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Indian Pharmacopoeia Commission Signs MoUs to Strengthen Drug Quality and Safety

The Indian Pharmacopoeia Commission has signed two MoUs to strengthen drug quality and safety. One MoU with PMBI aims to enhance quality assurance for medicines at Pradhan Mantri Bhartiya Janaushadhi Kendras. Another MoU with NIPER Hajipur focuses on collaborative research in pharmaceutical science. Both partnerships will promote pharmacovigilance, training, and capacity building in public health.

Key Points: IPC MoUs Boost Drug Quality Checks & Pharmacovigilance

  • MoU with PMBI to enhance quality checks for Jan Aushadhi medicines
  • Partnership to promote rational use via National Formulary of India
  • Strengthening pharmacovigilance with PvPI QR codes and helpline
  • MoU with NIPER Hajipur for collaborative research on impurities and biologics
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Indian Pharmacopoeia Commission signs MoUs to boost quality checks, pharmacovigilance

Indian Pharmacopoeia Commission signs MoUs with PMBI and NIPER Hajipur to enhance quality assurance, pharmacovigilance, and research for safer medicines.

"The collaboration will include joint research on impurity profiling, including genotoxic impurities such as nitrosamines and their correlation with adverse drug reaction data - Official Statement"

New Delhi, April 24

The Central government's Indian Pharmacopoeia Commission has signed two memoranda of understandings with two government institutes to strengthen quality assurance, ensure rational use of medicines, pharmacovigilance and collaborative research, an official statement said on Friday.

One MoU with the Pharmaceuticals & Medical Devices Bureau of India aims to enhance the quality assurance framework for medicines made available through Pradhan Mantri Bhartiya Janaushadhi Kendras (PMBJKs).

It will allow PMBI to submit randomly selected batches of Jan Aushadhi medicines to IPC for quality testing. The partnership will further promote the use of the National Formulary of India (NFI) across Pradhan Mantri Bhartiya Janaushadhi Kendras (PMBJKs) to ensure rational use of medicines.

It also seeks to strengthen pharmacovigilance activities by displaying the Pharmacovigilance Programme of India (PvPI) QR code and toll-free helpline number (1800-180-3024) at PMBJKs across the country, thereby encouraging adverse drug reaction (ADR) reporting and improving patient safety.

Further, IPC and PMBI will jointly organize sensitization, awareness, and training programmes for pharmacists and stakeholders on rational use of medicines, pharmacovigilance, ADR reporting tools, and the role of pharmacists in safeguarding public health.

Another MoU with the National Institute of Pharmaceutical Education and Research, Hajipur focuses on collaborative research, academic exchange, and capacity building in the area of pharmaceutical science and healthcare products.

NIPER Hajipur, an Institute of National Importance, possesses advanced expertise in pharmaceutical analysis, biologics, and clinical research, making it a valuable partner in strengthening pharmacopoeial science and patient safety, the statement said..

The collaboration will include joint research on impurity profiling, including genotoxic impurities such as nitrosamines and their correlation with adverse drug reaction data to establish evidence-based pharmacopoeial limits.

It will also focus on the development of analytical methods, quality control protocols, and reference standards for biologics, biosimilars, and emerging cell and gene therapy products for inclusion in the Indian Pharmacopoeia.

Both institutions will also collaborate in organizing training programmes, workshops, seminars, and conferences, along with faculty exchange initiatives and sharing of advanced analytical instrumentation facilities.

Internship and fellowship opportunities for pharmacy graduates and postgraduates, as well as joint publication of research papers, training manuals, and educational materials, will further strengthen scientific engagement and institutional capacity building.

- IANS

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Reader Comments

R
Rohit P
I hope this isn't just another paper MoU. The real test will be in implementation. Also, the pharmacovigilance helpline number and QR codes at PMBJKs is a great idea - common people need to know where to report side effects. Let's see how many Kendras actually display it.
P
Priya S
Finally, some focus on nitrosamine impurities! With all the global recalls of common drugs like ranitidine and metformin due to these genotoxic impurities, it's crucial for IPC to set evidence-based limits. We need our own standards, not just blindly follow USFDA or EMA.
A
Aman W
The collaboration with NIPER Hajipur on biologics and cell/gene therapy is forward-looking. India needs to build capacity in biosimilars - they're the future of affordable treatment for cancer and autoimmune diseases. Faculty exchange and shared instrumentation will help a lot. Good job, IPC!
S
Sarah B
As someone who works in pharma, I appreciate this systematic approach. The training programmes for pharmacists on rational use of medicines and ADR reporting are particularly important. Many pharmacists in smaller towns don't even know about PvPI. Let's hope these MoUs lead to real change on the ground.
M
Michael C
It's good to see IPC working with academic institutes like NIPER. The joint research on impurity profiling and analytical methods will definitely strengthen the Indian Pharmacopoeia. But we need to ensure that these MoUs result in timely publication of standards and not get stuck in bureaucracy. 🙏

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