Indian Pharmacopoeia and National Formulary of India
The Indian Pharmacopoeia Commission (IPC) publishes the Indian Pharmacopoeia (IP) on behalf of the Ministry of Health & Family Welfare, Government of India, in accordance with the Drugs and Cosmetics Act, 1940, and its Rules 1945. In India, IP is regarded as the official book of standards for pharmaceuticals that are made and/or commercialised. IP is a collection of authorised techniques and specifications for determining the identification, purity, and potency of medicines. The IP standards are authoritative in nature, and they are enforced by regulatory agencies in India to ensure medicine quality. IP standards are legally acceptable during quality assurance and in the event of a legal dispute. The IP’s Standards are used to determine if an article complies with regulatory standards. The following are the conditions that must be followed: The interpretation of a monograph must be consistent with all of the IP’s general criteria, testing procedures, documents, and notifications. A product is not of standard quality unless it meets all of the monograph’s standards.
- Pharmacopoeia is a legal and official book published by a recognized authority authorized by the Indian government that contains a list of pharmaceutical compounds, formulae, standards, and quality control tests in order to improve quality and uniformity.
- First edition published in 1955, till now 7 editions of Indian Pharmacopoeias are published
National Formulary of India:
- It is a legal handbook issued by recognized authorities appointed by the government of India containing essential information about drug, action, uses, dosage forms, adverse reactions, etc
- National Formulary of India
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