Kotipalli Jyothirmaye*, Yarra Sai Phanindra, Beram Saranya, Doonaboyina Raghava, Kavala Nageswara Rao
Department of Pharmaceutical Drug Regulatory Affairs, K.G.R.L College of Pharmacy, Bhimavaram-534201, Andhra Pradesh, India
A B S T R A C T
In drug development, two partly overlapping phases can be differentiated, namely the preclinical and clinical phase. During the first part of drug development necessary requirements for first use in man are met be performing preclinical pharmacological, toxicological, and pharmacokinetic investigations in the animal and in-vitro testing. The Central Drugs Standard Control Organization (CDSCO) is the National Regulatory Authority in India. Its equivalent counterparts elsewhere include United States Food and Drug Administration (US FDA), Health Canada (HC) and the, European Medicines Agency (EMA). The Drugs Controller General of India (DCGI), an official of the CDSCO, is the final regulatory authority for the approval of clinical trials in the country. DCGI office is also responsible for inspections of trial sites, sponsors of clinical research and manufacturing facilities in the country. In case of noncompliance, study may be rejected or discontinued; suspend or cancel the clinical trial permission, or debar the investigator(s), sponsor including his representative to conduct any clinical trial in future by DCGI. In future steps, the CDSCO office may start working on filling some of gaps in areas of Subject Expert Committee (SEC) and post-trial access guidance document. Finally, there could be difficulty in implementing these rules and it will be interesting to watch how the CDSCO office takes on the challenging task of meeting the objectives laid out by these rules. The review concludes that the clinical trial industry in India has great potential to become the most favourable destination in the world because of low cost of doing business, the availability of skilled professionals, and, the availability of a large and diverse patient pool. Many global CROs relocate their research units to India for drug development activities. Though the CT industry has been taking advantage of the huge financial gains, technological transformation for development of NCE is not happening. Also, the Indian public health industry only partially benefits from CTs. The Government of India needs to establish a policy framework for the Indian CT industry to provide for easy access to affordable drugs developed through adaptive clinical trials in India. There is also a need to create a regulatory environment capable of ensuring the conduct of clinical trials without violation of humanitarian ethics and other social norms.
Keywords: CIOMS, CDSCO, GCP, ICMR, DCGI, USFDA