Quality assurance, not just volume, will decide India's position as the 'pharmacy of the world'. Evaluate the role of revised Schedule M and post-marketing surveillance.

India supplies generic medicines at scale, but scale does not earn trust on its own. In the 2025 Chhindwara cough-syrup deaths, a sample was found to contain diethylene glycol and CDSCO recommended cancelling the manufacturer's licence [1]. Revised Schedule M is the preventive tool and post-marketing surveillance is the detection tool. Both are sound in design, but neither yet has enough capacity behind it.

Revised Schedule M: preventing defects at the factory

• Strength: Good Manufacturing Practice rules were aligned with WHO standards in December 2023. They became binding on large firms (turnover above ₹250 crore) from June 2024 [2].
• It builds in quality systems, risk management and process validation, so the focus moves from punishing defects to preventing them.
• Weakness: MSMEs got a conditional extension to 31 December 2025 [2]. Many small units, which produce much of India's generic volume, are still upgrading.
• Risk-based inspections since December 2022 covered 960+ units and led to 860+ regulatory actions [3]. Compliance gaps are widespread.

Post-marketing surveillance: catching defects in the market

• Strength: In 2024-25, States/UTs tested 1,16,323 samples, of which 3,104 (~2.7%) were Not of Standard Quality (NSQ) [3]. CDSCO publishes monthly drug alerts and orders recalls [4].
• A draft amendment to the Drugs Rules, 1945 proposes immediate licence suspension for NSQ findings on sterility, assay, dissolution, impurities or related substances. The licence would be restored only after a verified root-cause analysis and corrective/preventive action (RCA–CAPA) [5].
• Weakness: Surveillance is reactive. Samples are drawn from the market, so patients have already been exposed.
• The Parliamentary Standing Committee on Health (175th–177th Reports) flagged Drugs Controller vacancies and CDSCO's generalist structure [6]. Both slow testing and verification.

Evaluation The two tools complement each other and together follow WHO's prevent–detect–respond approach to substandard drugs [7]. Schedule M is the more important lever because it stops defects at source. Surveillance keeps it credible by penalising failures that slip through. However, both are held back by MSME compliance costs and regulatory staffing gaps.

Revised Schedule M and stronger surveillance can together turn India's reputation from volume to reliability. The way forward is to:

• set firm MSME compliance deadlines with financial support;
• fill Drugs Controller vacancies;
• empanel more testing labs [6];
• verify RCA–CAPA within fixed deadlines.

These steps would advance SDG 3.8, access to safe and quality medicines, and show that quality, not quantity, secures India's place as the pharmacy of the world.