The Indian Pharmacopoeia Commission (IPC), India’s apex body for setting drug quality standards, has been designated as the Regional Centre of Excellence in Pharmacovigilance and the Technical Centre in Quality by the South-East Asia Regulatory Network (SEARN). The recognition came during SEARN’s 10th Anniversary Meeting, held in Kathmandu, Nepal, on 4-5 August 2026. The designation places India at the heart of efforts to make medicines across South-East Asia safer and more reliable.
What Is the South-East Asia Regulatory Network (SEARN)?
The South-East Asia Regulatory Network (SEARN) is a collaborative platform of the National Regulatory Authorities (NRAs) of the WHO South-East Asia Region, brought together by the WHO South-East Asia Regional Office (SEARO). It was launched in 2016 to strengthen the regulation of medical products, which include medicines, vaccines, diagnostics and medical devices, across its member states.
SEARN currently counts ten countries as members: Bangladesh, Bhutan, the Democratic People’s Republic of Korea, India, Maldives, Myanmar, Nepal, Sri Lanka, Thailand and Timor-Leste. Its vision is to support timely access to affordable medical products of assured quality, safety and efficacy across the region and beyond.
The network works towards four broad objectives: sharing information among regulators, strengthening regulatory systems and skills, promoting convergence of regulatory approaches with international standards, and developing collaboration and reliance mechanisms so that member countries can use each other’s assessment work instead of duplicating it. WHO initially provides the secretariat, with the intent that SEARN eventually becomes a self-sustaining network managed by its member states. Its Steering Group has three permanent members, India, Indonesia and Thailand, and two revolving members.
The Working Groups
SEARN operates through thematic working groups that tackle specific regulatory functions:
| Working Group | Focus Area |
|---|---|
| WG1 Quality | Quality assurance and standards, including support to quality control laboratories |
| WG2 Regulatory Strengthening | Capacity building, regulatory quality management and reliance |
| WG3 Vigilance | Pharmacovigilance, safety signals and risk management |
| WG4 Information Sharing | Sharing of alerts, urgent information and regulatory intelligence |
| WG5 Medical Devices | Regulation and post-market surveillance of medical devices |
| WG6 Traditional Medical Products | Capacity building and convergence for traditional medicines |
The grouping shows how SEARN coordinates its work across the entire lifecycle of a medical product, from setting standards at the factory gate to watching over safety once the product reaches patients.
What Was Announced at the Kathmandu Meeting
The 10th Anniversary Meeting of SEARN was held in Kathmandu, Nepal, on 4-5 August 2026, bringing together representatives of National Regulatory Authorities, pharmacopoeias and international organisations from across the region. The gathering marked a decade of regional regulatory collaboration and discussed how to further strengthen systems that ensure the quality, safety and efficacy of medical products.
The central outcome of the meeting for India was the formal recognition of the IPC as the WHO-SEARN Regional Centre of Excellence in Pharmacovigilance and the Technical Centre in Quality. The designation acknowledges the IPC’s sustained contributions to strengthening pharmacovigilance systems, advancing pharmaceutical quality standards and supporting regulatory capacity building across the WHO South-East Asia Region.
The IPC delegation was led by Dr V. Kalaiselvan, Secretary-cum-Scientific Director of the Commission. During the meeting, the delegation showcased India’s work in developing and publishing the Indian Pharmacopoeia, establishing Indian Pharmacopoeia Reference Substances (IPRS) and Impurity Reference Standards (IMPRS), running pharmacovigilance and materiovigilance activities under the Pharmacovigilance Programme of India (PvPI) and the Materiovigilance Programme of India (MvPI), and conducting capacity-building programmes for regulators and stakeholders.
The Kathmandu meeting also served as a forum for exchanging scientific knowledge and discussing emerging challenges in pharmaceutical regulation, including quality assurance, safety, regulatory reliance, digital transformation and regional cooperation.
About the Indian Pharmacopoeia Commission (IPC)
The Indian Pharmacopoeia Commission (IPC) is an autonomous institution under the Ministry of Health and Family Welfare (MoHFW), Government of India. It was established in 1956 and is headquartered in Ghaziabad, Uttar Pradesh.
The Commission’s core mandate is to set standards for drugs manufactured and marketed in India. It regularly revises and publishes the Indian Pharmacopoeia (IP), the official book of drug standards that is legally enforceable in the country. The IP covers drug substances, dosage forms, excipients, biological products, vaccines, blood and blood products, and medical devices.
The IPC also publishes the National Formulary of India (NFI) to promote the rational use of generic medicines, develops and supplies Indian Pharmacopoeia Reference Substances (IPRS) and Impurity Reference Standards (IMPRS) that manufacturers and testing laboratories rely on for quality testing, and runs training programmes for stakeholders across the pharmaceutical sector.
India’s stake in setting these standards is enormous. The country’s pharmaceutical industry is the third largest in the world by volume and around 11th by value, and India is the largest global supplier of generic medicines, providing roughly 20% of the world’s generics. Strengthening pharmacopoeial and safety standards therefore has direct consequences not just for Indian patients but for health systems across Africa, Asia and beyond.
