Indian regulatory officers will carry out random on-the-spot inspections on clinical trial sites to check deviations from July 2010.
Random random on-the-spot inspections on clinical trial sites to ensure their compliance with the current Good Clinical Practice (GCP) norms is among a series of new reforms to have an extensive regulatory system for clinical trials the regulatory agency is planning to bring in the next eighteen months, according to Drug Controller General of India (DCGI) Surinder Singh.
“We will completely change the regulatory landscape for clinical trials in 2010. This will be a historic year in that regard. We are putting in place a system brick-by-brick by the next one year or 18 months,” Mr Singh was quoted as saying.
Regulatory inspectors will visit trial sites with updated checklist in random to verify the compliance of standard practice norms from July.
Indian government has made registration of all clinical trials conducted in the country mandatory from 15th June 2009.
The Drug Controller General of India (DCGI) brought out a notification to this effect informing the applicants to register the clinical trial in ICMR Clinical Trial Registry before initiating the trial process.
The new registration norm will be applicable to the clinical trials started after 15th June 2009, stated the notification from the Central Drugs Standard Control Organisation (CDSCO) –the DCGI’s office.
Registration of clinical research organizations which conduct human studies on drugs, cosmetics and medical devices would also be made mandatory in India.
Central Drug Standard Control Organisation (CDSCO), the apex body regulation drugs in India, has already published the draft rules and guidelines for the registration of CROs seeking comments from the stakeholders of the industry.
The new set of guidelines mandating the registration of all organization conducting human research comes in the wake of looming controversies that large drug companies are making a killing using Indian patients guinea pigs and on the ethical nature of clinical research being practiced in the country.
The draft rules termed as Schedule Y 1 have already been approved by Drug Technical Advisory Board (DTAB), the expert committee that advises the drug regulator on technical aspects. Schedule Y of the Drug and Cosmetics Act of India –the rule book of regulation for drugs and cosmetics –stipulates the broader guidelines for clinical research.
The set of guidelines mandates strict adherence of standard operating practices as pre-requisite for obtaining registration for clinical research organizations (CROs).
Licences will be granted with five years of validity. But the regulator will have the power to suspend or cancel the licence within the term if the CRO is found not complying with or violating the stated guidelines.
Once the licence is suspended or cancelled, the CRO can appeal the Central Government within ninety days.
Schedule Y1 requires that all CROs to be “under the charge of a person who is responsible for the overall activities of the organization,’’ and the person in charge should be thoroughly familiar with the investigational product(s), the protocol, written informed consent forms or other information provided to the subjects, the standard operative procedures by the sponsors, Good Clinical Practice Guidelines (GCP) guidelines and other rules applicable to the conduct of clinical trials.
CROs are mandated to implement and document all SOPs designed for quality control and quality assurance, besides training the staff – including the investigators – to update their skills. Training will include protocol adherence, seeking a free and fair informed consent and responding to concerns of research participants during the study.
CROs should also check the accuracy and completeness of the data/documents and keep all the records (written documents, electronic, magnetic or optical records, scans, etc.) such as protocols, approvals from the CDSCO & ethics committee, investigator(s) particulars, consent forms, monitor reports, audit certificates, relevant letters, reference ranges, completed and the final reports for further verification.
The draft guidelines also seeks an undertaking from the CROs that they will have no objection to “allow the licensing authority and/or any person authorized 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 for which the registration certificate has been made.’’
Clinical trial outsourcing market in India is forecasted to grow at a CAGR of over 30% during 2010-2012 to around US$ 600 million by 2012, according to a new report by RNCOS.
India will become one of the highest growing clinical trial destinations in the world, with this kind of growth, according to the study titled “Booming Clinical Trials Market in India”.
India is becoming a major hub for clinical studies because all the major pharmaceutical and biotech players as well as major CROs are making India their base for conducting global clinical trials.
Finding and recruiting patients – the most crucial part of the clinical research — who can qualify for a clinical trial, is relatively much easier in India as compared to the Western countries.
Increasing prevalence of diseases and low cost of clinical trials are other factors promoting this market. Syngene and Quintiles are right on top in terms of market share in a market which are rather crowd with more than 100 firms working in India in the clinical trial market.