INDIA Law and Practice Contributed by: Malathi Lakshmikumaran, Vindhya S Mani, Pallaash Shankhdhar and Khushi Lokwani, Lakshmikumaran & Sridharan Attorneys
India does not have a dedicated statutory regime for protecting regulatory or commercially confidential information beyond this practice, but the protection of commercially confidential information related to individuals, to the extent it can be used to identify an individual, shall be regulated under the scope of the DPDP ACT, and hence a data fiduciary shall be liable to undertake the obligations specified under the DPDP ACT and DPDP Rules. 4. Regulatory Reliance and Fast-Track Registration Routes 4.1 Fast-Track Registration Routes India’s regulatory framework provides accelerated or relaxed approval pathways for both medicines and medical devices in defined public interest circum- stances. Pharmaceuticals The NDCT Rules empower the CLA to waive local clinical trials for certain new drugs on a case‑by‑case basis. This may occur where the drug is already approved and marketed in specified reference juris- dictions without major unexpected safety concerns, or where scientific evidence indicates that the drug is unlikely to behave differently in the Indian population. In addition, the New Drugs and Clinical Trials (Amend- ment) Rules, 2026 introduce a “prior intimation” regime for the manufacture of certain drugs, enabling activi- ties to commence upon regulator acknowledgement instead of waiting for formal approval. Permit timelines have also been reduced from 90 to 45 working days, effectively accelerating regulatory reviews. Medical Devices Under the MDR, the CLA may defer, abbreviate or waive clinical investigation/clinical performance evalu- ation requirements, on a case-by-case basis. 4.2 Regulatory Reliance Pharmaceuticals By a notification dated 7 August 2024, CDSCO exer- cised its powers to waive clinical trial requirements for the USA, the UK, Japan, Australia, Canada and the EU with respect to the following drugs:
• orphan drugs for rare diseases; • gene and cellular therapy products; • new drugs used in pandemic situations; • new drugs used for special defence purposes; and • new drugs having significant therapeutic advances over the current standard of care. Medical Devices The results of a clinical investigation may not be sub- mitted if the investigational medical device has already received approval from the regulatory authorities of the UK, the USA, Australia, Canada or Japan and has been commercially available in that country for at least two years, and the CLA is satisfied with the exist- ing evidence regarding its safety, performance and post‑market surveillance. 5. Manufacturing of Pharmaceuticals and Medical Devices 5.1 Requirement for Authorisation for Manufacturing Plants Pharmaceuticals In India, there is no separate manufacturing plant authorisation requirement. Instead, the manufactur- ing or import licence application must include evi- dence that the manufacturing site (India or overseas) complies with Good Manufacturing Practices (GMP) enshrined under Schedule M of the DCR. Here, the manufacturing licence itself acts as the authorisation, subject to fulfilment of GMP obligations under Sched- ule M. Please see 3.3 Period of Validity of Marketing Authorisations and 3.4 Procedure for Obtaining a Marketing Authorisation regarding the detailed pro- cedure with respect to said licences. The 2023 revised version of Schedule M introduced a comprehensive Pharmaceutical Quality System, Qual- ity Risk Management and Product Quality Review for inspectors to assess enhanced GMP elements and align them with the International Council for Harmo- nisation Q10 and WHO-GMP standards. In practice, the relevant SLA, after considering evi- dence of Schedule M compliance, issues a Schedule M/GMP compliance certificate as a pre‑condition.
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