|
IP gets recognition as book of standards in 17 countries since 2019 to boost pharma exports
|
|
Shardul Nautiyal, Mumbai
November 11 , 2025
|
|
|
The Indian Pharmacopoeia (IP) as a book of standards for medicines has been recognized by 17 countries till date. This will ensure quality medicines being manufactured and/or imported in the respective foreign countries and hence boost exports.
The Indian Pharmacopoeia Commission (IPC) signed its first IP recognition Memorandum of Understanding (MoU) with Afghanistan in 2019, making it the first country to officially recognize the IP.
In order to ensure the quality of medicinal products, the legal and scientific standards of IP are published at regular intervals by the IPC. Standards prescribed in the IP are authoritative in nature and are enforced by the regulatory authorities for quality control of medicines in India.
This recognition of IP in the respective foreign countries would remove double regulation, duplication in testing and post importation checks to boost the India pharma exports to these countries. Indian drug exporters would thus, gain a competitive edge and trade would become more remunerative.
The MoUs on pharmacopoeial cooperation has been signed with countries like Afghanistan, Ghana, Nepal, Mauritius, Suriname, Nicaragua, Bhutan, Mozambique, Solomon Islands, Sri Lanka, Nauru, Malawi, Guyana, Fiji, Cuba, Maldives, Trinidad and Tobago. These MoUs established the IP as the recognized compendium of standards for medicines in these countries.
This would also facilitate the exchange of information and documentation relating to the development of monographs of IP. This would further enhance the ability of regulatory authorities in the provision of their services relating to or in connection with public health.
The recognition of IP in these foreign countries will help to accept the Certificate of Analysis (CoA) issued by Indian manufacturers as per IP and to do away with requirement of duplicate testing of the medicines in these foreign countries.
International recognition of the IP standards has several benefits to the Indian pharmaceutical sector. These include importing nations would gain access to quality Indian medical products at affordable prices.
Manufacturers in importing countries would have better scope for development of generic medicines contributing to availability of affordable medicines to their citizens.
This would help foreign countries to get IP Reference Substances (IPRS) and Impurity standards from IPC at reasonably low cost to be used during the quality control analysis. This would support collaboration to improve access to quality-assured and affordable medicines.
Discussions with other countries are ongoing to expand this list. Stakeholders are encouraged to benefit from the recognition of the IP in these countries. This will facilitate export of medical products leading to foreign exchange earnings and a step towards an Atmanirbhar Bharat.
As per the Second Schedule of the Drugs and Cosmetics (D&C) Act 1940, 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. IPC has been making efforts towards recognition and acceptance of IP in foreign countries and proposals in this regard have been submitted to various countries through ministry of health & family welfare (MoHFW), ministry of external affairs (MEA), Department of Commerce (DoC), and Department of Pharmaceuticals (DoP).
|
|
|
|
|
|
|
|
TOPICS
|
The Food and Drug Administration (FDA), Maharashtra, has issued a public advisory urging citizens to report any misleadi ...
|
|
|
|
|