidavit filed by the ministry in the Supreme Court in April 2024 in a matter related to a petition filed by the Indian Medical Association against the government of India, Patanjali Ayurveda and Divya Yoga Pharmacy, promoted by yoga guru Ramdev, upholding its decision to omit the rules.
In its final notification dated July 1, 2024, the ministry said the Drugs (Fourth Amendment) Rules, 2024 will come into force on the date of publication in the Official Gazette. The draft notification inviting suggestions and objections regarding the amendments was issued in February 2024, along with various other amendments.
Besides omitting Rule 170 relating to prohibition of advertisement of Ayurvedic, Siddha and Unani medicines, the final notification also omits Form 26 E4 and Form 26 E5 in Schedule A of the Rules, which are applications for advertisement of Ayurvedic, Siddha and Unani medicines and forms for state licensing authorities to approve such applications.
Rule 170, enshrined in the Drugs Rules, 1945 through notification dated December 24, 2018, states that no manufacturer of Ayurvedic, Siddha or Unani drug or his agent shall take part in publishing advertisements in respect of any drug for use in the diagnosis, cure, mitigation, treatment or prevention of any disease, disorder, syndrome or symptom and such drugs shall be promoted for other than the aforesaid purposes after allotment of a Unique Identification Number (UIN) and obtaining permission from the Drugs Regulatory Authority.
It also details the provisions under which the State Licensing Authority (SLA) may refuse an advertising application, the procedure the SLA must follow when considering an application, the appeals process and the action to be taken if the SLA’s instructions are not followed.
However, the ministry subsequently said Rule 170 was being challenged in litigation in various high courts, some of which had issued interim orders directing regulators not to take enforcement action against companies.
Following the recommendation of the Expert Committee for review of Rule 170, the Ayurveda, Siddha and Unani Drugs Technical Advisory Board (ASUDTAB) considered the proposed gazette notification for deletion of the rule on March 15, 2021 and recommended deletion of the rule.
This was in view of the fact that action to be taken with regard to misleading advertisement of ASU medicines would be contemplated under the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954. The proposed rules for the omission of the rules were first published in the Official Gazette on July 2, 2021, for objections and suggestions by interested parties.
In a twist to the decision-making progress, the Drugs Controller General of India (DCGI), a member of ASUDTAB, noted that it may not be appropriate to omit the rule in anticipation of the inclusion of a similar provision in the Drugs and Magical Remedies Act. However, in a subsequent meeting held on May 25, 2023, ASUDTAB reconsidered the issue and recommended going ahead with a final notification regarding the omission of the rule and associated forms.
The ministry, in its affidavit before the Supreme Court, justified its direction to the SLAs not to initiate or take any action under the Rules in August 2023 as final notification of the omission of the Rules and its relevant provisions would take time.The ministry informed the court that this was to avoid confusion among the SLAs of various states and union territories and to prevent inevitable litigation.
The ministry also announced that it has constituted an expert committee to consider the comments of various stakeholders on the draft notification and its report will be submitted to the next ASUDTAB meeting.
The ministry said it was also working with the Advertising Standards Council of India (ASCI) and under the guidance of the National Coordination Centre for Drug Safety and Compliance to combat misleading advertisements.
The issue of misleading advertising has been subsumed under the umbrella of pharmacovigilance along with collection and reporting of Adverse Drug Reactions (ADRs), it said, adding that to address this issue, a National Pharmacovigilance Coordination Centre (NPCC) has been set up at the All India Institute of Ayurveda (AIIA), New Delhi besides five Intermediate Pharmacovigilance Centres, one each at national laboratories in the cities of Jamnagar, Jaipur, Chennai, Bangalore and Kolkata, and 99 Peripheral Pharmacovigilance Centres (PPvC) established and functioning across the country.
The ministry told the court that as per the NPCC report, a total of 36,040 cases of misleading advertisements have been reported across the country since 2018, which stands at 2,091 in 2024. It added that up to March 2024, 354 cases have been filed by the SLA in six states.
