INDIA Law and Practice Contributed by: Malathi Lakshmikumaran, Vindhya S Mani, Pallaash Shankhdhar and Khushi Lokwani, Lakshmikumaran & Sridharan Attorneys
3.2 Marketing Authorisation for Biologic Medicinal Products In India, biological medicinal products are not sub- ject to a separate approval pathway under the NDCT Rules and are regulated in the same manner as other new drugs. As a rule, local clinical trials are required to establish safety and efficacy, unless a waiver is grant- ed by the CLA. Where a biological product involves hazardous micro-organisms or genetically engineered organisms, an additional biosafety approval from the Review Committee on Genetic Manipulation is required. Biological products – including vaccines, recombinant DNA-based products, monoclonal anti- bodies, and cell or gene therapies – are treated as new drugs indefinitely under the NDCT Rules, unlike small molecule drugs, which lose this status after four years. Consequently, significant modifications or new ver- sions of a biological product may trigger fresh clinical trial requirements. For instance, under the Guidelines on Similar Biologics, 2016, biosimilar (generic ver- sions of biologics) marketing authorisation is subject to a step‑wise comparability exercise demonstrating similarity to a licensed reference biologic in terms of quality, safety and efficacy, based on extensive ana- lytical characterisation, manufacturing consistency and quality data. This must mandatorily be support- ed, as required, by non‑clinical and clinical studies (including pharmacokinetic and pharmacodynamic immunogenicity, and confirmatory safety/efficacy where necessary), along with a post‑marketing phar- macovigilance plan, before approval is granted by CDSCO. 3.3 Period of Validity of Marketing Authorisations Period of Validity and Renewal of Marketing Authorisation Under the NDCT Rules, the DCR, the DCA or the MDR, pharmaceutical marketing authorisations in India are currently valid indefinitely, provided a specified reten- tion fee is paid every five years. Medical device licenc- es are also perpetual, subject to the payment of a five-yearly retention fee under the MDR.
mined as a “drug” under Section 3 (b) of the DCA. The determination is made based on the primary intend- ed use and dominant mode of action, as evidenced by the product’s composition, labelling, claims and mechanism of action. Upon classification as a drug, the product is required to comply with Chapter IV of the DCA, including obli- gations relating to manufacturing licence, regulatory approvals by CDSCO or the SLA, clinical data where applicable, and prescription controls. Medical Devices On the other hand, if a product is intended for the diagnosis, prevention, monitoring or treatment of dis- ease primarily by physical, mechanical or structural means, it is determined as a “medical device”, as statutorily defined under Section 3 (b) of the DCA and Rule 2 (zb) of the MDR. The classification of a product as a medical device is determined with reference to its intended purpose, principal mode of action and risk profile, and such devices are categorised into Class A to Class D in accordance with Schedule I of the MDR (see 1.3 Cat- egories of Pharmaceuticals and Medical Devices ). Upon classification as a medical device, the product is required to comply with the risk‑based regulatory framework, including applicable conformity assess- ment procedures, quality management system requirements, registration or licensing, and post‑mar- ket surveillance obligations, in lieu of the drug approv- al pathway. Notably, a draft bill titled New Drugs, Medical Devices and Cosmetics Bill, 2022 is underway, which seeks to replace the DCA. The Bill proposes a separate and modern regulatory framework for medical devices, distinct from drugs, with device‑specific definitions, approvals and oversight. It introduces a dedicat- ed advisory board, strengthens powers for recalls and emergency approvals, and promotes digital, risk‑based regulation with improved Centre–State co-ordination.
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