Blockbuster weight loss and anti-diabetes drugs could soon be available in India

Aditi Tandon

New Delhi, August 8

The USFDA-approved blockbuster weight loss and anti-diabetes drugs—Ozempic and Wegovy—could soon make it to the Indian market.

The Ministry of Health on Thursday approved local clinical trial waivers for high-end select drugs approved by the stringent national regulators of US, UK, Japan, Australia, Canada and EU.

The waiver will apply to drugs that fall in the following five categories—orphan drugs for rare diseases; gene and cellular therapies, new drugs used in pandemic situations, new drugs used for special defence purposes and new drugs with significant therapeutic advance over the current available standard care.

Asked if weight loss drugs, currently a range in Hollywood, with even Tesla's Elon Musk learnt to be using, could qualify in the waiver category, government officials here said, "yes, if the manufacturers prove these have significant therapeutic value over the currently available treatment."

The USFDA has earlier approved a new indication for use for Wegovy (semaglutide) injection to reduce the risk of cardiovascular death, heart attack and stroke in adults with cardiovascular disease and either obesity or overweight

Wegovy is now the first weight loss medication to also be approved to help prevent life-threatening cardiovascular events in adults with cardiovascular disease and either obesity or overweight.

Likewise, the USFDA has also approved Ozempic injection and Rybelsus tablets to lower blood sugar levels in adults with type-2 diabetes mellitus, in addition to diet and exercise.

Ozempic is also approved to reduce the risk of heart attack, stroke, or death in adults with type-2 diabetes mellitus and known heart disease.

Under the new waiver rule—effected by amendment to Rule 101 of the New Drugs and Cosmetics Rules 2019 in India—Danish firm Novo Nordisk can seek market authorisation of its weight loss drugs Ozempic and Wegovy in India after proving to the subject experts of our drug regulator that these drugs—Ozempic and Wegovy—have greater value in reducing obesity and diabetes burden in the Indian people than what's currently available in the medicine range available here.

A Lancet study recently revealed alarming obesity rates in India, with 70% of urban population overweight. India ranks third globally in obesity, following the US and China. Approximately 8 crore Indians are obese, with 1 crore aged 5-19.