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Indian Pharmacopoeia Commission (IPC) is an Autonomous Institution of the Ministry of Health and Family Welfare, Govt. of India. IPC is created to set standards of drugs in the country. It’s basic function is to update regularly the standards of drugs commonly required for treatment of diseases prevailing in this region. It publishes official documents for improving Quality of Medicines by way of adding new and updating existing monographs in the form of Indian Pharmacopoeia (IP). It further promotes rational use of generic medicines by publishing National Formulary of India.
IP prescribes standards for identity, purity and strength of drugs essentially required from health care perspective of human beings and animals.
IPC also provides IP Reference Substances (IPRS) which act as a finger print for identification of an article under test and its purity as prescribed in IP.
IP standards are authoritative in nature. They 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.
IP is an official document meant for overall Quality Control and Assurance of Pharmaceutical products marketed in India by way of contributing on their safety, efficacy and affordability. The work of the IPC is performed in collaboration with members of the Scientific Body, subject experts as well as with representatives from Central Drugs Standard Control Organization (CDSCO), State Regulatory authorities, specialist from Industries, Associations, Councils and from other Scientific and Academic Institutions.
IP contains a collection of authoritative procedures of analysis and specifications for Drugs. 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.
As per the policy of IPC, IP monographs are not framed to detect all possible impurities. The prescribed tests are designed to determine impurities on which attention are required to be focused, to fix the limits of those that are tolerable to a certain extent, and to indicate methods for ensuring the absence of those, that are undesirable. It is, therefore, not to be presumed that the impurities can be tolerated because they have not been precluded by the prescribed tests.
Distinction exists between Pharmacopoeial Standards and Manufacturer’s release specifications. Pharmacopoeial standards are publicly-available compliance document that provide the means for an independent check about the quality of a product, all time during its shelf-life. To ensure compliance related to pharmacopoeial requirements, the manufacturer’s specifications may need to be more exacting than corresponding pharmacopoeial specifications.
