MoHFW publishes the Draft Drugs and Cosmetics (Amendment) Rules, 2019

Nov 07, 2019 | by Avantis RegTech Legal Research Team


The Ministry of Health and Family Welfare (MoHFW) on November 06, 2019, has published the Draft Drugs and Cosmetics (Amendment) Rules, 2019 to further amend the Drugs and Cosmetics Rules, 1945.

However, in Schedule K which provides extent and conditions of exemptions for various class of Drugs, against serial number 23, for the entries under the column “Class of Drugs”, the following shall be substituted, namely:

Drugs supplied by:

(i)            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,

(ii)         Community Health Volunteers such as Accredited Social Health Activists (ASHAs) under the National Health Mission, and

(iii)             Anganwadi Workers.

The Draft Rules will be taken into consideration by MoHFW 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 (November 06, 2019).

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 [email protected].

[Notification No. G.S.R. 827(E)]


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