Nicaragua becomes first Spanish-speaking nation to recognise Indian pharma standards

News Excerpt:

Nicaragua has become the first nation in the Spanish-speaking world to recognise Indian Pharmacopoeia, as India and Nicaragua signed an MoU on cooperation in the field of the regulation of medicines.

More about the news:

  • This recognition by Nicaragua adds another feather to the Indian Pharmacopoeia's (IP) cap, solidifying its global standing and influence. 
  • Before Nicaragua five other countries - Afghanistan, Ghana, Nepal, Mauritius, and Suriname have already acknowledged IP’s importance in ensuring the quality and safety of medicinal products.
  • The move is expected to foster stronger ties between the two nations in the areas of healthcare, encouraging the exchange of expertise and resources for improved medical standards. 
  • The formal recognition of the Indian Pharmacopoeia serves as a testament to the growing importance of standardised regulations in the global pharmaceutical landscape.

Indian Pharmacopoeia (IP):

  • The Indian Pharmacopoeia (IP) serves as the official compendium of standards for drugs in India.
  • It is compiled and published by the Indian Pharmacopoeia Commission (IPC) under the Ministry of Health & Family Welfare.
  • Latest edition of IP, which was published in 2022 comprises over 3,000 monographs, establishing precise limits and testing methods for both raw materials and finished pharmaceutical products.
  • The legal significance of the IP within India is enshrined in the Second Schedule of the Drugs & Cosmetics Act, 1940.
    • The Act necessitates adherence to its standards for all imported, manufactured, and distributed drugs within the country. 
    • The standards of the IP are authoritative in nature and are enforced by the regulatory authorities for ensuring the quality of drugs in India. 
    • During quality assurance and at the time of dispute in the court of law the IP standards are legally acceptable.

About Indian Pharmacopoeia Commission (IPC)

  • Indian Pharmacopoeia Commission (IPC) is an Autonomous Institution of the Ministry of Health and Family Welfare. 
  • Indian Pharmacopoeia Commission (IPC) to deal with matters relating to the official book of standards for drugs included therein, in terms of the Second Schedule to the Drugs and Cosmetics Act, 1940. 
    • The Commission became fully operational on 1st January 2009 as an Autonomous Body, fully financed by the Central Government.

Functions of IPC:

  • Its basic function is to regularly update the standards of drugs commonly required for the treatment of diseases prevailing in this region. 
  • It publishes official documents for improving the 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. 
  • IP prescribes standards for the identity, purity and strength of drugs essentially required from the health care perspective of human beings and animals. 
  • IPC also provides IP Reference Substances (IPRS) which act as a fingerprint for identification of an article under test and its purity as prescribed in IP.

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