jrnls.org logo
Submit

BROWSE ALL JOURNALS

SEE ALL 19 JOURNALS
Indian Journal of Pharmaceutical Education and ResearchNOW IN
Review

Emerging Dynamics of the Medical Devices Sector in India

Rakesh Kumar Tekade1,2★, Shailendra Saraf1,2, Pallab Bhattacharya1, Swarnalata Saraf3★★ Corresponding author

  1. 1National Institute of Pharmaceutical Education and Research (NIPER)-Ahmedabad (An Institute of National Importance, Government of India), Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Palaj, Opp. Air Force Station, Gandhinagar, Gujarat, INDIA.
  2. 2Centre for Medical Devices, National Institute of Pharmaceutical Education and Research (NIPER)-Ahmedabad (An Institute of National Importance, Government of India), Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Palaj, Opp. Air Force Station, Gandhinagar, Gujarat, INDIA.
  3. 3Department of Pharmaceutics, University Institute of Pharmacy, Pt. Ravishankar Shukla University, Raipur, Chhattisgarh, INDIA.

CORRESPONDENCE

Rakesh Kumar Tekade

National Institute of Pharmaceutical Education and Research (NIPER)-Ahmedabad (An Institute of National Importance, Government of India), Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Palaj, Opp. Air Force Station, Gandhinagar, Gujarat, INDIA.

rakeshtekade@gmail.com

Received: 17-03-2025; Revised: 10-05-2025; Accepted: 29-06-2025.

Volume 60, Issue 2S · pp. s385–s410 · PUBLISHED · DOI: 10.5530/ijper.20260002

View on IJPER original site ↗

ABSTRACT

With a current compounded annual growth rate of more than 16% and a projected market value of 12 billion US$, the medical device industry in the Indian subcontinent alone is projected to reach a market size of over 50 billion US$ by 2030. Despite being a vast market, emerging markets like India rely heavily on imports to meet most of their medical device needs. To bridge this gap, the government has envisioned developing innovative policies, indigenous facilities, practices, rules, and regulations to foster the production of medical devices. Keeping this in view, a series of initiatives have been rolled out, concealing the aspects related to classification, registration, manufacturing, pricing, sales, and market supplies. This review provides a comprehensive 360-degree understanding of the Dynamics of the medical device perspective, using a case study of an emerging market like India. The primary objective is to outline the ongoing regulatory amendments, new policy enforcement, adopted quality management tools, and quality standards required for medical device products. This review will also assist as a guide for stakeholders in subjects related to this sector, providing insight into the federal government's efforts to strengthen the country's medical device production capabilities, thereby improving access and affordability. It is anticipated that continued debate and effective action will benefit diverse sectors and ultimately enhance the worldwide development of medical device industries.

KEYWORDS

Open in new tab

REFERENCES

As published

Showing references and in-text citations exactly as published.

    Cite this article

    SELECT FORMAT

    Tekade, R. K., Saraf, S., Bhattacharya, P., & Saraf, S. (). Emerging Dynamics of the Medical Devices Sector in India. Indian Journal of Pharmaceutical Education and Research, 60(2S), s385–s410. https://doi.org/10.5530/ijper.20260002