Pharmacovigilance Programme of India (PvPI)
Pharmacovigilance is the science of detecting, assessing and preventing adverse effects of medicines. The Pharmacovigilance Programme of India (PvPI) was launched in July 2010 by the Ministry of Health and Family Welfare to create a nationwide system for reporting adverse drug reactions (ADRs), which are harmful or unintended responses to medicines.
The programme began with the All India Institute of Medical Sciences (AIIMS), New Delhi, as its National Coordination Centre. In April 2011, the IPC took over this role and has since functioned as the National Coordination Centre (NCC-PvPI). The programme operates through a network of Adverse Drug Reaction Monitoring Centres (AMCs) located in medical colleges, district hospitals and corporate hospitals across the country, which collect ADR reports and forward them to the NCC.
A landmark step came in 2017, when the NCC-PvPI at the IPC was designated the WHO Collaborating Centre for Pharmacovigilance in Public Health Programmes and Regulatory Services, the first WHO collaborating centre on this theme anywhere in the world. India also contributes to the WHO Programme for International Drug Monitoring, run by the Uppsala Monitoring Centre (UMC) in Sweden, feeding Indian safety reports into the global database.
Materiovigilance Programme of India (MvPI)
In 2015, the government launched the Materiovigilance Programme of India (MvPI) under the IPC to monitor the safety of medical devices. Materiovigilance is the systematic collection and analysis of adverse events linked to medical devices, in the same way that pharmacovigilance tracks medicine side effects.
The programme is coordinated by the IPC in collaboration with the Central Drugs Standard Control Organisation (CDSCO), the national drug regulator, which takes regulatory decisions based on the safety signals identified. The MvPI has gained importance as India’s medical devices market has grown rapidly and as more devices, from pacemakers to surgical implants, are now regulated under the Drugs and Cosmetics Act, 1940.
Why This Recognition Matters
The designation carries weight on several counts. First, it is a validation of the technical capacity of Indian institutions. Being chosen as the regional centre of excellence means other countries in the region will look to India for training, guidance and technical leadership in pharmacovigilance and pharmaceutical quality, a role similar to the one the country has long played as a supplier of affordable medicines.
Second, it fits squarely with India’s broader strategy of positioning itself as a reliable global hub for drug manufacturing and regulation. Stronger safety and quality systems make Indian medicines more credible in export markets. For a country that supplies one in every five generic medicines used worldwide, credibility is a commercial asset as much as a public health one.
Third, the recognition deepens India’s leadership inside SEARN. India is already a permanent member of the network’s Steering Group and leads the thematic area of vigilance within it. The new designation gives the IPC an institutional identity to anchor regional cooperation, including the regional pharmacovigilance newsletter and capacity-building activities that SEARN’s Working Group 3 on vigilance has been developing with support from the IPC.
Fourth, there is a public health dimension. The South-East Asia Region faces persistent challenges such as substandard and falsified medicines, low adverse event reporting and weak regulatory capacity in several countries. A regional centre of excellence can help raise reporting standards, build the skills of regulators and improve access to safe, effective and quality-assured medical products for millions of people.
The Way Forward
The IPC’s new role carries expectations. The Commission has said it will continue to support SEARN initiatives, foster regulatory excellence and work towards ensuring the availability of safe, effective and quality-assured medical products across the region. In practical terms, this means more training programmes for regulators from member countries, deeper cooperation on reference standards and quality testing, and stronger digital tools for reporting adverse drug reactions.
India’s own pharmacovigilance network is also being expanded. The IPC has prioritised widening the geographic and institutional coverage of its ADR monitoring centres, improving the quality and timeliness of reporting, and using digital technologies and data analytics to detect safety signals faster. These efforts, aligned with the Digital India mission and the broader Viksit Bharat 2047 vision, will determine whether the regional centre of excellence delivers on its promise.
Key Takeaways
- The Indian Pharmacopoeia Commission (IPC) was designated as the WHO-SEARN Regional Centre of Excellence in Pharmacovigilance and Technical Centre in Quality at SEARN’s 10th Anniversary Meeting in Kathmandu on 4-5 August 2026.
- The South-East Asia Regulatory Network (SEARN) was launched in 2016 by the WHO South-East Asia Regional Office (SEARO) to strengthen regulation of medical products across its member states.
- SEARN has ten member countries, including India, Bangladesh, Bhutan, Maldives, Myanmar, Nepal, Sri Lanka, Thailand and Timor-Leste, and its Steering Group has India, Indonesia and Thailand as permanent members.
- The IPC, established in 1956 and headquartered in Ghaziabad, Uttar Pradesh, is an autonomous body under the Ministry of Health and Family Welfare that publishes the Indian Pharmacopoeia (IP).
- The Pharmacovigilance Programme of India (PvPI), launched in July 2010, is coordinated by the IPC as its National Coordination Centre, and the NCC-PvPI became a WHO Collaborating Centre in 2017.
- India’s pharmaceutical industry is the third largest in the world by volume and the largest global supplier of generic medicines, providing around 20% of the world’s generics.
