Around 5,000 Small Pharma Units at Risk as Centre Enforces Tougher GMP Norms

With thousands of units now under scrutiny, industry estimates suggest that up to 5,000 small pharma firms may face closure, raising concerns about supply chain disruptions and the potential shortage of essential medicines. The crackdown focuses heavily on enforcing strict facility upgrades, raw-material testing, documentation standards and end-to-end compliance before the year-end deadline.

A major push followed the DCGI’s directive issued on November 7, which ordered state drug controllers to immediately begin inspections of companies that had sought a one-year extension to comply with revised GMP norms. These firms are now required to demonstrate substantial progress in plant upgrades, while those that failed to apply for an extension are at immediate risk of punitive action. Officials have initiated a fresh round of audits across MSME-run facilities, checking infrastructure, quality systems, contamination controls and material procurement processes.

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The crackdown gained further momentum after WHO alerts raised global concern over diethylene glycol (DEG) and ethylene glycol (EG) contamination in cough syrups manufactured by smaller Indian units. Toxic substances were detected in products such as Coldrif, Respifresh TR, and ReLife, prompting detailed investigations that uncovered rusted machinery, unhygienic premises, lack of pest control and the use of non-pharmaceutical-grade solvents. These findings exposed significant failures in quality control systems and accelerated the regulatory overhaul.

In response, the CDSCO introduced stricter raw-material rules, requiring manufacturers to purchase solvents only from pre-qualified suppliers and mandating DEG/EG testing for every batch. Industry bodies acknowledge that the heightened safety framework is necessary but caution that the aggressive deadlines could severely impact MSME manufacturers, who constitute nearly 80% of India’s 10,000-plus drug units, reports LiveMint.

According to a recent media report in The Economic Times, many small-scale manufacturers fear large-scale shutdowns as they struggle to meet the capital and compliance requirements linked to the revised Schedule M norms.