Indian Pharmacopoeia Commission becomes member of Pharmacopoeial Discussion Group

The Pharmacopoeial Discussion Group (PDG), with the Pharmacopoeia Commissions from US, Europe and Japan as members to harmonise pharmacopeial standards globally, has announced the Indian Pharmacopoeia Commission (IPC) as a PDG member.

The PDG announced the new membership on October 5, 2023 during PDG Stakeholder’s meeting in Hyderabad and IPC officially joined as a member in the Group at the PDG’s Annual Meeting which was held on October 3-4, 2023 in Hyderabad, said the Union Ministry of Health and Family Welfare on October 10, 2023. The World Health Organization (WHO) also continues to serve as an observer of the PDG.

“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. 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,” it said.

PDG has defined harmonisation of a pharmacopoeial monograph or general chapter as, “A pharmacopoeial general chapter or other pharmacopoeial document is harmonised when a pharmaceutical substance or product tested by the document’s harmonised procedure yields the same results and the same accept/reject decision is reached”.

IPC was only Pharmacopoeia body in the world to be selected for pilot phase of global expansion 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. This represented IPC’s continued commitment and capability to develop world class quality standards for drugs and pharmaceuticals.

“After one year of pilot phase, based on IPC’s involvement, contribution and future potential, the decision on inclusion as permanent member of PDG was taken. An official letter was sent to IPC by the PDG on September 18, 2023 regarding confirmation of membership of IPC in the PDG,” said the Ministry.

Inclusion of IP in PDG will significantly increase the visibility of the Indian Pharmacopeia on international platform. It will establish IP as progressive pharmacopoeia which designs drug quality standards at par with global standards. Application of these standards will lead to production of world class pharmaceutical products for domestic and export markets. IPC’s inclusion in PDG will help in effort towards its recognition by other countries.

It will help IPC to collaborate and harmonise pharmacopoeial standards with other major regulatory/standard setting authorities which in turn will help in ensuring the quality and safety of pharmaceuticals at a global level.

Membership in the PDG would enhance the international recognition of the standards set by the IPC. This also has potential to improve the acceptance of Indian pharmaceutical products in global markets, as they adhere to internationally recognised quality standards.

Besides, IPC will benefit from the exchange of information and best practices with other PDG members. This collaboration will help India in aligning its regulatory processes and practices with global standards, making it easier for Indian pharmaceutical companies to comply with international regulations.

Membership in the PDG will facilitate enhanced export of Indian pharmaceutical products to other member countries. Aligning with international standards will reduce trade barriers and make it easier for Indian pharmaceutical companies to access global markets, it said.

The harmonisation of pharmacopoeial standards among PDG members will contribute to the global effort to ensure the safety and efficacy of marketed pharmaceutical products. This will have a direct impact on public health worldwide, as it helps to prevent the circulation of substandard or counterfeit drugs.

“IPC’s membership in the PDG is one step forward towards promoting harmonisation of pharmaceutical standards, improving regulatory compliance, facilitating international recognition, and ultimately contributing to global public health through the assurance of drug quality and safety,” added the Ministry.

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