Schedule M Draft Sets Zero Microbial Growth for Sterile Drugs
Health Ministry proposes Schedule M changes requiring zero microbial growth in Grade A sterile drug areas, aligning Indian GMP rules with WHO TRS 1044.
SCHEDULE-M
CDSCO Asks States to Enforce Batch Testing of Raw Materials, Excipients and Finished Drugs
In a 27 October notice, DCGI Rajeev Raghuvanshi has asked state and UT drug regulators to make manufacturers test every batch of raw materials, critical excipients such as propylene glycol, glycerol and sorbitol, and finished products, and to enforce vendor qualification after inspections found lapses.
The Future of Pharma: Innovation, Self-Reliance, and Skilling as Key Pillars
India’s pharmaceutical sector is entering a transformative phase, driven by innovation, digital technologies, regulatory reforms, and a renewed focus on […]
