Though the launch of the clinical trials registry marks a new chapter in the clinical trial registration process in india, there are daunting challenges ahead since its launch in 2007, 64 clinical trials have been registered, but there is still no legal obligation to register. The drug controller general of india is responsible for giving regulatory permission for the conduct of clinical trials in india the dgci provides approval in 12 weeks from the date of submission after the dossier is submitted to the regulatory authorities, parallel submission is done to the respective ethics committees of the potential sites. The fda and who warnings concern the integrity of clinical trial data prepared by semler research center fda and who warn about clinical trials run by an indian company india, saying. Besides the fact that the ill in india are largely drug naïve (read 'untreated'), the company also lists high enrolment rates, good patient compliance/retention, competitive costs, and an increasingly accommodating regulatory environment as the other benefits of conducting clinical research in india.
Issues like approval delays, deficiencies of functioning of cros and other stake holders, liabilities and compensation to injured subjects, insurance issues etc still remain in india, which has made multinational companies to rethink on opting for india to conduct clinical trials in india recently. The clinical trials registry- india (ctri) has been set up by the icmr's national institute of medical statistics (nims) and is funded by the department of science and technology (dst) through the indian council of medical research (icmr) it also receives financial and technical support through the who, who-searo, and the who india country office. The report included the case of clinical trials in uganda between 1997 and 2003, when women taking the anti-transmission drug nevirapine experienced thousands of serious adverse effects (saes. Objectives of the talk evolution of ct in india regulatory procedures requirement for registration ierb issues insurance and compensation the elderly as a vulnerable group this chapter will discuss the evolution of clinical trials and clinical research in india, regulatory issues and challenges sp\cific to the country and the process of multicentre studies in the country.
The indian government’s tightening of regulations for clinical trials was met by criticism from many in the industry, including the association of clinical research organizations (acro), based. Benefits of global outsourcing in clinical trials the price per case report in india in a first rate medical center adds up to 1,500 to 2,000 us dollars, only one tenth of the cost if the same case report is run in a second-tier medical center in the us10 ethical issues in clinical trial outsourcing. Although ip protection issues still linger, some us companies are now outsourcing all phases of product development, including drug discovery, research and development, clinical trials, and manufacturing.
Clinical trials of drugs in india have seen a drastic fall this year after toughened norms were introduced following supreme court directives not only have the number of trial approvals in the. India’s central drugs standard control organization (cdsco) has issued guidance for regulators and sponsors on clinical trial inspection procedures the document issued by cdsco, part of the directorate general of health services at india’s ministry of health and family welfare, sets out the. Ethical concerns in clinical trials in india: an investigation i executive summary this report is the product of a journalistic investigation on clinical trials. As the clinical trial industry is facing lot of resistance in india, industry experts are of the view that the indian regulatory system should undergo massive reforms to contain unethical practices in clinical trials and should pave way to open up at least 10 per cent of global clinical trials in. Clinical case study series cultural issues in informed consent in india, the physician is held in very high esteem, and patients typically and encourages thoughtful discussion of the ethical issues in clinical research as these examples show, effective implementation of informed consent takes.
India's strong value proposition has enticed multinational pharmaceutical companies to enter into or significantly expand existing operations in india in the fields of drug discovery, contract manufacturing and clinical research. One of the major problems of clinical trials in india is that they are not publicized as clinical trials, says dr chandra m gulhati, editor of the civil society journal monthly index of medical specialties. Global spread of clinical trials data from clinicaltrialsgov show that 14% of global clinical trials are currently carried out in india compared with 32% in china, 15% in the czech republic. Journal of clinical trials open access, dialysis and clinical practice open access, annals of clinical and laboratory research, ethics in human experimentation, journal of medical ethics - bmj, journal of clinical & experimental research, american journal of experimental and clinical research (ajecr), international journal of clinical trials.
Recent changes in indian regulation of clinical trials have seemingly impacted the number of registered drug clinical trials based on data from clinicaltrialsgov , registered drug clinical trials in india declined from 2010 to 2015. Clinical research is the key to the discovery of latest diagnostic methods and to develop modern drugs for treatment of diseases good clinical practices (gcp) is an ethical and scientific quality standard for designing, conducting and recording trials that involve the participation of human subjects general of india or an office nominated. Clinical trials industry in india: a systematic review about the institute the institute for studies in industrial development (isid), successor to the corporate studies group 34 legal and ethical issues in recent clinical research 12.