Amendment in Schedule K Drugs and Cosmetic Act

Amendment in Schedule K Drugs and Cosmetic Act

Dr KK Aggarwal

President HCFI

The government under the drugs and cosmetic rules scheduler K (5.23) provides special provision under the National Health Program to SUPPLY defined drugs under the National Health Program by health care providers ( other than doctors).

I am personally of the opinion

1.     The non MBBS healthcare providers SUPPLY and not PRESCRIBE

2.     Under the National Health Program the treatments are always under supervision and are accountable by the CMO

3.     Treatments are standard protocol based and not intellect based.

4.     All ASHA workers are already giving Injection Gentamycin to a new born suspected to be with sepsis before transfer

5.     All Asha workers are already giving IV Methargin for PPH before transfer

6.     Most ANMs are delivering babies

7.     Most Asha Workers are already giving vaccinations, contraception

8.     All malaria workers are giving anti-malarial drugs

9.     All drugs used in National Health Programs are essential drugs classified in NLEM

10. Under the Essential Commodities act 1955: the government has power to control production, supply, distribution, etc., of essential commodities: 2d: for regulating by licences, permits or otherwise the storage, transport, distribution, disposal, acquisition, use or consumption of , any essential commodity;

What is the original clause:

5. 23: Drugs supplied by:

(i) Multipurpose Workers attached to Primary Health Centres/Sub-Centres,

(ii) (ii) Community Health Volunteers under the Rural Health Scheme and

(iii) Nurses, Auxiliary Nurse, Midwives and Lady Health Visitors attached to Urban Family Welfare Centers/Primary Health Centre/Sub Centres and Anganwadi Workers.]    

The provision of Chapter IV of the Act and the Rules thereunder which require them to be covered by a sale licence are excluded, provided the drugs are supplied under the Health or Family Welfare Programme of the Central or State Gov

What is the Amendment

It now will include “ in Health & Wellness Centres in rural and urban areas, Community Health Volunteers such as Accredited Social Health Activists (ASHAs) under the National Health Mission” before Anganwadi Workers in 23 III

They have only added the word Wellness centers which are equivalent to primary health centers and clarified defined the term ASHA workers