India, Brazil Ink Pharma Regulatory Cooperation Pact

The partnership reflects a shared commitment to ensuring the availability of safe, effective and quality-assured medicines for citizens of both nations.

India and Brazil on Friday deepened their health-sector partnership with the exchange of a Memorandum of Understanding (MoU) to strengthen cooperation in the regulation of pharmaceutical and medical products.

The MoU was exchanged at Hyderabad House between India’s Central Drugs Standard Control Organisation (CDSCO) and Brazil’s Health Regulatory Agency (ANVISA) in the presence of Prime Minister Shri Narendra Modi and Brazilian President H.E. Luiz Inácio Lula da Silva.

Director-President of ANVISA Mr. Leandro Safatle and Indian Ambassador to Brazil Shri Dinesh Bhatia formally exchanged the agreement, signalling a new phase of structured regulatory collaboration between the two leading Global South economies.

Framework for Regulatory Convergence

The MoU establishes a structured framework for cooperation and information exchange in the regulation of:

• Pharmaceutical ingredients

• Finished drugs

• Biological products

• Medical devices

It aims to promote convergence in regulatory practices, improve mutual understanding of regulatory systems and facilitate coordinated oversight of medical products in both countries.

Officials said the agreement will enhance transparency, support regulatory best practices and create more predictable pathways for approvals and compliance.

Strengthening Supply Chains and Public Health

The partnership reflects a shared commitment to ensuring the availability of safe, effective and quality-assured medicines for citizens of both nations.

By strengthening regulatory cooperation, the MoU is expected to:

• Improve resilience of pharmaceutical supply chains

• Facilitate smoother market access

• Encourage regulatory capacity building

• Support affordable healthcare solutions

India is one of the world’s largest producers of generic medicines and vaccines, while Brazil represents one of the largest pharmaceutical markets in Latin America. Enhanced regulatory alignment could streamline trade flows and support greater collaboration in medical technologies and biologics.

Expanding India–Brazil Health Partnership

The agreement builds on broader India–Brazil cooperation in the health sector and complements existing bilateral engagement mechanisms.

As prominent voices of the Global South, both countries have consistently advocated for equitable access to medicines and stronger South–South collaboration in public health.

Through the MoU, CDSCO and ANVISA have reaffirmed their intent to cooperate in areas such as information sharing, regulatory capacity development and coordinated approaches to pharmaceutical oversight, in accordance with their respective national laws.

The move is expected to open new avenues for collaboration in pharmaceuticals and medical devices, further strengthening India–Brazil relations and contributing to improved public health outcomes in both countries.