News about Regulation

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 |  100

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

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 |  107

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 |  122

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 |  198

Centre Prohibits Manufacturing and Sale of High-Dose Nimesulide Oral Formulations over Safety Risks

The Union Ministry of Health and Family Welfare has banned the manufacture, sale and distribution of all oral formulations of nimesulide containing more than 100 mg in immediate-release dosage form for human use. The order has come into force with immediate effect.

Regulation | 31/12/2025 | By Darshana |  239

CDSCO Flags 205 Not of Standard Quality Drug Samples in November Despite Data Gaps from States

Even as data submissions were pending from nearly 18 states and five Union Territories, the Central Drugs Standard Control Organisation (CDSCO) reported a total of 205 drug samples as Not of Standard Quality (NSQ) during November 2025.

Regulation | 26/12/2025 | By Darshana |  148

WHO Report Highlights Major Equity Gaps in Human Genomics Research

A new WHO analysis highlights major equity gaps in human genomics research, despite rapid growth in the field, with over 6,500 clinical studies registered globally, largely focused on cancer and rare diseases.

Regulation | 24/12/2025 | By News Bureau