Key Points
The USFDA-approved blockbuster weight loss and anti-diabetes drugsOzempic and Wegovycould 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 categoriesorphan 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...
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..
Under the new waiver ruleeffected by amendment to Rule 101 of the New Drugs and Cosmetics Rules 2019 in IndiaDanish 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 drugsOzempic and Wegovyhave greater value in reducing obesity and diabetes burden in the Indian people than what's currently available in the medicine range available here...
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