Regulatory Framework for Ayush Medicines

December 5, 2024

The regulatory framework for Ayurveda, Siddha, and Unani medicines is governed by specific guidelines, which ensure safety, efficacy, and quality in drug manufacturing and distribution. The Drugs Rules, 1945, play a very important role in this process.

Licensing Requirements

Manufacturers must obtain licenses to produce Ayurveda, Siddha, and Unani drugs. They must provide evidence of safety and effectiveness. Compliance with Good Manufacturing Practices (GMP) is mandatory. Failure to comply can lead to license suspension or cancellation under Rule 159.

Role of Authorities

State Drug Controllers and Licensing Authorities enforce the rules. They oversee licensing and compliance for manufacturers. They ensure that the guidelines are strictly followed to maintain drug quality.

Drug Testing Laboratories

The Drugs Rules outline the approval process for Drug Testing Laboratories. Currently, 106 laboratories are authorised to test the quality of Ayush drugs and raw materials. Thirty-four State laboratories have received support to enhance their testing capabilities.

Quality Control Standards

The Ministry of Ayush, via the Central Council for Indian Medicine and Homeopathy (PCIM&H), establishes quality control standards. These standards cover identity, purity, and strength of the drugs. Thousands of quality standards for raw materials and formulations have been published.

Advertising Regulations

The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, prohibits misleading drug advertisements. Penalties are imposed on violators. The Ministry of Ayush monitors Ayush drugs through Pharmacovigilance Centres, allowing consumer feedback on misleading ads.

Research Initiatives

The government promotes scientific research in Ayush systems. Councils for research focus on medicinal plants, drug standardisation, and clinical trials. Collaborative efforts with universities and hospitals enhance research credibility.

The National Commission for Indian System of Medicine and the National Commission for Homeopathy provide ethical guidelines. These guidelines ensure practitioners maintain high standards of practice in their respective fields.

Important Facts for Exams:
PCIM&H – The Central Council for Indian Medicine and Homeopathy ensures quality control for Ayush medicines. It trains drug analysts and regulatory authorities for effective drug testing and compliance.
GMP – Good Manufacturing Practices are mandatory for manufacturers of Ayurveda, Siddha, and Unani drugs. Compliance ensures safety and quality in drug production, protecting consumer health and maintaining industry standards.
Pharmacovigilance Centres – These centres monitor the safety of Ayush drugs. They allow consumers to report misleading advertisements, ensuring accountability and reinforcing trust in traditional medicine practices.
Drugs Rules, 1945 – This legislation sets forth guidelines for licensing and safety studies for Ayush drugs. Compliance is crucial for manufacturers to maintain their licenses and ensure drug effectiveness.

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