New Drugs and Clinical Trials Rules, 2019

What it does

The New Drugs and Clinical Trials Rules, 2019 are made under the Drugs and Cosmetics Act, 1940. They state how a new drug is approved for manufacture or import in India, how a clinical trial may be conducted, and how studies of bioavailability and bioequivalence, which compare a generic with a reference product, are to be run. They also deal with the registration of ethics committees, with the obligations of sponsors and investigators, and with compensation where a participant is injured or dies in a trial.

The rules brought together provisions that were earlier spread through the Drugs and Cosmetics Rules, 1945, including the old Schedule Y, and put them in a separate instrument. The central licensing authority, which is the Drugs Controller General of India working through the Central Drugs Standard Control Organisation, grants approvals. The rules set time limits for decisions on applications, and different periods apply according to where the drug was developed.

Who it binds

They bind sponsors of trials, which include pharmaceutical companies and research organisations, investigators and the institutions where trials are held, ethics committees, contract research organisations that run trials for a sponsor, and manufacturers and importers who apply to market a new drug. They bind the licensing authority as well, which must decide within the time the rules allow and give reasons for a refusal. A participant is protected by the rules on consent, on safety reporting and on compensation.

What has changed, and when

• The rules were notified in 2019 under the Drugs and Cosmetics Act, 1940, and replaced the earlier provisions on new drugs and trials in the Drugs and Cosmetics Rules, 1945.
• They have been amended since, and the amendments should be checked against the date of any application, since a requirement or a waiver can change.
• Medical devices are dealt with separately, under their own rules, and are not covered here.

What turns on it in practice

The first matter is approval before the trial. A sponsor must have the trial protocol approved by the licensing authority and by a registered ethics committee before enrolling participants, and the rules set what the application has to contain. A sponsor that starts without the approvals risks the trial data being unusable and exposes itself to action under the parent Act.

The second is compensation. If a participant suffers injury or death related to the trial, the sponsor or the person who obtained the permission must pay compensation under the formula and procedures that the rules lay down, and must also provide medical care. A contract between a sponsor and a site, or between a sponsor and a research organisation, should allocate the cost of that obligation and the insurance behind it, because the duty to the participant does not move with the contract.

The third is the record. Informed consent, audiovisual recording of the consent process in the cases the rules require, adverse event reporting and the retention of data are the points an inspection will test. A deviation can result in suspension or cancellation of the permission.

The fourth is the position of a company seeking to market a drug that has already been approved elsewhere. The rules allow, in stated cases, a waiver of a local clinical trial. The conditions and the countries covered are set in the rules and in later amendments, so the version in force at the time of the application decides the answer.

The site's healthcare and pharma work meets these rules at each of those points: the structure of a trial agreement, the approval path for a new product, and the position of a company whose trial has gone wrong. The related regime for good manufacturing practice is separate, and the revised Schedule M timelines, covered in the site's notes, concern manufacturing and not trials.