News about Regulation

DoP Extends Deadline for Pharma Companies to Submit UCPMP Declarations and FY25 Marketing Expenses to August 31

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 |  310

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 |  405

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 |  483

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 |  262

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 |  174

Indoco Secures EU GMP Compliance Certificate for its Sterile Drug Product Manufacturing Facility in Goa - Plant II

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 |  349

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 |  300

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 |  413

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 |  552

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 |  457