The Subject Expert Committee of CDSCO has asked for additional trial results for Ajanta Pharma's film-coated tablets containing Telmisartan 40 mg and Cilnidipine 20 mg in a in a combination formulation. In light of the requirements outlined in the November 15, 2023, permission form, Ajanta Pharma is submitting the Phase IV clinical trial protocol to the committee.

The combination of telmisartan IP 40 mg and cilnidipine IP 20 mg is believed to offer numerous purported benefits for treating hypertension. While, Telmisartan, an angiotensin receptor blocker (ARB), relaxes blood vessels by blocking the action of a natural substance that tightens them, leading to lower blood pressure and reduced strain on the heart, Cilnidipine, a calcium channel blocker (CCB), also relaxes blood vessels, allowing blood to flow more easily and further lowering blood pressure.

Together, this combination is believed to help the heart pump blood more efficiently, reducing its workload. This combination has the potential to significantly lowering the risk of heart attacks and strokes by effectively controlling high blood pressure. Additionally, it is believed to safeguard vital organs, including the kidneys and brain, from the damaging effects of chronic hypertension.

Using a combination of these drugs in lower doses may reduce the incidence of side effects compared to higher doses of a single medication. While Telmisartan may improve symptoms in patients with chronic heart failure by reducing heart strain, cilnidipine's vasodilatory effect can reduce symptoms of angina and enhance overall heart function.

Furthermore, Telmisartan also offers kidney protection by reducing proteinuria, a common issue in high blood pressure patients with diabetes, and Cilnidipine's ability to dilate both arteries and veins can reduce the risk of kidney damage from high blood pressure.

The committee has recommended a few modifications after long deliberations. Before enrolling each person in the study, the committee has advised performing a renal Doppler test and a serum creatinine test during the follow-up visit on day 28.

Ajanta Pharma has been asked to modify its Phase IV clinical trial protocol following these suggestions and presenting it to CDSCO for assessment, following which the Committee will undertake further review, a statement from the drug regulatory body stated.