DCGI Approves Pulse Pharma's Nano-Carrier Vitamin D3 Oral Dispersion

"After strict scientific evaluation, Pulse Pharmaceuticals achieved regulatory approval for its pioneering nanocarrier technology in Vitamin D3 delivery, such an approval is probably first in the world," Pulse Pharmaceuticals Founder and Managing Director K V Rambabu told reporters here.

This approval transforms advanced nano pharmaceutical research into a regulated, patient-ready product, he said.

Clinical studies have demonstrated 50-60% higher serum vitamin D levels with Nano-carrier entrapped Vitamin D3 Oral Dispersion compared to conventional formulations, he said.

The company has been working in nano pharmaceutical drug delivery since 2010, he said, adding that their proprietary "Aqueol" platform technology is specifically designed to effectively deliver lipophilic compounds in water-based mediums.

Rambabu said the Drugs Controller General of India (DCGI) approval came last week.

Regarding applying for approval from the US Food and Drug Administration (USFDA), he said they are working on it and have developed a clinical development strategy. "For the US, we need to develop a new clinical study again. We are looking for a big partner to join hands with us, and then we want to take this product into the US and Europe as well," he said.

"We were waiting for the DCGI approval, and now (this approval) will become the basis for us to file and then convince the other regulatory agencies," he said.

Rambabu said Pulse has developed several proprietary platform technologies to deliver medicines effectively.

Beyond Vitamin D3, Pulse is applying these platforms to other essential nutrients (like Vitamin K2-7, Vitamin B12, and Iron) and widely used medications, he said.

An EU patent for their Aqueol technology is in the final stages of approval, he said.

The company has filed patents for four other proprietary platforms across seven countries and is actively working on filing three more, he added.