AYUSH Drug Manufacturers: Government Issues Advisory on Proper Labelling

The Ministry of Ayush has issued an advisory to address concerns regarding the labelling and advertisement practices with respect to Ayurveda, Siddha, Unani, and Homoeopathy (ASU&H) drugs. This advisory aims to rectify misleading practices observed in the industry and promote transparency and accuracy in product marketing.

The Ministry has observed that some manufacturers have been labelling their products as “Approved/Certified by Ministry of Ayush”. The Ministry has clarified that the license to manufacture drugs is issued by the State Drug Licensing Authority upon fulfilment of conditions specified in Rule 158B of the Drugs Rules, 1945, and not by the Ministry of Ayush.

Additionally, the labels and advertisements of AYUSH drugs making claims such as “100% Safe”, “Free from side effects”, “Permanent cure”, or “100% vegetarian” have also caught the attention of the Ministry. The Ministry has advised the manufacturers to adhere to the labelling requirements specified in Rule 161, 161A and 161B of the Drugs Rules, 1945

As far as advertisements are concerned, Rule 170(4)(viii) of the Drugs Rules, 1945 states that an application for advertisement of AYUSH drugs will be rejected if “it makes a misleading or exaggerated claim about the effectiveness of the said drug.” Furthermore, an advertisement which directly or indirectly gives a false impression of the true character of the drug is prohibited under Section 4 of the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954.

The Advisory places a strong emphasis on adhering strictly to the labelling regulations set forth in various Acts and Rules, to avoid misleading the consumers.

To access the Advisory, click https://lnkd.in/grqvBCHu

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