Issue of patent and proprietary medicine in India – Lure of a magic cure

Source-This post on Issue of patent and proprietary medicine in India has been created based on the article “Patanjali controversy and the lure of a magic cure: Safety standards dangerously fail consumers” published in “Indian Express” on 1 March 2024.

UPSC Syllabus – GS Paper 2 – Issues Relating to Development and Management of Social Sector/Services relating to Health, Education.

News – The article highlights the lack of safety standards for Ayurvedic medicines and the issue of misleading advertisements. Issue of patent and proprietary medicine in India – Lure of a magic cure

Background – The Supreme court has criticized Patanjali Ayurveda, for making misleading claims in advertisements about its products curing diseases.

What is the difference between classical and patent and proprietary medicine?

The difference between classical medicine and patent and proprietary medicine is explained in Drugs and Cosmetics (D&C) Act.

1) Classical ASU medicine-It refers to drugs that are manufactured strictly in accordance with the authoritative ancient texts (granthas or samhitas) listed under the D&C Act.

2) Patent and Proprietary (P&P) medicine-It refers to manufacture of ASU drugs by modifying the classical recipe and introducing new combinations. Patanjali and several other companies have been proactively promoting their Patent and Proprietary (P&P) drugs.

Read more- Perils of misleading advertisements

What are the regulations regarding Patent Proprietary (P&P) drugs?

1) Advertising drugs intended to treat or cure certain diseases is prohibited under Drugs and Magic Remedies (Objectionable Advertisements) Act 1954, which applies to all systems of medicine.

2) Drug manufactures have to follow the Good Clinical Practice Guidelines issued by the Ministry of Ayush. This is done to document evidence of safe and effective use.

3) To obtain a manufacturing license, citing scientific sources is essential and if unavailable, pre-clinical or clinical trials are required to be produced.

4) The Ayush Ministry had mandated the registration of all medical research projects with the Indian Council of Medical Research’s CTRI — Clinical Trials Registry of India database without distinction between allopathic or ASU (Ayurveda, Siddha and Unani) research.

What are the issues associated with the regulation of Patent and Proprietary (P&P) drugs?

1) Limitation of Drugs and Magic Remedies Act– It does not have the power to check the license of products, to check if the products are evidence based or not.

2) Misconception in minds of consumers– The consumer assumes that all ASU products are natural and consequently safe. Attracted by advertisements, consumer purchases P&P medicine over the counter without consulting any Vaidya or medical practitioner.

3) No requirement of license-Unlike allopathic drugs, selling ASU medicine requires no sale license and all pharmacists, and even general stores and groceries, can sell these drugs without any knowledge of the drug use and dosage.

4) Lax implementation by state drug controllers– The two Drug Acts are not administered properly by state drug controllers due to vacancies or mishandling by non-qualified persons.

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What should be the way forward?

The country needs a unified structure and system for regulating and administering the licensing, manufacture, sale, and drug advertising of ASU drugs.

Question for practice

Highlight the issues in regulation of Ayurvedic drugs? What steps can be taken to address the issue?