Strengthening Quality: Ayush Ministry Enhances Drug Testing Labs
The Pharmacopoeia Commission for Indian Medicine and Homoeopathy (PCIM&H), operating under the Ministry of Ayush, plays a pivotal role as the Appellate Drugs Testing Laboratory for Ayurveda, Siddha, Unani, and Homoeopathy (ASU&H) drugs. With a focus on regulatory compliance, the PCIM&H ensures that these traditional medicines meet stringent safety and quality standards.
According to the Drugs Rules, 1945, sections 160 A to J outline the guidelines for approving drug testing laboratories. These laboratories are tasked with verifying the identity, purity, quality, and strength of ASU&H drugs. Currently, 34 state drug testing laboratories have received support for improving their infrastructure and operational capabilities. In total, 108 laboratories have received approval or licensing to perform quality tests on Ayurvedic, Siddha, and Unani drugs, with three regional research institutions affiliated with the Central Council for Research in Ayurvedic Sciences recognized under Rule 160E.
Pharmacovigilance Program Strengthens Consumer Protection
The Ministry of Ayush has launched a comprehensive Pharmacovigilance Program for ASU&H drugs under the Central Sector Scheme Ayush Oushadhi Gunavatta Evam Uttpadan Samvardhan Yojana (AOGUSY). This initiative features a three-tier network comprising a National Pharmacovigilance Centre (NPvCC), five Intermediary Pharmacovigilance Centers (IPvCs), and 97 Peripheral Pharmacovigilance Centers (PPvCs) throughout the country. These entities are essential for monitoring misleading advertisements and reporting them to state regulatory authorities, thereby safeguarding consumers against unverified claims. So far, 3,533 awareness programs have reached over 318,575 beneficiaries nationwide.
Certification and Quality Assurance Initiatives
The Ministry encourages certification of Ayush products through two primary schemes. The Certification of Pharmaceutical Product (CoPP) program, aligned with World Health Organization (WHO) guidelines, extends to ASU medicines. This scheme, overseen by the Central Drugs Standard Control Organization (CDSCO), requires joint inspections by representatives from the CDSCO, the Ministry of Ayush, and relevant state licensing authorities. Additionally, the Quality Certifications Scheme implemented by the Quality Council of India (QCI) awards an Ayush mark based on third-party evaluations of product quality.
Financial Commitment to Ayurvedic Standards
To further ensure these certifications and enhancements, the Ministry of Ayush has allocated Rs 122 crores over five years (2021-22 to 2025-26) for the AOGUSY scheme. This funding emphasizes upgrading Ayush pharmacies and drug testing laboratories to meet higher international standards.
Regulatory Frameworks for ASU&H Drugs
The regulatory framework for Ayurveda, Siddha, Sowa-Rigpa, Unani, and Homoeopathy is firmly established within the Drugs & Cosmetics Act of 1940 and its accompanying rules. These regulations mandate that manufacturers adhere to Good Manufacturing Practices (GMP) and quality standards outlined in various schedules of the Act and the rules. These quality benchmarks are crucial for ensuring that ASU&H drugs are produced safely and effectively.
Research Initiatives and Capacity Building
The Ministry of Ayush is keen on enhancing research and innovation in Ayush systems through several initiatives. The Ayurgyan Scheme, initiated in 2021-22, aims to support research and education in Ayush via extramural research activities. The scheme focuses on capacity building, continuous medical education, and research innovation.
Moreover, multiple councils have been established under the Ministry of Ayush to promote scientific research in various fields of traditional medicine, further strengthening the backbone of Ayush systems across India. The PCIM&H also conducts regular training programs aimed at enhancing the capabilities of state drug regulators and quality personnel involved in ASU&H drug testing.
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