The time is ripe and the tide is in favor of India to position itself in the emerging global business as a 'CRO' and establish its credentials as a one-stop shop offering solutions to all the requirements of clinical research and drug research.
While the word 'CRO' (contract research organizations) encompasses a wide plethora of services including custom chemical synthesis, methodology development in analytical techniques, process up gradation & development, scale up process & intermediate chemical synthesis, etc. the common connotation is of contract research in the areas of clinical research.
All CROs established, exist and thrive on the principle of highly specific, technology driven, competency intensive, niche areas by adding significant value and completing objectives within projected timelines and budgets. The above cardinal objectives of CROs differentiate them from sponsoring organizations.
TIME IS RIPE
India, the second most populous country in the world is no longer one among the developing nations. Our progress in the field of information technology (IT) and biotechnology (BT) is laudable and is gaining increasing acceptance world over. The fact that our foray into the CRO market is gaining credibility is evident from mushrooming of not only many Indian CROs but also is further strengthened by the interest evinced by most multinational companies to outsource such work to either their own subsidiaries here in India or to other Indian CROs.
Indian CROs are at present and in the very near future capable of contributing to the following areas of clinical research and drug discovery: Bio-availability, Bio-equivalence Studies, Clinical Trial Site Management, Clinical Operations Management, Clinical Trial Management, Multi-centric Clinical Trials, Central Bio-analytical Lab Facilities, Data management, Bio-statistics, Report writing and Global Clinical Trials - Phase I, II, III, IV.
Most generic drug manufacturers with their own formulation facilities are now attempting to put up state-of-art Bioavailability and Bio-equivalence infrastructure to cater not only to our regulatory requirements but also to that of the U.S and European markets. Indian expertise in IT and availability of skilled and competent manpower can best be harnessed and utilized for clinical trials sole management - clinical operations management, Data management, Bio-statistics and report writing.
The conduct of simultaneous successful multi-centric global clinical trials with Indian sites leading in patient recruitment, retention and completion of all trial related activities by Indian subsidiaries of multinationals like Eli Lilly, Pfizer, Novo Nordisk to name a few, have proved beyond doubt the choice of India as a destination for Clinical Trials. Most if not all multinational companies are eying India as economically viable trial centers capable of rapid subject recruitment and study implementation.
The advent of reputable central Bio analytical laboratory facilities, their certification and accreditation by national & international agencies and CAP (College of American Pathologists) have added an important & crucial dimension to conduct of clinical trials. No longer are we in India, required to rush our trial samples for analysis to international laboratories and no longer do we have time-consuming formalities for sample export and import. With improved telecom and courier service & LIMS, our Investigators are well equipped and confident of meeting recruitment and implementation timelines.
TIDE IN OUR FAVOR
The Regulatory requirement guidelines of India are being revisited by the Ministry of Health, DCGI, ICMR and DBT working in tandem to promote growth of clinical research in India. The availability of specific guidelines to conduct clinical trials of new drugs (chemicals, biologicals, vaccines and r-DNA drugs) and easing of import - export rules for new drug molecules, samples and biological specimen have paved way for progress. The open transparent and rapid scrutiny of clinical trial applications has facilitated new guidelines to conduct Phase I to Phase IV clinical studies in India.
ADVANTAGE INDIA
The availability of heterogeneous patient population with diverse ethnic and genetic backgrounds, coupled with a naïve new drug group, ensures faster patient recruitment cutting timelines, thereby permitting cost benefit. The Indian medical fraternity is familiar with western medical facilities, competent in English and work in premier hospitals with world-class medical infrastructure. Most of our reputed clinical investigators are aware of and comply with ICH - GCP guidelines and ensure that their medical assistants, paramedical staff and clinical trial monitors do the same.
WHAT WE NEED TO DO!
In this competitive world, it is necessary that we excel and we can do that only when we rapidly build up the required infrastructure and implementation competencies. We will attain international recognition and acceptance only when trustworthy, reliable data generated by us in India is accepted by global regulatory authorities and the medical fraternity. This again is possible only when we consciously adopt ICH-GCP, GLP, GMP, GRP to GXP guidelines.
Towards this, let us train ourselves and attain global recognition by constant upgradation, fine tuning, certifications and accreditations. Time and tide wait for none.
-- The authors: Dr R S Nadig is vice president, Medical Services and C Omprakash is Manager - Regulatory & Data Management at Clinigene International
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