The record
Written from the 2 reports below. Nothing here is unsourced.
- The government has made revised Schedule M quality norms mandatory from January 1, and pharmaceutical companies that fail to meet WHO-GMP standards are being asked to shut down unless they upgrade, with non-compliant firms also barred from government tenders.
- Pharmaceuticals Secretary Manoj Joshi said restoring confidence in Indian drug manufacturing through stricter regulation is the immediate priority.
- He outlined three long-term goals: building a biopharma ecosystem, reducing dependence on imported bulk drugs (30-35 per cent of drugs still rely on Chinese APIs), and tightening quality surveillance.
- On prices, essential medicines remain under price control capped at 10 per cent annual increases, while trade margin rationalisation for expensive drugs is under consideration.
What to watch next
- Enforcement of the revised Schedule M norms — which companies shut down or upgrade
- NPPA decisions on evidence-backed price hike requests and possible trade margin caps
- Expansion of the PLI scheme to further reduce dependence on Chinese APIs
What changed2
Every report on this story, newest first. Times are when each outlet published.
The Hindu BusinessLine[1]
India tightens drug quality norms, eyes biopharma push: Pharma SecretaryThe Hindu BusinessLine[2]
Quality Reforms, Biopharma Ecosystem Top Priority to Keep India as ‘Pharmacy of World’: Pharma Secy Manoj Joshi
Coverage1
2 reports
English national2
All filed from IndiaSingle origin
Named India · China · Europe · GLP-1 · Jan Aushadhi · Japan · Semaglutide · United States · CDSCO · Department of Pharmaceuticals · Government of India · Manoj Joshi
The 2 reports are listed beside the record.
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