PharmaLytica 2021 Hyderabad review.

CDSCO to Govern Medical Devices Quality Standard

In order to ensure safety of end users of medical devices, the Central Drugs Standard Control Organization (CDSCO), to take charge in investigating quality, safety- related issues and complaints and further to suspend the registration if not found satisfactory post- investigation.

The government is stepping ahead in making it mandatory for all the imported and locally-made medical devices to meet the required standards of quality and effectiveness before entering the market. Framing the rules, i.e., to be included in regulation has been started by the government, moreover a draft notification to this effect is expected to be put out soon.

According to sources, CDSCO, the regulatory authority in this case will be on voluntary basis up to a period of 18 months from the date of notification, within the said period all import, manufacture and sale of medical devices will need to be certified by the CDSCO and thereafter it will be made mandatory. Reports indicate that new rules will be incorporated in the existing Act.

Govt cannot be lax about standardization and quality of medical devices. There is a consensus among all departments to put up a draft notification. Medical devices will have to be registered with the regulatory authority before entering the market.

Last year, problems due to hip implants manufactured by subsidiary of Johnson &Johnson (J&J) required some patients to undergo revision surgery, such incidents led the government to realize the need of a system to improve safety standard of medical devices.

Though, there are 23 categories of medical devices that are regulated under the Drugs and Cosmetics (D&C) Act in India, the government does not have an exact figure of how many non-notified medical devices are available in the country. There have also been complaints of refurbished imported equipment making their way into the country. No such mechanism has yet been developed to report malfunctioning of non- notified medical devices.

Department of pharmaceuticals, government think tank Niti Aayog, the department of biotechnology, the Indian Council of Medical Research, the Bureau of Indian Standards, industry experts and associations have guided the health ministry in examining the roadmap for the rules of regulation, which mandates every manufacturer and importer of medical devices to report serious adverse events to India’s drug regulatory authority and the materiovigilance programme of India.

Reports can be analyzed to assess the safety and performance of the devices and appropriate regulatory interventions can be taken to ensure patients’ safety, as per the document on roadmap of medical devices.

Further, the health ministry is all set to declare a new definition of medical devices by including diagnostic equipment, nebulizers, syringes, stents and other implants.

As per the sources the new definition for medical devices will be aligned with that of the International Medical Device Regulators Forum (IMDRF) and one which is globally accepted.

Reports indicate the authorized notification by the ministry will be put out soon.

Post notification of new definition, all medical devices will fall under the health ministry’s regulatory purview and will be mandatory for them to undergo scrutiny by the Central Drugs Standard Control Organization before entering the market. Further all manufacturing companies of medical devices will have to seek approval from CDSCO before manufacture, import and distribution of any medical device. Moreover they will have to report adverse events and carry out clinical trials for new products as per the regulatory requirement. All medical devices will be examined for their quality, safety and efficacy that are manufactured or sold in India.

The idea is to have a roadmap for medical devices so that manufacturing of products can be promoted in the country. Approval, certification and registration from a central authority under the health ministry will help in strengthening the credibility of ‘Made in India’ medical devices, as per the sources.

Imprint comment

High quality standards is not to be seen as making medical products expensive for the average Indian. High quality standards is the key to creating world-class manufacturing. This is the key to develop leading-edge machinery and super-tech factories and sci-fi materials sourcing. Imprint approves this move by government.

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