The Association of Clinical Research Organisations (ACRO) has welcomed new trial inspection guidance released by India’s Central Drugs Standard Control Organisation.
The guidance, part of wider government efforts to shore up the regulatory framework for clinical research, is designed to protect the rights, safety and well-being of study participants, as well as ensuring better GCP compliance during clinical trial inspections.
John Lewis, Vice President of Public Affairs at ACRO which represents a number of CROs operating in India, told OutsourcingPharma that the guidance is “another step toward building a strong regulatory infrastructure in India that will support the continued development of clinical research in the country”.
Clinical research in India represents between 3 to 5 per cent of global clinical trials market making it a “very important emerging country for clinical research”, said Lewis.
He added that the guidelines, which are “very consistent with those of other countries”, will have “little practical impact on operations” as ACRO’s status as an association representing global CROs already bestows it with standardization and consistency.
While its members are said to operate at all times with an expectation that their work will be inspected or audited by a regulator or sponsor, ACRO has stated that it might seek further clarification about what type of ‘specific’ circumstances would trigger unannounced inspections.
“But overall, there is nothing surprising or burdensome in the guidance,” said Lewis.
More inspection time
Quintiles, an international CRO and member of ACRO, has said the ‘clearer directions’ will lead to “greater consistency in the quality of how clinical trials are inspected”.
Suneela Thatte, Executive Director at Quintiles India, told Outsourcing-pharma that the new guidelines will not affect how the firm conducts research in India, adding that: “we are always ready to be inspected as we strictly adhere to all international guidelines such as GCP-ICH.”
However, Thatte continued, “if there is an increase in the time we have to allocate to inspections we welcome the changes because of the value it will add to the overall quality of clinical research in India.”
Inspections provide a means of ensuring patient safety and compliance to GCP-ICH guidelines, claimed Thatte, which concerns all regulatory authorities irrespective of the country involved.