New Delhi: India as one of the best, easiest, digital friendly and most proficient Good Regulatory Practices (GRP)-driven regulatory systems in place and is striving towards a better ecosystem by reducing the compliance burden or redundant procedures, informed Dr V G Somani, Drug Controller General (India).
Speaking at the medical technology industry representatives in a plenary session on demand generation, triggering the growth of med tech industry, organised by Confederation of Indian Industry (CII) in its 13th Global MedTech Summit, Somani said the demand for med tech is always there and the regulatory ecosystem is also good.
He added that the government is trying to reduce the compliance burden or the redundant procedures to increase India’s ranking on the ease of doing business, and these measures are being taken as part of that.
“As for the medical devices industry, the regulators will keep on increasing its barriers in a predictable manner over a period of time so that there are no knee jerk reactions, no unpredictability. If we have to move fast at the pace which is required, we have to work shoulder to shoulder. That is what we are doing and we are having one of the best, easiest, most digital friendly and most competent and Good Regulatory Practices-driven regulatory systems,” he said.
The GRP starts with making the customer satisfied, he noted that the customer includes patients, doctors, industry and NGOs, government everybody. Pointed out that consensus building on how the regulators can frame the regulation is important.
“We can frame the best of best regulation, but if they are not compilable, it has no meaning. People may start cutting corners,” he noted.
As for the challenges during the current pandemic, the country is reinventing itself, identifying the gaps and filling them with the strengths. The regulator has taken various steps including the GRP to grow in tandem with the changes, rather than remaining a mute spectator or a weak regulator.
Informing that in order to match the global standards, the drug regulator has adopted the medical device rule, which is at par with the IMDRF (International Medical Device Regulators Forum) or in line with the global regulatory requirement of the IMDRF.
“CDSCO adopted it and started moving in a short time and we are on the path of implementing it. With all industry and government partnering, it has created a roadmap which is ranging for 42 months and the office will move slowly towards the regime. First we know each other, with a voluntary registry system, and then giving advantage of that voluntary registry system to those who have come in our network by putting the registration number on your product. After 30 months for A & B and 42 months for C & D class of medical devices, you have a compulsory licensure system where you go through all pre-registration conformity assessment and post registration surveillance and others. In order to make this ecosystem well poised to be a real quality and affordable medical technology provider for the Indian patient and global patient, we have made all these through the Good Regulatory Practices,” he added.
With these efforts in place, many countries are now taking guidance from CDSCO. In pharmaceuticals, they have been asking India’s guidance for many years. But now they are asking in the medical technology sector also. CDSCO is starting these regulatory measures on medical devices.
Patients need to access the product regardless where it is coming from. If it can be made in India, it is further welcome. Being a country, India has a right to encourage the local supplies so that the affordability increases and if it is competitive in quality along with affordability it is certainly welcome.