Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIM&H), sub-ordinate organization under Ministry of Ayush acts as the Appellate Drugs testing Laboratory for testing or analysis of Ayurveda, Siddha, Unani and Homoeopathy (ASU&H) Drugs.

Rule 160 A to J of the Drugs Rules, 1945 provides the regulatory guidelines for approval of Drug Testing Laboratory for carrying out such tests of identity, purity, quality and strength of Ayurvedic, Siddha and Unani drugs as may be required under the provisions of these rules, on behalf of licensee for manufacture of Ayurveda, Siddha and Unani drugs. As on date, 34 State Drug Testing Laboratories have been supported for strengthening their infrastructural and functional capacity.  Further, 108 laboratories are approved or licensed under the provisions of Drugs Rules, 1945 for quality testing of Ayurvedic, Siddha and Unani drugs and raw materials. 03 Regional Research Institutions of Central Council for Research in Ayurveda Sciences are approved under Rule 160E of Drugs Rules 1945.

The Pharmacovigilance Program for Ayurvedic, Siddha, Unani and Homoeopathy (ASU & H) Drugs has been implemented under Central Sector Scheme Ayush Oushadhi Gunavatta Evam Uttpadan Samvardhan Yojana (AOGUSY), which work through a three-tier network of a National Pharmacovigilance Centre (NPvCC), Five Intermediary Pharmacovigilance Centers (IPvCs) and 97 Peripheral Pharmacovigilance Centers (PPvCs) established across the country. These centres are mandated to monitor and report misleading advertisements to the respective State Regulatory Authorities for suitable action against the defaulter. Objectives of this program is to keep vigilance over Ayush drugs and to reduce misleading advertisements to ensure the consumer protection and prevent the dissemination of unverified claims by Ayush product manufacturers. Till date 3533 awareness programs have been conducted with 318575 beneficiaries across the country.

Further, Ministry of Ayush encourages following certifications of Ayush products as per details below:-

• The scheme for Certification of Pharmaceutical Product (CoPP) as per World Health Organization (WHO) guidelines is extended to Ayurvedic, Siddha and Unani (ASU) medicines. This scheme is administered by Central Drugs Standard Control Organization (CDSCO) and the certificate is granted on the basis of joint inspection of the applicant manufacturing unit by the representatives of CDSCO, Ministry of Ayush and the concerned State Licensing Authority.
• Quality Certifications Scheme implemented by the Quality Council of India (QCI) for grant of Ayush mark to Ayurvedic, Siddha and Unani products on the basis of third party evaluation of quality in accordance with the status of compliance to domestic and international standards.

Ministry of Ayush has implemented Central Sector Scheme Ayush Oushadhi Gunvatta Evam Uttpadan Samvardhan Yojana (AOGUSY) with total financial allocation of Rs 122.00 crores for five years from 2021-22 to 2025-26. One of the components of this scheme is to strengthen and up-grade Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards.

The Drugs & Cosmetics Act, 1940 and Drugs Rules, 1945 have exclusive regulatory provisions for Ayurveda, Siddha, Sowa-Rigpa, Unani, and Homoeopathy drugs. Provisions related to Ayurveda, Siddha, Sowa-Rigpa, Unani Drugs are contained in Chapter IVA and Schedule- I of the Drugs and Cosmetics Act, 1940 and Rules 151 to 169, Schedules E(I), T & TA of the Drugs Rules, 1945. Further, second schedule (4A) of the Drugs and Cosmetics Act, 1940 provides standards for Homoeopathic drugs and Rules 2dd, 30AA, 67 (C-H), 85 (A to I), 106-A, Schedule K, Schedule M-I of the Drugs Rules, 1945 pertain to Homoeopathic drugs. It is mandatory for the manufacturers to adhere to the prescribed requirements of Good Manufacturing Practices (GMP) as per Schedule T of Drugs Rules, 1945 and quality standards given in the respective pharmacopoeia including proof of safety & effectiveness.

Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIM&H) lays down the formulary specifications and pharmacopoeial standards for Ayurveda, Siddha, Unani and Homoeopathy (ASU&H) drugs which serves as official compendia for ascertaining the quality (identity, purity and strength) of the ASU&H drugs. As per the Drugs & Cosmetics Act, 1940 and rules there under, the compliance to this quality standards are mandatory for manufacturing of ASU&H drugs. 

Ministry of Ayush has established an Ayush vertical in the Central Drugs Standard Control Organisation (CDSCO), inspect various manufacturing units in coordination with the licensing authorities/drugs inspectors of respective States/Union Territories for ensuring safety and quality of Ayush medicines.

The steps taken/proposed to be taken by the Government to strengthen research infrastructure, human resource capacity, and scientific validation of AYUSH systems to ensure national and international standards are as follows:-

• Ministry of Ayush is implementing a Central Sector Scheme namely Ayurgyan Scheme since 2021-22 with the aim to support Research & Innovation in Ayush through Extra Mural Research activities and Education by providing academic activities, training, capacity building etc. The scheme has three components viz. (i) Capacity Building & Continuing Medical Education (CME) in Ayush (ii) Research & Innovation in Ayush and (iii) Ayurveda Biology Integrated Health Research (ABIHR).
• Government of India has established Central Council for Research in Ayurvedic Sciences, Central Council for Research in Unani Medicine, Central Council for Research in Homoeopathy, Central Council for Research in Siddha and Central Council for Research in Yoga & Naturopathy under the Ministry of Ayush as apex organizations for undertaking, coordinating, formulating, developing and promoting research in Ayush system on scientific lines. Core Research activities comprise of Medicinal Plant Research (Medico-Ethno Botanical Survey, Pharmacognosy and cultivation), Drug Standardization, Pharmacological Research, Clinical Research, Literary Research & Documentation and Tribal Health Care Research Programme. Research activities are carried out through its peripheral Institutes/Units located across the country and also in collaboration with various Universities, Hospitals and Institutes.
• PCIM & H conducts periodically capacity-building training programs on standardization and quality control of ASU&H drugs for State Drug Regulators/Enforcement Authorities, Drug testing laboratories, quality control/Technical personnel related to ASU&H drugs.

This information was given by the Minister of State (IC) for Ayush Shri Pratap Rao Jadhav in a written reply to a question in Lok Sabha today.

******

SR/GS/SG

(रिलीज़ आईडी: 2209324) आगंतुक पटल : 267