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Regulatory Focus™ > News Articles > India's Health Ministry Releases New Clinical Trials Requirements

India's Health Ministry Releases New Clinical Trials Requirements

Posted 14 February 2013 | By Alexander Gaffney, RAC

India's Union Health Ministry has released a new rule requiring all ethics committees to be registered with licensing authorities, part of a broader effort to improve the quality of clinical trials in India, which have long been under fire by critics.


India's drug regulatory bodies were steeped in controversy in 2012. From the onset, Indian regulators and companies came under fire after media investigations found that clinical trials conducted in the country may not be affording adequate protections to participants, either in the form of compensation for injuries suffered in the course of the trial or from potentially unsafe drug products.

As the year went on, a seemingly endless wave of bad news hit regulators, and in particular the Central Drugs Standard Control Organization (CDSCO). Reports indicated that CDSCO had approved some drugs without the required clinical testing, while other news reports noted that nearly 2,000 Indian patients had died while enrolled in clinical trials between 2007 and 2010, leading to calls for reforms.


The Union Health Ministry's rule is directly aimed at introducing more accountability into the system, making it more difficult for potentially dangerous or unethical clinical trials to get under way without the knowledge of regulatory officials.

The rule, Notification No. GSR 72 (E)-also called the Drugs and Cosmetics (Third Amendment) Rules of 2013-explains that "No Ethics Committee shall review and accord its approval to a clinical trial protocol without prior registration with the Licensing Authority as defined [by the rule]." Those registrations will then be good for three years, after which time it will need to be reviewed and renewed. If that renewal notice is received three months prior to expiry, regulators will allow it to continue until they make a decision to the contrary.

The protocols will be reviewed for their adherence to good clinical practice (GCP) guidelines and "other applicable regulatory requirements for safeguarding the rights, safety and well-being of the trial subject," and will be reviewed on a regular basis. In the case of "any serious adverse event," the trial will be reviewed, and an opinion generated under Appendix XII of Schedule Y.

Ethics committees will also be required to allow CDSCO investigators to enter their trial sites to inspect records, data and other documents.

All existing protocols already approved by an ethics committee must be registered with licensing authorities within 45 days of the rule's enacting (8 February 2013), the rule says.

Notably, ethics committees will also now be required to "review every clinical trial proposal and evaluate the possible risks to the subjects, expected benefits and adequacy of documentation for ensuring privacy, confidentiality and justice."

The rule also dictates the requirements for the composition of the ethics committees, which are now similar in their requirements relative to those of the US in that at least one member must be from outside the institution, one member must be of a non-scientific background, and at least five members must be present to approve a protocol.

Other requirements, such as protocol-specific content and data maintenance, are also explained in the rule.

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