Deadline Looms: Small Pharma Units Beg for Schedule M Extension
Small pharmaceutical units, those with an annual turnover below Rs 50 crore, are pleading for a deadline extension regarding the revised Schedule M manufacturing standards. The current deadline is causing significant financial strain.
Many firms haven’t even submitted their upgrade plans yet, citing the substantial costs involved in meeting the new regulations. Industry insiders express grave concerns about widespread closures if the Ministry of Health doesn’t grant an extension.
The units are requesting a new deadline of December 2026, believing this would provide them sufficient time to comply. This delay is crucial to prevent widespread job losses and ensure the continued supply of affordable medicines.
The Ministry of Health’s decision will have a direct impact on the affordability and accessibility of essential medicines for millions of Indians. The coming weeks will be crucial for these small units, and the government’s response will be closely watched.
