Weight-loss drug Ozempic receives CDSCO approval for India launch

The race for a share of India’s growing obesity market is set to intensify with the Central Drugs Standard Control Organisation (CDSCO) giving Danish drugmaker Novo Nordisk approval for its blockbuster diabetes drug Ozempic.

 

Approval for the injectable semaglutide-based solution was given on September 26, according to the CDSCO’s website. While no timeline has been given, people in the know told Business Standard that the drug was expected to be launched soon.

 

Experts say Ozempic’s entry is expected to give a boost to the antiobesity market, estimated to be ₹752 crore. Of this market, semaglutide accounts for ₹426 crore.  

 

Vikrant Shrotriya, managing director, Novo Nordisk India, said with Ozempic’s launch, the company would complete its semaglutide portfolio in the country, providing a range of treatments.

 

Ozempic is a once-a-week injectable GLP-1 (glucagon-like peptide-1) agonist (a drug or a hormone to produce a reaction) used to treat type-II diabetes, and it has found global demand for its benefits in patients with obesity or other weight-management issues.  

 

With the world’s third-highest population with problems relating to overweight and obesity, India is an emerging hotspot for weight-loss treatments.

 

According to the Indian Council of Medical Research-INDIAB (India Diabetes) study, the country has 254 million people with generalised obesity and 351 million with abdominal obesity. Turn to India has two officially available forms of semaglutide — Rybelsus (oral) and Wegovy (injectable) — both manufactured and marketed by Novo Nordisk.

 

While the former is specifically approved to treat Type-II diabetes, Wegovy was launched for weight management in June.

 

The other obesity-management drug available in India is America-based Eli Lilly’s Mounjaro (tirzepetide).

 

Mounjaro and Wegovy have seen a sales jump within a short period of time since their launch this year.

 

While Mounjaro has rung up ₹154 crore in sales since its launch in March, Wegovy raked in revenue worth ₹19 crore in three months, according to market research firm Pharmarack.    

 

While Novo did not respond to queries over price, experts say the price points are expected to stay similar to Wegovy.

 

Wegovy is priced at a range of ₹17,345-26,050 per month for its five different dosage forms.  

 

Calling India a key market for the company, Shrotriya said the company was dedicated to improving access and affordability, so that more patients could benefit from our therapies and achieve better health outcomes.

 

The launch of Ozempic comes when Novo Nordisk’s patent for semaglutide is expected to expire in March, and unleash a wave of generic versions from Indian drugmakers such as Dr Reddy’s, Cipla, and Sun Pharma.

 

“There are more than 14 anti-obesity drugs in the pipeline,” said Sheetal Sapale, vice-president (commercial), Pharmarck.

 

However, experts say side-effects of such drugs may be nausea, vomiting, and digestive discomfort, particularly when starting the drug. Rare but serious risks include pancreatitis, gallbladder issues, and, in some cases, worsening thyroid conditions.

 

Sukhvinder Singh Saggu, director for minimal access, GI and bariatric surgery at Delhi’s CK Birla Hospital, said it should always be used under medical supervision, along with lifestyle modifications like healthy eating and regular exercise.

 

“Ozempic’s entry into the Indian market offers new hope for diabetes and obesity management, but responsible use and close medical monitoring remain crucial,” he added.