India has the best digital friendly regulatory system: DCGI

If we have to move fast at the pace which is required, we have to work shoulder to shoulder


Last Updated on September 8, 2021 by The Health Master

India is having one of the best, easiest, very digital friendly and most competent Good Regulatory Practices (GRP)-driven regulatory systems in place and is striving towards a better ecosystem by reducing the compliance burden or redundant procedures, said Dr V G Somani, Drug Controller General India (DCGI).

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.

Addressing 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, he said that the demand for med tech is always there and the regulatory ecosystem is also good.

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.

“Usually the regulators remain aloof from all these activities because otherwise the regulators will be having a lot of undue interaction. It was not considered good in the past. But that is a story of the past.

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 assure you that we are having one of the best, easiest, most digital friendly and most competent and Good Regulatory Practices-driven regulatory systems,” he said.

Demand generation will happen if there is access to masses, not only for classes and access to affordable and quality medical products and medical technology will help the industry not only to cater to the country, but also to the global market.

Amidst the challenges that came up 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.

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The GRP starts with making the customer satisfied, the customer includes patients, doctors, industry and NGOs, government everybody. Consensus building on how the regulators can frame the regulation, which can be complied with, is important.

“We can frame the best of best regulation, but if they are not compliable, it has no meaning. People may start cutting corners,” he added.

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.

Within no time, the CDSCO adopted it and started moving on that 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 from the low hanging fruit, from the easy path.

“We will keep on increasing our barriers in a predictable manner over a period of time so that there are no knee jerk reactions, no unpredictability,” he averred.

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.

It is a call from our Prime Minister that we should be Atma Nirbhar Bharat. It should not be taken in a manner that it is not welcome for good technology health solutions which are available elsewhere and not available here, he added.

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