Virology and Microbiology

Clinical trial is a systematic study of new drugs in human subjects to generate data for discovering, verifying the clinically, pharmacological and adverse effects with the objective of determining safety and efficacy of the new drug. ICH GCP provides the guidelines as an international ethical and scientific quality standard to design, conduct, report and record trials conducted on the human participants. India has the potential to contribute meaningfully to global clinical drug development as the value of clinical research in India is being appreciated. Recently, pharmaceutical companies that are involved in clinical trials are being trailed by a growing concern over the clinical research ethics followed in India. In India, pharmaceutical companies carry out about 60% of clinical trials, while the other 40% are handled by CROs in India. Clinical trials are more than 50 percent cheaper in India compared to developed countries. Global pharmaceutical companies are contracting their projects with Indian companies for several reasons: increasing profit, cost-reduction process of drug development and fast process of regulatory approval & fostering a less hostile environment among the world’s impoverished ill. It is advantageous to perform clinical trials in India as it offers large patient pool, low cost of doing business, availability of expert researchers and huge market opportunities. Top multinational pharmaceutical companies like Pfizer, Glaxo Smith Kline, Aventis, Novartis, Novo Nordisk, Astra Zenica, Eli Lilly are conducting clinical trials in India apart from the Indian companies like Dr. Reddys, Nicholas Piramal, Cipla and Lupin etc. The country is organizing to attract more and more researchers from around the world to conduct their clinical trial studies in India. The regulatory system is being improved. Laws are being amended to smooth the path of entry. India is now balanced to provide the global pharmaceutical industry high quality and cost-effective contract services to support drug discovery, clinical trial conduct, data management and manufacturing.