Published By: GDC Classes
Quick Summary
The CDSCO Subject Expert Committee (SEC) has declined to recommend approval of the proposed Dexlansoprazole 60 mg + Domperidone SR 30 mg Fixed Dose Combination (FDC) submitted by MSN Laboratories Pvt. Ltd. The committee cited previous rejection, lack of international approval for Domperidone SR, and updated patient safety concerns before forwarding its recommendation to CDSCO for the final regulatory decision.
CDSCO Rejects Dexlansoprazole–Domperidone FDC Proposal
The Central Drugs Standard Control Organisation (CDSCO) has taken another significant step toward strengthening drug safety in India. During the 08th/26 Subject Expert Committee (SEC) meeting on Gastroenterology and Hepatology, the committee did not recommend approval of the proposed Fixed Dose Combination (FDC) containing Dexlansoprazole (Enteric Coated Pellets) 60 mg and Domperidone (Sustained Release Pellets) 30 mg.
The proposal was submitted by MSN Laboratories Private Limited and presented before the committee on 9 July 2026 at the CDSCO Headquarters, New Delhi.
Overview
| Particular | Details |
|---|---|
| Regulatory Authority | Central Drugs Standard Control Organisation (CDSCO) |
| Committee | Subject Expert Committee (SEC) – Gastroenterology & Hepatology |
| Meeting | 08th/26 SEC Meeting |
| Meeting Date | 9 July 2026 |
| Applicant | MSN Laboratories Private Limited |
| Drug Combination | Dexlansoprazole 60 mg + Domperidone SR 30 mg |
| Decision | Not Recommended by SEC |
| Final Decision | To be taken by CDSCO |
About the Proposed Fixed Dose Combination (FDC)
The proposed capsule contained the following medicines:
| Drug | Strength | Formulation |
|---|---|---|
| Dexlansoprazole | 60 mg | Enteric Coated Pellets |
| Domperidone | 30 mg | Sustained Release Pellets |
The combination was intended for the treatment of gastrointestinal disorders such as gastroesophageal reflux disease (GERD) and acid-related conditions by combining acid suppression with improved gastric motility.
Why Did the SEC Reject the Proposal?
After reviewing the company’s presentation and available scientific evidence, the committee highlighted several important concerns.
1. Similar Proposal Was Already Rejected
The SEC noted that the same Fixed Dose Combination had already been rejected during the meeting held on 18 March 2021.
Since no convincing new evidence was presented, the committee maintained its earlier position.
2. Domperidone SR Is Not Approved Internationally
The committee observed that the Sustained Release (SR) formulation of Domperidone does not have international approval.
This raised concerns regarding its global regulatory acceptance and long-term safety.
3. Updated Safety Profile Raised Concerns
Although Domperidone SR received CDSCO approval nearly two decades ago, updated safety information has become available since then.
The committee considered these patient safety concerns while evaluating the proposed combination and concluded that approval was not justified based on the current evidence.
SEC Recommendation
Based on its scientific evaluation, the Subject Expert Committee did not recommend approval of the proposed Fixed Dose Combination of:
- Dexlansoprazole 60 mg (Enteric Coated Pellets)
- Domperidone 30 mg (Sustained Release Pellets)
The recommendation has now been forwarded to CDSCO, which will make the final regulatory decision.
What Happens Next?
The Subject Expert Committee serves as an advisory body.
After receiving the SEC recommendation, CDSCO may:
- Accept the recommendation
- Seek additional scientific or clinical data
- Request further clarification from the applicant
- Take the final regulatory decision
The final approval or rejection has not yet been announced by CDSCO.
Why Is This Decision Important?
This decision demonstrates CDSCO’s continued emphasis on:
- Patient safety
- Evidence-based drug approvals
- Rational Fixed Dose Combinations
- Updated clinical evidence
- International regulatory standards
It also shows that older formulations can be re-evaluated when new safety data become available.
Impact on the Pharmaceutical Industry
The decision sends an important message to pharmaceutical companies that new Fixed Dose Combination proposals should be supported by:
- Strong clinical evidence
- Updated safety data
- Clear therapeutic benefits
- Robust scientific justification
- Compliance with current regulatory expectations
Key Highlights
- SEC meeting held on 9 July 2026
- Proposal submitted by MSN Laboratories Pvt. Ltd.
- Combination included Dexlansoprazole 60 mg + Domperidone SR 30 mg
- Similar proposal was rejected in March 2021
- Domperidone SR lacks international approval
- Updated patient safety concerns influenced the decision
- SEC did not recommend approval
- Final regulatory decision will be taken by CDSCO
Why Should Pharmacy Students and Professionals Know This?
Understanding CDSCO’s regulatory decisions helps pharmacy students and professionals:
- Learn how drug approvals are evaluated.
- Understand the importance of benefit-risk assessment.
- Stay updated with pharmaceutical regulatory affairs.
- Prepare for GPAT, NIPER, Drug Inspector, and Pharmacist competitive exams.
- Build knowledge for careers in regulatory affairs and clinical research.
Important Dates
| Event | Date |
|---|---|
| SEC Meeting | 9 July 2026 |
| SEC Recommendation | Proposal Not Recommended |
| Final CDSCO Decision | Not yet announced |
Important Links
| Description | Link |
|---|---|
| Official CDSCO Website | https://cdsco.gov.in |
| SEC Meeting Minutes | Available on the CDSCO website (when published) |
Frequently Asked Questions (FAQs)
1. Which drug combination did the CDSCO SEC reject?
The committee did not recommend the proposed Fixed Dose Combination of Dexlansoprazole 60 mg and Domperidone SR 30 mg.
2. Which company submitted the proposal?
The proposal was submitted by MSN Laboratories Private Limited.
3. Why did the SEC reject the proposal?
The committee cited:
- Previous rejection in 2021
- Lack of international approval for Domperidone SR
- Updated patient safety concerns
4. Is the drug combination permanently banned?
No. The SEC has only not recommended approval. The final decision will be taken by CDSCO.
5. What is a Fixed Dose Combination (FDC)?
A Fixed Dose Combination is a medicine containing two or more active pharmaceutical ingredients in a single dosage form to improve treatment convenience and therapeutic outcomes.
6. What role does the SEC play in drug approval?
The Subject Expert Committee reviews scientific, clinical, and safety data and provides recommendations to CDSCO regarding drug approvals.
7. What happens after the SEC recommendation?
CDSCO reviews the recommendation and makes the final regulatory decision.
8. Why is this update important for pharmacy students?
It provides insight into India’s drug approval process, regulatory science, and patient safety, making it valuable for academic learning and competitive exam preparation.
Conclusion
The CDSCO SEC’s decision to reject the proposed Dexlansoprazole–Domperidone Fixed Dose Combination reflects India’s growing emphasis on evidence-based regulation and patient safety. By considering updated clinical evidence, historical decisions, and international regulatory practices, the committee has reinforced the importance of robust scientific data in the approval of Fixed Dose Combinations. The final decision now rests with CDSCO.
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