• India
  • Dec 21

Short Takes / Drug standards blueprint

Afghanistan has become the first country to formally recognise the Indian Pharmacopoeia (IP) by the national department of regulation of medicines and health products of the ministry of public health. It will be used based on the requirement as reputable pharmacopoeia in the laboratory of medicines and health products quality.

IP is the book of standards for drugs

IP is an officially recognised book of standards as per the Drugs and Cosmetics Act, 1940, and Rules 1945 thereunder. The IP specifies the standards of drugs manufactured and marketed in India in terms of their identity, purity and strength.

The quality, efficacy and safety of the medicines are important from a health care perspective. In order to ensure the quality of medicinal products, the legal and scientific standards are provided by Indian Pharmacopoeia Commission (IPC) in the form of IP.

As per, the Second Schedule of the Drugs and Cosmetics Act, IP is designated as the official book of standards for drugs imported and / or manufactured for sale, stock or exhibition for sale or distribution in India.

Standards prescribed in the IP are authoritative in nature and are enforced by the regulatory authorities for quality control of medicines in India.

What is the Pharmacopoeia Commission?

The Indian Pharmacopoeia Commission (IPC) is an autonomous institution of the ministry of health and family welfare. It became fully operational from January 1, 2009.

The IPC was 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 the rational use of generic medicines by publishing the National Formulary of India.

The IPC’s mission is to promote public and animal health in India by bringing out authoritative and officially accepted standards for quality of drugs, including active pharmaceutical ingredients, excipients and dosage forms, used by health professionals, patients and consumers.

This is achieved by developing the standards for medicines and supporting their implementation. In addition, the IPC also develops IP Reference Substances (IPRS), which act as a fingerprint for identification of an article under test and its purity as prescribed in the IP monographs.

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