India joins pharmacopoeia grouping: Govt – Hindustan Times

Subscribe Now! Get features like
India has joined a global effort to harmonise various pharmacopoeias, which are lists of medicinal drugs with their effects and directions for use, the government said in a statement on Tuesday. A standardised pharmacopoeia will make it easier for drugmakers to adhere to procedural norms for multiple markets.
The Indian Pharmacopoeia Commission has officially joined as a member in the Pharmacopoeial Discussion Group (PDG), which was established in 1989to harmonise pharmacopeial standards in the world, the statement said.
“The PDG will now bring together the European Pharmacopoeia (Ph. Eur.), the Japanese Pharmacopoeia (JP), the United States Pharmacopeia (USP) and Indian Pharmacopoeia (IP) to harmonize global pharmacopoeial standards,” it said. “The objective is to reduce manufacturers’ burden of having to perform analytical procedures in different ways, using different acceptance criteria, in order to satisfy pharmacopoeial requirements that vary across regions.”
The Indian commission’s membership to the global group will significantly increase the visibility of the Indian Pharmacopoeia on an international platform and recognition of standards set by it by other countries.
The move will establish IP as progressive pharmacopoeia that designs drug quality standards at par with global standards, according to the health ministry. Application of these standards will lead to production of world-class pharmaceutical products for domestic and export markets, it said.
It will also help the local commission to collaborate and harmonise pharmacopoeial standards with other major regulatory or standard setting authorities, leading potentially to improve the acceptance of Indian medicinal products in global markets, as they adhere to globally recognized quality standards. In the long run, it will reduce trade barriers.
The Indian commission will also benefit from the exchange of information and best practices with other members, helping India in aligning its regulatory processes and practices with global standards. It will contribute to the global effort to ensure the safety and efficacy of marketed pharmaceutical products having a direct impact on public health worldwide, as it would help to prevent the circulation of substandard or counterfeit drugs.
The World Health Organization is an observer of the group. The PDG announced the Indian Pharmacopoeia Commission as one of its members on October 5 during a stakeholder meeting in Hyderabad, the government statement said. The group’s pilot for global expansion started in September last year.
“IPC was only Pharmacopoeia body in the world to be selected for pilot phase initiated in September 2022. After reviewing each application, the PDG agreed by consensus, to start the pilot phase with the IPC, the only applicant that met all the requirements in the entry criteria for the pilot,” the statement said. “This represented IPC’s continued commitment and capability to develop world-class quality standards for drugs and pharmaceuticals.”
The PDG sent a letter to domestic commission on September 18, confirming its membership. “IPC’s membership in the PDG is one step forward towards promoting harmonization of pharmaceutical standards, improving regulatory compliance, facilitating international recognition, and ultimately contributing to global public health through the assurance of drug quality and safety,” the statement said.
“It is a good development, no doubt, but eventually everything boils down to quality of drugs, and India needs to work harder in that direction given the cases of contamination of India-made drugs that have come to light in recent past. If we are competing with the best in the world then there can be no room for loopholes. The regulators need to work more towards ensuring that our manufacturers adhere to regulatory guidelines,” said a senior pharmaceuticals expert, requesting anonymity.
Rhythma Kaul works as an assistant editor at Hindustan Times. She covers health and related topics, including ministry of health and family welfare, government of India.


Leave a Comment

Your email address will not be published. Required fields are marked *

Scroll to Top
Join Whatsapp Group!
Scan the code