News about Regulation

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 |  254

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 |  367

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 |  435

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 |  1184

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 |  1199

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 |  523

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 |  178

AstraZeneca Secures CDSCO Approval for Breast Cancer Drug in India

AstraZeneca Pharma India has received approval from the Central Drugs Standard Control Organisation (CDSCO) to import, sell and distribute its breast cancer therapy Datopotamab Deruxtecan in India.

Regulation | 20/12/2025 | By Darshana |  252

Parliamentary Panel Calls for Faster, Fully Digitised Medical Device Approvals at CDSCO

The Parliamentary Standing Committee on Health and Family Welfare has urged the Department of Health to ensure complete digitisation and automation of the medical device licensing process at the Central Drugs Standard Control Organisation (CDSCO).

Regulation | 16/12/2025 | By Darshana |  330

Government's Price Control Measures on Pharma Products Deliver Annual Savings of INR 25,000 Crore

The National Pharmaceutical Pricing Authority (NPPA) has fixed ceiling prices for 935 scheduled formulations as of early December, resulting in estimated annual savings of around INR 3,802 crore for the public.

Regulation | 11/12/2025 | By Darshana |  228