Pulse Pharmaceuticals Gets DCGI Nod for Nano-Carrier Vitamin D3 Formulation

Pulse Pharmaceuticals has received regulatory approval from the Drugs Controller General of India (DCGI) for its Nano-Carrier Entrapped Vitamin D3 Oral Dispersion, marking a significant step in the company’s efforts to commercialise advanced drug-delivery technology.

The Hyderabad-based pharmaceutical company said the approval followed a detailed scientific evaluation and could represent a first-of-its-kind regulatory clearance globally for nanocarrier-based Vitamin D3 delivery. Pulse Pharmaceuticals Founder and Managing Director K V Rambabu said the approval would help translate the company’s nanopharmaceutical research into a regulated, patient-ready product.

According to the company, clinical studies showed that the nano-carrier formulation produced 50–60% higher serum Vitamin D levels compared with conventional Vitamin D3 formulations. The technology is designed to improve the delivery of lipophilic compounds, which have limited solubility in water-based environments.

Pulse has been working on nanopharmaceutical drug delivery since 2010 and has developed its proprietary “Aqueol” platform technology to facilitate the effective delivery of lipophilic compounds through water-based formulations.

The company is also targeting international markets. Rambabu said Pulse is developing a clinical strategy for seeking approval from the US Food and Drug Administration (USFDA). However, the US market would require a fresh clinical study, prompting the company to seek a strategic partner to support its expansion into the US and Europe.

The DCGI approval is expected to provide a regulatory foundation for the company’s future international submissions.

Beyond Vitamin D3, Pulse is applying its proprietary technologies to Vitamin K2-7, Vitamin B12 and iron, as well as commonly used medicines. The company said an EU patent for its Aqueol technology is in the final stages of approval.

Pulse has also filed patents for four other proprietary platforms across seven countries and is working on three additional patent filings, underscoring its broader focus on advanced pharmaceutical drug-delivery systems.