India’s active pharmaceutical ingredient (API) manufacturers have urged the government to introduce import curbs and support for GMP upgrades in the upcoming Union Budget 2026, citing rising compliance costs and pressure from low-priced imports.

The industry highlighted that the implementation of revised Schedule M norms has increased the cost of upgrading manufacturing facilities, making compliance challenging, particularly for small and medium-sized API producers. Manufacturers have stated that while quality upgrades are necessary, financial support is required to meet the new standards.

API makers also pointed to continued dependence on imported APIs and key starting materials (KSMs), mainly from China, which are often priced lower than domestically produced materials. This pricing gap has impacted the competitiveness of local manufacturers despite investments in compliance and capacity upgrades.

Ahead of the budget, the sector is seeking measures such as extension of the Production Linked Incentive (PLI) scheme, minimum import price mechanisms, and anti-dumping duties to protect domestic manufacturing. These measures are aimed at reducing reliance on imports and strengthening local API production.

In addition, manufacturers are asking for subsidies, soft loans and financial incentives to support GMP upgrades and modernisation, especially for MSMEs that play a key role in the API supply chain but face capital constraints.

The demands come as the industry looks to Budget 2026 for policy measures that can support domestic API manufacturing while ensuring compliance with updated quality standards.

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