India’s clinical research business is heading towards a serious crisis with recent detection of data fraud by the global drug regulatory authorities. Allegations of falsification of data by the Bengaluru based contract research organisation (CRO), Semler Research Centre, has affected the credibility of Indian human studies, noted a section of industry experts.
With two regulatory majors USFDA and WHO pinpointing data integrity concerns on drugs which were earlier based on bio analytical data of BE studies have now rejected Semler’s applications approval.
US FDA has said that the sponsors are now asked to repeat the clinical studies following rejection of their New Drug Applications (NDAs) and Abbreviated New Drug Applications. WHO stated that Bio Equivalence studies of anti-virals and antibiotics for Indian companies are not pre-qualified but under assessment.
The incident also affects the morale of Semler employees who fear that their future job prospects could be jeopardised because of the company being named by US FDA and WHO for data integrity issues, experts said.
“India has 16 per cent of the world’s population, 20 per cent of the global disease burden and yet less than 1.4 per cent of global research is done here. While we cannot comment on the specifics of this case, we would like to stress our commitment to ensure clinical research is conducted in India in an environment where quality, ethics and patient safety are not compromised,” Suneela Thatte, president, Indian Society for Clinical Research (ISCR) told Pharmabiz in an email.
“In this specific instance, the company concerned has been given 30 days to confirm action taken and prevent similar violations in the future. We expect they will do so to ensure that patient data and safety are protected,” she added.
Industry observers contend that such an allegation is not new to Indian CROs. In July 2015, Hyderabad-based European Union banned 700 generic drugs where the BE studies were conducted by GVK Biosciences following concerns of tampering of clinical data and for bio-analytical data by French medicines standards agency ANSM. But the company clearly clarified its stand following the Union government’s effort to form a panel of experts within three months to examine the issue and established no falsification of data by the company.
“While we do not condone any irregularities, we would also like to acknowledge there are several hundreds of clinical trials taking place in India complying with international and local guidelines. Given India’s increasing disease burden there is an urgent need to build confidence and trust amongst global stakeholders in doing clinical research in India and foster an environment and ecosystem that encourages clinical research,” pointed out the ISCR president.
But pharma consultants are apprehensive that this instance could lead to all Indian CROs be painted with the same brush even if they are upright and following good clinical practices.
Until 2010-2011, the Indian clinical research industry valued at Rs. 8,000 crore was sought-after for its medical expertise, large patient pool English speaking work force, capability in information technology, and modern hospital infrastructure, besides quick turnaround and data management skills. In October 2013, following the Supreme Court order halting 162 human studies, India’s clinical research faced a debacle. But an expert committee under late professor Ranjit Roy Chaudhury brought about some revival in human studies with norms to prevent and stall illegal practices, experts pointed out.
“There are steps put in place by the ministry of health and family welfare to strengthen the regulatory governance for clinical research. Even as there may be violations and deviations which are less common, there are robust guidelines in place to conduct clinical research which ensures highest standards of ethics and quality and where patient rights and safety are protected. It is only through clinical research that newer and better treatment options are made available to Indian patients, particularly for illnesses where there is an unmet medical need,” stated Thatte.