India stands tall in the clinical research and services landscape like a colossus. It has a large patient pool, qualified medical workforce and the adequate infrastructure. There is a huge demand for drugs in the areas of rare diseases, allergic conjunctivitis, Duchenne Muscular Dystrophy (DMD), malaria, TB and diabetes, cardiovascular conditions among others.
Though India has 17 per cent of the world’s population and 20 per cent of the global disease burden yet, less than 1.4 per cent of global trials take place in India. In order to create an enabling environment for clinical research by raising awareness about its role and relevance, the Indian Society of Clinical Research (ISCR) has launched a nationwide advocacy programme called NavChetana which operates through three tracks: Education Track which collaboration with educational institutions to sensitise students on clinical research; Professional Alliance Track which involves outreach with professional bodies, associations, NGOs, etc and Media Track which aims to generate mass awareness about clinical research.
Says Dr. Chirag Trivedi, president of ISCR, “Every medicine or treatment we take has been made possible because of a patient who participated in a clinical trial. Our theme "Patients First" acknowledges the selfless contribution and our appreciation of clinical trial patients in bringing new drugs and new treatment to market. It is also dedicated to patients who are hoping for a better quality of life made possible through new treatment and to whom we commit the work we do as clinical research professionals.”
“We call upon all clinical research professionals and patients in the country to join us in commemorating International Clinical Trials Day. We need greater awareness created about clinical research so that patients are aware of their rights and responsibilities. We need to encourage more innovation and research and development in India to make Make in India a reality for clinical research. We also need to ensure that global stakeholders are aware about the balanced regulatory environment we have in the country today. More clinical trials in India will mean that more patients can access the benefits of more effective and newer treatment,” added Dr Trivedi.
Dr. E Reddy, joint drugs controller of India, CDSCO, said that India is one country where regulators monitor the compensation to the trial participants. We have designed the consent form, where the participant’s qualification, occupation and income are noted. Another key feature is the audio visual recording of consent process.
In the case of medical devices, the Central Drugs Standards Control Organisation (CDSCO) has mandated that the companies can seek a one-time license with no renewal. Only in cases where the company license is cancelled , then it will need to renew the same after it complies to the requirement. Another aspect is materiovigilance to monitor adverse reactions, said Dr. Reddy. .
In 2007, India created a Clinical Trial Registry of India. The registry was created to keep tabs on the access to data and the studies that are on-going. This will enable evidence-based medicine.
According to him, Clinical Trials Registry of India hold immense potential for benefiting patients, improving therapeutic regimens and ensuring advancement in medical practice that is evidence based. The registry has created a platform for transparency, accountability and accessibility in order to re-establish public trust in clinical trial data. This would be feasible only if all clinical trials conducted are registered in a centralized clinical trials registry. Registration of trials will ensure transparency, accountability and accessibility of clinical trials.
According to Prof Y K Gupta, professor and head, department of pharmacology, AIIMS, clinical research is essential not only for developing medicines for emerging health concerns such as XDR TB, antibiotic resistant pathogens, H1N1, Ebola virus, etc. but also for finding safer and better medicines for entrenched diseases such as HIV, malaria, diabetes, hypertension etc.
India, with its large patient population, unmet health needs, and limited resources, needs to make newer and better treatment options available to its population in a quick, economical and dependable manner. For this, India must take a proactive part in clinical research and assume leadership role globally,” said Prof Gupta.
Govt mandates clinical trials for FDCs
In June 2017, the Drugs Controller General of India (DCGI) has once again asked the pharmaceutical companies which are manufacturing the Fixed Dose Combinations (FDCs) without due approval from DCG1 office to submit phase IV trial protocols of these combination drugs with main focus on safety of drugs.
Earlier on January 15, 2013, taking a sterner view about the FDC issue, the DCGI had asked the manufacturers to prove the safety and efficacy of the FDCs approved before October 1, 2012 and made it clear that those FDCs approved by the state licensing authorities from October without the permission of the DCGI will be considered for ban. As the companies failed to submit the data, the DCGI kept on extending the final date for submitting the same.
This year in March and June DCGI issued notices asking for examination for safety and efficacy of FDCs licensed for manufacture for sale in the country without due approval from office of DCGI and to submit phase IV trial protocol based on recommendations of Expert Committee on FDC.
Since most of the companies are yet to submit phase IV trial protocols, the matter was once again taken up with the Expert Committee on FDC in order to facilitate the stakeholders for submission of these protocols.
The committee opined that the FDCs for which the post marketing trials have been asked are those FDCs which appear to be rational. However safety in such FDCs is yet to be further ascertained. Therefore the committee recommended that the main focus and primary objective for conducting such trials in these FDCs could be safety and efficacy could be secondary objective. The study could be open label/double blind/ comparative/ single arm/crossover multi-centric trial depending upon the concerned FDC and its therapeutic indication and the number of subjects should be statistically significant.
The committee further recommended that the scientific evaluation by validated parameters/methods should be included for assessing the safety and efficacy. During the study, anticipated safety parameter should be defined clearly along with its monitoring mechanism. The study sites should be geographically distributed.
Tech use to speed up human studies
In June 2017, Ecron Acunova (EA), a fully owned subsidiary of Take Solutions and a globally recognized full service CRO with clinical and BA/BE expertise, consolidated its capabilities to form a unified go-to-market brand Navitas Life Sciences.
Take is known for its Navitas and Intelent big data and analytics expertise. Although Ecron Acunova commenced operations in 2005 as Manipal Acunova, it acquired the German-headquartered Ecron in 2007, and became part of Take Solutions in 2016 to expand operations across Europe, APAC and the Americas.
EA’s clinical capabilities will now be augmented by Navitas’s technology led solutions across clinical, regulatory and safety. Intelent’s big data and analytics expertise will form the 360 degree service provider Navitas Life Sciences. This will help address the critical challenges and achieve outcomes.
According to Dr. Ayaaz Hussain Khan, managing director, Ecron Acunova, capitalizing on the phenomenal growth opportunities in the life sciences industry calls for diverse capabilities. The unification of Ecron Acunova, Navitas and Intelent will enable a seamless consolidation of capabilities in the form of Navitas Life Sciences, which will enable us to offer clients a full-service coverage of the pharma and biotech R&D market to carry forward our legacy of servicing patients across the world.
“With this coming together of capabilities, Navitas Life Sciences is poised to offer its clients the best combination of industry expertise, data and analytics-driven insights and a motivated global team to deliver sustainable and valuable outcomes”, said Srinivasan H.R., Vice Chairman & Managing Director TAKE Solutions.
According to Shukrit Chimote, CEO, Sayre Therapeutics Considering the surge in the cancer associated mortality and morbidity in India, there is a compelling need for effective use of available drugs, and rapid inclusion of novel and life-saving oncology drugs approved in the developed markets such as the US and European Union. The early availability of such drugs can be facilitated by concerted efforts of the authorities and the industry, to ensure that Indian patients are included in relevant global clinical trials which comply with the highest standards. Fast-tracking product approvals for those useful novel cancer drugs approved in reference countries will be a huge boost to the patient community as well”.
Quoting the World Health Organization (WHO) report, Chimote said that cancer is the leading cause of death in the world. In 2012, there were 8.2 million deaths due to cancer, with 70 per cent of them in Africa, Asia, Central and South America. As per ICMR estimates, cancer related deaths are projected to go up by 20 per cent to over 8.8 lakh over the next four years in India.