India Tightens Clinical Trial Oversight

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Global regulatory news tracker RegLink weighs in on India's new drug and device clinical trial rules

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Stepping up to its status as a preferred venue for clinical trials on new drugs, India has just taken some significant steps to ensure that human research conducted locally conforms to internationally recognized standards. The country’s Ministry of Health has released three new draft rules governing the approval of Indian clinical trials, the registration of ethics committees in charge of reviewing and approving investigation protocols, and the compensation payable to patients enrolled in trials in the case of injury or death.

The first of the three new rules requires registration of all trials with the government’s Clinical Trial Registry before patient enrollment can proceed. For the first time, the country’s FDA-equivalent, the Central Drugs Standard Control Organization (CDSCO), will have the authority to inspect clinical trial sites and “seize any record, data, document books, or investigational drugs” related to clinical trials during the inspection. A second rule sets out requirements for the composition of the ethics committees in charge of reviewing and approving investigation protocols, and lists the information that has to be included in the registration application, such as whether the committee has been audited or inspected and if so by whom. The final draft released by the Ministry of Health covers all trials conducted on drugs and medical devices, as well as bioavailability and equivalence studies, and provides a formula for determining the level of compensation payable to patients injured or killed in the course of a trial. The formula factors age, income and the severity of the disease the patient was suffering at the time of the clinical trial.

India’s new rules come on the heels of the recent announcement by the European Commission of plans to make it easier – and therefore less costly – to conduct multinational trials in Europe. According to Ansis Helmanis, partner at global regulatory news tracker RegLink Associates, “Sponsors of clinical trials choose countries such as India for practical cost containment reasons rather than any problem with bureaucracy in established markets such as Europe. India is simply less expensive.” National policies in Europe and elsewhere have relentlessly targeted the research-based industry for cost containment - and this in turn has forced the industry to implement its own cost containment policies. And India recognizes what it must do to ensure that the clinical trial data developed in India will support marketing approval applications in the established markets.

About RegLink:
RegLink Associates, LLC is an online publisher of two e-weekly Global Updates that provide a round-up of the previous week’s regulatory, clinical, reimbursement, commercial and health technology assessment developments worldwide. Its Global Drugs and Biologics Update and Global Medical Device Update aggregate the “What’s New” from major markets around the world by country, region and topic with links to source documents and brief translation of title and content. RegLink offers a free 30-day trial of its Updates.

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Louise Zornoza
RegLink Associates
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