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US & Indian Pharmacopoeia Commission Ink MoU for Pharma Safety Globally

Written by : Jayati Dubey

March 18, 2024

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The partnership aims to fortify pharmaceutical standards and enhance the global supply chain for safe and reliable medicines.

The United States Pharmacopoeia (USP) and the Indian Pharmacopoeia Commission (IPC) have solidified a memorandum of understanding (MoU) aimed at enhancing the quality and safety of pharmaceuticals worldwide,

The partnership aims to fortify pharmaceutical standards and enhance the global supply chain for safe and reliable medicines.

The visit of a distinguished delegation from the Government of India to USP's headquarters in Rockville, Maryland, underlined the commitment of both parties to advancing public health objectives through international cooperation.

Notable officials from the Union Ministry of Health and the Embassy of India to the United States were present, affirming the significance attached to this alliance.

Strengthening Pharmaceutical Standards

Per the collaboration effort, USP, renowned for its dedication to ensuring the quality and safety of medications worldwide, is poised to leverage its expertise in support of India's endeavors to uphold high standards in pharmaceutical manufacturing.

Talking about the MoU, Ronald Piervincenzi, CEO, USP, said, "This visit underscores the importance of international collaboration in shaping quality standards for medicines, strengthening the supply chain, and improving public health globally."

The involvement of key stakeholders, such as the Joint Secretary of the Union Ministry of Health, Rajiv Wadhawan, and the Drugs Controller General of India (DCGI), Rajeev Raghuvanshi, further accentuates the gravity of this collaborative endeavor.

Dr Raghuvanshi's participation highlighted the alignment between regulatory bodies and standards-setting organizations in India, underscoring the shared objective of ensuring consistency in pharmaceutical standards across regions.

This synergy is instrumental in ensuring consistency and compatibility of pharmaceutical standards across different areas, thereby bolstering public health on a global scale.

Global Participation in Raising Pharma Standards

In October of last year, the IPC became a member of the Pharmacopoeial Discussion Group (PDG), an international coalition established to synchronize pharmacopoeial standards.

The IPC's participation in the PDG underscores India's commitment to aligning its standards with international benchmarks, thereby reducing the burden on manufacturers and promoting global harmonization in pharmaceutical regulation.

Aside from formalizing the MoU, the delegation visited USP laboratories and engaged in a fireside chat discussion with Dr Piervincenzi, sharing their insights and perspectives on pharmaceutical opportunities and challenges in India.

The Union Ministry of Health and Family Welfare stated on October 10, 2023, that the PDG announced IPC's new membership during its stakeholders meeting in Hyderabad on October 5, 2023.

IPC officially became a member of the Group during the PDG's Annual Meeting, held on October 3-4, 2023, in Hyderabad. The World Health Organization (WHO) remains an observer of the PDG.

As the IPC joins esteemed counterparts in the PDG, including the European Pharmacopoeia (Ph. Eur.) and the Japanese Pharmacopoeia (JP), prospects for global collaboration in harmonizing pharmacopoeial standards are promising.

The objective of harmonizing pharmacopoeial standards across regions holds immense promise for streamlining regulatory processes and enhancing the efficiency of pharmaceutical manufacturing.

In a similar development related to pharmaceutical marketing, the Union Government rolled out the Uniform Code for Pharmaceutical Marketing Practices (UCPMP) 2024 to curb unethical practices within the pharmaceutical industry.

Led by the Ministry of Chemicals and Fertilizers, this initiative aims to address misleading promotional activities and promote responsible marketing within the pharmaceutical sector.

The UCPMP guidelines include drug endorsement, promotion, ethical conduct for medical representatives, and maintaining relationships with healthcare professionals. The new regulation aims to promote transparency, integrity, and accountability in marketing pharmaceutical products.


About Chime India

The College of Healthcare Information Management Executives (CHIME) is an executive organization dedicated to serving senior digital health leaders. CHIME includes more than 5,000 members in 56 countries and two US territories and partners with over 150 healthcare IT businesses and professional services firms. CHIME enables its members and business partners to collaborate, exchange ideas, develop professionally and advocate the effective use of information management to improve the health and care throughout the communities they serve. CHIME's members are chief information officers (CIOs), chief medical information officers (CMIOs), chief nursing information officers (CNIOs), chief innovation officers (CIOs), chief digital officers (CDOs), and other senior healthcare leaders. The CHIME India Chapter became the first international chapter outside North America in 2016 and is now a community of over 70+ members in India. For more information, please visit www.chimecentral.org

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