Ayurvedic, Siddha, Unani (ASU), and Homeopathic medicines in India are governed by the Drugs and Cosmetics Act, 1940. Chapter IVA regulates ASU drugs, while Chapter IVB covers Homeopathic medicines. The rules ensure safe manufacturing, sale, and distribution, with compliance monitored by State Drug Controllers and the Ministry of AYUSH.
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How Does The Regulation of Ayurvedic, Siddha, and Unani Drugs Work
Chapter IVA sets the framework for ASU drugs. It regulates manufacturing, sale, and distribution. The law establishes the Technical Advisory Board and Consultative Committee to advise on technical matters.
The Act defines misbranded, adulterated, and spurious drugs and imposes penalties. Section 33EEC prohibits the manufacture or sale of such drugs or those with incorrect labels.
Moreover, manufacturers must obtain a license from the State Licensing Authority. The process requires compliance with Good Manufacturing Practices (GMP), proof of safety and efficacy, and adherence to labeling norms. GMP standards cover premises, equipment, quality control, and record-keeping.
What Are The Licensing Standards for Ayurvedic Medicines
To start manufacturing Ayurvedic medicines, companies must secure an AYUSH manufacturing license. Facilities must meet minimum space requirements, usually 1,200 sq. ft. for one product line.
The license application must include site layouts, process details, equipment lists, technical staff qualifications, and batch validation reports. Rule 158B mandates proof of safety and effectiveness. Products must meet pharmacopoeial standards, including limits for heavy metals and pesticides.
Also, state regulators conduct regular inspections to ensure ongoing compliance.
Chapter IVB governs Homeopathic medicines. The Drugs and Cosmetics Rules, 1945 outline specific requirements, including licensing through Form 25-C for manufacturing and Form 19-B for sale.
Manufacturers must hold GMP certification. Applications must provide facility details, staff profiles, and product safety data. Imported homeopathic medicines require proof of safety and efficacy.
Sales and distribution licenses can be applied for through the e-AUSHADHI portal. State authorities enforce compliance through inspections and quality testing.
What Is The Common Standards for Both Systems
Ayurvedic and Homeopathic products must be free from misbranding, adulteration, and spurious content. Labels must comply with legal standards.
The GMP guidelines ensure clean premises, proper raw material handling, accurate documentation, and robust quality control. Inspectors regularly check manufacturing units and test samples.
The Pharmacopoeial Commission for Indian Medicine and Homoeopathy (PCIM&H) sets mandatory standards for identity, purity, and strength.
Conclusion
India’s regulation of Ayurvedic and Homeopathic medicines ensures safety, quality, and authenticity. Strict licensing, GMP compliance, and state-level enforcement protect consumers and promote trust in traditional and alternative systems of medicine.
