Amendment in the Schedule K Drugs Allows Health Workers to Dispense Drugs

Amendment in the Schedule K Drugs Allows Health Workers to Dispense Drugs

by Ramya Rachamanti on Jan 7 2020 5:30 PM
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  • The Ministry of Health and Family Welfare has proposed changes to the drugs and cosmetics rules 1945, which allows healthcare functionaries (non-doctors) to prescribe medications
  • At present, only doctors and pharmacists are allowed to provide medicine to patients
  • The Doctor of Pharmacy Association, Indian Pharmaceutical Association (IPA), Pharmacy Council of India (PCI), strongly opposed the amendment
The drugs and cosmetics rules, 1945 under the drugs and cosmetics act, 1940 has provisions for drug classification under various schedules and various guidelines for the storage, sale, display, and prescription of each schedule. Schedule K contains certain substances and drugs, and their regulation. These rules can be called drugs and cosmetics -13th amendment rules, 2019.
One of the vital amendments in the Schedule K Serial No. 23 of the drugs and cosmetic rules 1945, which was published in a notification of the Gazette of India Dated- 6 November 2019, which came into force the same day, was as follows:

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 Centers/ Sub-Centers/ Health & Wellness Centers 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

  • Dispensing medications by a person other than a registered medical practitioner or a pharmacist from now onwards may be unethical and is a violation of Section 42 of Pharmacy Act 1948, which mentions that no person other than a registered pharmacist shall dispense any medicine on the prescription of a medical practitioner. A person who violates will be punished with an imprisonment for up to six months or with fine or with both.
  • Only a registered pharmacist knows:
1) Appropriate storage condition, dosage form, dose, route of administration and, duration of drug treatment.

2) Special instructions and precautions while dispensing drugs to a pregnant and breastfeeding woman.

3) Side effects, drug-drug interactions, drug-food interactions, contraindications

4) The right amount, the right duration and the right dose- the rational drug usage.
  • Public health may be in danger if the amendment is not reversed back.
  • A community health worker may have only completed his SSC-secondary school education, who may not have complete knowledge about drugs.

Protests in the Country:

Around 3,000 pharmacists and members of 36 associations of pharmacists belonging to public and private sectors protested at Jantar Mantar in New Delhi against the Union Health Ministry’s Notification, empowering anyone to supply around 80 types of different drugs at sub-centers in rural & urban health centers.

Some associations also state that this amendment violates Article 16, Article 21 and Article 47 of the Indian Constitution, mentioning that the fundamental right to practice their profession for earning their livelihood.

How to Address the Issue?

Utilizing more than 1.3 million registered pharmacists available in India for dispensing drugs to the public could address the issue. This would be a safer option, as many such pharmacies are notorious at dispensing medication without any prescription in India. This type of legislation sends out a wrong message to the general public and the erring pharmacies. Nowhere else in the world is this allowed.

In a nutshell, we are endangering the health of the citizens of the country rather than safeguarding them and there are no short cuts in healthcare and medical practice.