News about Regulation

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

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

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 |  586

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

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 |  155

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 |  138

FDA Lifts Partial Clinical Hold on Vanda's Tradipitant for Motion Sickness

The lift allows Vanda to extend clinical studies of tradipitant in motion sickness. Meanwhile, the review of the fully completed New Drug Application for tradipitant for the prevention of vomiting induced by motion remains on track.

Regulation | 05/12/2025 | By Dineshwori

FDA Approves Expanded Use of Eli Lilly's Jaypirca in Relapsed or Refractory CLL/SLL

Eli Lilly’s Jaypirca (pirtobrutinib) is the only medicine in CLL or SLL that has been prospectively studied in a randomised trial of patients previously treated with a covalent BTK inhibitor.

Regulation | 04/12/2025 | By Dineshwori

NPPA Fixes Retail Prices for 11 Drug Formulations Under DPCO 2013

The National Pharmaceutical Pricing Authority (NPPA) has issued a fresh notification fixing retail prices for multiple essential drug formulations—including antihypertensives, antibiotics, antidiabetics, and paediatric syrups—under the Drugs (Prices Control) Order, 2013. The revised prices apply to approved manufacturers and exclude GST.

Regulation | 02/12/2025 | By Dineshwori

Biocomposites Gains Expanded Approval in India for STIMULAN Rapid Cure

According to Biocomposites, India is the first country in the world to approve STIMULAN Rapid Cure to be mixed with antifungals.

Regulation | 01/12/2025 | By Dineshwori