India, July 30 -- India's drug regulator, the Central Drugs Standard Control Organisation (CDSCO), has adopted a stricter approach towards the approval of new drugs linked to nearly 40 million patients in the country. During separate meetings of various Subject Expert Committees (SECs) held in July, experts made it clear that approvals granted in the United States or Europe alone would not be sufficient for marketing new drugs in India. Wherever necessary, companies will have to submit additional clinical data from Indian patients, safety studies, and other scientific evidence before receiving regulatory clearance.

The most significant decision concerned AstraZeneca's new anti-hypertensive drug Baxdrostat. While the company informed the ...