India Mulls Allowing MNCs to Conduct First-in-Human Phase I Clinical Trials
Mumbai: India is considering a significant overhaul of its pharmaceutical regulatory framework to align drug regulation with international standards and strengthen its position as a global destination for pharmaceutical research and development. A key proposal under discussion is allowing multinational pharmaceutical companies (MNCs) to conduct first-in-human (FIH) Phase I clinical trials in the country.
The proposed changes come as India seeks to strengthen its regulatory expertise and specialist capabilities following improvements in manufacturing compliance over the past two years, according to government and industry sources.
Informal discussions have reportedly begun between the drug regulator and stakeholders regarding the possibility of permitting multinational companies to undertake early-stage clinical trials in India. The move could encourage global pharmaceutical companies to consider India for innovative drug development and potentially accelerate the regulatory approval process for new medicines.
A senior government official indicated that international companies have expressed interest in conducting such studies in India. However, a formal decision would require a clearly defined regulatory process along with appropriate safeguards.
Under the existing regulatory framework, companies seeking approval for new drug substances discovered or developed outside India are generally required to submit Phase I clinical trial data along with their applications. Following submission of overseas Phase I data to the Central Licensing Authority, permission may be granted to repeat Phase I studies or proceed with Phase II trials, followed by Phase III trials, alongside global development programmes.
Government sources told The Economic Times that the existing mechanism permitting Indian pharmaceutical companies to conduct Phase I trials could potentially be extended to multinational companies as well.
Australia has become an attractive destination for early-stage clinical research, with regulatory clearances reportedly taking around four to six weeks. The country also provides financial incentives for conducting Phase I studies. Government officials noted that several Indian pharmaceutical companies are already conducting first-in-human studies in Australia.
Industry experts believe India has considerable potential to emerge as a preferred destination for early-stage drug research because of its large population, provided it develops the necessary clinical infrastructure, skilled workforce and research capabilities.
However, industry stakeholders also highlighted that multinational companies would carefully evaluate the feasibility of conducting Phase I trials in India, particularly when studies involve relatively small groups of approximately 20–25 participants.
Kausik Maiti, Vice President, Safety Medical Sciences at Parexel, emphasised the need for comprehensive and publicly accessible regulatory guidelines for first-in-human studies involving molecules developed outside India. He noted that although the regulatory pathway for Indian-origin molecules is comparatively well defined, greater clarity is required for molecules discovered overseas.
He also suggested adopting a risk-based regulatory approach that clearly specifies the conditions under which such studies may be permitted. Additionally, establishing a structured and time-bound scientific advice mechanism for early-phase clinical development could provide greater certainty to pharmaceutical companies.
The Economic Times reports that industry experts believe that encouraging multinational pharmaceutical companies to engage with Indian regulators during the early stages of drug development could help India participate more actively in global Phase I clinical research programmes.
Also Read: Gujarat FDCA Cancels Licenses of 50 Drug Firms, Orders Closure of 2 Units
