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Provisions Of DPCO, 2013 Applicable To Notified Medical Devices: NPPA

The National Pharmaceutical Pricing Authority (NPPA) has clarified that orthopaedic implants along with other medical devices will be treated as drugs, hence provisions of DPCO, 2013 are applicable to notified medical devices.

Refuting the contention of the medical devices manufacturers, especially the manufacturers of orthopaedic implants, that the provisions of DPCO 2013 are not applicable to medical devices, the NPPA said, “Para 20 of DPCO, 2013 provides for monitoring of non-scheduled formulations. Orthopaedic implants along with other medical devices are notified as ‘drug’ under Drugs & Cosmetics Act & Rules thereunder. Therefore your contention that the provisions of DPCO, 2013 are not applicable to medical devices is totally incorrect...

Gujarat FDCA To Meet Commerce Ministry To Seek Release Of Funds For Biocompatibility & Medical Device Testing Lab

Gujarat Food & Drugs Control Administration (FDCA) is expected to meet commerce ministry to speed up the release of funds for setting up of the country’s first biocompatibility and medical device testing lab. The state drug regulator had earlier this year drafted a proposal to the Centre to sanction a budgetary allocation of Rs.15 crore for the same...

U.S.-India Business Council Concludes Successful Medical Device Trade Mission To India

The U.S.-India Business Council (USIBC) concluded its Medical Device Trade Mission to New Delhi and Gandhinagar. The delegation expressed its commitment to addressing India’s most pressing public health challenges, and called for further dialogue with the government on issues related to ease of doing business, disease management, and the implementation of training programs for medical device regulators...