India's medical device sector is set for closer regulatory scrutiny, with the Central Drugs Standard Control Organisation (CDSCO) preparing to significantly increase inspections of manufacturing facilities. Speaking at CII's 18th Global MedTech Summit, Drugs Controller General of India (DCGI) Dr Rajeev Raghuvanshi said the regulator had focused on facilitating approvals over the past two years, during which around 30,000 product licenses were issued. With additional resources now becoming available, he said facility audits and inspections would increase substantially.

Dr Raghuvanshi noted that manufacturers had been given adequate time to adapt to the evolving regulatory framework and were aware of the regulator's expectations. The message was straightforward: upcoming inspections should not come as a surprise. India's medical device industry is currently valued at about $16 billion and…