India’s CDSCO sets up registration site for CROs ahead of April deadline
Indian regulators have launched a website to allow CROs operating in the country to officially log their businesses ahead of the impending registration deadline.
The site – called Sugam - was rolled out by Indian regulator the Central Drugs Standard Control Organization last week. It allows CROs to register and pay a required Rs 5 lakh (roughly $5,000) fee.
In an official notice, India’s drugs controller general, Rajeev Singh Raghuvanshi, wrote, “The online registration of clinical research organization (CRO) is now functional on the Sugam portal.
“Applications for registration shall be submitted through the Sugam portal only, along with the prescribed checklist of documents for registration,” Singh Raghuvanshi added.
Approved applications will be valid for five years, unless they are suspended or cancelled by India’s Central Licencing Authority
According to the CDSCO, the new site will streamline the registration process, enhance transparency and efficiency in regulatory oversight, help ensure compliance with the mandatory registration requirements, and provide a central location for records.
CRO registration
Under Indian law, all CROs operating in the country need to register with the CDSCO by April 1. The requirement was set out in legislation — G.S.R 581 (E) — introduced by the Ministry of Health and Family Welfare in September.
According to the law, “no Clinical Research Organization shall conduct any clinical trial or bioavailability or bioequivalence study of new drug or investigational new drug in human subjects without registration granted by the Central Licensing Authority.”
The law defines a CRO as “the sponsor or a body, commercial or academic or of other category, owned by an individual or an organization having status of legal entity by whatever name called, to which the sponsor may, delegate or transfer in writing, some or all of the tasks, duties or obligations regarding clinical trial or bioavailability or bioequivalence study”.
CDSCO did not respond to a request for more information.
DepositPhotos/Artem Maltsev