In a pioneering regulatory action, the Kerala Deputy Drugs Controller (Ayurveda) has warned Pankajakasthuri Herbals India Pvt Ltd for the violation of Rule 170 of the Drugs and Cosmetics Rules, 1945. This is the first governmental action in the country following the readoption of the rule that requires pre-approval of advertisements of Ayurvedic medicines.

Key highlights

Violation of advertising rules for AYUSH medicines

• The firm had run an advertisement for Orthoherb tablets in a Malayalam daily on 9 January 2025 without clearance.

• Rule 170 mandates that all advertisements for Ayurvedic, Siddha, and Unani (ASU) drugs must be cleared by state licensing authorities first.

Origin of the complaint

• The move followed a complaint lodged on 11 February 2025 by ophthalmologist and RTI activist Dr. K. V. Babu.

• The company subsequently admitted the slip and promised to be compliant in the future.

Regulatory warning and penalties

• The Deputy Drugs Controller (Ayurveda) gave a strong warning to Pankajakasthuri Herbals.

• Future offending may lead to production license suspension or cancellation.

Legal background of rule 170

• Although gazetted in December 2018, Rule 170 was stayed in 2019 by the Delhi and Bombay High Courts.

• The Supreme Court reinstated Rule 170 on 27 August 2024, and this is the first enforcement action after reinstatement.

Significance for AYUSH industry

• This case establishes a regulatory benchmark for Ayurvedic and traditional medicine producers all over India.

• It highlights the importance of responsible advertisement within the AYUSH sector, particularly with increased scrutiny of deceptive health claims.

The notice to Pankajakasthuri Herbals is a landmark in India's bid to regulate advertising of traditional medicine. With Rule 170 now operational, manufacturers of Ayurvedic drugs must comply strictly or risk penalties, ensuring greater transparency and consumer protection in the AYUSH industry.