After more than a decade’s experience in participating in global clinical research, India has firmly established itself as an emerging destination for global biopharmaceutical companies. India’s success story has been aided by uniquely differentiating factors which are well documented including a huge and growing disease burden, diseases unique to the region, medical expertise, transforming healthcare market manifested by growing infrastructure and technology, significant and diverse population, talented resources and an enabling regulatory environment that has swiftly adapted itself to global standards. The last decade saw these advantages being gradually translated from a foreseen business potential into reality.
Recently, there have been mixed developments influenced by an evolving regulatory and legal framework, and adverse media reports, that have placed India’s clinical research in the limelight. Product patent requirements that India has signed as a part of the TRIPS agreement make it imperative for India to innovate and introduce products that are relevant to the country. The disease profile and burden of our population is also transforming from communicable diseases, rampant in the past, to lifestyle disorders in addition to certain neglected diseases. Hence, in many ways, we are now globalized even from a health stand point, which necessitates us to innovate and propagate clinical research to help alleviate the unmet health needs of India.
On the regulatory front, there have been developments which have evoked a lot of response from industry stakeholders. The issue of compensation, which has been a grey area for long, is now receiving much desired attention. The initiative by the Ministry of Health to engage various stake-holders in discussions on the draft compensation guidelines is a welcome move. The industry, academia and all relevant stakeholders agree and believe in-principle to compensate clinical research participants. A comprehensive framework on compensation will help plug the hole on a highly contentious issue.
The appointment and constitution of New Drug Appraisal committees (NDAC) to assist in reviewing clinical research proposals across therapeutic areas is a good initiative in strengthening the technical review process by regulatory authorities and has been well received by the industry. The time to review and comment is expected to normalize once the process becomes well oiled.
The recent media reporting and activism against clinical research has significantly impacted the decision making and future plans of various stakeholders in the clinical research industry. The intentions in most cases may be noble, but misconceptions and misreporting have triggered knee-jerk reactions that have led to unpredictability in decision making. Despite the clinical research journey in India being about 15 years, the industry has evolved significantly and has a fairly robust framework in place for the conduct of clinical trials.
If anything, the recent turn of events have led to fortifying the fundamentals of conducting clinical research in India with the industry stepping up the ante on compliance, quality and zero tolerance towards unethical practices at sites and often going beyond their roles and responsibilities in doing so. Many of the sites have put in additional resources, procedures and processes to ensure that there is consistency and scalability in doing multiple projects. The depth of scrutiny and review of proposals by regulatory authorities is instilling more confidence amongst stakeholders, including sponsors and patients.
Given the existing strong fundamentals in India and lessons learnt, it is reasonable to say that some of the current setbacks are temporary and that the clinical research paradigm will equilibrate to a better and balanced one in the near term future.
The global biopharmaceutical industry is at an inflection point with rising costs and dwindling research pipelines. This is further compounded by the 2015 patent cliff when a significant number of molecules go off-patent. One of the big emerging opportunities for India is in the biosimilars space. Indian biopharma companies are already partnering with global CROs, thereby reversing trends in global clinical development.
The US FDA’s recent endorsement of risk-based approach to monitoring vide the draft monitoring guidance is expected to change the monitoring paradigm in the future. The single approach that was applied uniformly across all geographies and sites irrespective of the risk criteria could cease and be replaced with a smarter methodology of applying increasing or decreasing monitoring efforts depending on a variety of risk factors like geographies, type of sites, maturity of sites, compliance levels, previous track records and so on.
Technology will be increasingly used as a driving force to develop services and solutions and we are already seeing this at Quintiles through Quintiles Infosario®, a comprehensive, fully integrated suite of data-driven services that enables optimized drug development. Given the technical expertise and skilled manpower available in India, we have the advantage in being an early adopter and driver in these technology-enabled services and to be able to service global needs in this domain.
India’s advantage in business processes has already been leveraged in preclinical services like data management and pharmacovigilance. This is expected to grow at a healthy rate in future as well. New models of engagement and outsourcing will emerge to create a more efficient and effective delivery system.
Efforts to enhance communication to sites and patients as well as simplifying management of clinical studies at the hospitals has opened up new avenues for technology solution development, which requires a combination of experience in clinical research as well as software solution development.
Central laboratory and related analysis for standardized safety testing is another area that will evolve with the growth of clinical trials in India. The current offering by central labs will have to move upstream in being able to perform sophisticated analysis of unconventional biomarkers. India in the past has always prided itself on replicating complex wet lab analysis. In the clinical research arena, complex tests that have been retained in western geographies could be expected to move East to countries like India and China.
Every difficult situation can be viewed as a problem or an opportunity. In the current environment of increased regulatory, legal and media related challenges, there will be avenues where entrepreneurs will convert challenges into opportunities.
It will be fair to say that though there are temporary challenges in clinical research, the outlook in the medium to long term is bright given the strong fundamentals in this domain. When this happens it will open up opportunities on multiple fronts which will not be on the same template witnessed in early 2000.
India has every opportunity to rise stronger and become a region of excellence in multiple areas.
Source: PB
by
Akshaya Srikanth
Pharm.D Resident
India
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