More 'predictable' rules sought in Brazil to boost pharma trade
India called for a more predictable regulatory environment in Brazil to facilitate greater market access for Indian pharmaceutical exports.
Both countries reaffirmed their shared objective of expanding bilateral trade to USD 30 billion by 2030, with pharmaceuticals, chemicals, engineering goods, and machinery identified as priority sectors for diversification.
India and Brazil agreed to work toward early finalisation of the Terms of Reference for expanding and modernising the existing India-MERCOSUR Preferential Trade Agreement (PTA).
The discussions built on a Memorandum of Understanding signed in February 2026 between India's Central Drugs Standard Control Organisation (CDSCO) and Brazil's national health regulatory agency, ANVISA, intended to serve as an institutional foundation for closer pharmaceutical and medical-product regulatory cooperation.
Bilateral trade between India and Brazil reached USD 15.07 billion in 2025-26, while India-MERCOSUR bloc-wide trade reached USD 20.84 billion in 2025.
India-MERCOSUR Preferential Trade Agreement (PTA)
MERCOSUR (Mercado Común del Sur / Southern Common Market) is a South American trade bloc comprising Argentina, Brazil, Paraguay, and Uruguay, formed to promote free movement of goods, services, and factors of production among member states. India signed a Framework Agreement with MERCOSUR in 2003, followed by a Preferential Trade Agreement (PTA) signed in 2004 that entered into force on 1 June 2009. Unlike a Free Trade Agreement (FTA), a PTA offers only partial, negotiated tariff concessions on a limited list of products rather than near-complete tariff elimination.
Key Details
- India-MERCOSUR PTA covers roughly 450 tariff lines, with preferential duty concessions (typically 10-20%) offered reciprocally by both sides
- Entered into force: 1 June 2009; original framework agreement: 2003
- India-MERCOSUR bloc-wide trade reached USD 20.84 billion in 2025
- MERCOSUR members: Argentina, Brazil, Paraguay, Uruguay (Venezuela's membership remains suspended)
The push for pharma market access sits within the broader move to expand and modernise the 2009-vintage India-MERCOSUR PTA, with both sides agreeing to finalise Terms of Reference for negotiating an upgraded/expanded agreement covering more product lines and services.
Drug Regulatory Harmonisation: CDSCO and International Counterparts
The Central Drugs Standard Control Organisation (CDSCO), functioning under the Directorate General of Health Services, Ministry of Health and Family Welfare, is India's national regulatory authority for pharmaceuticals and medical devices, responsible for approving new drugs, clinical trials, and setting quality standards under the Drugs and Cosmetics Act, 1940 and its Rules. Regulatory cooperation MoUs with counterpart agencies abroad — such as Brazil's ANVISA (Agência Nacional de Vigilância Sanitária) — aim to reduce duplicate approval processes, enable mutual recognition of inspections/standards, and thereby ease market access for pharma exporters, who often cite "unpredictable" or duplicative foreign regulatory requirements as a bigger barrier to trade than tariffs.
Key Details
- CDSCO operates under the Drugs and Cosmetics Act, 1940, and Drugs and Cosmetics Rules, 1945
- Headed by the Drugs Controller General of India (DCGI)
- CDSCO-ANVISA MoU signed: February 2026, covering cooperation in regulation of pharmaceutical and medical products
- India is often called the "pharmacy of the world," supplying a large share of generic medicines and vaccines globally
The call for "predictable rules" in Brazil is a direct reference to non-tariff/regulatory barriers, which the CDSCO-ANVISA MoU is intended to address by creating a formal institutional channel for harmonising drug approval and inspection standards.
India-Brazil Bilateral Trade Mechanisms
India and Brazil conduct structured bilateral economic engagement through mechanisms such as the India-Brazil Trade Monitoring Mechanism, a periodic senior-official-level dialogue reviewing trade trends, market access issues, and non-tariff barriers between the two countries. Such institutional mechanisms are common tools in India's economic diplomacy, allowing incremental resolution of sector-specific market access issues even where a comprehensive new trade agreement is still under negotiation.
Key Details
- Both India and Brazil are members of BRICS, G20, and IBSA (India-Brazil-South Africa Dialogue Forum)
- Brazil is South America's largest economy and a key gateway for India's engagement with MERCOSUR
- Trade diversification priority sectors identified: pharmaceuticals, chemicals, engineering goods, machinery
The bilateral trade target of USD 30 billion by 2030 (roughly double the current USD 15.07 billion level) depends on resolving sector-specific regulatory friction of the kind flagged for pharmaceuticals, alongside progress on the broader India-MERCOSUR PTA expansion.
- India-Brazil bilateral trade: USD 15.07 billion in 2025-26; target USD 30 billion by 2030.
- India-MERCOSUR (bloc-wide) trade: USD 20.84 billion in 2025.
- India-MERCOSUR PTA: signed 2004 (framework agreement 2003), in force since 1 June 2009; covers approximately 450 tariff lines with preferential duties of roughly 10-20%.
- MERCOSUR members: Argentina, Brazil, Paraguay, Uruguay.
- CDSCO-ANVISA regulatory cooperation MoU: signed February 2026.
- CDSCO functions under the Drugs and Cosmetics Act, 1940, and is headed by the Drugs Controller General of India (DCGI), under the Ministry of Health and Family Welfare.