The Union Cabinet recently approved the re-establishment of the Pharmacopoeia Commission for Indian Medicine and Homoeopathy (PCIM&H) as a subordinate office operating under the Ministry of AYUSH. The Pharmacopoeia Laboratory for Indian Medicine (PLIM) and the Homoeopathic Pharmacopoeia Laboratory (HPL), two central laboratories established in Ghaziabad (Uttar Pradesh) since 1975, will be merged into the PCIM&H.
Current Status of PCIM&H
At present, PCIM&H is an autonomous body functioning under the Ministry of AYUSH. It has been operational since 2010. In accordance with the Drugs and Cosmetics Act of 1940 and subsequent Rules of 1945, the pharmacopoeia is an officially recognized book of standards. As per the Second Schedule of the Drugs and Cosmetics Act, this book is regarded as the official standard for drugs that are manufactured and/or imported for sale, stock or exhibition for distribution in India. It establishes the standards of drugs produced and available in India in terms of their identity, purity, and strength.
The Implications of the Merger
The merger aims to provide legal status to the consolidated structure of PCIM&H and its laboratory. This is done by implementing necessary modifications and provisions in the Drugs and Cosmetics Rules, 1945. The Director General Health Services, Drugs Controller General, and the Ayurveda, Siddha, and Unani Drugs Technical Advisory Board (ASUDTAB) have all been consulted regarding this move.
Benefits of the Merger
The merging process is expected to ensure the optimal utilization of infrastructural facilities, technical manpower, and financial resources belonging to the three organizations. This would ultimately result in enhancing their standardized outcomes. The merger also aims at promoting focused and cohesive development of standards for AYUSH drugs and the publication of pharmacopoeias and formularies.
About Ayurveda, Siddha and Unani Drugs Technical Advisory Board (ASUDTAB)
ASUDTAB is a statutory body under the provisions of the Drugs and Cosmetics Act, 1940. It advises both the central and state governments on regulatory matters relating to Accelerated Shelf Life Testing (ASLT) drugs.
Understanding Accelerated Shelf Life Testing
Accelerated Shelf Life Testing (ASLT) is an indirect method used to gauge and estimate the stability of a product. This is achieved by storing the product under controlled conditions that intensify the rate of degradation that typically occurs in the product under normal storage conditions.
ASLT can be advantageous for several purposes such as predicting product stability including color, determining product safety under harsh conditions, tackling issues in the initial stages of product development, and assessing a product’s packaging performance.
