The 2015-2016 has been a mixed year for the Indian clinical services industry. While on the one hand Syngene International, the contract research arm of biotechnology major Biocon, made an impressive market debut on the Indian bourses in August 2015, on the other, the global regulators cracked down on Semler Research and GVK Bio.

The industry observers feel that as the global regulations are evolving, the government of India should now put in place effective norms at the earliest to tap the emerging opportunities in areas such as new generic drugs, biologics, biosimilars and vaccines.

Clinical service experts are of the view that researchers should be accountable and responsible in collating data and should adhere to existing norms.

Though India has 16 per cent of the world’s population, 20 per cent of the global disease burden yet only less than 1.4 per cent of global research takes place in India.

Given India’s increasing burden of disease, there is an urgent need to build confidence and trust amongst global stakeholders in doing clinical research and foster an environment and ecosystem that encourage clinical research, pointed out Suneela Thatte, president, Indian Society for Clinical Research (ISCR).

Advantages for India
The big advantage for India over and above its access to patient pool, largest English speaking medical and patient group along with the hospitals for conducting clinical trials is that the country also accounts for USFDA, WHO, EMA and Asia-Pacific region’s regulatory approvals. Moreover, it is a signatory to the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) which is aimed at protection of undisclosed information.

Clinical research is critical in the wake of antibiotic resistance, drug resistant TB, malaria, dengue, H1N1 and HIV, besides chronic diseases like diabetes, hypertension, cardiovascular diseases skin disorders and cancer.

Even as the world is looking at India to conduct clinical trials, the Union government through its Ministry of health and family welfare should look at taking the initiative to build quality standards and risk management into the design and planning of clinical trials to ensure high quality human studies. This is the only way to enable effective risk-based monitoring (RBM), said experts.

According to Dr. Saral Thangam, CEO, Norwich Clinical Services, there is great potential for growth of clinical research companies that ensure highest quality standards and conduct the studies in a compliant manner and prove reliability and consistency in data submissions.

“However, the government of India needs to support this sector with consistent policies and ensure dependable timelines for approvals. While there are no delays in clearances for bio-studies, clinical trials consents warrants a minimum 6-month duration from the Indian regulator as compared to the two month clearance from USFDA. In an age where advanced generics, biosimilars and biologicals like insulin and monoclonal antibodies are proving to be the medication choice as lifesaving drugs, the Union government should now make efforts to speed up related policy announcements and extend the much needed support to the industry in a transparent, reliable and consistent manner,” pointed out Dr. Thangam.

A visible trend in the pharma-biotech industry is a drastic shift from simple to complex molecule production. These large compounds call for large complex clinical studies and safety evaluation. These also challenge the capabilities of the Indian CROs and raises the bar on scientific and technical competence. While guidelines for these complex molecules are still in an evolving phase. USFDA and EMA have put in place norms which is still evolving in India, said Dr. Thangam.

Human studies
Human studies are both complex and expensive to conduct as it demands patient safety at every level. Now clinical trials is a platform where pharma companies look to collaborate with reliable and high quality partners. It is a globalized interconnected business model where responsibility and accountability are the key factors to spur growth, said Dr. Thangam.

 “India is a hub for clinical trials and this country cannot be ignored for human studies. But the need of the hour is reliability and integrity of not just the principal investigator but the entire team comprising of doctors, pharmacologists and related qualified personnel. There is need to effectively communicate to the patient on the requirement of being part of a clinical trial. There is absolutely no compulsion by clinical research organizations to force people into a human study. Now we are dealing with the health of the people and there is a scientific and an emotive aspect while undertaking a clinical trail,” said a senior industry official who did not wish to be named .

The medical team which is engaged in the conduct of the clinical trial needs to be objective in patient selection and counselling. Ensuring highest integrity in thought and word could only enable accuracy in a drug study which is most valuable as it deals with saving patient lives. At every point, a patient is impatient in either a short or long clinical trial programme. He is not willing to go through the study and even could discontinue it. In order to avoid such a situation, it is vital to make sure that the trial participant is convinced to take a decision voluntarily based on the pros and cons of the study provided by the medical teams and the clinical research coordinators. This is makes a huge difference to the data emanating from the human study, said the official.

Another aspect is that access to accredited laboratories and diagnostic systems to ensure data accuracy. Now this is largely deficient in developing world. It happens because of the absence of protocols. Since there are more global trials happening in India and only a handful of Indian company studies going on, the country will need to put in place stringent regulations to enable that systems and processes for high quality data generation are in place, besides the dependency on faster turnaround which would be recognized by the global pharma majors, said the official.

The January 4, 2013 Supreme Court order had stalled clinical research activity in India. It was estimated by late Prof. Ranjit Roy Choudhury that the out of the 120 CROs in the country the numbers drastically fell to a mere 20. The current well-known companies engaged in clinical trails include Syngene, Veeda, Lambda, Norwich, SS Medical Research India Ltd., formerly Max Neeman International and Clintec to name a few.