Separate regulatory authority

A recent hurdle which is being faced by segments across the biotech sector is the frequent changes of the DCGI. "In the last couple of months, two DCGIs have been changed who were there for a temporary period of time. This has led to a lot of our approvals getting delayed because by the time we submitted our approvals to one DCGI, it was time for him to move on and we had to repeat the whole process from the start when the new person came," adds Tripathi.

Speaking to BioSpectrum, most of the industry experts from the top indigenous companies demand that there should be a separate regulatory authority for approving diagnostic products where specific dossiers can be submitted. Saxena says, "It is high time DCGI looked beyond drugs. They need separate teams for vaccines, devices, and diagnostics."

Many domestic companies have also said that there is a dire need for a central testing lab for diagnostic products which can come about only when there is a clear well-defined pathway for the sector.
The Association of Diagnostic Manufacturers of India (ADMI), an association of Indian in vitro diagnostics manufacturers, has approached the government with various proposals for reforms , but it has not received any response so far. To bring about uniformity in classification and specifications among all diagnostic products, the association had made a list of above 100 products along with their respective classifications and specifications. Tripathi, who is also the president of the association, recalls, "We had collected and collated a list of diagnostic products from all the companies in India along with their specifications and submitted to the DCGI for reference, but there was no result. It took us one year to collate such data but the entire effort was waste."

India is at an inflection point today when it comes to innovation in diagnostics. Investments, both in terms of time and money, towards this sector by the Government of India will not just lead to a spurt in affordable new products, but also bolster the quality infrastructure in the country.