The Drug Controller General of India (DCGI) has released draft rules for registration of clinical research organisations (CROs) mandating strict adherence of standard operating procedures by the individuals, institutions or organisations conducting clinical trials in the country.

As per the draft rule, to be included in the Drugs and Cosmetics Act, 1945, as Schedule Y-1 and with the title Rule 122 DAB, the CROs can carry out its activities according to the contract with the sponsor only if it is duly registered, under the rules, by the Licensing Authority defined in Clause (b) of Rule 21.

The guidelines cover all organisations, individuals, institutions and companies that take the responsibility of the initiation or management or coordination of a clinical trial even as the clinical trial sites are exempted from registration. The organisations have to submit an application for the registration with the information as required under Schedule Y-1, for the approval from the licensing Authority.

The validity of registration is fixed for a period of five years from the date of issue, unless the regulatory authority has not suspended or cancelled the approval within the said time, explains the draft rule approved by the Drug Technical Advisory Board (DTAB). The DCGI has informed the interested parties to file their response with the drug regulator within a period of 45 days from the period of publication of the draft rules.

India is the first country in the world to come up with such registration criteria for CROs, informs industry experts. "This is a good move from the DCGI's part to assure the global pharma industry and the general public that the clinical trials conducted in the country is now strictly monitored by us. From an industry perspective, it doesn't affect us any way unless intend is not manipulated," said Dr Arun Bhatt, a well-known clinical research expert and president, ClinInvent Research Pvt Ltd.

However, he added that the declaration to be filed by the organisations for registration, which agrees that it should allow surprise inspections by the licensing authority in the clinical trial premises may create some problem, is not implemented in goodwill.

The draft rule mandates that the CROs should undertake a declaration which reads, "We shall allow the licensing authority and/or any person authorised by him in that behalf to enter and inspect the premises and to examine the process/procedure and documents in respect of any clinical trial conducted by us for which the registration certificate has been made."

The draft rules further clarifies that the licensing authority would suspend or cancel the license of the organisation if the latter fails to comply with the conditions of registration and the CRO has to appeal to the central government within 90 days of the receipt of the copy of the order. The central government has the final authority to confirm, reverse or modify such order, after giving an opportunity of being heard.

The guideline also mandates the CROs that all records like written documents, electronic, magnetic or optical records and scans such as protocols, approvals from the Central Drug Standard Control Organisation (CDSCO) and ethics committee, investigators' particulars, consent forms, monitor reports, audit certificates, relevant letters, reference ranges, completed and the final reports, shall be maintained and strict confidentiality has to be observed during access and retrieval procedures.