Waiver of trials for proven drugs will make availability faster, says Tim Regan
Bengaluru: The George Institute for Global Health of Australia has been in India for a decade, conducting studies and evidence based research to improve the health of people and reduce premature deaths and disability from non-communicable diseases. Its centre in Bengaluru conducts trials for large pharma companies globally, particularly in diabetes, besides working for local companies. Its chief operating officer and chief financial officer, Tim Regan, who was in the city recently, speaks to Joyeeta Chakravorty about the future of clinical trial in India. Excerpts :
The Indian government has recently proposed a waiver on clinical trials for proven drugs if they have been approved and marketed, with no major adverse effects on patients, for at least two years in the European Union, United Kingdom, United States, Australia, Canada, and Japan. What is your take on this?
The proposed move could reduce the time significantly for pharma companies to introduce new drugs into the Indian market and to make them available at a lower cost. But several aspects need to be considered like the introduction of necessary rules and regulations to support this change, consideration of ethnicity representation of the Indian population in the trial conducted for these in other countries and the like. However, it will surely eliminate the need for unnecessary trials.
What are the key challenges in facilitating clinical trials in India as opposed to China?
There are significant incentives for global pharma to conduct international multi-centre trials in the emerging markets of India and China such as access to large markets, lower costs, access to large groups of patients with substantial genetic variation, and the like. Both countries are working actively on addressing the challenge of creating a stable and predictable regulatory environment and developing a government supported machinery that can uphold quality in the application process, implementation and scrutiny of the clinical trials. The recent regulatory changes in both countries clearly demonstrate this intent and they are well positioned to support better quality clinical trials, while balancing patient safety.
What are the diseases that you intend to support in terms of clinical trials?
Broadly, we are looking at stroke, cardiovascular diseases, diabetes, respiratory diseases, emergency and traffic accident injuries. We are also looking at the influence of salt and sugar in manufactured food.
What are your current projects in Karnataka?
We have multiple ongoing clinical trials in various phases in India, including Bengaluru.
Do you think India as a country needs to participate in major clinical trials, considering the disease burden?
Absolutely, India clearly has a strategic advantage due to the availability of a large patient population, a highly educated manpower, a wide spectrum of disease, and lower operational costs for conducting cost effective and quality trials. Representation of the Indian population in global clinical trials (performed prior to marketing authorisations in foreign countries) will help the regulators assess the safety of the drugs in the Indian context and aid decisions on granting the waiver.
