CODE FOR MEDICAL DEVICES

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Context - The Ministry of Chemicals and Fertilizers has released a draft of the Uniform Code for Medical Device Marketing Practices (UCMDMP).

Details

The Department of Pharmaceuticals, under the Ministry of Chemicals and Fertilizers, has released a draft of the Uniform Code for Medical Device Marketing Practices (UCMDMP).
The aim of the draft is at introducing a voluntary code to regulate the marketing practices of the medical device industry.

Objectives of the Draft Policy

The Ministry of Chemicals and Fertilizers said that the Draft policy aims at addressing the core objectives of accessibility, affordability, safety and quality, focusing on self-sustainability, innovation and growth in the medical devices sector.
Regulatory streamlining to optimize regulatory processes and promote ease of doing business.
Quality Standards and Safety of the Devices in order to provide safety devices to the consumers.
Infrastructure Development to provide the best physical foundation, including medical devices parks with common facilities such as testing centres, to improve cost competitiveness and enhance the attraction of domestic manufacturers.
Promoting Research and Development and Innovation.
Human Resource Development to create manpower with required skills.
Awareness Creation and Brand Positioning in creating awareness and positioning India as a hub for manufacturing of medical devices as part of the “Make in India, Make for the World” initiative.
This Policy targets that by 2047, India
- Will be home and originator to 25 high-end futuristic technologies in MedTech.
- Will have a MedTech Industry of $100-300 Billion size with 10-12% of Global Market Share.

Significance of the Medical Device Sector in India

The medical devices sector in India is an essential and integral constituent of the Indian healthcare sector, particularly for the prevention, diagnosis, treatment and management of all medical conditions, diseases, illnesses, and disabilities.
The Sector is expected to grow in market size from the present 11 billion US dollars to 50 billion US dollars by 2025.
The medical device is a multi-product sector, with the following broad classifications:
- Electronics Equipment
- Implants
- Consumables and Disposables
- Surgical Instruments.
The Indian medical devices sector’s contribution has become even more prominent as India supported the global battle against the COVID-19 pandemic through the production of medical devices and diagnostic kits, e.g., Ventilators, RT-PCR kits, IR Thermometers, PPE Kits & N-95 masks.