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.