Urges that building trust in India’s medicines and positive image of regulators is the need of the hour
The first session of IPC 2018 began with BV Patel Memorial lecture by Dr S Eswara Reddy, Drugs Controller General (India). He gave a brief introduction about CDSCO, its activities and the challenges faced by the regulators.
He opined that deficit of trust and confidence in the public mind on the quality of pharma products; building of regulators’ images and improving their competency; to have a predictable, transparent and efficient regulatory system; to ensure accessibility, affordability and availability of medical products; to harmonise Indian drug regulations with international standards; to promote innovation by providing regulatory support and ease of doing business, are the need of the pharma industry today.
He also highlighted that the major regulatory challenges are in enforcing uniformity in the implementation of Acts and Rules. He said, “The act has provision under Section 7 for securing uniformity of implementation across the country. DCC is a statutory body for securing the uniformity of implementation. However, efforts towards ensuring uniformity in implementation have not been fruitful as the DCC decisions are only recommendatory in nature.
Dr Chandrasekhar Rao, Deputy Drug Controller (India), CDSCO continued with the lecture and informed the audience about the various measures taken by the Government of India such as online submission of data through SUGAM portal, single window clearance for transparency, ease of doing business etc.
Rao also informed that the recent measures taken have led to considerable improvement in the regulatory system.
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