New Delhi: India is ready to rework standards for medical devices, strengthening the regulatory framework for $ 12 billion and harmonization with quality scales of the European and European Union (EU).
The Pharmacopoeia Indian Commission (IPC), an autonomous body under the Ministry of Health and family care, will create standards for medical devices for the first time in cooperation with the Indian standards (BIS), according to documents reviewed by mint and officials who are familiar with this matter. Historically, IPC focused on developing drugs for drugs, but has now also expanded its mandate to include medical devices.
IPC has already launched an audit of medical companies and develops monographs that will outline standards and specifications for medical equipment. The aim is to strengthen India’s global reputation for the production of medical devices and to strengthen exports.
National Health Policy 2023 also emphasizes that Indian standards are gradually expanding their standards for products, processes, wireless technologies and performance. This will help the local industry become worldwide competitive and achieve the goal to adopt other Indian standards for medical devices. The aim of this policy by 2030 is to increase the size of the Indian medical market to $ 50 billion and to capture 10-12% of the share in the global market in 25 years.
There are currently approximately 1,500 standards in India for different products for medical devices, as approved by BIS.
Cooperation for global recognition
According to documents at a recent meeting, the IPC scientific body discussed the upgrading standards of medical devices and decided to work closely with BIS to prevent duplicate standards.
In addition, IPC establishes its own laboratory for testing medical devices. He recommended that his newly created medical division to carefully plan the scope of testing to comply with the current available infrastructure, facilities and expertise. This will ensure that their efforts are effective and effective.
“Creating standards is not a difficult part. The most important task is now to harmonize Indian standards of medical devices with global standards. Once Indian standards are accepted, the country may require exporting nations to follow them. The ultimate goal of IPC and BIS is to ensure the quality and safety of medical devices.
Questions sent to the Ministry of Health remained unanswered.
Himanshu Baid, CEO, PolyMedicure LTD, said IPC, which took the lead in the formulation of monographs for medical devices, is a timely and progressive step. “Since the Indian Medtech sector is constantly growing, with a market size to be reached $ 50 billion … Determination of clear, indigenous standards is necessary to ensure quality, security and global competitiveness. Cooperation between IPC and BIS will help harmonize regulatory framework and prevent duplicity and added industry.”
The scientific body has also reviewed the progress of the Indian Materiovigilance Program in India (MVPI), which monitors the safety of medical devices.
India imports 60-70% of its medical devices. Once Indian standards are adopted worldwide, the country may require that the exporting nations follow them, the person said.
Growth and regulation in the Indian sector of medical devices
The Indian medical market is currently awarded approximately $ 12 billion and by 2030 it is expected that by 2030 it will rise to $ 50 billion. This growth is supported by regulations according to the 2017 medical rules that require the Central License Authority to classify medical devices based on risk. The Central License Authority operates within the Standard Control Organization (CDSCO), which is the highest regulatory body for drugs and medical devices in India.
The industry is relatively diverse and the device is widely classified into five categories: electronic devices, implants, consumables and disposable, surgical tools and diagnostic agents in vitro.
CDSCO categorizes medical devices into four risk -based classes: low -risk equipment such as bandages and cotton swabs (class A); Devices with low to medium risk, such as thermometers (class B); Mild to high risk devices such as sprayers and X -ray machines (class C); High risk devices such as defibrillators and implants (class D).
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