The New Drugs Bill

Source: The post is based on the article The New Drugs Bill” published in The Business Standard on 22nd August 2022.

Syllabus: GS 2 – Governance.

News: The recently unveiled New Drugs, Cosmetics and Medical Devices Bill, 2022, has left many issues unaddressed.

History of laws associated with the AYUSH industry.

1940 – The parliament enacted the Drugs Act in 1940. But the definition of “drugs” in that law excluded Ayurvedic and Unani (Ayush) medicines. It was because standardization of traditional medicine was not possible like modern medicine. Ayush drugs are prepared from plants and herbs with little knowledge of the “active pharmaceutical ingredient”.

1964 – The government brought Ayush drugs within the purview of the Drugs & Cosmetics Act, 1940, but without standardization.

1982 – The law was amended to introduce the concept of “patent & proprietary” Ayush drugs, which allowed for the creation of new Ayush medicines using ingredients mentioned in the traditional texts.

Provisions under New Drugs, Cosmetics and Medical Devices Bill, 2022 and issues associated with it.

First, it requires Ayush drugs to meet the “standards of identity, purity, and strength specified in Ayurveda or Siddha, or Sowa- Rigpa or Unani Pharmacopoeia of India”.

Issues: a) Ayush pharmacopeias are exceptionally vague and very different from the rigorous standardization introduced by modern pharmacopeias. b) Most Ayush products in the market are “patent or proprietary” and are not included in the Pharmacopoeia. c) Also, this requirement has existed since 1995 in the Drugs and Cosmetic Rules, the drafting committee merely relocated it from the rules to the main law.

Second, it creates a new category called “innovative drug of Ayurveda or Unani”. It does not require Ayush medicines seeking “patent & proprietary”, to undergo the same testing and evaluation in clinical trials as for modern medicine. Instead, AYUSH medicines will be tested in accordance with the guidelines to be laid down by a new body called the “Scientific Research Board” (SRB) which will be staffed by Ayush experts.

Issues: It is not clear why these drugs cannot be approved by the same experts approving modern medicine.

Third, Section 108(a) of the new Bill treats the issue of safety such as the presence of heavy metals in Ayurvedic drugs in a light manner. It has reduced the punishment for this offense to a mere fine of Rs 50,000 despite the dire health consequences.

Issues: Causing harm to patients due to heavy metal contamination deserves to be punished with jail time and not a mere fine.

Print Friendly and PDF