Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

Indian Pharmacopoeia (IP)

Note4Students

From UPSC perspective, the following things are important :

Prelims level : Indian Pharmacopoeia (IP)

Mains level : Not Much

The Indian Pharmacopoeia (IP) has been recognised officially by the National Department of Regulation of Medicines and Health Products of the Ministry of Public Health of Republic of Afghanistan.

Significance of the move

  • With this, a new beginning has been made and Afghanistan has become the first country to recognize IP pursuant to the efforts of Department of Commerce and Ministry of Health and Family Welfare.

Indian Pharmacopoeia (IP)

  • The quality, efficacy and safety of the medicines are important from healthcare 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 Indian Pharmacopoeia (IP).
  • IP is an officially recognized book of standards as per the Drugs and Cosmetics Act, 1940 and Rules 1945 thereunder.
  • 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 IP Commission?

  • The IP Commission’s mission is to promote public and animal health in India by bringing out authoritative and officially accepted standards for quality of drugs.
  • It includes 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, IPC also develops IP Reference Substances (IPRS) that act as fingerprint for identification of an article under test and its purity as prescribed in the IP monographs.
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