(a) whether the Government of India has mandated that the manufacturers of Ayurvedic medicines should seek permission from Drugs Controller of India before placing any advertisements and that there should be a designated monitoring cell involving officials for the purpose: and
(b) if so, the details thereof ?
THE MINISTER OF AYUSH
(SHRI SARBANANDA SONOWAL)
(a) & (b) Sir, as prescribed in Drugs and Cosmetics Act 1940 and Rules 1945 made thereunder, enforcement of the legal provisions pertaining to regulation and Quality Control of Ayurveda, Siddha, and Unani drugs, is vested with the State drug Controllers/ State Licensing Authorities appointed by the concerned State Government/ Union Territory.
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. Central Government has notified insertion of Rule 170 in the Drugs & Cosmetics Rules, 1945 on 24th December, 2018 specifically for controlling inappropriate advertisements of Ayurvedic, Siddha and Unani medicines.
State/UT Governments are empowered to enforce the provisions of Drugs & Magic Remedies (Objectionable Advertisements) Act, 1954 and Rules there under and Rule 170 of the Drugs & Cosmetics Rules, 1945 pertaining to control and prohibition of misleading advertisements and exaggerated claims of drugs. Accordingly, directives have been issued to the States/UTs for appointing Officers to enter, search any premises or examine or seize any record related to the alleged misleading or improper advertisements and initiate action against the cases of default.
Pharmacovigilance Centres for Ayurveda, Siddha, Unani and Homoeopathy (ASU&H) Drugs set up in different parts of the country under the Central Scheme 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 program for Ayurveda, Siddha, Unani & Homoeopathy drugs. Objectionable advertisements are being reported to the respective State Licensing Authorities by PPvC at regular intervals.
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