INDIA Law and Practice Contributed by: Malathi Lakshmikumaran, Vindhya S Mani, Pallaash Shankhdhar and Khushi Lokwani, Lakshmikumaran & Sridharan Attorneys
Cancellation and Suspension of Licences Pharmaceuticals Under the DCR, the CLA has the power to suspend or cancel a pharmaceutical licence if the licensee fails to comply with any condition of the licence or vio- lates any provision of the DCA or the DCR. This may include, among other grounds: • failure to place the authorised drug on the market or to maintain its supply; • non‑compliance with approved quality, safety or efficacy specifications; • breach of labelling or packaging requirements; • failure to submit Periodic Safety Update Reports (PSURs) or adverse event reports; or • any situation where continued marketing may pose a risk to public health. Such action can only be taken after giving the licensee an opportunity to show cause, and the authority must issue a reasoned written order. Where the non‑com- pliance arises due to the act or omission of an agent or employee, the licence will not be cancelled or sus- pended if the licensee can demonstrate that: • the contravention was not instigated or connived; • due diligence was exercised; and • there was no prior similar misconduct within the preceding 12 months, or that the licensee could not reasonably have had knowledge of such mis- conduct. Medical devices Under the MDR, the competent authority (CLA or SLA as the case may be) may suspend or cancel a market- ing authorisation, wholly or in part, where the licensee contravenes any provision of the DCA or the DCR. Such action must follow due process, including giving the licensee an opportunity to show cause, and must be supported by a reasoned written order specifying the grounds for suspension or cancellation. 3.4 Procedure for Obtaining a Marketing Authorisation Obtaining Marketing Authorisation Pharmaceuticals The manufacturer or importer must submit a market- ing authorisation application under the NDCT Rules,
with clinical, preclinical and formulation data. The CLA then reviews the application and may request addi- tional information to ensure safety, efficacy and qual- ity. If satisfied, the CLA grants marketing permission, after which the manufacturer must obtain a manufac- turing or import licence under the DCA and the DCR. Medical devices The manufacturer must submit a marketing authori- sation application for medical devices to the relevant authority (SLA or the CLA, as the case may be) under the MDR, including details on intended use, safety and performance. The applying pathway depends on device class (A–D): • for Class A/B products, applications are submitted via Form MD-3 to the SLA; and • for Class C/D and IVDs, submission is via Form MD-7 to the CLA, accompanied by the relevant documents. The relevant authority then reviews the application and, if satisfied, grants marketing permission, after which the applicant can obtain a manufacturing or import licence. Any major changes affecting quality, safety, performance or intended use require prior CLA approval before implementation. Changes in Approved Drugs/Medical Devices Pharmaceuticals Any post‑approval change is first assessed against Rule 2 (w) of the NDCT Rules, which treats certain changes as a “new drug”. Changes such as thera- peutic indication, posology, patient population, route of administration, or formulation are treated as a sub - sequent new drug. For such changes, the marketing authorisation holder must apply to CDSCO (CLA) through the SUGAM portal. The application must include supporting CMC, non‑clinical and/or clinical data, depending on the nature of the change. The CLA reviews the application (it may seek an expert opinion) and issues prior approval before the change can be implemented. Labelling or packaging changes that affect approved indications, dosage, warnings or directions for use also require prior CDSCO approval; purely cosmetic changes are generally handled by notification.
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