Singapore, Sep 25, 2009: In an effort to give a conducive business environment to CROs in the country the Indian regulatory agency has released draft rules for mandatory registration of all Clinical Research Organizations (CRO) across the country. Approved by the Drug Technical Advisory Board (DTAB), India, the draft guidelines are to standardize practices among such organizations and mandate strict adherence of standard operating procedures.
The guidelines are not standalone, the objective is to improve overall quality of clinical trials by working hand-in-hand with other applicable rules, like Schedule Y, Indian GCP guidelines and Ethical Guidelines for Research on human subjects by ICMR.
According to the draft made available to the public, the guidelines cover all organizations, individuals, institutions and companies that take the responsibility of initiation, management or coordination of a clinical trial. Thus, the draft rule makes it clear that the CRO 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.
The application for registering is to be submitted along with details required under Schedule Y1, which is the new rule waiting to be implemented. The registration will be granted if the organization satisfies the requirements of the compiled rules and conditions. The licensing authority may even probe an enquiry before completion of the process. The registration will then be valid for five years, while the licensing authority holds the right to reject applications, ask show cause suspend or cancel registrations. Later, if an organization gets suspended, it will have to appeal to the Central government within 90 days, and in turn, the government after giving an opportunity of being heard, may confirm, reverse or modify such order.
A person thoroughly familiar with the nitty-gritty of clinical trial operative procedures should be in-charge of the CRO, while taking responsibility for its overall activities, as per the rule. While revisiting basics like ensuring adequate resources, implementing quality assurance and having qualified staff, the guideline requisites regular training for the staff to update their skills. In fact, the rule also mandates conducting education programs by the CRO to help its investigators carry out the research studies. This training is expected to include protocol adherence, seeking a free and fair informed consent and responding to concerns of research participants during the study.
Among others, Schedule Y1 stresses on the right kind of record keeping during trials. Records in all forms such as, written documents, electronic, magnetic, optical records and scans are to be maintained. Information pertaining to protocols, approvals from the Central Drugs Standard Control Organization (CDSCO), audit certificates, completed final reports, along with all documentation and communication are to be dated, filed and preserved according to written procedures.
Finally, before the organization registers, it needs to declare that the licensing authority has the right to inspect its premises at any given time and examine the process, procedure and documents of any trial taken care by the organization.
The policy scenario in India is bucking up to its long proclaimed name of the hot destination for clinical trials in Asia. Another step forward towards better trials was when in June 2009 India’s CDSCO, announced the mandatory registration of clinical trial across the country. Hence, from June 15, 2009, all trials in India are being registered in the ICMR Clinical Trial Registry, before initiation.
China okays speedy custom clearance
China is looking to create an attractive environment for CROs in the country. Responding to the demands of this flourishing industry, the government in China is implementing measures to speed up customs clearance processes at Pudong International Airport.
Three CROs from Zhangjiang Hi-Tech Park have been selected for a trial operation of Express Clearance, which aims at reducing time at customs. The timing of CRO shipments is seen to be critical for successful CRO operations. Accordingly, one of the companies has already reported shortening of shipment time from three days to one day on an average.
"With these efforts from Chinese customs, the shipments to our clients are delivered without any delay at customs. The Express Custom Clearance privilege granted to Sundia greatly benefits our clients with high-quality and effective service on a timely basis," says Dr Wang Xiaochuan, Chairman of Sundia.
Also, as part of the effort, trained customer service professionals at Shanghai customs have been assigned to assist CRO companies to ensure a smooth declaration and clearance process. The other two companies who are granted with this clearance privilege are Huiyuan Biotechnology and Frontage Laboratories. This new customs clearance model will be implemented for more CRO companies after the successful trial.
China along with India and other emerging countries have of late, been important destinations for clinical trials. There has been an influx of CROs in these regions. And the Chinese government are looking at this move to give a push to the local organizations. According to market research, the Chinese CRO market was valued at $250 million in 2008. This market is also expected to grow at a compound annual growth rate of 33 percent over the next four years to reach $791million in 2012. By that time, Chinese CROs will account for an estimated 2.3 percent of the global CRO market.
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