Draft Accessibility Standards for Healthcare
On June 2, 2022, the Ministry released the Draft Accessibility Standards for Healthcare, 2022 ("Accessibility Standards") with an intent to ensure that healthcare and public spaces remain accessible to all, especially to persons with disabilities. It aims to ensure that individuals with physical, auditory, speech, visual, cognitive, and mental disabilities have equal and seamless access to healthcare facilities.
The Accessibility Standards comprehensively deal with potential barriers to access healthcare in an egalitarian manner and attempts to address these barriers by devising detailed frameworks for delivering accessible healthcare. Broadly, it includes measures for creating accessible facilities, such as: (a) accessible outdoor patient and emergency department; (b) accessible indoor patient department; and (c) accessible medical equipment and furniture.
Guidance on performance evaluation / external evaluation of in vitro diagnostic medical devices
On July 7, 2022, the Central Drugs Standard Control Organisation ("CDSCO"), Directorate General of Health Services, Ministry, Government of India, released a Guidance Document on Performance Evaluation / External Evaluation of In Vitro Diagnostic Medical Devices ("IVD Guidance Document") for public comments. The objective of the IVD Guidance Document is to facilitate the manufacturers/ importers / testing laboratories (to whom the guidance document applies) of in vitro diagnostics medical devices ("IVD MDs") in India and sensitize them regarding performance evaluation / external evaluation of IVD MDs.
The IVD Guidance Document deals with evaluation of IVD MDs, utilized to conduct diagnostic tests to ascertain specific details about a person's health, or possible ailments. It comprehensively deals with the standards to be followed for testing, safety, dispatch, storage, recording of result, disposal of samples and storage of results.
Guidance on stability studies of in-vitro diagnostic medical device
On July 7, 2022, the CDSCO released a Guidance document on stability studies of in-vitro diagnostic medical device ("SS Guidance Document") for public comments. The SS Guidance Document provides instructions and guidelines for manufacturers and importers of IVD MDs, specifically with respect to shelf life, and the in-use stability of the IVD MDs.
The CDSCO strongly encourages manufacturers to follow the SS Guidance Document when submitting Class C and Class D IVDMD license applications and post approval change applications. Based on the purpose for which they are used, IVD MDs are classified as (i) low risk- Class A; (ii) low moderate risk- Class B; (iii) moderate high risk- Class C; and (iv) high risk- Class D. The SS Guidance Document contains an array of mechanisms to ensure and ascertain the stability of the IVD MDs.
Guidance on post-market surveillance of in-vitro diagnostic medical device
On July 7, 2022, the CDSCO released a Guidance document on post-market surveillance of in-vitro diagnostic medical devices ("Surveillance Guidance Document") for public comments. The Surveillance Guidance Document seeks to ensure that after having put the IVD MDs into the marketplace, their safety features and adequate functionality are complied with. This would be relevant for all persons who import, distribute, manufacture or use IVD MDs.
The Surveillance Guidance Document provides an in-depth analysis as to which complaints may be identified, detailed guidance into the types of tests that may be carried out, along with standards of harm or detriment to those undergoing such tests. This ensures compliance with rigorous standards of post-market success of the IVD MDs. It also provides checklists for the ascertaining of incorrect test results, standards of adverse events, incorrect manufacturer instructions, responsibilities of manufacturers, and other such specifications to ensure adherence to quality checks.
The Drugs, Medical Devices and Cosmetics Bill, 2022
On July 8, 2022, the Ministry released a draft of the Drugs, Medical Devices and Cosmetics Bill, 2022 ("Bill"). The Bill seeks to overhaul the existing Drugs and Cosmetics Act, 1940, which is the primary legislation dealing with the regulation of drugs, medical devices and cosmetics in India.
The Bill has been drafted on the basis of recommendations of an eight-member panel headed by the Drugs Controller General of India with the stated objective of "consolidating all laws relating to the import, manufacture, distribution and sale of drugs, medical devices and cosmetics to ensure their quality, safety, efficacy, performance and clinical trial of new drugs and clinical investigation of investigational medical devices..".
It has been published for public comments to be given until August 22, 2022. For detailed analysis of the Bill, please refer to the JSA Prism of July 15, 2022.
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