Investigational New Drug (IND) approval process in India - Limitations, challenges and recommendations

Regulatory approval in India is a complex and ever-changing phenomenon governed primarily by the Central Drugs Standard Control Organization (CDSCO) under the guidance of the Drug Controller General of India (DCGI). It is a complex procedure that ensures all drugs meet the required norms of safety, efficacy, and quality before they are released into the market. It is a lengthy procedure for manufacturers and also poses a problem with the interpretation of the rules by different states. Moreover, the lack of harmonization with international regulatory systems also causes a delay in international collaborations. The lack of infrastructure for clinical trials and the need for a large number of trained regulatory experts also add to the problems. It not only delays the approval of drugs but also discourages foreign investors from investing in the country. In order to overcome these hurdles, India needs to focus more on regulatory transparency, digitalization of applications, and the use of a risk-based evaluation approach. Training of regulatory staff, the use of real-world evidence, and alignment with international best practices such as ICH and WHO guidelines can help speed up the regulatory approvals in India. This will, in turn, help India to become a more collaborative and technologically advanced regulatory environment, thereby promoting innovation, safety, and competitiveness in the field of pharmaceutical drug development globally.