Development of clinical trials in regulatory point of view in India

Yarra Sai Phanindra*¹, Kandregula Kesava Uma Maheswari², Doonaboyina Raghava³, Kavala Nageswara Rao^4
1,2,3,4Department of Regulatory Affair, K.G.R.L College of Pharmacy, Bhimavaram-534201, Andhra Pradesh, India

ABSTRACT
The journey moves from dietary therapy – legumes and lemons – to drugs. After basic approach of clinical trial was described in 18th century, the efforts were made to refine the design and statistical aspects. Clinical trials hold enormous potential for benefiting patients, improving therapeutic regimens and ensuring advancement in medical practice that is evidence based. Unfortunately, the data and reports of various trials are often difficult to find and in some cases do not even exist as many trials abandoned or are not published due to “negative” or equivocal results. In India, in spite of all the present pitfalls, the country is certainly gearing up to attract more and more researchers from around the world to conduct their clinical trial studies. Laws are being amended to facilitate the entry of global clinical trials and the regulatory system is being polished. The current situation improves by massive and concerted efforts are on to train research professionals and increase the base of investigators and supporting staff. India is already off the starting blocks and gearing up for an inundation of clinical research trials and this will ensure the timely conduct and completion of the clinical trials and at the same time generate high quality data for international submission. India is poised to offer the global pharmaceutical industry high quality and cost effective contract services (a proven track record for some of these services and an enthusiasm to expand into services at the higher end of the value chain.) to support drug discovery, clinical trial conduct, data management and manufacturing. An increasing number of international pharmaceutical companies will seek to establish outsourcing arrangements in variety of forms after uphold international intellectual property laws with high ethical standards. The primary driver for outsourcing will change from cost saving to the quest for high quality and speed as the sector matures. India’s more ambitious pharmaceutical companies to fulfill their aspirations of becoming players in global pharmaceutical industry through a thriving contract Skills developed by Indian workforce.
Keywords: clinical trials, regulatory, dietary therapy, legumes, drugs, human testing, Harmonisation.