Change in Drug Supplying entities: New Draft Drugs and Cosmetic Amendment Rules


The Ministry of Health and Family Welfare in its Notification dated 6th November, 2019 has published the Draft Drugs and Cosmetics (Amendment) Rules, 2019 by amending the classes of drugs supplied by entities and their extent and conditions of exemption.

The Amendment is brought under schedule k of Drugs and Cosmetics Rules, 1945 which deals with extent and conditions of exemptions for various class of Drugs. Serial number 23 that dealt with the drugs supplied by a list of entities mentioned under it and provisions to be complied for such goods. These list of entities is amended to include only:

  • Health Functionaries including Community Health Officers, Nurses, Auxiliary Nurse Midwives and Lady Health Visitors attached to Primary Health Centres/ Sub-Centres/ Health & Wellness Centres in rural and urban areas,
  • Community Health Volunteers such as Accredited Social Health Activists (ASHAs) under the National Health Mission, and
  • Anganwadi Workers.

The Draft rules shall be taken into consideration on or after the expiry of a period of forty-five days from the date on which the copies of the Gazette of India containing these draft rules are made available to public. Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, Room No. 414 A, D Wing, Nirman Bhavan, New Delhi – 110011 or emailed at

Click here to read the Notification

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