
The Union Health Ministry is in discussions with states regarding potential extensions for pharmaceutical companies to comply with revised Schedule M regulations on good manufacturing practices. Some state drug regulatory officials suggest a six-month extension might be granted on a case-by-case basis, particularly for units that have submitted upgrade plans. The revised rules, notified in December 2023, had staggered deadlines for larger companies and MSMEs. Industry groups warn that a strict deadline could lead to medicine shortages, job losses, and impact India's medicine security.
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