Sun Pharmaceutical Industries, a prominent pharmaceutical company, has faced a setback in its attempt to secure approval from the Central Drugs Standard Control Organisation (CDSCO) for a bioequivalence (BE) study and Phase III clinical trial waiver for its fixed-dose combination (FDC) drug containing sitagliptin, glimepiride, and metformin.
The CDSCO, India’s drug regulatory agency, has denied the waiver, which means that Sun Pharma will now have to conduct a full Phase III clinical trial to demonstrate the safety and efficacy of the FDC drug. This decision is likely to delay the launch of the drug in the Indian market.
The FDC drug in question combines three established anti-diabetic medications: sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor; glimepiride, a sulfonylurea; and metformin, a biguanide. The combination of these drugs is intended to provide a convenient and effective treatment option for patients with type 2 diabetes.
The BE study and Phase III clinical trial waiver are crucial steps in the regulatory approval process for new drugs in India. The BE study is designed to demonstrate that the generic version of a drug is equivalent to the branded version in terms of pharmacokinetic and pharmacodynamic parameters. The Phase III clinical trial is a pivotal study that evaluates the safety and efficacy of a drug in a large population of patients.
Sun Pharma’s failure to secure the CDSCO nod for the BE study and Phase III waiver may be due to various reasons, including concerns about the safety and efficacy of the FDC drug or the adequacy of the data submitted by the company. The company will now have to conduct a full Phase III clinical trial, which will involve significant time, effort, and resources.
The setback is likely to impact Sun Pharma’s business plans and revenue projections for the FDC drug. However, the company can still pursue the development and launch of the drug in other markets, including the United States and Europe, where the regulatory requirements may be different. The company will have to re-strategize and re-submit its application to the CDSCO, addressing the concerns and objections raised by the regulator.