Six states/UTs including Delhi, Maharashtra, Gujarat, Kerala, Karnataka and Chandigarh have reported 573 instances of such misleading advertisement during the last three years.
Ministry of AYUSH has been receiving written and online complaints of misleading advertisements of Ayush medicines including herbal medicines/products. 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.
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.
As such the terms ‘herbal medicines’ and ‘clinical trials’ are not provided or prescribed in the provisions of Drugs & Cosmetics Act, 1940 and Rules there under pertaining to ASU drugs but certain complaints received in the Ministry referred to these aspects. Two incidents of death have come to the notice of Ministry of AYUSH after consuming herbal medicines/products, one in Tamil Nadu and one in Kerala.
In order to check the veracity of misleading advertisements and claims of AYUSH products, the Central Government has taken following steps-
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.
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.
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.
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.
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 pharmavigilance initiative.
This information was given by the Minister of State (Independent Charge) for AYUSH, Shripad Yesso Naik in written reply to a question in Rajya Sabha today.