IVD devices are medical devices that perform tests on samples taken from the body to detect disease, conditions, or infections.
The Drugs Technical Advisory Board (DTAB), India’s top advisory on drugs, took up the issue in their recent meeting and 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.
In case of IVDs, the decision was taken, “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,” said the minutes of the meeting.
The matter was deliberated earlier, too, in January this year and the experts had not agreed to amendment under medical devices Rules 2017. However, they took up the matter again and decided not to give a leeway in case of IVDs.
The IVD market in India is growing at a faster pace due to the growth of lifestyle ailments and heightened awareness of minimally invasive and non-invasive diagnostic techniques. The market is expected to reach $2.34 billion by 2029.The matter to grant clinical trial waiver to medical devices approved in the developed countries has been under consideration since 2018.
That time during the meeting of the India-EU sub-commission on trade, the EU officials said that for the regulation of new products, the new regulations stated that clinical investigation may not be required to be submitted where the investigational medical device is approved by the regulatory authorities of the US, UK, Australia, Canada or Japan, but did not include the EU, as per Rule 63(1).
The proposal was sent to the health ministry for amendment to Rule 63(1) in 2021. However, it was referred back to the Central Drugs Standard Control Organisation (CDSCO) for critical review in the context of updated rules and recent notifications. The ministry also asked for deliberations in consultation with the DTAB for a fresh proposal.
The government in August decided to consider clinical trial waiver for drugs for rare diseases, gene and cellular therapy products, new drugs used in pandemic situations, new drugs used for special defense purposes and are approved in these developed countries.
