ANSWER
THE MINISTER OF STATE(IC) OF THE MINISTRY OF AYURVEDA, YOGA & NATUROPATHY, UNANI, SIDDHA AND HOMOEOPATHY
(SHRI SHRIPAD YESSO NAIK)
(a) to (c): A statement is laid on the Table of the House.
STATEMENT REFFERED TO IN REPLY TO LOK SABHA
STARRED QUESTION NO. 293 FOR 4TH AUGUST, 2017
(a) Ministry of AYUSH received 79 complaints in the year 2014 about advertisements and misleading claims allegedly of herbal and AYUSH products. Thereafter, 515 AYUSH-related complaints of misleading advertisements appeared in the print and electronic media have been escalated by Advertising Standards Council of India (ASCI) out of the cases registered in the “Grievances Against Misleading Advertisements (GAMA)” portal of the Department of Consumer Affairs since March 2015 till date.
(b) & c) A news item appeared in The Times of India dated 25th October, 2016, came to the notice of Ministry of AYUSH about the death of three persons in Tenkasi town of Tamil Nadu after consuming herbal medicine taken from a local practitioner. The issue was Suo-moto taken up with the concerned State Licensing Authority, who after investigating the matter, reported that the alleged herbal medicine in the form of concoction for diabetes and hypertension was given by an unregistered practitioner to three patients and two of them died. The practitioner in an attempt to demonstrate the safety of that concoction before the public consumed the said herbal medicine and he also died. Analysis report of the herbal medicine did not reveal presence of any poisonous content, whereas the viscera reports of the deceased persons found the presence of organophosphorus insecticide in the liver, kidney, stomach and intestine. One of the patients who consumed the alleged herbal medicine is reported to have recovered.
In the given context, it is pertinent to state that the category of herbal medicines/products, as such, is not defined in the Drugs & Cosmetics Act, 1940 and Rules thereunder. However, proof of safety and effectiveness, as required for issuing license to manufacture Ayurvedic, Siddha or Unani medicines, is prescribed in the guidelines under Rule 158-B of the Drugs & Cosmetics Rules, 1945, which can either be based on textual rationale from the authoritative books listed in the First Schedule to the Drugs & Cosmetics Act or published literature; and if no such evidence of effectiveness of the drug is available, it needs to be generated by conducting the pilot study.
In order to check the veracity of misleading advertisements of AYUSH products, the Central Government has taken following steps-
I. Issued directives to the State Governments for appointing Gazetted officers for monitoring of advertisements of drugs.
II. 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. States have reported action taken against the defaulters.
III. Ministry of AYUSH has signed MoU with Advertising Standards Council of India (ASCI) on 20th January, 2017 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.
IV. Press Council of India has laid down norms for advising the newspapers to reject advertisements that offend the provisions of Drugs & Magic Remedies (Objectionable Advertisements) Act, 1954.
V. Ministry of Information & Broadcasting has 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. TV channels have been advised to advertise only those AYUSH products, which have valid manufacturing license.
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