India Pharma Monitor

Pharmaceutical Industry in India

Drug Approvals

New DCGI Approved Medicines in 2026

1. Brexpiprazole Tablets (0.25/0.5/1/2/3/4 mg)

  • Indication: Treatment of schizophrenia
  • Approval Date: February 16, 2026
  • Company: MSN Laboratories

2. Brexpiprazole Bulk Drug

  • Indication: Not applicable (bulk drug)
  • Approval Date: February 24, 2026
  • Company: MSN Laboratories

3. Sotorasib 240mg Film Coated Tablets

  • Indication: Treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), who have received at least one prior systemic therapy
  • Approval Date: March 10, 2026

4. Vonoprazan-Based Drugs

  • Indication: Acid-Related Disorders (GERD/Erosive Esophagitis)
  • Approval Date: May 4, 2026
  • Company: Multiple Companies

5. Durvalumab (Immunotherapy Drug)

  • Indication: Cancer Immunotherapy (Ovarian/Breast Cancer)
  • Approval Date: March 31, 2026
  • Company: AstraZeneca

6. Eslicarbazepine Acetate Tablets (200/400/800 mg)

  • Indication: Epilepsy/Seizure Disorders
  • Approval Date: March 2026
  • Company: Multiple Manufacturers

7. Resmetirom Tablet (80/100 mg)

  • Indication: NASH (Non-Alcoholic Steatohepatitis)
  • Approval Date: May 4, 2026
  • Company: Cipla Ltd

8. Ivosidenib 250 mg

  • Indication: Cancer (Acute Myeloid Leukemia – AML)
  • Approval Date: May 4, 2026
  • Company: Servier India

9. Linzagolix Tablets

  • Indication: Endometriosis/Uterine Fibroids
  • Approval Date: May 4, 2026
  • Company: Exemed Pharmaceuticals

10. Polmacoxib Capsules

  • Indication: Pain Management/NSAID
  • Approval Date: May 4, 2026
  • Company: Precise Biopharma

11. Tucatinib Tablets 150 mg

  • Indication: Cancer (Breast Cancer – HER2+)
  • Approval Date: May 4, 2026
  • Company: BDR Pharmaceuticals

12. Quadrivalent HPV Vaccine (0.5 mL)

  • Indication: Vaccine (HPV Prevention)
  • Approval Date: February 26, 2026
  • Company: Serum Institute of India

13. Daratumumab Concentrate

  • Indication: Cancer (Multiple Myeloma)
  • Approval Date: March 31, 2026
  • Company: Intas Pharmaceuticals

14. Pembrolizumab Injection

  • Indication: Cancer Immunotherapy
  • Approval Date: March 31, 2026
  • Company: Sun Pharma

India's pharma sector is witnessing notable activity in drug and approved, with important updates emerging around market. The Drug Approvals section provides a curated, regularly updated overview of developments that matter to professionals across the value chain.

Sources in this section include Barchart.com, Yahoo Finance, and The Cancer Letter. The coverage spans regulatory updates, corporate news, and research findings — providing professionals with a well-rounded perspective on current developments in drug and adjacent areas.

Key reference resources include CDSCO Drug Approvals for official guidelines and US FDA Drug Approvals for industry intelligence. Those tracking the science underpinning these developments will find WHO Prequalification Programme a reliable resource for peer-reviewed evidence and data.

Showing 30 articles

Drug NameActive IngredientApproval DateFDA-Approved Use
1. CypsedoCipepofolMay 29, 2026General anesthesia for adults undergoing surgery 
2. XocovaEnsitrelvirMay 29, 2026Post-exposure prophylaxis for COVID-19 
3. ZaynichCefepime & ZidebactamMay 29, 2026Complicated urinary tract infections including pyelonephritis 
4. DecnupazPivekimab SunirineMay 27, 2026Treatment of blastic plasmacytoid dendritic cell neoplasm 
5. HepcludexBulevirtideMay 22, 2026Chronic hepatitis delta virus infection in adults 
6. FoundayoOrforglipronApril 1, 2026Obesity/weight loss in adults 
7. AwiqliInsulin IcodecMarch 26, 2026Type 2 diabetes mellitus