Re-establishment of PCIM&H | 04 Jun 2020
Why in News
Recently, the Union Cabinet has given its approval to re-establish Pharmacopoeia Commission for Indian Medicine and Homoeopathy (PCIM&H) as a subordinate office under the Ministry of AYUSH.
- Pharmacopoeia Laboratory for Indian Medicine (PLIM) and Homoeopathic Pharmacopoeia Laboratory (HPL), central laboratories established at Ghaziabad (Uttar Pradesh) since 1975, will be merged into the PCIM&H.
Key Points
- Presently, PCIM&H is an autonomous body under the aegis of Ministry of AYUSH, established since 2010.
- Pharmacopoeia is an officially recognized book of standards as per the Drugs and Cosmetics Act, 1940 and Rules 1945 thereunder.
- As per the Second Schedule of the Drugs and Cosmetics Act, it is designated as the official book of standards for drugs imported and/or manufactured for sale, stock or exhibition for sale or distribution in India.
- It specifies the standards of drugs manufactured and marketed in India in terms of their identity, purity and strength.
- The merger intends to accord legal status to the merged structure of PCIM&H and its laboratory by making the necessary amendments and enabling provisions in the Drugs and Cosmetics Rules, 1945.
- Consultations have been done with the Director General Health Services, Drugs Controller General and the Ayurveda, Siddha and Unani Drugs Technical Advisory Board (ASUDTAB).
- Benefits of the Merger:
- Optimum use of infrastructural facilities, technical manpower and financial resources of the three organizations for enhancing their standardised outcomes.
- Focused and cohesive development of standards of AYUSH drugs and publication of pharmacopoeias and formularies.
Ayurveda, Siddha and Unani Drugs Technical Advisory Board
- ASUDTAB is a statutory body under the provisions of Drugs and Cosmetics Act, 1940.
- It advises the central and state governments in regulatory matters of Accelerated Shelf Life Testing (ASLT) drugs.
Accelerated Shelf Life Testing
- It is an indirect method of measuring and estimating the stability of a product by storing the product under controlled conditions that increase the rate of degradation occurring in the product under normal storage conditions.
- ASLT is useful for a number of purposes like:
- To predict product stability including colour.
- To determine product safety under abuse conditions.
- To troubleshoot in the initial stages of product development.
- To assess the packaging performance of a product.