News about Regulation

FDA Warns It Will Take Action on Misleading Copycat Drug Marketing

The United States Food and Drug Administration (FDA) has warned it will take swift action against companies that mass-market unapproved “copycat” drugs by promoting them as if they were similar to FDA-approved products, the agency’s commissioner said.

Regulation | 06/02/2026 | By Darshana |  104

Government Imposes Minimum Import Price on Key Antibiotic APIs to Support Domestic Manufacturing

The Union Ministry of Commerce and Industry has imposed a Minimum Import Price (MIP) on three key active pharmaceutical ingredients—penicillin and its salts, amoxycillin and its salts, and 6-aminopenicillanic acid (6-APA)—for a period of one year.

Regulation | 03/02/2026 | By Darshana |  483

USPTO Issues New Patent to Acurx for DNA Polymerase IIIC Inhibitor Technology

The newly granted patent covers DNA polymerase IIIC inhibitors, including compositions of matter, methods of use and pharmaceutical formulations, further strengthening Acurx’s Intellectual Property (IP) portfolio and expanding its growing patent estate in the US and international markets.

Regulation | 03/02/2026 | By News Bureau |  134

Union Health Ministry Revises NDCT Rules

The Union Health Ministry has notified amendments to the NDCT Rules, 2019 to ease compliance and speed up drug development, introducing a prior-intimation mechanism in place of licensing, waiving permissions for select low-risk BA/BE studies, and cutting test licence processing timelines to 45 days.

Regulation | 28/01/2026 | By News Bureau

FDA Publishes Guidance on Modern Statistical Methods for Clinical Research

The FDA guidance provides a framework for applying Bayesian analyses in clinical research, enabling data-driven assessments of safety and efficacy using both current and prior evidence.

Regulation | 14/01/2026 | By News Bureau

WuXi Biologics' Wuxi Facilities Receive MHRA GMP Approval for Ophthalmic Biologic Manufacturing

The UK regulator has certified WuXi Biologics’ DP5 and DPPC sites in Wuxi for commercial production, reinforcing the company’s global GMP-compliant manufacturing capabilities.

Regulation | 13/01/2026 | By News Bureau |  221

AXS-05 by Axsome Therapeutics Advances as Novel Multimodal Therapy for CNS Disorders, Receives FDA Breakthrough Designation

Axsome Therapeutics’ investigational oral drug AXS-05 is advancing clinical development for Alzheimer’s disease agitation and smoking cessation, leveraging a unique multimodal mechanism targeting key neurotransmitter pathways.

Regulation | 03/01/2026 | By News Bureau |  136

Health Minister Highlights Expansion of Jan Aushadhi Kendras and AMRIT Pharmacies

Union Health Minister JP Nadda underscored the importance of expanding Jan Aushadhi Kendras and AMRIT pharmacies across the country, while emphasising the need for a robust drug regulatory framework that ensures quality, safety and compliance from manufacturing through last-mile distribution.

Regulation | 03/01/2026 | By News Bureau |  215

Health Minister JP Nadda Unveils 10th Indian Pharmacopoeia

The Union Health Minister highlighted the Indian Pharmacopoeia’s recognition in 19 Global South countries, India’s rise to eighth globally in WHO pharmacovigilance, and key updates in IP 2026, including 121 new monographs and the first inclusion of blood component standards.

Regulation | 02/01/2026 | By News Bureau |  241

Government Proposes Amendment to Make Cough Syrups Prescription-Only Drugs

The Union Health Ministry has issued a draft amendment to the Drugs Rules, 1945, proposing to remove cough syrups from Schedule K—a move that would end their Over-the-Counter (OTC) availability and mandate prescription-only sales in the interest of public safety.

Regulation | 01/01/2026 | By News Bureau |  486