The Minister of State for the Ministry of Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy (AYUSH), in a written reply to a query from Lok Sabha, has stated that increasing number of misleading advertisements of AYUSH products are being reported in recent years1. Such complaints are also registered in the GAMA (Grievances against Misleading Advertisements) portal maintained by the Department of Consumer Affairs (DoCA). About 809 complaints of advertisements pertaining to AYUSH and herbal medicines/products have been received during the period from April, 2015 to March, 2018. Advertising Standards Council of India (ASCI), with whom Ministry had signed a MoU for suo moto monitoring of AYUSH advertisements appearing in print and TV media, reported 732 complaints in the period from 20th January, 2017 to 19th January, 20182.

Regulatory framework for AYUSH drugs

The manufacturing, sale and distribution of Ayurvedic, Siddha and Unani medicines is regulated under various provisions of Drugs and Cosmetics Act, 1940 (the 'Act') and the Drugs and cosmetic Rule, 1945. However, there is no exclusive definition for herbal medicines clinical trial in said Act and Rules thereunder. In the year 2015, the central government introduced a new category of drugs derived from herbal materials or medicinal plants called as "Phytopharmaceuticals" under Drugs and Cosmetics Rules, 1945, to provide regulatory provisions for such drugs, made from purified and standardized fraction of minimum four bio-active or phyto-chemical compounds extracted from a medicinal plant or its part. Further, The provisions of Rule 158-B of the Drugs & Cosmetics Rules, 1945 provide for pilot studies for generating proof of safety and effectiveness for grant of license to manufacture for sale certain categories of Ayurveda, Siddha and Unani drugs.

The advertising regulation of AYUSH products comes under the ambit of the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 (the '1954 Act'), since the definition of 'drug' given in the Act covers all medicines, substances and articles other than food. For checking the veracity and for monitoring of misleading advertisements, powers are vested with the State Governments to authorize Gazetted Officers to search, seize, examine any record, register, document or any other material object related to any objectionable advertisement under the provisions of Section 8(1) of the 1954 Act.

Central Government's efforts to tackle misleading advertisement

In order to check the veracity of misleading advertisements and claims of AYUSH products, the Central Government has taken following steps-

  1. State Governments have been directed for appointing Gazetted Officers under section 8 (1) of the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 to  enter, search any premises  or examine or seize any record which contravenes any provisions of the Act. About 621 Gazetted Officers for this purpose are reported to have been appointed in 22 states.
  2. Complaints of misleading advertisements of Ayurvedic, Siddha, Unani and Homoeopathic medicines are forwarded to the concerned State Licensing Authorities for action in accordance with the provisions of Drugs & Cosmetics Act, 1940 and Rules thereunder and Drugs & Magic Remedies (Objectionable Advertisements) Act, 1954 and Rules thereunder. Out of the 809 complaints reflected on GAMA portal, about 274 complaints have been resolved and 585 complaints forwarded to concerned state authorities for appropriate action in accordance with the legal provisions. States have reported action taken by them against the defaulters.
  3. Ministry of AYUSH signed MoU with Advertising Standards Council of India (ASCI) to undertake monitoring of the misleading AYUSH –related advertisements appearing in print and TV media and bring the instances of improper advertisements to the notice of the State Regulatory Authorities for taking necessary action. ASCI reported that 233 alleged advertisements were rectified or withdrawn by the advertisers and about 456 complaints were escalated to the State regulators for appropriate action.
  4. On the request of Ministry of AYUSH, Ministry of Information & Broadcasting issued an advisory to all media channels to ensure strict compliance of the provisions of Drugs & Cosmetics Act, 1940 and Drugs & Magic Remedies (Objectionable Advertisements) Act, 1954 in respect of AYUSH health products/drugs being advertised. TV channels have been advised to advertise only those AYUSH products, which have valid manufacturing license.
  5. Provision of surveillance of AYUSH advertisements has been kept in the central scheme implemented for safety monitoring of Ayurvedic, Siddha, Unani and Homeopathy drugs under the pharma vigilance initiative.

Note: The Ministry of AYUSH, established to ensure the optimal development and propagation of AYUSH systems of health care in the country has issued State-wise/company-wise list of 407 such misleading advertising  instances along with the details of 585 complaints forwarded to the respective State Regulatory Authorities for necessary action in accordance with the legal provisions in last three years.

Footnotes

1. https://www.ascionline.org/images/pdf/au1336.pdf

2. http://pib.nic.in/PressReleseDetail.aspx?PRID=1541936

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.