Functioning of clinical research organisations become more transparent

The conditions of registration include that the organisation should maintain the facilities and have suitably qualified and trained personnel as specified in the ninth schedule for performing its functions, and it shall initiate conduct of any clinical trial of BA/BE study of any new drug or investigational new drug in human subjects after approval of the protocol and other related documents by the ethics committee, and permission of such study granted by the CLA

In what can be termed as a good move that is aimed at furthering transparency in operations of Clinical Research Organisations (CROs), the Union Health Ministry will soon amend the New Drugs and Clinical Trials Rules (NDCTR), 2019 to redefine CROs and accordingly revise their rules for registration, inspection and renewals. In this regard, the Ministry has recently issued a draft notification with rules and new chapters added to the NDCTR, 2019. The draft indicates that registration of CROs will be valid for five years from the date of its issue, unless suspended or cancelled by the Central Licensing Authority (CLA), the Central Drugs Standard Control Organisation (CDSCO).

The amendments suggest inserting the definition of CRO in rule 2, sub-rule (1) after clause (i) of the NDCTR, 2016, apart from incorporating a new chapter VA under the Chapter V to deal with the registration and other related matters of CROs. According to this, no CRO shall conduct any clinical trial or bioavailability or bioequivalence (BA/BE) study of new drug or investigational new drug in human subjects except in accordance with the registration granted by the CLA under the rules. According to the draft rules, the CROs for the purpose of conducting clinical trials or BA/BE study with CLA should submit the application for registration in a new form inserted into the rules through the draft amendment. The BA/BE study centres already registered under Rule 44 of the NDCTR will be considered as CRO as per the newly inserted definition of CROs under the rule, for BA/BE study and registered under Rule 38A of these Rules. Such institutions will not be required to make any application under this rule for BA/BE study.

Indeed, the new rules will allow much more streamlined working of CROs as clinical research is a sunrise sector and there is good momentum for India to become the hub for clinical trials in the near future.

The conditions of registration include that the organisation should maintain the facilities and have suitably qualified and trained personnel as specified in the ninth schedule for performing its functions, and it shall initiate conduct of any clinical trial of BA/BE study of any new drug or investigational new drug in human subjects after approval of the protocol and other related documents by the ethics committee, and permission of such study granted by the CLA. The CLA should be informed about the approval of the ethics committee for clinical trial or BA/BE studies and the study shall be registered with the Clinical Trial Registry of India. The CLA should also be informed if the study is terminated prematurely, with detailed reasons for such termination. If there is any change in the constitution or ownership of the CRO, it should inform CLA in writing within 30 days. The organisation should maintain data, records and other documents related to the conduct of the clinical trials for a period of five years after completion of such study or for at least two years after the expiration date of the batch of the new drug or investigational new drug studies, whichever is later. The CRO should allow any authorised officer of CLA, accompanied by an authorised officer from the State Licensing Authority (SLA), to enter the premises with or without prior notice, to inspect any record, statistical observation or results or any documents related to clinical trials and furnish information to the queries raised by such authorised person.

The CLA can impose additional conditions in writing with justification, in respect of specific clinical trials regarding the objective, design, subject population, subject eligibility, assessments, conduct and treatment of such specific study. The amendment also lays down the rules for inspection of the CRO, conditions for suspension or cancellation of registration, among others.

Of course, the Union Health Ministry’s initiative will bring in added transparency in operations of these organizations. It is a fact that India is now 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. The new rules will have a positive impact on the functioning of all stakeholders in clinical research.

The new 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 BA/BE study. The earlier rules required that the CRO, who is doing BA/BE study, has to be registered. In another positive development, the clauses for inspection as well as suspension or cancellation of registration of CRO registered with CSDCO are also clearly stated in the proposed amendment. Obviously, the government has extended timely support for companies involved in the clinical research sector.

The new changes will lead to easy approvals and adoption of digital technology for increased transparency and clarity in the operations of CROs in the country.

(The author is freelance journalist with varied experience in different fields)