In this regard, it is pertinent to state that the proof of safety and effectiveness as required for issuing license to manufacture Ayurvedic, Siddha or Unani medicine 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 issued directives to the State Governments for appointing Gazetted Officers for monitoring of advertisements of such drugs. Complaints of misleading advertisements of 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. Ministry of AYUSH has also 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.
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