India is fast becoming one of the favoured destinations for clinical trials among South Asian countries, thanks to the time zone advantage, lower labour costs, edge in information technology and availability of human resources. All these factors have helped India to gain more share in global clinical trial market.
According to the Confederation of Indian Industry study, clinical trials in India in 2002 generated $70 million in revenues and predicts that it would grow anywhere between $500 million and $1 billion by 2010. The clinical trials market is currently worth US $385 million. Intellectual property protection has tightened up in the last couple of years, and there is strong government support for turning India into a global hub for conducting clinical trials.
To conduct clinical trials in India, clinical research organisations (CROs) have to obtain 'no objection' letter from Drugs Controller General of India (DCGI) at New Delhi and import licence to import the research drug. Once CROs obtain the approval from DCGI, they can start their research. During the research the biological samples will be collected from the subjects for confirming the inclusion and exclusion criteria for participating in the trial. Later the biochemical parameters would also be tested with the help of the biological samples. The biological samples will be exported to central lab situated outside the country. For this, CROs have to obtain the export license from Directorate General of Foreign Trade (DGFT) at New Delhi. Once DGFT issues permission, the applicant has to garner the export licence from the regional JDGFT office situated in their jurisdiction. During this entire regulatory process, enormous time is consumed as DGFT don't give permission until an approval is obtained from DCGI.
As Indian government is always pro industry, it has considered the plight of CROs and to bring down the time delay, DCGI have released new format for export application. This format has to be filled by CROs and submit to DCGI along with clinical trial application.
The requirements as per the new format for exporting biological samples for testing purpose are:
● Name and address of the firm
● Type of application (global trial/bioequivalence study/others)
● Name of the drug
● Purpose of the export of biological samples whether any permission granted by this directorate for clinical trial of the subject drug
● Tentative date of completion of clinical trial
● Import export code number
● Type of sample (e.g. whole human blood, serum, plasma, urine, others) with their import tariff code and quantity of samples
● Shipment details such as port of loading, port of discharge and country of export
● Name and address of the laboratory where analysis to be conducted
● Whether the application is already submitted in DGFT, if so, submit the copy of the same
Once the DCGI receives the application in above format, his office will scrutinise the application for its completeness and issue the 'no objection' (NoC) letter to the applicant as well as internal copy to DGFT office. This NoC will allow the CROs to speed up their file lay in the DGFT office.
Again Indian government has proved its pro pharma industry approach with the Ministry of Commerce and Industry making a policy decision in last week of February 2009. As per the decision, 'no objection' letter obtained from DCGI alone will suffice CROs to export their biological samples and requires no export licence from DGFT and JDGFT office.
Yet, industry is constantly watching to see how this new policy is going to get implemented. Once this becomes a practice, it is learnt that main regulatory time hurdles faced by the clinical research organisation would be removed.
In sum, the entire timelines have been reduced significantly from four weeks to one week and as a single window system, DCGI will grant all the required approvals such as NoC for conducting clinical trial in India with issuing import license and NoC for export license altogether, thanks to Indian government which always protects the interests of the pharma companies who are constantly involved in improving the healthcare of the citizens.
(The authors are with PharmaLeaf India Private Limited, an International Regulatory Consultancy at Bangalore)