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News about Regulation
PLI Scheme Brings Down Rare Disease Treatment Costs from Crores to Lakhs: Pharma Secretary
The Production Linked Incentive (PLI) Scheme for pharmaceuticals has significantly reduced the cost of treating rare diseases in India, bringing expenses down from crores to just a few lakhs, said Amit Agrawal, Secretary, Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers.
Regulation | 22/08/2025 | By Dineshwori | 151
Eli Lilly has voiced opposition to proposed tariffs on pharmaceutical products, cautioning that such measures could increase costs, limit patient access, and weaken US leadership in biopharmaceutical innovation.
Regulation | 16/08/2025 | By Dineshwori | 219
India Launches SHRESTH to Strengthen State Drug Regulatory Systems
The initiative, proposed by the Central Drugs Standard Control Organization (CDSCO), aims to drive improvements in the performance of state drug regulatory authorities across India, ensuring drug safety and quality standards are consistently met.
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Regulation | 13/08/2025 | By Dineshwori | 328
The Pharmaceuticals Export Promotion Council of India (Pharmexcil) has called on all member companies exporting formulations to Zambia to comply with the country's new pre-shipment regulations aimed at curbing the import of counterfeit and substandard medicines.
Regulation | 12/08/2025 | By Dineshwori | 187
Paracetamol Not Banned in India, Clarifies Union Minister Anupriya Patel
Union Minister of State for Chemicals and Fertilizers Anupriya Patel has clarified on social media rumours regarding a ban on paracetamol and other common medicines.
Regulation | 06/08/2025 | By Dineshwori | 482
In a bid to ease regulatory compliance and enhance the ease of doing business, the Central Drugs Standard Control Organisation (CDSCO) will launch a new online system for issuing No Objection Certificates (NOCs) for bulk drug imports intended for non-medicinal use.
Regulation | 05/08/2025 | By Darshana | 722
As per UCPMP norms, managing directors or CEOs of pharmaceutical companies must provide a signed declaration confirming ethical marketing practices and full compliance with the Code. These include rules around promotional spending, gifting, hospitality, brand reminders, event sponsorships, and free samples.
Regulation | 05/08/2025 | By Darshana | 287
Granules India's Shamirpet Manufacturing Unit Flagged by USFDA with Observation
Granules India has received one observation from the US Food and Drug Administration (USFDA) following a pre-approval inspection at its oral solid manufacturing facility located in Shamirpet, Hyderabad.
Regulation | 04/08/2025 | By Darshana | 366
Caliway Cleared by US FDA to Launch Phase 3 Trial of First-in-Class Injectable Fat Reduction Drug
Caliway Biopharmaceuticals has received clearance from the US FDA to initiate SUPREME-01 (CBL-0301)—a pivotal global Phase 3 trial of CBL-514, the first investigational drug aimed at large-area localized fat reduction. This FDA nod marks a key regulatory milestone for Caliway’s global development strategy.
Regulation | 29/07/2025 | By Darshana | 446
Medicines UK Hails India-UK Trade Deal, Calls for Clear Regulatory Pathway
Medicines UK has called for the establishment of a clear regulatory framework to fully unlock the benefits of the newly signed Comprehensive Economic and Trade Agreement (CETA) between India and the UK.
Regulation | 25/07/2025 | By Dineshwori | 240
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