Currently, the Drugs Controller General of India (DCGI), under the Drugs & Cosmetics (D&C) Act, 1940 and Medical Device Rules (MDR), is not regulating medical mobile apps that could be brought within the purview of medical devices.
However, in view of the surge in mobile medical applications and the scope of their capabilities, including the threat to Electronic Health Records (EHRs) and individuals, the Ministry of Health and Family Welfare has been facilitating the implementation of standards in India in terms of the maintenance of such EHR while it is engaged in fine-tuning the drafts regulating the applications in their entirety.
Please click here to read the full article by Sanjay Kumar, published in Financial Express.
