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 approval, with important updates emerging around woman. 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 PR Newswire, 1News, and Everyday Health. 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
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Dr. Gary Lawton Yale-Trained Plastic Surgeon: New Non-Opioid Pain Medication for Recovery Protocols
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Medsafe approves RSV prevention medicine for babies, Pharmac urged to fund
Medsafe approves RSV prevention medicine for babies, Pharmac urged to fund 1News
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Simtriyo (Centanafadine) for ADHD: How It Works and Side Effects
Simtriyo (Centanafadine) for ADHD: How It Works and Side Effects Everyday Health
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NUZOLVENCE® Approved in Thailand for Gonorrhoea
NUZOLVENCE® Approved in Thailand for Gonorrhoea TheReporterAsia
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Regulatory tracker: MannKind gets FDA nod for speedy edema autoinjector
Regulatory tracker: MannKind gets FDA nod for speedy edema autoinjector Fierce Pharma
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Co Kilkenny woman diagnosed with rare disease sues HSE over access to drug
Co Kilkenny woman diagnosed with rare disease sues HSE over access to drug BreakingNews.ie
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‘Irreversible consequences’ – woman with Friedreich’s ataxia sues HSE over alleged delays in application determination
‘Irreversible consequences’ – woman with Friedreich’s ataxia sues HSE over alleged delays in application determination Irish Independent
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Woman, 28, with rare disease Friedreich's ataxia sues HSE over access to drug
Woman, 28, with rare disease Friedreich's ataxia sues HSE over access to drug Irish Examiner
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From Approval to Practice: Auvelity's Place in Alzheimer Disease Agitation Care
From Approval to Practice: Auvelity's Place in Alzheimer Disease Agitation Care Pharmacy Times
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Prediction market wagering on drug approvals draws fire from researchers
Prediction market wagering on drug approvals draws fire from researchers Baton Rouge Business Report
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‘Irreversible consequences’ – Woman with Friedrich’s Ataxia sues HSE over alleged delays in application determination
‘Irreversible consequences’ – Woman with Friedrich’s Ataxia sues HSE over alleged delays in application determination Irish Independent
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India Supplies 30% of Global Generic Medicines: MoS Health Anupriya Patel | Akashvani News
India Supplies 30% of Global Generic Medicines: MoS Health Anupriya Patel | Akashvani News News On AIR
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FDA Approves Fast-Acting Acetaminophen-Naproxen Combo for Pain Relief
FDA Approves Fast-Acting Acetaminophen-Naproxen Combo for Pain Relief Healthline
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Lifesaving medication shouldn’t cause hypertension
Lifesaving medication shouldn’t cause hypertension The Shepparton Adviser
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Kerala gets in-principle approval for 100 MBBS seats at Karunakaran memorial medical college
Kerala gets in-principle approval for 100 MBBS seats at Karunakaran memorial medical college The Times of India
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PRM Pharma and Ingenus Pharmaceuticals Announce Orange Book Listing of Patent Protecting HemiClor® Formulation Technology
PRM Pharma and Ingenus Pharmaceuticals Announce Orange Book Listing of Patent Protecting HemiClor® Formulation Technology BioSpace
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Eli Lilly tops new biopharma ranking on launch success, development speed
Eli Lilly tops new biopharma ranking on launch success, development speed Fierce Biotech
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First Oral PCSK9 Drug for Lowering LDL Cholesterol, how the new tablet differs from traditional statins and injectable options
First Oral PCSK9 Drug for Lowering LDL Cholesterol, how the new tablet differs from traditional statins and injectable options Business Upturn
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Lupin Gets US FDA Approval For Diazepam Injection
Lupin Gets US FDA Approval For Diazepam Injection Sahi
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APAC roundup: NMPA nods; Lupin’s $1.6M spinoff; CAR T data, more
APAC roundup: NMPA nods; Lupin’s $1.6M spinoff; CAR T data, more BioWorld News
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Here's How LLY's Non-GLP-1 Portfolio Is Poised Ahead of Q2 Earnings
Here's How LLY's Non-GLP-1 Portfolio Is Poised Ahead of Q2 Earnings TradingView
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Prediction Market Betting on Drug Trials and Approvals Sparks Concern About Undermining Research
Prediction Market Betting on Drug Trials and Approvals Sparks Concern About Undermining Research The New York Times
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Beta Drugs Q1FY27 net profit rises 41% to ₹165 Mn on strong sales
Beta Drugs Q1FY27 net profit rises 41% to ₹165 Mn on strong sales scanx.trade
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Armenian company Gurus contributes to clinical trials of new medicines and trains industry specialists
Armenian company Gurus contributes to clinical trials of new medicines and trains industry specialists Armenpress
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Longevity medicine has gone peptide-crazy
Longevity medicine has gone peptide-crazy Medical Xpress
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USFDA Approves Cipla's Generic Advair Diskus for Asthma, COPD
USFDA Approves Cipla's Generic Advair Diskus for Asthma, COPD Medical Dialogues
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Three Cancer Drugs Advance Toward Broader EU Use
Three Cancer Drugs Advance Toward Broader EU Use Medscape
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Alembic Pharma Secures USFDA Final Approval for Generic Prucalopride Tablets
Alembic Pharma Secures USFDA Final Approval for Generic Prucalopride Tablets Medical Dialogues
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NanoViricides Awaits Approval from DR Congo Regulatory Agency for a Phase II Clinical Trial of NV-387 Oral Gummies as a Treatment for Ebola, Financing Completed to Support the Trial
NanoViricides Awaits Approval from DR Congo Regulatory Agency for a Phase II Clinical Trial of NV-387 Oral Gummies as a Treatment for Ebola, Financing Completed to Support the Trial ACCESS Newswire
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The New Rules of Global Drug Development
The New Rules of Global Drug Development The Medicine Maker
