Last Updated on October 10, 2024 by The Health Master
IPC Joins Pharmaceutical Discussion Group
The Indian Pharmacopoeia Commission (IPC) has become a member of the Pharmaceutical Discussion Group (PDG), which aims to promote the harmonization of pharmacopoeial standards across the globe.
The PDG consists of the European Pharmacopoeia (EP), the Japanese Pharmacopoeia (JP), and the United States Pharmacopoeia (USP), with the World Health Organization (WHO) as an observer.
The IPC’s membership in the PDG is expected to further the understanding of the challenges to pharmacopoeial harmonization, which will help in working within respective different regulatory environments.
IPC to Harmonize Indian Standards with Global Standards
As a member of the PDG, the harmonization of Indian standards with global standards is required to help the Indian Pharmacopoeia (IP) get recognized and accepted globally.
To achieve this, IPC is set to harmonize 31 general chapters and as many excipient monographs of IP with PDG in three phases.
The first phase will start from December 2024, and the last phase will end in December 2028. IPC has been selected by PDG for its year-long pilot for global expansion.
Year-Long Pilot to Harmonize IP’s General Chapters with EP, JP, and USP
The year-long pilot will facilitate the harmonization of IP’s general chapters on Tablet Friability and Optical Microscopy with the EP, the JP, and the USP, which are members of the PDG.
The pilot is expected to provide valuable lessons to refine the group’s working methods and identify any necessary changes to ensure the PDG’s continued efficiency.
PDG Welcomes IPC and Launches Pilot for Global Expansion
During the PDG’s meeting, Dr. Rajiv Singh Raghuvanshi, Secretary-cum-Scientific Director of IPC, highlighted the PDG’s achievements and shared IPC’s perspective.
He informed that the PDG brings together the European Pharmacopoeia (EP), the Japanese Pharmacopoeia (JP), and the United States Pharmacopeia (USP), with the World Health Organization (WHO) as an observer.
The PDG members were delighted to welcome the IPC in a meeting as a pilot participant in the PDG pilot for global expansion.
Consensus Reached on Proof-of-Concept Study for Maintenance of ICH Q4B Annexes
One of the primary outcomes of the meeting was the consensus reached on a proof-of-concept study for the maintenance of the ICH Q4B annexes.
Following exchanges with the four other pharmacopoeias involving the discussion at the PDG interim videoconferences, revised drafts of following three selected Q4B annexes had been prepared:
- Annex 6: Uniformity of Dosage Units,
- Annex 7: Dissolution,
- Annex 8: Sterility.
Based on these drafts, PDG finalized the report with recommendations for some key questions, which had been raised in this proof-of-concept study.
Improving Engagement with Regulators and Stakeholders
In addition to membership expansion as a means of enhancing its global outreach, the PDG has been working on two other critical areas to ensure its future:
- Stakeholder engagement
- Regulatory engagement.
A draft concept paper for the early engagement model for stakeholders was proposed, using the excipient “Polysorbate 20” as a pilot.
This was submitted in parallel with a revision proposal for the existing PDG monograph, “Polysorbate 80,” which has a similar technical content.
Conclusion:
The Indian Pharmacopoeia Commission‘s (IPC) membership in the Pharmaceutical Discussion Group (PDG) will help to harmonize Indian standards with global standards, enabling the Indian Pharmacopoeia (IP) to be recognized and accepted globally.
The harmonization of IP’s general chapters with the European Pharmacopoeia (EP), the Japanese Pharmacopoeia (JP), and the United States Pharmacopeia (USP) will occur in three phases from December 2024 to December 2028.
The year-long pilot for global expansion of the PDG will facilitate the harmonization of IP’s general chapters on Tablet Friability and Optical Microscopy with the EP, the JP, and the USP. The PDG is also working on improving stakeholder and regulatory engagement to ensure its future success.
The addition of “Purified Water” and “Water for Injection” to the PDG work program shows the organization’s commitment to preparing impactful harmonized texts.
The lessons learned from the pilot will be used to refine the group’s working methods and ensure that it continues to perform efficiently.
Overall, the harmonization of pharmacopoeial standards is crucial to ensuring the quality, safety, and efficacy of pharmaceutical products worldwide.
The efforts of organizations like the PDG and IPC are essential in achieving this goal, and their collaboration will benefit patients, regulatory agencies, and the pharmaceutical industry as a whole.
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