CDSCO can inspect trial sites and seize docs unannounced under new guidelines

By Gareth Macdonald

- Last updated on GMT

CDSCO, clinical trial, guidelines, new, India

Related tags: Clinical trial

Inspectors will be able to visit clinical trial sites unannounced and seize records under new draft guidelines issued by the Indian Central Drugs Standard Control Organisation (CDSCO).

The draft guidelines – set out in this slightly grainy PDF – are an amendment to the Drugs and Cosmetics Act and are designed to improve the oversight of India’s rapidly expanding clinical research sector following a number of scandals​ involving unethical practices at some research centres.

One of the the biggest developments is that sponsors and contract research organisations (CRO) must allow CDSCO officials to enter research premises without prior notice and give the full access to any records, data, documents and books relating to the study.

Registration

The new guidelines also reiterate that before enrolment can begin all trials are registered in the Clinical Trails Registry India (CTRI) – which was launched in 2009​ – and that sponsors and CROs provide an annual report on ongoing studies or explain why research has been terminated.

Suspected unexpected serious adverse reactions (SUSAR) must be communicated to the authorities within a fortnight.

Additionally, if injuries or deaths occurring during a trial sponsors are required to provide complete medical care and compensation for injury and say that this will be available in the informed consent forms signed by people talking part in the research.

Methods used to calculate the appropriate level of compensation are set out in this recently published document.

Ethics

The final area touched on by the guidelines is trial ethics committees – the individuals that safeguard the rights of study participants, which must be reregistered with the authorities every five years.

Under the new rules ethics committees must be composed of at least seven people, appoint a chairperson and secretary and be a mix of medical experts, scientists and members of the lay public.

The new draft guidelines – which are open for comment – are part of a wider effort by Indian regulators to improve oversight of the country’s clinical research sector that began earlier this year​.

Related news

Show more

Related products

show more

What should a clinical metadata repository do?

What should a clinical metadata repository do?

Formedix | 26-Jul-2021 | Technical / White Paper

Choosing a clinical metadata repository (MDR) software can be a tough task as the capabilities and features of your chosen MDR could make or break your...

Adapting supply chains to new ways of working

Adapting supply chains to new ways of working

World Courier | 15-Jul-2021 | Technical / White Paper

COVID-19 has changed the way we operate. We have adapted our supply chain solutions to meet our clients’ requirements while following World Courier standard...

What are the building blocks of DCTs?

What are the building blocks of DCTs?

Medable | 26-Apr-2021 | Technical / White Paper

How to create a seamless experience across eConsent, eCOA and more.

Over the past year, tremendous progress was made toward digitizing and...

How a clinical metadata repository helps with data

How a clinical metadata repository helps with data

Formedix | 22-Mar-2021 | Technical / White Paper

This article covers the various ways a clinical metadata repository helps with data quality, and in turn, with data quality in the clinical trials process....

Related suppliers

Follow us

Products

View more

Webinars