• Last week, the Supreme Court stayed a notification issued by the Ministry of AYUSH, which omitted rule 170 of the Drugs & Cosmetics Rules, 1945 that prohibits misleading advertisements of Ayurvedic, Siddha, and Unani drugs.

• A bench of Justices Hima Kohli and Sandeep Mehta said the notification issued by the ministry was in the teeth of its May 7, 2024 order.

• Clamping down on misleading advertisements, the Supreme Court on May 7, 2024 had directed that before an advertisement is permitted to be issued, a self-declaration be obtained from the advertisers on the line of the Cable Television Networks Rules, 1994.

• The Union government had earlier defended its August 2023 letter to states and Union Territories asking authorities not to initiate action against any entity for violating Rule 170 of the Drugs and Cosmetics Rules.

• In May 2024, the Supreme Court questioned the Centre over the letter by the Ministry of AYUSH asking the licensing authorities not to initiate or take any action under rule 170 of Drugs and Cosmetics Rules, 1945.

Tackling misleading advertisements of AYUSH drugs

• Under the Drug & Cosmetics Act 1940 and Drugs & Cosmetics Rules, 1945 framed thereunder, the regulatory control over the manufacture and sale of the drugs is exercised through a system of licensing and inspection by the State Licensing Authorities appointed by the state governments. 

• Licensee is required to comply with the conditions of license including Good manufacturing practices as prescribed under Drugs Rules, 1945. 

• State Licensing Authorities are empowered to take action on violation of any conditions of such licenses including prosecution in appropriate court of law. 

• Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 and Rules thereunder encompass the provisions for prohibition of misleading advertisements and exaggerated claims of drugs and medicinal substances including AYUSH medicines, which appear in the print and electronic media and government has taken note thereof. 

• State/UT governments are empowered to enforce the provisions of Drugs & Magic Remedies (Objectionable Advertisements) Act, 1954 & Rules thereunder. 

• Pharmacovigilance centres for Ayurveda, Siddha, Unani and Homoeopathy (ASU&H) Drugs set up in different parts of the country under the Central Sector Scheme ‘Ayush Oushadhi Gunvatta Evam Uttpadan Samvardhan Yojana’ (AOGUSY) of Ministry of AYUSH, are mandated to monitor and report the misleading advertisements to the respective state regulatory authorities. 

• A three tier structure comprising of a National Pharmacovigilance Co-ordination Centre (NPvCC), Intermediary Pharmacovigilance Centres (IPvCs) and Peripheral Pharmacovigilance Centres (PPvCs) is established. 

• All India Institute of Ayurveda (AIIA), New Delhi under Ministry of AYUSH is the National Pharmacovigilance Co-ordination Centre (NPvCC) for the implementation of the National Pharmacovigilance programme for Ayurveda, Siddha, Unani & Homoeopathy drugs. 

• Under the pharmacovigilance programme, objectionable/misleading advertisements are regularly reported to the respective State Licensing Authorities for initiating action against the defaulters. 

• The Department of Consumer Affairs maintains the Grievances Against Misleading Advertisements (GAMA) portal, providing a platform to address instances of misleading advertisements. 

• The regulations and enforcement for TV Channels falls under the mandate of the Ministry of Information and Broadcasting (MOIB). Therefore, references of misleading advertisements getting broadcasted on TV channels are forwarded to MOIB for action.

• Under the provisions of the Consumer Protection Act, 2019, the Central Consumer Protection Authority (CCPA) has been established to regulate matters relating to the violation of the rights of consumers, unfair trade practices, and false or misleading advertisements. 

• Further, CCPA has notified guidelines for the prevention of misleading advertisements and endorsements for misleading advertisements.

• These guidelines are applicable to manufacturers, service providers, or traders whose goods, products, or services are featured in an advertisement. Additionally, they apply to advertising agencies and endorsers whose services are utilised for the promotion of such goods, products, or services.

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