The Health Ministry's draft amendment on advertising of prescription medicines seeks to amend which rules?
- A.The Drugs Rules, 1945
- B.The Drugs and Magic Remedies Rules, 1955
- C.The Food Safety and Standards Rules, 2011
- D.The Clinical Establishments Rules, 2012
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Explanation
The correct answer is the Drugs Rules, 1945. The Union Ministry of Health and Family Welfare has proposed an amendment to these rules so that the requirement of prior Central Government sanction for advertising drugs listed in Schedule H, Schedule H1 and Schedule X extends to entities licensed to sell and distribute medicines, and not only to manufacturers. The vehicle is a new sub-rule inserted under Rule 65. Option B names a different legal instrument concerned with objectionable advertisements of remedies, which is not what the ministry has moved to change here. Option C deals with food and not with medicines, and is administered by a separate regulator. Option D concerns the registration and standards of clinical establishments, again outside the subject of drug advertisements. The point to carry is that schedules H, H1 and X sit inside the Drugs Rules of 1945.