New Delhi: The Ministry of Ayush has formulated a Central Sector Scheme-Ayush Oushadhi Gunvatta evam Uttpadan Samvardhan Yojana (AOGUSY) in the year 2021.
One of the components of this scheme is Pharmacovigilance Program for Ayurveda, Siddha, Unani & Homoeopathy Drugs (ASU & H Drugs). The program is working through a three-tier network of a National Pharmacovigilance Centre (NPvCC), Five Intermediary Pharmacovigilance Centres (IPvCs) and 99 Peripheral Pharmacovigilance Centres (PPvCs) established across the country.
Through this channel of Pharmacovigilance centers objectionable/misleading s are regularly reported to the respective State Licensing Authorities for contravening regulations under different rules like Drugs and Magic Remedies (Objectionable s) Act, 1954, the cable television network (Regulation) Act 1995, the consumer protection Act, the Emblems and Names (Prevention of Improper Use) Act, 1950, The Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply and Distribution) Act, 1992, the Young Persons (Harmful Publications) Act, 1956 etc., for initiating action against the defaulters. Also, as per National Commission for Indian System of Medicine Regulations 2022 and National Commission for Homoeopathy regulations 2022, Pharmacovigilance is a mandate component for all the Ayush system of medicine.
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Under the Pharmacovigilance program till date a total of 38539 misleading s related to Ayush drugs has been reported. As per the information received from various State/UTs government, no such compliant against has been received against sale of Ayush products in the market without any authentic clinical trial.
Under section 8 (1) of the Drugs and Magic Remedies (Objectionable s) Act, 1954, any Gazetted Officer authorized by the State Government may, within the local limits of the area for which he is so authorized, to enter, search any premises or examine or seize any record which contravenes any provisions of the Act.
Ministry of Ayush has also requested State Drug Licensing Authorities and State Drug Controllers to take corrective measures for preventing inappropriate in electronic and print media including newspapers and initiate action as per the section 8 (1) of the Drugs and Magic Remedies (Objectionable s) Act, 1954.
The details of the extent to which Government has succeeded in checking these s and misleading claims in the country-
i.Provision of surveillance of ASU&H drugs misleading s has been kept in a Central Sector Scheme Ayush Oushadhi Gunavatta evam Uttpadan Samvardhan Yojana (AOGUSY), for safety monitoring of Ayurvedic, Siddha, Unani and Homeopathy drugs under the pharmacovigilance components. 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.
Under the Pharmacovigilance Program for ASU & H Drugs component of Ayush Oushadhi Gunvatta evam Uttpadan Samvardhan Yojana (AOGUSY) scheme, till date a total of 38539 misleading s related to Ayush drugs has been reported to respective state licensing authorities for proper action against the defaulters.
The Department of Consumer Affairs (DoCA) maintains the Grievances Against Misleading s (GAMA) portal, providing a platform to address instances of misleading s. Further, as the regulations and enforcement for TV Channels falls under the mandate of Ministry of Information and Broadcasting (MOIB), therefore references of misleading getting broadcasted on TV channels are forwarded to MOIB for action.
Till date approximately 358 brands of Ayush system have been issued the notice for exploiting various regulations. Also, the Press Council of India (PCI) is regularly taking action against the defaulter.
Details of misleading s related to Ayush drugs noticed by Pharmacovigilance and reported to the SLAs in last three years are as follows:
Year
Misleading s
2021
8144 + 43 (COVID)
2022
7367 + 4 (COVID)
2023
7771
2024
4372
This information was given by the Minister of State (IC) for Ayush Shri Prataprao Jadhav in the Lok Sabha in a written reply to a question today.
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