Government of India is determined to boost the clinical trials industry to attract foreign investment and projects with measures like improving regulation, speeding up procedural process in clinical trials and creating institutions to increase the talent pool. But these have to be done by keeping the wellbeing of human being in mind, said Dr R Ramakrishna, deputy drugs controller (I), Central Drug Standards Control Organisation (CDSCO) at the International Conference on Clinical Trials organized by CII.
Though India has made giant leaps in many sectors, clinical trials sector has not grown substantially and hence, offers a great opportunity and chance to improve people’s lives. However, this nascent industry is fraught with problems. There’s a need for the industry to shift from capacity building to competency development, from seeking outsourced project to seeking entire portfolios and achieve higher levels of operating efficiency through integration and transfer of non core responsibility thus lowering the overall outsourcing cost.
According to Dr Rama Mukherjee, managing director, ARA Healthcare, “India should aim for 25 per cent of the global clinical trials business. Factors that can help us reach the target exist in the country.” She gave an example of China which has gone beyond generic drugs trials and have been active in emerging technologies and easing regulatory mechanism to achieve that goal. “India should also follow suit, besides this, we need to specialise and showcase our expertise and committed workers before clinical trials come to India,” she added.
Dr Arun Bhatt, president Clinivent Research, said, “The regulatory mechanism has to work in a way that is more pragmatic in nature.” He was of the view that the clearances should be time bound. Talking about the impact of recession on the global CTO industry, he said, “Recession forced companies to cut development programs resulting in fewer new projects and delaying new studies. This has also led to the reduction of fixed costs and consolidation of manpower and infrastructure. However, the need of the hour was the emergence of specialised niche players whose market is growing by over 20 per cent every year.”
Highlighting the global scenario in clinical trials through her presentation on the challenges and the opportunities, Suneela Thatte, executive director, Quintiles, said, “Globally the industry is pressurised by rising cost and declining productivity. Therapies have become complex with large patient numbers and longer trials, there’s increased stringency of regulations and trial designs are getting more complex. Though the amount spent in R&D has doubled in 2009, new biological entities are in constant decline. Failure rate of the industry has gone up, the time for research has increased but recruitment rate has declined. These pressures have forced companies to move beyond their own regions resulting in a surge in new clinical trial areas making it a truly global industry.”
The event highlighted that complacency will not do if India has to take advantage of these opportunities. In the short term, there is a need for adaptation, evolution, thought leadership and new business models. In the long term there is need to leverage on new technology, move from curing illness to promoting health, partner in a creative and effective manner across the value chain and create new products and services for emerging markets.
Shiva K Mishra, vice president, clinical research and medical services, Fresenius-Kabi Oncology, pointed out the reasons for the failure of new drug development and how they can be corrected. “Money put in R&D is higher with lesser returns, there’s a higher failure rate, development time is more, there’s increased number of clinical studies required for NDA submission and the number of subjects required per NDA has also gone up adding to cost and time. Yet, the way to correct this is by developing more efficient, faster trials, combining phases to reduce timeline, reduce costs and risk by stopping unsuccessful drug early, have fewer number of trials with less lag time between trials or phases, fewer patients enrolled, accelerated dose escalation methods, development of standard IT Tools and optimising team quality,” Mishra added.
If India has to take advantage of it and claim their rightful share of the opportunity that these changes present, it has to first change its outlook and goal, and more importantly, come together to form symbiotic and profitable alliance with each other.