Dr. Reddy’s Laboratories Receives DCGI Approval for Toripalimab in India

NEW DELHI — Dr. Reddy’s Laboratories announced on Wednesday that the Central Drugs Standard Control Organisation (CDSCO), operating under the Drugs Controller General of India (DCGI), has granted approval for Zytorvi, which is the brand name for toripalimab.

The drug has been approved for use in combination with cisplatin and paclitaxel. According to the company's release, this combination is cleared as a first-line treatment for adult patients diagnosed with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC).

Commenting on the regulatory milestone, M.V. Ramana, Chief Executive Officer of Global Generics at Dr. Reddy’s Laboratories, stated that the company continues to build its oncology portfolio with a focus on bringing meaningful advances and expanding access to innovative treatment options.

Dr. Reddy’s previously established a commercial footprint for the drug through a licensing and commercialization agreement signed with Junshi Biosciences in 2023. Under that agreement, Dr. Reddy’s secured rights to commercialize toripalimab across 21 countries.

Globally, toripalimab has already received regulatory clearances from several major international bodies, including the US Food and Drug Administration (USFDA), the European Medicines Agency (EMA), and the UK Medicines and Healthcare products Regulatory Agency (MHRA).

"Regulatory approvals like the DCGI clearance for toripalimab represent a significant step for pharmaceutical companies looking to strengthen their specialized oncology portfolios. Securing approvals for advanced treatments not only validates previous cross-border licensing agreements but also broadens access to critical therapies in key regional markets. For established players, expanding specialized product lines is essential to meeting complex healthcare demands." — Dr. Shishir Gupta, Founder & CEO, StartupLanes