India’s small and mid-sized pharmaceutical manufacturers are raising alarms over new good manufacturing practice (GMP) and bio-equivalence mandates, warning that the regulations could widen the gap between large companies and micro, small, and medium enterprises (MSMEs). While regulators aim to strengthen drug quality and global credibility, industry groups fear that the reforms may trigger factory closures, market consolidation, and potential shortages of essential generic medicines, according to GlobalData.

MSME associations have appealed to the Union Health Minister to delay the Central Drugs Standard Control Organisation’s (CDSCO) stringent new manufacturing requirements. They argue that the revised Schedule M GMP rules and mandatory bio-equivalence studies for all generics impose steep financial burdens—costing between INR 250,000 and 500,000 per product—and could cripple small firms.

Although the current Schedule M compliance deadline is set for 1 January 2026, industry groups are urging an extension to 1 April 2027, citing additional pressures from other regulatory changes, including QR code mandates for oncology drugs and stricter gene therapy oversight.

According to Leyla Hasanzadeh, Research Analyst, Health Economics and Market Access at GlobalData, MSMEs believe these quality-driven reforms disproportionately affect them compared with multinationals and could weaken their competitiveness in export markets such as Bangladesh, Sri Lanka, and China.

Meanwhile, China’s National Joint Drug Procurement Office has launched the 11th round of its National Centralised Drug Procurement programme, covering 55 active pharmaceutical ingredients (APIs). The updated framework prioritises balanced evaluation of quality, price, supply stability, and clinical need, with new bidding rules designed to prevent destructive underpricing and bid rigging.

Chia Hsuan Lin, Research Analyst at GlobalData, notes that these measures may benefit overseas manufacturers offering higher-quality, more stable products, while also helping domestic firms improve standards and achieve healthier margins.

The findings are part of GlobalData’s Q3 2025 Emerging Market Outsourcing Report, which tracks manufacturing trends, M&A activity, and regulatory shifts across emerging pharma markets including India, China, Latin America, and Eastern Europe.