Testing of new drugs for approval under ND&CT Rules, 2019

It is now mandatory that all Ethics Committees must be registered with CDSCO before they can approve any regulatory clinical trial.

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The Drugs Controller General of India (DCGI) has mandated testing of all categories of new drugs for their approval under the New Drugs and Clinical Trials Rules, 2019. The New Drugs and Clinical Trials Rules, 2019 was released on March 19, 2019 by the Central Drugs Standard Control Organisation (CDSCO) to promote ethical clinical research in India.

This is also required as concerns have been raised regarding requirement of such laboratory testing of new drugs which are pharmacopoeial products or which have additional strengths of already approved new drug. CDSCO grants permission for import and manufacture of new drugs for sale and distribution. One of the requirements is testing of the new drugs in the Central Government Laboratories before their approval.

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“In this regard, to streamline the new drug approval process, it has been decided that, testing will be carried out by the Central Government Laboratories as per the following timelines unless otherwise, there is any specific issue involved relating to testing of the drug,” as per the DCGI notice.

As per the notice, timeline for new drugs already approved is 4 weeks, timeline for new drugs which are pharmacopoeial is 6 weeks and timeline for other new drugs is 8 weeks.

New drugs significantly contribute to human welfare, either by making untreatable diseases treatable or by improving patient’s lifestyle and prolonging life for non-curable diseases. They, however, come with an element of risk associated with undesirable side effects.

The idea of ‘risk’ has indeed become a central concept in regulation making particularly in the pharmaceutical industry. Such risk based approaches were considered as not just science but also probability and impact of foreseeable detrimental results and thereby has been accepted as a central theme for a better regulation movement globally.

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While new drugs popularly mean new molecular entities, in reality, it takes various forms, ranging from reformulated generics to fixed-dose combinations (FDCs) of existing drugs.
It is now provisioned that any type of study involving human which is not a drug trial under regulation will be governed by the national ethical guidelines for biomedical and health research involving human participants. Compensation of any study related serious adverse events will be decided by the Ethics Committee.

It is now mandatory that all Ethics Committees must be registered with CDSCO before they can approve any regulatory clinical trial. However, accreditation by National Accreditation Board for Hospitals and Healthcare Providers (NABH) and Quality Council of India (QCI) is not mandatory although recommended. For granting approval of non-regulatory trials, there should be Ethics Committee which needs to be registered with Union health ministry.

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