FDCA + USP to share knowledge on drug standards

An MoU has also been signed between Indian Pharmacopoeia Commission (IPC) and USP on the same.

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The Gujarat Food and Drug Control Administration (FDCA) has collaborated with United States Pharmacopoeia (USP) for knowledge sharing on drug standards followed in the US. An MoU has also been signed between Indian Pharmacopoeia Commission (IPC) and USP on the same.

“The collaboration is an important landmark in terms of raising compliance levels for export purposes. As of today, 150 countries are voluntarily following USP and around 50 have been mandatorily following it,” Gujarat FDCA Commissioner Dr. HG Koshia said.

H G Koshia
Hemant Koshia, SDC, Gujarat

This comes close on the heels of US Food and Drug Administration (FDA) having recently announced its first bilateral enforcement operation with the Government of India named Operation Broadsword which prevented 500 shipments of dangerous, unapproved prescription drugs and combination medical devices from reaching American consumers.

USP is a pharmacopoeia (compendium of drug information) for the United States published annually by the United States Pharmacopoeial Convention (usually also called the USP), a nonprofit organization that owns the trademark and also owns the copyright on the pharmacopoeia itself.

IPC is an autonomous institution of the Union health ministry and has been created to set standards of drugs in the country. Its 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.

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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.

Indian Pharmacopoeia Reference Standards (IP) abbreviated to IPRS (and referred to as RS in the individual monographs) are the official standards issued by the Indian Pharmacopoeia Commission (IPC).

Biological reference substances are standardized against the International Standards and Reference Preparations established by the World Health Organization (WHO). The potency of these preparations is expressed in International Units.

Central Drugs Standard Control Organization (CDSCO) has also partnered with Quality Council of India (QCI) and Association of Indian Medical Device Industry (AiMed) to run a series of workshops on quality management systems (QMS) for safe medical device companies in the country.

A team of US FDA officials also recently visited Gujarat Food and Drug Control Administration as part of the global harmonization programme for capacity building, training, networking, knowledge sharing and compliance on safe medical devices.