Health Ministry issues draft Drug (Amendment) Rules, 2022; proposes to introduce various classes of drugs to Schedule K of the Drugs Rules; public comments invited on the draft Rules by 30th May, 2022

Ministry of Health and Family Welfare has proposed to further amend the Drug Rules, 1945. The draft amendment proposes to add classes of drugs to Schedule K of the Drugs Rules, 1945. Such classes of drugs may be sold by retail Over-The-Counter without prescription of a Registered Medical Practitioner subject to adhering to certain conditions.

Objections or Suggestions, if any, may be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, Room No. 434, C Wing, Nirman Bhavan, New Delhi – 110011 or e-mailed at drugsdiv-mohfw@gov.in by 30th May, 2022.

Key Highlights:

1. The proposed amendment introduces a list of a drugs to Schedule K which can be sold Over-the-Counter (OTC) by retail under valid licence.
2. The proposed amendment lays down extent and conditions for Over-the-Counter (OTC) retail:

1. 1. Maximum duration of treatment/use must not exceed 5 days;
   2. Patient must consult Medical Practitioner if symptoms unresolved;
   3. Pack size must only include maximum dose for five days;
   4. Each pack of drug must be accompanied with Patient Information Leaflet;
   5. The indications claimed must be same as approved by Licensing Authority, for mentioned categories.

A copy of the Notification is attached herewith for ease of reference.

Source: Ministry of Health and Family Welfare