DCGI Approves Nano Vitamin D3 Drug

Hyderabad-based Pulse Pharmaceuticals has announced that its nano-carrier entrapped Vitamin D3 oral drug has received approval from the Drugs Controller General of India (DCGI). Company founder and Managing Director K.V. Rambabu said the approval was granted after rigorous scientific and clinical evaluation. He claimed that the regulatory clearance is the first of its kind globally for a Vitamin D3 drug incorporating nanotechnology.

According to Rambabu, clinical trials showed a 50–60% increase in serum Vitamin D3 levels following administration of the drug. The company has been researching the formulation since 2010 and developed it using its proprietary ‘Aqeel’ platform technology. The platform is also being explored for Vitamin K2-7, Vitamin B12 and iron products. Pulse Pharmaceuticals operates plants in Roorkee, Baddi and Hyderabad and is investing ₹150 crore to establish a new manufacturing facility in Hyderabad’s Genome Valley.