Ayurvedic Quality Standards -- API, Schedule T, WHO-GMP

The regulatory framework in India

Ayurvedic medicine in India is regulated under the Drugs and Cosmetics Act 1940 and its associated rules -- specifically Schedule T, which governs the manufacture and quality of Ayurvedic, Siddha, and Unani (ASU) medicines. This framework is administered jointly by the Ministry of AYUSH at the national level and state drug licensing authorities at the state level.

The Ayurvedic Pharmacopoeia of India (API)

The API is the official quality standards document published by the Ministry of AYUSH. It serves the same function for Ayurvedic medicines that the Indian Pharmacopoeia serves for allopathic medicines -- defining identity, purity, and quality standards for individual drugs and formulations. The API currently comprises:

Part I (Single drugs): Monographs for individual herbs and minerals covering -- Botanical/mineral identity, macroscopic and microscopic characters, physical constants (moisture, ash, extractive values), chemical tests, TLC identity markers, and active compound content where applicable.

Part II (Compound formulations): Monographs for classical formulations covering -- Ingredients and proportions per classical source, preparation method, physical standards, identity tests, and assay parameters.

The API is the primary quality reference cited throughout this website when quality standards for specific preparations are mentioned.

Ministry of AYUSH official reference

API volumes, CCIM registration verification, and state drug licensing information: ayush.gov.in | CCIM registration verification: ccimindia.org | National Medicinal Plants Board: nmpb.nic.in

Schedule T GMP

Schedule T of the Drugs and Cosmetics Rules specifies Good Manufacturing Practice (GMP) requirements for ASU medicine manufacturers. Requirements include: licensed premises with specified environmental controls, qualified technical staff (minimum pharmacy graduate in charge of production), raw material testing and storage, in-process quality control, finished product testing, batch record keeping, and labelling compliance. All legally sold Ayurvedic medicines in India must be manufactured under Schedule T GMP conditions.

WHO-GMP

WHO-GMP certification (issued by CDSCO -- Central Drugs Standard Control Organisation under the Ministry of Health) meets international pharmaceutical manufacturing standards. Required for export to regulated markets (EU requires this for products making therapeutic claims under THMPD; Australia requires TGA registration; Canada requires NPN under the Natural Health Products Regulations). WHO-GMP certified facilities are audited by international inspectors and maintain standards equivalent to pharmaceutical facilities.

Heavy metal standards for Bhasma

The most technically complex area of Ayurvedic quality regulation. API specifies classical quality tests for Bhasma (Rekhapurna, Varitara, Apunarbhava, Nishchandra) alongside modern tests. The WHO guideline for heavy metals in traditional medicines specifies maximum limits for lead, arsenic, mercury, and cadmium. Indian API Bhasma standards specify that properly prepared Bhasma, where classical Shodhana and Marana are complete, meets these limits. Third-party ICP-MS testing is the current international standard for verification.

Research standards -- CCRAS and clinical trials

The Central Council for Research in Ayurvedic Sciences (CCRAS) follows the Indian Council of Medical Research (ICMR) Good Clinical Practice (GCP) guidelines for clinical trials of Ayurvedic preparations. Published CCRAS trials on Guduchi, Ashwagandha, and Triphala preparations use double-blind, placebo-controlled designs. The CTRI (Clinical Trials Registry India) is the official registry for all Ayurvedic clinical trials in India. International publication in peer-reviewed journals (Journal of Ethnopharmacology, Phytotherapy Research, Evidence-Based Complementary and Alternative Medicine) is the standard for clinical evidence documentation.