INDIA Law and Practice Contributed by: Malathi Lakshmikumaran, Vindhya S Mani, Pallaash Shankhdhar and Khushi Lokwani, Lakshmikumaran & Sridharan Attorneys
2. Clinical Trials 2.1 Regulation of Clinical Trials
drugs, not general OTC, and carry a high risk if taken without a doctor’s advice. Examples include aminop- terin, used to treat paediatric leukaemia and psoriasis. OTC medicines These are drugs that can be sold by a pharmacist without a doctor’s prescription. Currently, OTC medicines are not formally defined in any legislation. In practice, they include non‑pre- scription drugs outside Schedules H/H1/X, such as fever remedies, antifungals, antiseptics, vitamins and wellness products. Regulators are moving toward a formal OTC framework with a separate schedule and clear labelling and licensing norms, as recommended by the DTAB, to streamline regulation and approvals. Apart from OTCs, India also has Schedule K drugs listed under the DCR, and specifies classes of drugs that are exempt from certain licensing requirements, subject to stated conditions. In May 2022, the government of India issued a draft notification proposing to add a starter list of 16 OTC medicines (eg, paracetamol 500mg, clotrimazole cream, povidone‑iodine solution) with safeguards like a five‑day maximum use, limited pack sizes, a man- datory Patient Information Leaflet, and a direction to consult a doctor if symptoms persist. Medical Devices Based on invasiveness, contact with the body, dura- tion and intended use, under Schedule I of the MDR, medical devices are regulated under a risk-based classification in the following manner: • Class A – devices with minimal potential harm and simple design, such as thermometers or tongue depressors; • Class B – devices with limited risk requiring regula- tory control, such as hypodermic needles or suc- tion catheters; • Class C – devices that sustain life or have long‑term body contact, such as infusion pumps or orthopaedic implants; and • Class D – devices that are life‑supporting or life‑sustaining and pose the highest risk, such as heart valves or coronary stents.
Clinical trials in India are regulated by the DCA, the DCR and the NDCT Rules for pharmaceuticals, and under the MDR for medical devices using a risk‑based approach. In both cases, CDSCO and the DCGI are the central authorities responsible for granting approv- als, and prior approval from a DCGI‑registered Ethics Committee is mandatory before trial initiation. The NDCT Rules and MDR prescribe the procedures for application, review timelines, and the conduct of trials and clinical investigations. 2.2 Securing Authorisation to Undertake a Clinical Trial Both pharmaceuticals and medical devices have sep- arate procedures to secure an authorisation to under- • Ethics Committee registration: clinical trials for pharmaceuticals in India are regulated under the DCA and the NDCT Rules. The procedure is over- seen by CDSCO. Under the NDCT Rules, an Ethics Committee must have at least seven members and obtain registration from the CLA by applying with required documents; if the CLA is satisfied, it grants approval that is valid for five years. • Site‑specific Ethics Committee approval: anyone planning to conduct a clinical trial must first obtain approval of the study protocol from a registered Ethics Committee, which is responsible for review- ing and monitoring the trial before it begins and throughout its duration. Any serious adverse events must be reported to the Ethics Committee, the CLA and the host institution within the mandated timeframes. In addition, trial sites must remain accessible for inspections by CLA or SLA officials, or other authorised experts, to ensure compliance with regulatory requirements. take a clinical trial. Pharmaceuticals The procedures are as follows. • Application to the CLA (DCGI) for clinical trial per- mission (Form CT-04 using the SUGAM portal): fol- lowing the Ethics Committee’s approval, the appli- cant submits the protocol and required documents to the CLA. For new drugs or investigational new
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