Drug regulatory paradigm and challenges for Medical devices in India

  • Vikesh Kumar Shukla
  • Shikha Chauhan
  • Yamini Kanti SP
  • Sanjeev Kumar
  • Archita katrolia


The medical device industry in India   has made speedy growth in the last few years but lag behind as compared to developed nations like USA, UK, etc. The government has taken the right step by separating the medical devices from general medicines from regulation viewpoint. Medical devices in India are governed by national drug regulatory agency, CDSCO (Central Drug Standard Control Organization) for quality and manufacturing standards. The CDSCO regulations are given to maintain the quality in manufacturing, packing and distribution of medical products. Each developed country has their own regulatory approval procedure and renewal requirements. The Indian government also adopted strict rules and regulations with respect to medical device and framed the new Medical Device Rules-2017. The medical device industry is principally import driven market close up to 75% and export up to 38% only. The national medical device policy2015 is driven out to strengthen the market of medical device and to reduce the burden on import of medical device (1). Recently NPPA capped the prices of medical devices such as coronary stents and knee implants under the DPCO (Drug Price Control Order). NPPA is the organization of government of INDIA which was established, to regulate the prices of controlled bulk drugs and formulations and in some extent medical devices. The NPPA have a mixed impact on Indian population and market, a large number of Indian population have received major benefits with respect to their healthcare costs (2, 3), at the same time major device manufacturer such as Abbott Healthcare , Medtronic filed the application to NPPA to increase the ceiling prices of their latest generation medical devices. As a negative impact, the MNCs withdraw their latest innovated products, affecting the quality of medical services, medical tourism, no investment in research and development of medical device etc.

Recommendations to government include: spending more percentage of GDP on healthcare, prioritizing the most important medical devices and provide them at subsidize price to government organization. The government should have more focus on production/manufacturing of medical devices indigenously under “Make in India” scheme.

Keywords: Medical Devices, CDSCO, WHO, NPPA, Price Regulation


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How to Cite
Bansal, A., V. K. Shukla, S. Chauhan, Y. K. SP, S. Kumar, and A. katrolia. “Drug Regulatory Paradigm and Challenges for Medical Devices in India”. International Journal of Drug Regulatory Affairs, Vol. 7, no. 1, Mar. 2019, pp. 25-33, doi:10.22270/ijdra.v7i1.299.

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