CDSCO

The Subject Expert Committee (SEC) on Gastroenterology and Hepatology has declined to recommend approval of a Fixed Dose Combination (FDC) containing Dexlansoprazole (enteric coated pellets) 60 mg and Domperidone (sustained release pellets) 30 mg capsules proposed by MSN Laboratories Private Limited.

The decision was taken during the 08th/26 SEC meeting held on 9 July 2026 at the CDSCO Headquarters, New Delhi, after the company presented its proposal before the committee.

The Subject Expert Committee (SEC) on Oncology has declined Roche Products (India) Private Limited's request for a waiver of local Phase III and Phase IV clinical trials for Glofitamab and has instead recommended that the company conduct Phase III clinical trials in India before the drug can be considered for marketing approval.

The Central Drugs Standard Control Organization (CDSCO) has issued a major clarification regarding the regulatory approval process for formulation intermediates, including directly compressible granules, taste-masked granules, modified-release granules, pellets, and similar intermediates used in pharmaceutical manufacturing. The clarification aims to establish uniform licensing practices across India and eliminate confusion among manufacturers.

The Central Drugs Standard Control Organisation (CDSCO) has released its monthly drug quality alert for May 2026, identifying 157 drug samples as Not of Standard Quality (NSQ) and 2 drug samples as Spurious following testing by Central and State Drug Testing Laboratories across the country. The findings underscore the importance of continuous post-marketing surveillance to ensure the quality, safety and efficacy of medicines available to patients.

In a significant development in the biosimilar segment, the Subject Expert Committee (SEC) on Dermatology & Allergy has recommended granting permission to M/s Kemwell Biopharma Private Limited to conduct a comparative pharmacokinetic clinical study for its proposed Dupilumab biosimilar, ASP100.

The recommendation was made during the 6th SEC (Dermatology & Allergy) meeting of 2026, held on June 11, 2026, at the CDSCO Headquarters in New Delhi.

AstraZeneca Pharma India has announced that the Central Drugs Standard Control Organisation (CDSCO) has approved an additional indication for Trastuzumab Deruxtecan (Enhertu) 100 mg/5 mL, allowing its use in combination with pertuzumab as a first-line treatment for adults with unresectable or metastatic HER2-positive breast cancer. The approval covers patients whose tumors are classified as HER2-positive through IHC 3+ or ISH+ testing.