News about Regulation

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 |  580

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 |  321

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 |  106

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 |  153

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 |  215

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 |  165

FDA Qualifies First AI Tool to Accelerate Liver Disease Drug Development

The U.S. Food and Drug Administration (FDA) has qualified the world’s first artificial intelligence tool designed to speed up drug development for liver disease.

Regulation | 10/12/2025 | By Darshana |  1287

Mark Cuban Urges Trump to Remove FDA Fees to Boost USA Generics Manufacturing

Billionaire entrepreneur Mark Cuban has urged Donald Trump’s administration to scrap the high regulatory fees charged by the USA Food and Drug Administration (FDA) for generic drug approvals.

Regulation | 06/12/2025 | By Darshana |  141

Ipca Labs Receives US FDA Form 483 with Three Observations after Tarapur Facility Inspection

The US Food and Drug Administration (US FDA) has completed an inspection of Ipca Laboratories' Active Pharmaceutical Ingredients (APIs) manufacturing plant in Tarapur, Palghar (Maharashtra).

Regulation | 06/12/2025 | By Dineshwori |  564

Lupin Receives Tentative US FDA Nod for Siponimod Tablets, Generic to Novartis' Mayzent

Lupin has received tentative approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application for Siponimod Tablets in strengths of 0.25 mg, 1 mg and 2 mg.

Regulation | 05/12/2025 | By Dineshwori |  332