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Amending NDCTR, 2019 to lay down rules for registration will bring in added transparency in operations: CROs

Nandita Vijay, Bengaluru
Wednesday, May 17, 2023, 08:00 Hrs  [IST]

Clinical research organisations (CROs) in the country are of the view that the Union health ministry’s recent decision to amend the New Drugs and Clinical Trials Rules (NDCTR), 2019 to define CROs and to lay down rules for registration, inspection and renewal of registration for these organizations will bring in added transparency in operations of these organizations.

India is recognised as the global hub for human studies across phase I to IV. The country has an edge in this space because of its medical expertise, hospital infrastructure and highly qualified pool of clinical research support staff like nurses and paramedics. The adoption of technology too is much faster and easier because of the English speaking patients, physicians and paramedics, according to CROs.

According to Dr Sanish Davis, president, Indian Society for Clinical Research, the new rules that have been released can have a positive impact on the functioning of all stakeholders in clinical research. The rules specifically address the need for registering clinical research organizations. In this draft for the first time definition of CRO as well as the timeline to grant registration has been included and this will be also inserted into the NDCT Rules of 2019.
The regulation will mandate that all CROs have to be registered with CDSCO in order to be able to conduct clinical trials in India irrespective of whether they are conducting clinical trials or bioavailability or bioequivalence study. The earlier rules required that CRO who is doing BA/BE study has to be registered. There are 15 conditions to the registration that has been laid out by the government to be followed. In another positive development, the clauses for Inspection as well as suspension or cancellation of registration of clinical research organization registered with CSDCO are also stated. Similar rules to regulate the Site Management Organizations (SMOs), which also play a critical role in conduct of clinical trials at the site, would further strengthen the clinical trial oversight in the country, Dr Davis told Pharmabiz in an email.

The draft rules will allow much more streamlined working of CROs in the country as clinical research is a sunrise sector and there is good momentum for India to become the clinical trials destination in the near future.

ISCR is an association of clinical research professionals that aims to build awareness of clinical research as a specialty in India and to facilitate its growth in the country while helping to evolve the highest standards of quality and ethics.
From CROs like ICON to SIRO also noted that the government has extended timely support for companies involved in the clinical research sector. The regulatory framework changes have led to easy approvals and adoption of digital technology for increased transparency and clarity. New rules introduced are clear and in favour of the current market trends for the development of clinical trials.


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