A year back, a couple of days after India's finance minister presented the budget, a renowned expert from the diagnostic sector shared his disappointment with BioSpectrum about the budget's failure to address the sector's needs. "We have been a neglected sector. We are yet to have a separate set of regulatory guidelines for this sector," he said. One year hence, the situation hasn't changed.

India's diagnostics industry comprises biochemical testing, hematology, microbiology, immunology, coagulation, urinalysis, critical care, and molecular diagnostics. The Indian diagnostics market witnessed a growth of 22 percent, from $361 million (Rs 2,000 crore) to $440.8 million (Rs 2,440 crore), in 2010-11.

Despite the prime significance of this sector, a well-defined regulatory pathway for diagnostic products is awaited. Due to the lack of a regulatory legislation in the country, there is no clarity on the classification and requirements for approval of diagnostic products and novel medical devices in India.

Need for a change

Experts from the diagnostic sector are now clamoring for a change in the way approvals to such products are given by the drug controller general of India (DCGI). At the time of approval, diagnostic products and medical devices are categorized into critical and non-critical diagnostics. Any diagnostic tool developed by an indigenous company or academic institution has to go through a validation process conducted by an independent, DCGI-approved testing lab, such as National Institute of Biologicals (NIB), apart from the in-house validation procedures conducted by the company. For other products, it needs to be proven that there are same products approved in India. Despite the huge technological differences between the two, diagnostics are still treated as drugs by the DCGI.