Rule 170 of Drugs and Cosmetics Act, 2018

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

Rule 170 of Drugs and Cosmetics Act, 2018

Prelims Only | Governance | Mains Paper 2: Governance, Transparency & Accountability, Citizens Charters

Note4Students

From UPSC perspective, the following things are important :

Prelims level: Rule 170 of Drugs and Cosmetics Act, 2018

Why in the News?

The Supreme Court has raised concerns over the AYUSH ministry’s notification, which advised state licensing authorities not to take action under Rule 170 of the Drugs and Cosmetics Act in the context of the ongoing case against Patanjali Ayurved.

Rule 170 of the Drugs and Cosmetics Act, 2018:

	Details
What is it?	*Rule 170* was introduced in 2018 to *regulate the manufacture, storage, and sale of Ayurvedic, Siddha, and Unani medicines,* focusing on controlling misleading advertisements in the AYUSH sector.
Requirements	• AYUSH drug manufacturers must *obtain approval and a unique identification number* from state licensing authorities before advertising their products. • Required documentation includes *textual references, rationale, indications for use,* and *evidence of safety, effectiveness,* and *quality.*
Key Provisions	Prohibits advertisement of AYUSH products without prior state authority approval. Advertisements may be rejected if they: – Lack of contact details of the manufacturer. – Contain obscene or vulgar content. – Promote products for enhancing sexual organs. – Feature endorsements from celebrities or government officials. – Refer to government organizations. – Convey false impressions or make misleading or exaggerated claims.
Rationale Behind	• Introduced following a parliamentary standing *committee’s concerns about misleading claims in the AYUSH sector.* • Aims to *ensure proactive measures by the AYUSH ministry against such advertisements.*
Challenges	• AYUSH drug manufacturers are *required to obtain licenses from drug controllers similar to allopathic medicines.* • Unlike allopathic drugs, *AYUSH drugs do not need to undergo Phase I, II, or III trials* for approval.

PYQ:

[2019] How is the Government of India protecting traditional knowledge of medicine from patenting by pharmaceutical companies?

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