News about Regulation

Health Ministry Proposes Tighter Curbs on Prescription Drug Ads

Health Ministry has proposed tighter curbs on prescription drug advertising, extending restrictions on Schedule H, H1 and X medicines to retailers, wholesalers and distributors.

Regulation | 09/10/2026 | By News Bureau |  347

Government Caps Cancer Drug Margins, Targets INR 2,500 Crore Savings

The government has capped trade margins on non-scheduled cancer medicines at 30 percent of MRP, aiming to reduce prices by up to 70 percent.

Regulation | 09/10/2026 | By News Bureau |  193

Granules Gains First-to-File Status for Ruxolitinib ER Tablets

Granules India has filed a Paragraph IV certification for Ruxolitinib Extended-Release (ER) Tablets, and may qualify for first-to-file status.

Regulation | 09/10/2026 | By News Bureau |  249

Armata Pharmaceuticals Gets 2 US Patent Issuances

Armata Pharmaceuticals has secured 2 US patents for AP-SA02 and AP-PA02, extending IP protection for the clinical candidates until at least 2041.

Regulation | 08/10/2026 | By News Bureau |  298

US FDA Grants AbbVie's Telisotuzumab 2 Breakthrough Designations

The US FDA has granted AbbVie’s Temab-A 2 Breakthrough Therapy Designations (BTDs) for CRC and NSCLC, advancing its c-Met-directed ADC development in solid tumors.

Regulation | 08/10/2026 | By News Bureau |  267

US FDA Approves Tucatinib for HER2-Positive Breast Cancer

The US FDA has approved tucatinib with trastuzumab and pertuzumab for the maintenance treatment of HER2-positive breast cancer.

Regulation | 08/10/2026 | By News Bureau |  246

US FDA Accepts BridgeBio's Infigratinib NDA for Achondroplasia

BridgeBio has announced the US FDA acceptance and Priority Review (PR) of New Drug Application (NDA) for oral infigratinib for children with achondroplasia.

Regulation | 08/10/2026 | By News Bureau |  270

SIT Raids Three Bengaluru Pharmacies in Fake Medicine Probe

SIT expands its probe into an alleged fake medicine racket by examining pharmacy-level procurement and distribution links in Bengaluru.

Regulation | 07/10/2026 | By News Bureau

Aurobindo Pharma Gets US FDA Approval for Perampanel Tablets

Aurobindo Pharma has received US FDA final approval for Perampanel Tablets, 2 mg to 12 mg, equivalent to Fycompa Tablets.

Regulation | 06/10/2026 | By News Bureau |  192

SII's HPV Vaccine Cervavac Receives WHO Prequalification

The Serum Institute of India’s Cervavac HPV vaccine has received WHO prequalification, supporting broader global prevention of HPV-associated diseases.

Regulation | 06/10/2026 | By News Bureau