Guidelines to Restrict Ayush Products of Medicinal Use

· Misleading Ads for Medicines containing Poisonous Substances

· As per the provision of Rule 161 of Drugs Rules, 1945, it is mandatory for the container of a Ayurvedic, Siddha and Unani medicine for internal use to be labeled conspicuously with the words ‘Çaution: to be taken under medical supervision’ both in English and Hindi languages, if the ingredients are made up from a substance (poisonous) specified in Schedule E(1)

Instances of dubious claims and misleading advertisements of Ayush products have come to the notice of the Central Government. The Pharmacovigilance Centres for Ayurveda, Siddha, Unani and Homoeopathy Drugs set up in different parts of the country have reported 18812 objectionable advertisements since 2018 to December, 2021. On the Grievance against Misleading Advertisement (GAMA) portal of Department of Consumer Affairs, 1416 misleading advertisements of Ayush productsand services have been registered from April 2014 to July 2021.

Further, in the year 2017-19, Advertising Standards Council of India (ASCI) under MoU with Ministry of Ayush has reported 1229 misleading advertisements of Ayush products.

The protocol or guidelines are in force to restrict Ayush products of medicinal use with dubious claims and for selling certain medicines under medical supervision.

The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 and Rules there under encompass the provisions for prohibition of misleading advertisements and exaggerated claims of drugs and medicinal substances including Ayush medicines and for the penalty to be imposed on the defaulters. The State/UT Governments are empowered to enforce the legal provisions under Drugs & Cosmetics Act, 1940 and the Drugs & Magic Remedies (Objectionable Advertisements) Act, 1954 and rules made there under.

The Pharmacovigilance Centres for Ayurveda, Siddha, Unani and Homoeopathy (ASU&H) Drugs set up in different parts of the country under the Central Sector Scheme of Ministry of Ayush are mandated to monitor and report misleading advertisements to the respective state Drug Licensing Authorities for taking appropriate action under the provisions of Drugs & Cosmetics Act, 1940 and the Drugs & Magic Remedies (Objectionable Advertisements) Act, 1954.

Media regulators have also been approached to prevent the publication of inappropriate advertisements promoting sale of Ayurvedic and other such medicines in public interest. On this account, Ministry of Information & Broadcasting issued instructions/guidelines to all media channels to abstain from publishing and telecasting such misleading advertisements, which are in contravention of provisions of the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 and Rules thereunder.

Ministry of Ayush issued an Advisory dated 31^st August 2018 to the drug manufactures and the advertising agencies to refrain from using the name of Government Departments or Institutions in the advertisements of ASU & H Drugs. Also, Caution has been issued in November 2018 in leading newspapers for general public to not to fall prey to fake calls and advertisements of ASU & H Drugs. With the enforcement of these steps the advertisers have corrected or withdrawn the improper advertisements.

Also, as per the provision of Rule 161 of Drugs Rules, 1945, it is mandatory for the container of a Ayurvedic, Siddha and Unani medicine for internal use to be labeled conspicuously with the words ‘Çaution: to be taken under medical supervision’ both in English and Hindi languages, if the ingredients are made up from a substance (poisonous) specified in Schedule E(1).

This information was given by Minister of Ayush Sarbananda Sonowal in a written reply in Rajya Sabha 22 March 2022.