Last Updated on December 31, 2023 by The Health Master
Regulations for Medical Devices
India is set to introduce comprehensive regulations governing all medical devices in the country starting from October 1. Currently, only Class A and B medical devices are regulated.
However, the Drugs Controller General of India (DCGI), Rajeev Singh Raghuvanshi, announced that the regulations will encompass the remaining medical devices, which will be categorized into two additional groups.
These regulatory measures aim to ensure quality control and establish a conducive environment for the rapidly growing medical device manufacturing sector in India.
Regulating the Medical Device Industry:
The regulatory changes for medical devices were discussed by Raghuvanshi at the 9th International Pharmaceutical Exhibition (iPhex 2023) held in Hyderabad.
He emphasized that the new regulations aim to improve the overall quality standards of the medical device industry by regulating the entire sector, rather than focusing solely on individual manufacturers.
This shift is crucial to meet the increasing demand for medical devices, particularly during the COVID-19 pandemic, and aligns with the government’s “Make in India” initiative.
Transition to a Licensing Regime:
Earlier this year, the Central Drugs Standard Organisation (CDSCO) issued a circular setting a deadline of October 1 for Class C and D non-notified medical devices to transition from the existing mandatory registration process to a licensing regime.
The circular advised manufacturers and importers to apply for manufacturing or import licenses with all the necessary documents.
This transition will further streamline the regulatory framework and enhance quality control measures for these devices.
Amendments to the Drugs and Cosmetics Act:
During the event, Raghuvanshi also mentioned that discussions are underway regarding amendments to the Drugs and Cosmetics Act.
These amendments aim to capitalize on the opportunities in the pharmaceutical industry as India targets a growth trajectory from the existing $50 billion to $100 billion by 2028 and over $120 billion by 2030.
The focus will be on ensuring the highest quality standards for pharmaceutical products to harness this growth potential.
Overview of iPhex 2023:
iPhex 2023, organized by the Pharmaceuticals Export Promotion Council of India (Pharmexcil), is a three-day event comprising meetings and exhibitions.
This year’s edition holds special significance as it coincides with India’s presidency of the G-20. The event serves as a platform to foster collaboration between India and members of the Group.
With over 400 exhibitors showcasing their products and solutions, iPhex 2023 is expected to attract 6,000 overseas delegates.
The event will include buyer-seller meets and panel discussions involving industry leaders and regulators.
Conclusion:
India’s forthcoming regulations for medical devices, effective from October 1, reflect the country’s commitment to quality control and creating a conducive environment for the flourishing medical device manufacturing sector.
The comprehensive regulatory framework will cover all medical devices, bringing uniformity and enhanced standards to the industry.
These measures align with India’s aspirations to become a global leader in pharmaceutical exports, making quality the cornerstone of its growth strategy.
The concurrent iPhex 2023 event provides a platform for collaboration and showcases India’s advancements in the pharmaceutical industry.
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