Govt amends Sch K to empower Anganwadi workers to dispense drugs

. These rules may be called the Drugs and Cosmetics (Amendment) Rules, 2021.

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Last Updated on March 20, 2021 by The Health Master

Union health ministry has released gazette notification No. GSR 140(E) dated 26-02-2021 to amend provisions of Schedule K to empower anganwadi workers and community health officers (CHOs) at Ayushman Bharat health and wellness centres to dispense drugs as per the recommendation of the Drugs Technical Advisory Board (DTAB).

To read or download the above said notification No. GSR 140(E) dated 26-02-2021, click here

This has been done in accordance to notify draft Drug and Cosmetics (D&C) (Amendment Rules), 2019 for which stakeholders objections and suggestions were invited within a period of 45 days from the date of publication of the draft notification.

To read or download Schedule K, click here

As per the notification, In the D&C Rules, 1945, in Schedule K, against serial number 23, in the entries under the column “Class of Drugs”, for the words, brackets and figures “and (iv) Anganwadi Workers”, the following words, brackets and figures shall be substituted, namely:?“(iv) Anganwadi Workers; and (v) Community Health Officers at Ayushman Bharat Health and Wellness Centres.’’


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As per the earlier draft notification in November 2019, “In the D&C Rules, 1945, in Schedule K, against serial number 23, for the entries under the column “Class of Drugs”, the following shall be substituted as “Drugs supplied by health functionaries including community health officers, nurses, auxiliary nurse midwives and lady health visitors attached to primary health centres/sub-centres/health and wellness centres in rural and urban areas, community health volunteers such as accredited social health activists (ASHAs) under the National Health Mission (NHM) and Anganwadi Workers.”


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As per the current provisions of Rule 123 of Schedule K, multipurpose workers attached to primary health centres, sub-centres, community health volunteers under the rural health scheme, nurses, auxiliary nurse, midwives and lady health visitors attached to urban family welfare centres, primary health centre, sub centres and Anganwadi workers are exempted from the provision of Chapter IV of the D&C Act and the Rules there under which require them to have a sale licence under the condition that drugs are supplied under the health or family welfare programme of the central or state governments.

“Now, therefore, in exercise of the powers conferred under sections 12 and 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with the DTAB, hereby makes the following rules further to amend the Drugs and Cosmetics Rules, 1945, namely:

(1) Short title and commencement. These rules may be called the Drugs and Cosmetics (Amendment) Rules, 2021.
(2) They shall come into force on the date of their final publication in the Official Gazette,” as per the notification.

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