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To keep pace with the rapidly changing standards of drug all over world, the Indian Pharmacopoeia Commission (IPC) has released the Eighth Edition of Indian Pharmacopoeia (IP-2018) which will play a significant role in improving the quality of medicines which in turn promote public health and accelerate the growth and development of pharma sector in India.
The new edition of Indian Pharmacopoeia has been brought out in 4 Volumes incorporating 220 new monographs (Chemical Monographs (170), Herbal Monographs (15), Blood and Blood related products (10), Vaccines and Immunosera for Human use monographs (02), Radiopharmaceutical monographs (03), Biotechnology Derived Therapeutic Products (06), Veterinary monographs (14)), 366 revised monographs and 7 omissions. Standards for new drugs and drugs used under National Health Programmes are also included. 53 New Fixed Dose Combination (FDC’s) combination monographs have been included, out of which 25 FDC monographs are not available in any Pharmacopoeia.
According to senior IPC officials, there are several salient features in the IP-2018. Keeping in view the essential requirement for harmonization of analytical methods with those accepted internationally, steps have been taken for monitoring drug standards. General chemical tests & Thin Layer Chromatography (TLC) for identification of an article have been almost eliminated and more specific infrared, ultraviolet spectrophotometer and HPLC tests have been given emphasis. The concept of relying on published infrared spectra as a basis for identification has been continued. The use of chromatographic methods has been greatly extended to cope with the need for more specificity in assays and in particular, in assessing the nature and extent of impurities in ingredients and products.
Most of the existing Assays and Related Substances Test methods are upgraded by liquid chromatographic in view to harmonize with other International Pharmacopoeia. Pyrogen test have been replaced by Bacterial Endotoxin test (BET) in parenteral preparations and other monographs. For ease of access to make Pharmacopoeia more user friendly, Index has been incorporated in Volume-I along with that already existing in Volume-IV of IP. 53 New Fixed Dose Combination (FDC’s) combination monographs have been included, out of which 25 FDC monographs are not available in any Pharmacopoeia. General Chapters on Volumetric Glassware, Conductivity, Dissolution test, Disintegration test, Dimensions of Hard Gelatin Capsule Shells etc. have been revised. For Controlling the Microbial quality of all the medicinal product general chapter on Maintenance, Identification, Preservation and Disposal of Microorganism have been revised. The IP-2018 has been released on 29th September, 2017 by C K Mishra, Secretary, Union Ministry of Health.
The IP is an authoritative and legally enforceable book of standard of drugs manufactured/marketed in India. It is published by the IPC on behalf of the Union Health Ministry in fulfillment of the requirements of the Drugs and Cosmetics Act, 1940 and the Rules thereunder. It intends to help in the licensing of manufacturing, inspection and distribution of medicines.
Publication of IP on regular basis is an important mandate of IPC aimed at improvement of health of the people through ensuring the quality, safety and efficacy of medicines. The Commission has been receiving significant advisory and directions from regulatory and valuable inputs from industrial houses, academic institutions, national laboratories, individual scientists and others.
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