AYUSH RULE 170 : NATIONAL ISSUE
NEWS
: Supreme Court pulled up AYUSH Ministry over
Rule 170 of Drugs Act. Here’s what it says
WHAT’S IN THE NEWS ?
The rule, introduced in
2018, is designed to prevent misleading advertisements of AYUSH products. The
AYUSH ministry’s July 1 notification reiterated its position made in a previous
letter, dated August 29, 2023.
Rule 170
of the Drugs and Cosmetics Act:
- Purpose: Introduced in 2018 to
regulate the manufacture, storage, and sale of Ayurvedic, Siddha, and
Unani medicines, particularly to prevent misleading advertisements.
- Requirements:
- Manufacturers must obtain
approval and a unique identification number from state licensing
authorities before advertising.
- Applications must include
textual references, safety evidence, and quality assurance.
- Prohibits misleading,
obscene, or exaggerated claims in advertisements.
- Background: Introduced due to concerns
about misleading claims in AYUSH product advertisements raised by a
parliamentary standing committee.
Challenges
in Regulating AYUSH Drugs:
- Licensing: AYUSH drug manufacturers
require a license but do not need Phase I, II, and III clinical trials for
approval, unlike allopathic drugs.
- Safety Trials: Only certain formulations,
such as those containing snake venom and heavy metals, require safety
trials.
AYUSH
Ministry’s Directive:
- ASUDTAB Recommendation: Suggested omitting Rule 170
due to pending amendments to the Drugs and Magic Remedies Act.
- Ministry’s Notification: Advised state licensing
authorities to ignore Rule 170, leading to criticism from the Supreme
Court.
Source : https://indianexpress.com/article/explained/explained-health/supreme-court-pulled-up-ayush-ministey-over-rule-170-of-drugs-act-heres-what-it-says-9545226/