The Ministry of health and family welfare is likely to amend the Drugs and Cosmetics Rules, 1945 to regulate advertisements of drugs included in Schedule G. The draft notification issued on July 10, 2024 is open for the public feedback for 45 days.
Schedule G has drugs that are of essential nature. They are used in the treatment of diseases like Tetanus and Hepatitis B and life-saving drugs for chronic medical conditions such as insulin and metformin for diabetes management.
The move highlights the government's efforts to prevent misleading advertisements that can have serious consequences if prescribed without seeking advice from a medical practitioner.
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Schedule G contains an exhaustive list of medications that can be used only under medical supervision. The drugs under the category are not prescription drugs and are critical.
In India, regulations under the Drugs and Cosmetics Act 1940 are in place to regulate imports, manufacturing, distribution and sales of drugs and cosmetics. As per the requirement of the Drugs Rules, 1945, the medications specified in Schedule G must contain a label saying, "Caution: it is dangerous to take this preparation except under medical supervision."
The conversation around the proposed amendments have been happening for the past few years. The Ministry of Health and Family Welfare has consulted with the Drugs Technical Advisory Board (DTAB) on the proposed draft.
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The false claims in advertisements have become a concern, especially after the Patanjali Ayurved case which reached the corridors of the Supreme Court. The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, is responsible for drug advertisement regulation. It restricts ads which mislead people about nature or effectiveness of drugs.
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