INDIA Law and Practice Contributed by: Malathi Lakshmikumaran, Vindhya S Mani, Pallaash Shankhdhar and Khushi Lokwani, Lakshmikumaran & Sridharan Attorneys
Medical devices Post‑approval changes are classified under the MDR (Sixth Schedule) as major (requires prior approval) or minor (notify within 30 days). • “Major changes” include updates to intended use/ indications, design affecting performance/specifi- cations, material of construction, method of sterili- sation, shelf life, primary packaging, and changes to the name/address of the manufacturer/overseas site/authorised agent (imports). • IVD/device guidance: CDSCO has issued post‑approval guidance (eg, stability packages to support IVD changes such as shelf life or pack- aging updates). Under this framework, when a post‑approval change may affect the performance or claimed shelf life of an IVD, the applicant is expected to submit appropriate stability data (eg, real‑time or accelerated studies, in‑use stability or transport stability, as relevant). Third-party transfers The marketing permission is issued specifically in the name of the applicant and its organisation, and can- not be transferred to another person or entity. Any person seeking to market the same medical device must submit a fresh application to the CLA and obtain a separate marketing permission. 3.5 Access to Pharmaceuticals and Medical Devices Without Marketing Authorisations The NDCT Rules provide for specific exceptions to assist individuals in need of life-saving drugs that may not otherwise be authorised for use/supply in India. This mechanism applies where the patient suffers from a life‑threatening disease, a disease causing seri- ous permanent disability, or a condition with unmet medical needs, and where the drug is approved in the country of origin or is under clinical trial in India. Supply is permitted either through import or limited manufacture, solely for patient‑specific treatment, and commercial sale is expressly prohibited. It requires prior permission from the CLA, is time‑limited, quantity‑restricted, subject to strict record‑keeping, reporting, inspection and adverse event reporting obligations, and may be suspended or cancelled for non‑compliance. Individuals may also import small
quantities of such drugs for personal use with CLA approval and a valid prescription. 3.6 Ongoing Obligations Imposed by Marketing Authorisations In India, the holder of a medical device/pharmaceuti- cal marketing authorisation is mandatorily required to conduct technovigilance and pharmacovigilance. For pharmaceutical drugs, mandatory pharmacovigi- lance includes the detection, assessment and preven- tion of adverse drug reactions, along with the prepara- tion and submission of PSURs to the CLA. The CLA may impose post‑marketing commitments, including Phase IV clinical trials, particularly when approvals are granted on limited clinical data or accelerated pathways, or for products addressing unmet medi- cal needs. Pursuant to the Fifth Schedule (read with Rules 77 and 82) of the NDCT Rules, such obliga- tions are typically applied to new drugs, biologics, vaccines and products requiring long‑term safety evaluation. The purpose is to ensure the monitoring of rare adverse events, real‑world effectiveness and long‑term risk–benefit assessment after the product enters the market. For medical devices, once a company obtains a licence, it must continue to monitor the safety and performance of the device after it is sold. This means the company must collect and report any adverse incidents, device problems or failures and take cor- rective actions if needed (such as repairs, warnings or recalls). Schedule VII Rule 3 of the MDR essentially outlines the framework for post‑approval changes, recalls and vigilance obligations, making it clear that manufacturers/importers must act immediately when a device poses a safety risk. 3.7 Third-Party Access to Pending Applications for Marketing Authorisations Third parties can view general status information on pending drug and medical device applications on the CDSCO website, but product-specific details remain accessible only to the applicant. Once approved, the basic details of drugs and medical devices (such as name and indication) are published by CDSCO and are publicly available, while application data is kept confidential until approval.
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