India’s small drugmakers are sounding the alarm as new good manufacturing practice (GMP) and bio-equivalence mandates could deepen the divide between regulators and micro, small and medium enterprises (MSME). Their appeal to delay enforcement highlights growing concern that India’s drive for stricter quality standards, while well-intentioned, may strain smaller manufacturers, forcing consolidation, factory shutdowns, and potential shortages of vital generic medicines, according to GlobalData.
Reportedly, MSME associations have appealed to the Union Health Minister to hit the brakes on new stringent manufacturing rules imposed by the Central Drugs Standard Control Organisation (CDSCO).
They warn that abrupt implementation timelines—especially the revised Schedule M GMP requirements and mandatory bio-equivalence studies for all generics—could financially cripple small drugmakers and force many to close, risking shortages of generic and critical medicines, as mentioned in the Q3 2025 Emerging Market Outsourcing Report.
Although the Schedule M deadline has been extended several times and currently stands at 1 January 2026, the groups want it pushed back to at least 1 April 2027, citing high compliance costs (bio‑equivalence studies cost INR 250,000–500,000 per product) and the cumulative burden of other mandates like QR codes for cancer drugs, updated rules for gene therapies, and tougher penalties for quality failures.
Leyla Hasanzadeh, Research Analyst, Health Economics and Market Access at GlobalData, states, “MSMEs argue that these quality‑focused measures disproportionately strain them compared with multinationals, threaten competitiveness in domestic and export markets (such as Bangladesh, Sri Lanka, and China), and could lead to market exits and shortages of critical therapies, including oncology and cardiovascular medicines.”
Additionally, China’s National Joint Drug Procurement Office launched the 11th round of its National Centralised Drug Procurement program, covering 55 APIs, and introduced bidding rules designed to balance drug quality, price, stable supply, and clinical need rather than simply awarding contracts to the lowest bidder.
The new guidelines include a revised “anchor price” formula to prevent destructive low-price bids, clearer eligibility and bidding procedures, and an emphasis on preventing bid rigging and ensuring fair competition.
Chia Hsuan Lin, Research Analyst, Health Economics and Market Access at GlobalData, adds, “While the changes could benefit overseas manufacturers—which often offer higher-priced products with stronger quality control and supply stability—domestic firms have also improved safety standards, and overall, the rules aim to curb excessive low-price competition and support healthier industry margins.”
The Emerging Market Outsourcing Report is a quarterly analysis of news and trends affecting contract manufacturing organisations in emerging pharma markets such as China, India, Latin America, the Middle East, and Eastern Europe. The report also lists the latest M&A and financing of CDMOs, expansions and investments in facilities, and manufacturing inspections.