Dr. Reddy’s Laboratories secured final approval from India’s drug regulator to manufacture and market generic versions of semaglutide tablets, intensifying competition in the country’s rapidly growing diabetes and weight-loss drug market.
Approval Clears Path for Generic Rybelsus Alternative
While the core semaglutide patent expired in India last month, Novo’s patent covering oral formulations remains valid until 2031. Hyderabad-based Dr Reddy’s confirmed that the Central Drugs Standard Control Organisation (CDSCO) granted regulatory approval for the product. However, the company has not yet disclosed its commercial launch timeline. The formulation underwent a head-to-head comparative clinical study in India, which demonstrated non-inferiority to Novo Nordisk’s Rybelsus. “The formulation was clinically evaluated in a comparative study conducted in India, establishing non-inferiority to Novo Nordisk’s oral semaglutide,” the company stated. Based on this evidence, the product received approval through India’s biosimilar regulatory pathway.
Growing Competition in India’s Weight-Loss Drug Market
The approval is expected to intensify competition in India’s booming anti-diabetes and obesity treatment market, which has crossed the ₹1,600-crore mark within just over a year. Industry experts believe the market will witness aggressive pricing and expanded patient access as more domestic drugmakers enter the segment. An expert committee had also issued a favourable opinion on Dr Reddy’s application after reviewing data from local clinical trials.
Approved Dosages and Manufacturing Details
The company has received approval for three dosage strengths — 3 mg, 7 mg, and 14 mg. The tablets are indicated as an adjunct to diet and exercise for improving glycaemic control in adults with type-2 diabetes mellitus. As reported by The Economic Times, according to regulatory documents, the drug substance (API) will be sourced from Hangzhou Zhongemeihuadong Pharmaceutical Jiangdong Co., while the final tablet formulations will be manufactured at Dr Reddy’s facility in Andhra Pradesh.
