No Trial Waiver: CDSCO Panel Directs Sun Pharma to Run Phase III Study for Somatropin Liquid Injection Citing Lack of India-Specific Data
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) has opined that the drug major Sun Pharmaceutical Industries should conduct a Phase III clinical trial comparing its Somatropin liquid injection with the innovator's liquid growth hormone product to generate India specific data on therapeutic performance and safety profile.
Earlier, at the SEC meeting for endocrinology and metabolism, the firm had presented the proposal of additional strength of the already approved product Somatropin Injection 15 IU in liquid, cartridge presentation with the request for a local clinical trial waiver.
At the earlier meeting the committee had asked the firm to submit the PMS report conducted as part of the new drug permission for further deliberation.
In light of the earlier SEC recommendations dated 08.04.2025, Sun Pharmaceutical Industries was unable to submit and present the PMS report conducted as part of the new drug permission for the already approved 4IU lyophilized powder form in vial presentation.
Further, in continuation of the earlier recommendation, the committee also noted that there is no pharmacovigilance data available for the lyophilized formulation and no comparative safety and efficacy data available for somatropin liquid injection in the Indian population.
Somatotropin is a recombinant human growth hormone used as replacement therapy in various conditions of growth failure, growth hormone deficiency, and weakness in children and adults.
Human growth hormone (HGH), also known as somatotropin, is a peptide hormone that is synthesized and secreted by the somatotropic cells of the anterior pituitary gland. Growth hormone plays an essential role in growth regulation during childhood as well as other basal metabolic functions, muscle and fat mass regulation, blood glucose level regulation, and lipid regulation in both children and adults.
Now in continuation, at the recent SEC meeting the expert panel again recommended
"...to conduct the Phase III Clinical Trial to compare the safety and efficacy of the Somatropin liquid injection with that of the innovator’s liquid growth hormone injection."
