The Indian Government has launched the Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIM&H) as a subordinate office under the Ministry of Ayush. This new entity is an amalgamation of PCIM&H and two central laboratories: the Pharmacopoeia Laboratory for Indian Medicine (PLIM) and the Homoeopathic Pharmacopoeia Laboratory (HPL). This consolidation aims to enhance the standardized outcomes by the optimum use of resources, facilities, and technical manpower of the three organizations.
Understanding the Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIM&H)
Under the governance of the Ministry of Ayush, PCIM&H was established in 2010. As per the Drugs and Cosmetics Act, 1940 and Rules 1945, Pharmacopoeia is a recognized book of standards that identifies the belongings, purity, and strength of drugs manufactured and marketed in India. The Commission focuses on the development of Pharmacopoial Standards for Ayurvedic, Unani, Siddha, and Homeopathic drugs. Furthermore, PCIM&H acts as the Central Drug Testing cum Appellate Laboratory for the Indian systems of Medicine & Homoeopathy.
Merger Benefits for PLIM & HPL
The merging of these entities targets the focused and cohesive development of standards of AYUSH drugs. It also emphasizes on publication of pharmacopoeias and formularies. The merger aims to provide legal status to the merged structure of PCIM&H and its laboratory, with amendments and enabling provisions in the Drugs and Cosmetics Rules, 1940. Consultations have been held with the Director General Health Services, Drugs Controller General, and the Ayurveda, Siddha and Unani Drugs Technical Advisory Board (ASUDTAB).
About the Ayurveda, Siddha and Unani Drugs Technical Advisory Board
ASUDTAB is a statutory body as per provisions of the Drugs and Cosmetics Act, 1940. It is responsible for providing advice to the central and state governments about the regulatory aspects of Accelerated Shelf Life Testing (ASLT) drugs. ASLT is a method used for estimating the stability of a product by storing the product under controlled conditions that hasten the rate of degradation occurring in the product under normal storage conditions.
Government Support for AYUSH Products/Drugs
The enforcement of legal provisions related to Quality Control and issuance of drug licenses of Ayurveda, Siddha, Unani lies with the State drug Controllers appointed by the concerned state as per the Drugs and Cosmetics Act 1940. The Ministry of Ayush encourages certifications of AYUSH products to facilitate exports. For instance, the Certification of Pharmaceutical Products (CoPP) is encouraged as per WHO Guidelines for herbal products.
AYUSH Oushadhi Gunvatta Evam Uttpadan Samvardhan Yojana (AOGUSY)
The Ministry of Ayush has implemented the Central Sector Scheme of AOGUSY with the objective to boost India’s manufacturing capabilities and exports of traditional medicines and health promotion products under the initiative of Atmanirbhar Bharat. The scheme also aims to enhance infrastructural & technological upgradation and institutional activities in public and private sector for standardization, quality manufacturing, and analytical testing of Ayush drugs & materials.
Regulatory Frameworks for Quality Control
Under the AOGUSY scheme, there are initiatives to strengthen regulatory frameworks at Central and State level for effective quality control, safety monitoring and surveillance of misleading advertisements of Ayush drugs. The scheme also encourages collaborations and convergent approaches for promoting standards and quality of Ayush drugs & materials.
