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News about Regulation
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 | 541
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 | 301
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 | 186
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 | 368
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 | 325
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 | 444
DCC Backs Inclusion of Good Distribution Practices in Drugs Rules, 1945
Recognizing this as a potential risk to drug quality and patient safety, the committee recommended revising the guidelines in line with WHO standards, giving them legal backing by incorporating them into the Drugs Rules.
Regulation | 30/06/2025 | By Darshana | 584
DCC Agrees with DTAB Proposal to Fix QR Codes on Vaccines, Antimicrobials, Anticancer and NDPS Drugs
The Drugs Consultative Committee (DCC) has asked the pharma industry to raise public awareness regarding the use of Quick-Response code, while dismissing concerns raised by some stakeholders that the usage of QR codes for scanning by the public is dismal, as not substantial in public interest.
Regulation | 27/06/2025 | By Darshana | 562
CDSCO Eases Licensing Norms for Outsourced Sterilisation of Medical Devices
The move addresses longstanding concerns from industry stakeholders about the need for a separate loan license under the Medical Devices Rules (MDR), 2017, when outsourcing sterilisation to another licensed facility.
Regulation | 26/06/2025 | By Darshana | 486
Further, this absence directly impacts both the students’ and teachers’ abilities to contribute for manufacturing sector, according to Prof. Shekhar Varma, former registrar of Chhattisgarh State Pharmacy Council and professor of pharmaceutical sciences at the Central University in Bilaspur.
Regulation | 24/06/2025 | By Darshana | 303
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