**Executive Summary**
On April 24, 2026, the National Institute of Pharmaceutical Education and Research (NIPER), Hajipur, signed a Memorandum of Understanding (MoU) with the Indian Pharmacopoeia Commission (IPC) to strengthen pharmaceutical standards and patient safety. The collaboration focuses on advancing regulatory science, joint research, and capacity building to ensure the availability of quality-assured healthcare products. Key initiatives include the development of standards for complex biologics and emerging therapies for inclusion in the Indian Pharmacopoeia.
**Key Points / Main Content**
**Core Objectives**
* Promote collaboration in pharmaceutical standards, regulatory science, and patient safety.
* Strengthen the national regulatory science ecosystem and enhance pharmacopeial standards.
* Advance scientific research across pharmaceuticals, medical devices, and related healthcare products.
**Joint Research and Development**
* Conduct research on impurity profiling and the safety correlation of drugs.
* Develop and validate advanced analytical methods for pharmaceutical testing.
* Establish robust quality control protocols to ensure product efficacy and safety.
**Emerging Therapeutic Standards**
* Develop reference standards for complex biologics and biosimilars.
* Support the inclusion of emerging therapeutic products, such as cell and gene therapies, in the Indian Pharmacopoeia.
**Capacity Building and Training**
* Implement training initiatives in specialized domains, including biosimilars and blood-related products.
* Strengthen national capabilities through specialized education in cell and gene therapy.
**Impact Analysis**
**NIPER Hajipur**
**Impact**
The institute gains a strategic partnership to enhance its research capabilities and contribute directly to national standard-setting.
**Action Required**
Engage in joint research initiatives and lead training programs in specialized pharmaceutical domains.
**Indian Pharmacopoeia Commission (IPC)**
**Impact**
The IPC will benefit from academic research support to update and expand the Indian Pharmacopoeia with emerging therapies.
**Action Required**
Collaborate on the development of reference standards and quality control protocols for new healthcare products.
**Healthcare Industry and Citizens**
**Impact**
Citizens will have improved access to safe, effective, and quality-assured healthcare products. The industry benefits from clearer regulatory standards for complex biologics.
**Action Required**
No direct action is required, but stakeholders must align with the new standards and protocols developed under the MoU.
**Department of Pharmaceuticals**
**Impact**
The department fulfills its objective of strengthening the national regulatory science ecosystem through inter-agency cooperation.
**Action Required**
Provide oversight and support to ensure the successful implementation of the MoU’s objectives.
Key Entities Referenced
Indian Pharmacopoeia Commission (IPC): The national standard-setting body for pharmaceuticals in India that signed a Memorandum of Understanding to enhance regulatory science, research, and patient safety.
National Institute of Pharmaceutical Education and Research (NIPER), Hajipur: A premier academic institution collaborating with the IPC on joint research initiatives, including impurity profiling, drug safety correlation, and quality control protocols.
Department of Pharmaceuticals: The administrative department under the Ministry of Chemicals and Fertilizers responsible for overseeing the partnership to strengthen India’s regulatory science ecosystem.
Indian Pharmacopoeia: The official document of pharmaceutical standards which the collaboration aims to update with reference standards for complex biologics, biosimilars, and cell therapies.
Ministry of Chemicals and Fertilizers :
Department of Pharmaceuticals
NIPER Hajipur Signs MoU with IPC to Strengthen
Pharmaceutical Standards and Patient Safety
Collaboration to Boost Regulatory Science, Research, and
Capacity Building
Posted On: 24 APR 2026 3:17PM by PIB Delhi
The National Institute of Pharmaceutical Education and Research (NIPER), Hajipur has signed a
Memorandum of Understanding (MoU) with the Indian Pharmacopoeia Commission (IPC),
Ghaziabad, under the Ministry of Health & Family Welfare, Government of India, to promote
collaboration in the areas of pharmaceutical standards, regulatory science, and patient safety, today at
Kartavya Bhawan, New Delhi.
The MoU was signed in the presence of Manoj Joshi, Secretary, Department of Pharmaceuticals, Ministry
of Chemicals and Fertilizers. The collaboration aims to foster cooperation in areas of mutual interest,
with a focus on strengthening pharmacopeial standards, enhancing patient safety, and advancing
scientific research across pharmaceuticals, medical devices, and related healthcare products.
Speaking on the occasion, Shri Manoj Joshi emphasized that such collaborations between premier
academic institutions and national standard-setting bodies are crucial for strengthening India’s regulatory
science ecosystem. He highlighted that the initiative will help ensure the availability of safe, effective, and
quality-assured healthcare products for citizens.
Under the MoU, NIPER Hajipur and IPC will undertake joint research initiatives in key areas, including
impurity profiling and safety correlation of drugs, development and validation of advanced
analytical methods, and establishment of quality control protocols. The partnership will also support
the development of reference standards for complex biologics, biosimilars, and emerging therapeutic
products, including cell and gene therapies, facilitating their inclusion in the Indian Pharmacopoeia.The MoU further envisages capacity building and training initiatives in specialized domains such as
biosimilars, cell and gene therapy, and blood and blood-related products, with the objective of
strengthening national capabilities in these critical areas.
Prof. K. Ruckmani, Director, NIPER Hajipur; Dr. Kinny Singh, Deputy Secretary, Department of
Pharmaceuticals, Dr. V. Kalaiselvan, Secretary, IPC; along with other senior officials and scientists were
present during the signing ceremony.
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