RULE 170 OF DRUGS ACT (Syllabus GS Paper 2 – Gov. Policies)

Context: The Supreme Court stayed the July 1, 2024 notification issued by the Ministry of Ayush, omitting Rule 170 of the Drug and Cosmetic Rules, 1945 that deals with prohibition of advertisements of Ayurvedic, Siddha and Unani drugs without licensing authority’s approval.

Rule 170 

• Introduced in: 2018, is designed to prevent misleading advertise- ments of AYUSH products.
• Objective: To regulate the manufacture, storage, and sale of medicines in India, specifically targeting the control of inappropriate advertisements of Ayurvedic, Siddha, and Unani medicines.
• Advertisement Prohibition: Rule 170 prohibits AYUSH drug manufacturers from advertising their products without obtaining prior approval and a unique identification number from the state licensing authority.
• Submission Requirements: Manufacturers must submit comprehensive details, including textual references, the rationale for the medicine from authoritative books, indications for use, and evidence of safety, effectiveness, and quality.
• Grounds for Rejection: Applications will be rejected if manufacturers fail to provide contact details, if the advertisement contains obscene or vulgar content, promotes products for the enhancement of sexual organs, includes testimonials from celebrities or government officials, refers to any government organization, or makes misleading or exaggerated claims.
• Reason for Introduction: Rule 170 was introduced following concerns raised by a parliamentary standing committee about the problem of misleading claims and the need for the AYUSH ministry to take proactive measures on this issue.

Challenges to Regulate AYUSH Drugs

• Licensing Requirements: AYUSH drug manufacturers, like those of allopathic medicines, must seek a license from the drug controller.
• Absence of Clinical Trials: Unlike allopathic medicines, AYUSH drugs do not require phase I, II, and III clinical trials or equivalence studies for approval.
• Effectiveness Proof Requirement: Drugs containing the specified ingredients or traditional drugs used for new indications must provide proof of effectiveness as per the Act.