The government is considering amendments to the Medical Devices Rules, 2017, that could give regulators stronger powers to stop the manufacture, sale or distribution of unsafe, defective, substandard or spurious medical devices.
Stronger Enforcement Powers
The proposed changes to Rule 30(1) would empower state licensing authorities and the Central Drugs Standard Control Organisation (CDSCO) to direct manufacturers to stop the production, sale or distribution of devices that pose safety or public health concerns.
Regulators may also be given the power to order the destruction of affected devices and stocks where necessary.
Currently, licensing authorities can suspend or cancel licences when manufacturers violate provisions of the Drugs and Cosmetics Act, 1940, or the Medical Devices Rules, 2017. However, the existing framework does not explicitly provide some of the stronger enforcement measures now being proposed.
Focus on Patient Safety
The proposed amendments aim to ensure that potentially unsafe devices are removed from circulation more quickly. Medical devices, including implants, surgical instruments, diagnostic equipment and consumables, are widely used in critical healthcare settings, making product quality and safety essential.
As per the ETHealthworld report, the proposal has been placed before the Drugs Consultative Committee for deliberation and recommendations.
Strengthening Regulatory Oversight
The proposed changes also seek to establish clearer procedures for the destruction of unsafe or defective medical devices, including regulatory oversight and proper documentation.
The move forms part of broader efforts to strengthen India’s medical-device regulatory framework and improve oversight of product quality, safety and compliance.