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Opinion: Amendment in Schedule K Drugs and Cosmetic Act

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Dr KK Aggarwal    03 January 2020

The government under the drugs and cosmetic rules schedule 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 that,

  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 licenses, permits or otherwise the storage, transport, distribution,disposal, acquisition, use or consumption of , any essential commodity

What is the original clause? 

  1. 23: Drugs supplied by:

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

(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 license 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 will now 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

Only the word Wellness centers has been added which are equivalent to primary health centers and clarified the term ASHA workers.

 

Dr KK Aggarwal

President CMAAO, HCFI and Past National President IMA. Recipient of Padma Shri

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