CDSCO Panel Asks Dr Reddy's to Submit Indian Data for Triptorelin Pediatric Use
New Delhi: The Subject Expert Committee (SEC) under the Endocrinology and Metabolism division of the Central Drugs Standard Control Organisation (CDSCO) has withheld approval for Dr Reddy's Laboratories Limited's proposal to import and market Triptorelin Powder for Injection 22.5 mg for a pediatric indication, recommending that the firm first submit additional data on Indian population-specific studies and the unmet medical need before further consideration.
The Panel evaluated a proposal submitted by Dr. Reddy's seeking permission to import and market Triptorelin Powder for Injection 22.5 mg for an additional pediatric indication.
The company applied for approval to use Triptorelin in the treatment of confirmed central precocious puberty (CPP) in children aged 2 years and above — specifically for girls with onset before age 8 and boys before age 9. The proposal also included a request for a waiver of local clinical trials.
The matter was initially deliberated during the SEC meeting held on 22nd May 2025 and was later reconsidered in the 14th meeting of the SEC (Endocrinology & Metabolism) on 20th June 2025 at CDSCO Headquarters, New Delhi.
After thorough discussions, the SEC withheld approval and recommended that the firm present additional data to support the clinical trial waiver and the proposed pediatric indication. The official meeting minutes stated,
"The Committee desired that firm should present more data in respect of followings:1. Clinical Studies, published reports on Indian Race population2. Unmet need of the drug for applied indication in Indian population."
Triptorelin is a synthetic gonadotropin-releasing hormone (GnRH) agonist that acts by suppressing luteinizing hormone (LH) and follicle-stimulating hormone (FSH), thereby halting premature sexual development in children with CPP. It is already approved in several global markets for CPP management, but its expanded use in India — particularly in pediatric settings — remains under scrutiny, especially in cases where clinical trial waivers are sought.
