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IPC to amend monographs of vaccines & immunosera for human use in IP 2018
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Shardul Nautiyal, Mumbai
January 18 , 2021
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The Indian Pharmacopoeia Commission (IPC) has asked stakeholders for suggestions with reference to amendments in monographs of vaccines and immunosera for human use, blood and blood related products and biotechnology derived therapeutic products in Indian Pharmacopoeia (IP) 2018.
IP standards are authoritative in nature and are enforced by the regulatory authorities for quality control of medicines in India. During quality assurance and at the time of dispute in the court of law the IP standards are legally acceptable.
This is a relevant development as human vaccines and immunosera have taken centrestage in drug discovery and development with enhanced safety profiles for human use among others like blood and blood related products. The amendments will bring about upgradation in the IP standards.
As per the IPC notice, stakeholder's may provide comments within 45 days of upload of the monographs to lab.ipc@gov.in.
The significant features of IP-2018 are framed in accordance with the essential prerequisite for harmonization of analytical methods with those accepted internationally for monitoring drug standards. These include general chemical tests and 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 edition of IP-2018 was released in September, 2017. It is in 4 volumes incorporating 220 new monographs covering Chemical: 170, Herbal: 15, Blood and Blood related products :10, Vaccines and Immunosera for Human use:02, Radiopharmaceutical monographs:03, Biotechnology Derived Therapeutic Products: 06, Veterinary monographs:14, besides 366 revised monographs and 7 omissions.
India is one of the leading manufacturers of vaccines worldwide and supplies large quantities of basic and advanced vaccines across the globe. Vaccines have greatly reduced the prevalence of diseases and they continue to be important for global health today.
IPC as an autonomous Institution of the union health ministry sets standards of drugs in the country with a vision to promote the highest standards of drugs for use in human and animals. It has basic function to update regularly the standards of drugs by publishing official written standard in the form of IP.
IPC also provides measurement standards in the form of IPRS which act as a finger print for identification of an article under test and its purity as prescribed in IP. The IP, or any part of it, has got legal status under the Second Schedule of the Drugs & Cosmetics Act, 1940 and Rules 1945 there under.
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