REGULATION OF MEDICAL DEVICES BILL
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- Recently the Union Health Ministry released the new draft of the ‘Drug, Medical Devices, and Cosmetics Bill-2022’.
- The draft separately defines medical devices.
- It has provisions to establish a separate expert group on medical devices.
- It calls for the setting up of central and state medical device-testing laboratories.
- It also highlighted that the Central government will formulate rules for the regulation of online pharmacies.
- The Union government has released the draft bill and invited comments, objections, and suggestions on the draft Bill.
About the Draft Bill
- It introduced a separate definition for medical devices, which includes;
- All types of diagnostic equipment and its software.
- Implants and devices for assistance with disabilities.
- Life support system.
- Instruments used for disinfection, and any kits.
- It made a provision for the creation of a ‘medical devices technical advisory board’.
- This board will include medical professionals, and also people with technical knowledge of the devices.
- Officials from the Health Ministry, department of atomic energy, department of science and technology, Ministry of Electronics, DRDO, and experts in the field of biomedical technology, biomaterials, and polymer technology will be part of the Advisory board.
- At present, all the decisions regarding medical devices are taken by the drugs technical advisory board, the board is not fully equipped to understand the engineering aspects of the device.
- The Draft Bill also proposes medical device testing centers in states and at the central level.
- The Bill has stated that clinical trials or clinical investigations of drugs and medical devices will need compulsory permission from the central licensing authority.
- The Bill highlighted that medical management and compensation have to be provided to persons who are injured while participating in clinical trials.
- In case of death, the legal heir of the participant should be awarded compensation.
- The Bill also recognized the issue of e-pharmacies; it states that the Union government would come up with rules and regulations to regulate the online sale of drugs.
- The Union Government would come up with new sets of rules for online pharmacies.
Objectives of the Draft Bill
- The Ministry 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.
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.
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