|
The Ministry of Ayush has released the final notification eliminating Rule 170 and related Forms in the Drugs Rules, 1945, even as the problem of purportedly deceptive advertisements pertaining to Ayurveda and herbal items is the subject of numerous litigations in Courts, including the Supreme Court of India.
The Ministry stated in a final notification dated July 1, 2024, that the Drugs (Fourth Amendment) Rules, 2024 will take effect on the day they are published in the official gazette. Along with a number of additional revisions, a draft notification asking for comments and ideas on the amendment was released in February 2024.
The final notification also omits Forms 26 E4 and 26 E5, which are application Forms for advertising Ayurvedic, Siddha, and Unani drugs, as well as the Form for the State Licensing Authority to approve such an application, under Schedule A of the Rules. Rule 170, which prohibits advertisements of Ayurvedic, Siddha, and Unani drugs, is missing.
What is Form 26 E4?
Form 26 E4 is an application for the promotion of Ayurvedic, Siddha, and Unani medicines in India. It asks for facts about the applicant's identity and company, the planned advertisement's content and media, the language used, and references for any claims or medical indications expressed. In addition, the applicant must provide supporting documentation such as a current manufacturing license, evidence of safety and effectiveness, and quality standards. The application must be completed, signed, and dated, together with the applicant's address and contact details.
Advertising Standards Council of India and Ayush’s empowered committee
The Ministry of Ayurveda, Yoga and Naturopathy, Unani, Siddha, and Homoeopathy established a commission to regulate deceptive advertising and inflated claims of Ayush drugs in an efficient, preventative measure.
Since its founding in 1985, the Advertising Standards Council of India (ASCI) has worked to promote self-regulation in advertising while safeguarding consumers' interests. The ASCI is the lone non-governmental participant. Representatives from Ayush, Health and Family Welfare, and DoCA make up the seven-member empowered committee.
Covid-19 advertising advisory by ASCI
Advertisers of ASU goods and services were recommended to follow the Ministry of Ayush's April 1, 2020, order regarding Covid-19 advertisements.
In order to comply with ASCI code clauses 1.4 (‘Advertisements shall neither distort facts nor mislead consumers by means of implications and omissions’) and 1.5 (‘Advertisements shall not be so framed as to abuse the trust of consumers or exploit their lack of experience and knowledge’), it was advised that advertisements during the coronavirus pandemic refrain from claiming destruction or removal of any virus other than coronavirus. Advertisers should insert a disclaimer with the size and placement specified by the ASCI disclaimer guidelines, such as "claim not applicable to corona virus” or a similar statement, if they chose to make any claims about the elimination of other viruses from their advertisements.
It was recommended that advertisers exercise extra caution when claiming - directly or indirectly - those they can lower their risk of contracting the coronavirus or develop immunity to it. Advertisers should be able to provide evidence for any claims of immunity to the coronavirus or treatment for it. This evidence can come from regulatory-approved clinical research carried out by a recognized medical institution or laboratory, well-known medical/technical literature, or technical support recognized or approved by health authorities such as the ICMR, MoHFW, Ayush, DCGI, CDC (USA), or health organizations of similar stature.
Products that are not applied to the body or consumed internally - that is, those that do not need a license under the Drug & Cosmetic Act - should exercise extra caution when making claims about treating or preventing the coronavirus, unless they have the data necessary to support those claims, as stated in clause 3 above.
Indian government’s efforts
Indian government has taken the following steps to combat deceptive Ayush medicine advertising:
The government has taken note of the provisions of the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 and the Rules there under, which prohibit deceptive advertising and making exaggerated claims about drugs and medicinal substances, including Ayush medicines, in print and electronic media. Drugs and Magic Remedies Act, 1954 & Rules thereunder are enforced by State/UT governments.
Pharmacovigilance Centers for Ayurveda, Siddha, Unani, and Homoeopathy (ASU&H) drugs, established across the nation under the Ministry of Ayush's Central sector "Ayush Oushadhi Gunvatta Evam Uttpadan Samvardhan Yojana Scheme", are tasked with keeping an eye out for deceptive advertisements and reporting them to the appropriate State regulatory authorities. A National Pharmacovigilance Coordination Center, Intermediary Pharmacovigilance Centers, and Peripheral Pharmacovigilance Centers make up the three tier system that is set up. The National Pharmacovigilance Co-ordination Center for the execution of the National Pharmacovigilance programme for Ayurvedic, Siddha, Unani, and Homoeopathic medicine products is the All India Institute of Ayurveda, New Delhi, under the Ministry of Ayush.
The grievances against misleading marketing webpage is managed by the Department of Consumer Affairs and offers a forum for reporting incidents of deceptive marketing. Furthermore, the Ministry of Information and Broadcasting (MoIB) is responsible for enforcing TV channel laws. As such, any reports of deceptive advertisements airing on TV channels are referred to MoIB for appropriate action.
Where is Ayurveda, Siddha, Unani Drugs Technical Advisory Board?
The Ayush ministry reversed course in 2018 and recommended that the regulation be removed from the Drugs and Cosmetics Rules, 1945, which had been amended to prohibit improper advertising of Ayush medicines. This is true even though the board was contacted by the government prior to implementing the Rule. Furthermore, the board had suggested at its June 2022 meeting that Rule 170 omission was not necessary.
According to reports, the Supreme Court pulled up Patanjali Ayurved Ltd in relation to a case involving false ads, prompting the Ministry of Ayush to issue a warning to all manufacturers of ASU drugs.
Provisions of Rule 158-B of D&C Rules, 1945
Under the terms of Rule 158-B of the D&C Rules, 1945, licenses to manufacture and sell specific kinds of Ayurvedic, Siddha, and Unani drugs may be granted only when pilot studies have produced evidence of their efficacy and safety. Consequently, the definitions of "herbal medicines" and "clinical trials" are not included in the Drugs & Cosmetics Act, 1940 or its implementing regulations when it comes to ASU pharmaceuticals; yet, the Ministry received several objections regarding these matters. The Ministry of Ayush is aware of two fatalities - one in Tamil Nadu and one in Kerala - that resulted from the use of herbal remedies or products.
Under Section 8(1) of the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, State governments are required to designate gazetted officers who may enter, inspect, examine, or seize any record that violates any Act provisions. It is reported that 621 gazetted officers have been appointed in 22 States for this purpose.
The concerned State Licensing Authorities receive complaints about deceptive advertisements for ASU medicines. These complaints are then investigated in line with the provisions of the D&C Act, 1940 and Rules, 1945 there under, as well as the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 and Rules thereunder.
(Author is a herbal consultant, based in Mohali)
|