The Indian government has reaffirmed its stance on requiring clinical trials for In-Vitro Diagnostics (IVDs) before they can be approved for use in the country, regardless of prior approvals in other regions. This decision was made by the Drugs Technical Advisory Board (DTAB), India's top advisory body on drugs, during a recent meeting. The DTAB has decided not to waiver in line with waiver given for other medical devices. The government has done away with the requirement of clinical investigation of those new drugs having significant therapeutic advance over the current standard care and has already got approval in the US, UK, Japan, Australia, Canada and EU.
Rationale Behind the Decision
The primary reason cited for maintaining the clinical trial requirement is the potential for significant variations in IVD performance due to biological differences within the Indian population. According to the meeting minutes, genetic and environmental factors can contribute to these variations, making it crucial to assess and confirm the performance of IVDs specifically within the Indian context. "Considering that the performance of IVDs can vary significantly due to biological differences among the population, genetic and environmental factors contributing to the variations making it crucial to assess and confirm the performance of IVDs in the Indian population. Therefore waiver of clinical performance evaluation under Rule 64 for approval of IVDs in the country was not considered by the board," the minutes stated.
Market Growth and Regulatory Considerations
India's IVD market is experiencing rapid growth, fueled by an increase in lifestyle-related diseases and a growing awareness of minimally invasive and non-invasive diagnostic techniques. The market is projected to reach $2.34 billion by 2029. This growth underscores the importance of ensuring the reliability and accuracy of IVDs used within the country.
The decision to maintain clinical trial requirements aligns with the government's broader approach to regulating medical devices. While the possibility of granting clinical trial waivers to medical devices approved in developed countries has been under consideration since 2018, the DTAB has consistently maintained a cautious approach, particularly concerning IVDs.
Exceptions for Certain Drug Categories
It's important to note that the government has adopted a more flexible approach for certain categories of drugs. In August, it was decided that clinical trial waivers would be considered for drugs targeting rare diseases, gene and cellular therapy products, new drugs used in pandemic situations, and new drugs intended for special defense purposes, provided these drugs have already received approval in developed countries.
