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News about Regulation
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 | 371
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 | 413
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 | 147
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 | 233
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 | 289
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 | 173
UK Introduces 'World-First' Law Enabling Point-Of-Care Manufacture of Personalised Medicines
Introduced by the Medicines and Healthcare products Regulatory Agency (MHRA), the new legislation allows personalised medicines to be prepared in small or individual batches right where patients are treated.
Regulation | 24/07/2025 | By Dineshwori | 114
Indoco Remedies Ltd. has received EU GMP certification from the European Health Authorities for its sterile drug manufacturing facility located in South Goa – Goa Plant II.
Regulation | 24/07/2025 | By Mrinmoy Dey | 235
Pharmexcil Urges CDSCO to Delay ONDLS-Only CoPP Mandate Amid Export Concerns
The ONDLS portal, developed by the Centre for Development of Advanced Computing (CDAC) in collaboration with CDSCO, the Directorate General of Health Services (DGHS), the Ministry of Health and Family Welfare, and state regulatory authorities, is intended to streamline pharmaceutical regulatory processes.
Regulation | 15/07/2025 | By Darshana | 174
US FDA Tightens Global Oversight as Tariff Pressures Mount on Indian Pharma Exports
The FDA’s renewed focus on foreign inspections coincides with internal restructuring, including rehiring logistical support staff to manage the increase in site visits.
Regulation | 13/07/2025 | By Darshana | 273
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