In a notification dated 6th November 2019 the Ministry of Health and Family Welfare has issued a draft amendment to the Drugs and Cosmetics Rules, 1945 where entry no. 23 under the column Class of Drugs in Schedule K is proposed to be amended.
The Draft Amendment is open for objections and suggestion till 21st December, 2019, that must 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 drugsdiv-mohfw@gov.in.
Please see below the tabular representation of the amendment and its implication:
| Class of Drugs | Extent and Conditions of Exemption | |
| Principle Rule | Drugs supplied by ( i ) Multipurpose Workers attached to Primary Health Centres/Sub- Centres, (ii) Community Health Volunteers under the Rural Health Scheme, (iii) Nurses, Auxiliary Nurses, Midwives an d Lady Health Visitors attached to Urban Family Welfare Centres/Primary Health Centres/SubCentres and 41[(iv) Anganwadi Workers | All the provisions of Chapter IV of the Drugs and Cosmetics Act and Rules (deals with Manufacture, Sale and Distribution of Drugs and Cosmetics), which require them to be covered by a sale licence, provided the drugs are supplied under the Health or Family Welfare Programme of the Central or State Government. |
| Amended Rule | 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 | All the provisions of Chapter IV of the Drugs and Cosmetics Act and Rules (deals with Manufacture, Sale and Distribution of Drugs and Cosmetics), which require them to be covered by a sale licence, provided the drugs are supplied under the Health or Family Welfare Programme of the Central or State Government. |
Implication:
- With this proposed amendment the exemption would no longer apply to multi purpose workers that are attached to Primary Health Centres/Sub- Centres.
- The proposed amendment has altered the scope of exemption to Community Health Volunteers, currently Volunteers under the Rural Health Scheme are covered but the proposed amendment would apply the exemption to Volunteers of National Health Mission instead.
- The scope of exemption to Nurses, Auxiliary Nurses, Midwives and Lady Health Visitors is proposed to be expanded as it now includes Health & Wellness Centres in urban and rural areas. Previously the exemption only extended to Urban Family Welfare Centres/Primary Health Centres/SubCentres while the proposed amendment would extend it to Primary Health Centres/ Sub-Centres/ Health & Wellness Centres in rural and urban areas.
Source: Ministry of Health and Family Welfare
