The Central Drugs Standard Control Organisation (CDSCO) has issued an order allowing the existing manufacturers/ importers of nebulizer, blood pressure monitoring devices, digital thermometer and glucometer to continue to import / manufacture these products for another six months.
As per the communication issued on December 28, 2020 by Dr V G Somani, Drug Controller General of India to all State drug controllers and zonal and sub zonal and post offices, communicated that the Ministry of Health and Family Welfare (MoHFW) has notified nebulizer, blood pressure monitoring devices, digital thermometer and glucometer as a drug as per order 4671 (E) dated December 27, 2019, which will be effective from January 1, 2021. And as per the said order the importer/ manufacturers are required to take import/ manufacturing licences from Central licencing authority. However, in the meantime, a representation had been received requesting to extend the implementation of notification for another three to six months because a lot of procedural work is to be done such as resolution of queries, audit of facilities by the regulators and notified bodies, as the case may be testing of products at the requisite testing labs etc.”
The authority has informed that under the provisions of Medical Device Rule (MDR) 2017, the existing manufacturer / importer submitted application to central licensing authority or state licensing authority for grant of manufacturing/ import licence will be deemed valid and can continue upto six months.
“It has been decided that an existing manufacturer/ importer who is already importing manufacturing any of these devices has submitted application to central licencing authority or state licencing authority, as the case may be for grant of import/ manufacturing licence in respect of the nebulizer, blood pressure monitoring devices, digital thermometer and glucometer, under the provision of MDR 2017, the said application shall be deemed valid and the importer / manufacturer can continue to import/ manufacture the said device(s) upto six months from the issue of the order, or till the time the central licencing authority or state licencing authority takes a decision on the said application, whichever is earlier,” stated in the CDSCO order.
According to the Rule 97 of MDR 2017, provides details about the applicability of the said rule in respect of various actions/ operations undertaken under the Drugs and Cosmetic Rules for the substances and devices referred to in rule 2 of MDR 2017 prior to commencement of MDR 2017.
Commenting on the order, Pavan Choudary, Chairman and DG, Medical Technology association of India ( MTaI) expressed, “We are thankful to CDSCO, which on the one hand is setting a very high standard of medical device regulation by harmonising the best practices of global standards and on the other painstakingly conducting the due diligence before allowing market release of drugs and devices. This responsible, seasoned and farsighted poise will help local Indian device industry to go global as per PM’s dream. Simultaneously, CDSCO well realises the challenges the medical device industry is facing amidst the pandemic, in arranging the necessary dossiers and documents endorsed by competent authorities. This vital extension will ensure – continuity of supply of essential life saving devices and is in line with our government’s vision of continuing healthcare access.”
Whereas, Harpreet Singh, Joint Secretary, Surgical Manufacturers and Traders Association said, “The order only grants extension to manufacturer /importer for six months who have already submitted an application for license to CDSCO to continue their manufacturing/import upto six months till license application is decided. It is not a deferment of notification dated 27 /12/2019 as sought by many stakeholders.”
He continued, “The order does not consider the plight of thousands of wholesalers and lakhs of retailers of these devices who are not having the wholesale drug license or retail drug license. The effect is that although the products can be manufactured or imported by those who have applied for license, but still it cannot be sold in the market unless the seller has wholesale or retail drug license. Further many small retailers who are otherwise experienced in selling these devices since many decades, but unable to afford a pharmacist which is a pre-condition for retail license would need to close shop from 01-01-2021.”
“Similarly many wholesalers whose premises do not qualify on grounds of size / zoning restrictions for the wholesale license would close and further aggravate the unemployment and economic crisis the country is going through. We request to authority to understand that this year 2020 has not been a normal year and many govternmet / private offices have been working in a limited restrictive manner on account of COVID. Therefore, it would be unfair to expect many manufacturers/importers too to get the requisite infrastructure / documents / testing done especially from the micro and small enterprises during this pandemic when survival is the foremost in mind. The entire effort should be to first regulate the extremely critical devices being those that are sterile, implantable and invasive rather than simple non sterile no implantable non invasive transient use devices so as to optimally use their resources to the best effect,” he added.
He further continued and said, “And another factor is license charges of 28-140 times on imported devices as compared to locally manufactured one would raise the cost of the imported device by several times as India imports nearly 80 per cent of devices and increase in product cost would ultimately be paid by the consumer on account of higher healthcare costs. The licensing procedure is so onerous and tormenting that as on date only one manufacturing licence has been given for manufacture digital blood pressure monitor and digital thermometer ( both to one co), infact this order is cover up the CDSCO own inefficiencies rather than consideration of any request from the scores of manufacturer /importers who had been vociferously requesting for deferment of this notification till 2022 as 2020 was lost due to COVID and 2021 still COVID is not gone and there are talks of other strains appearing in India /internationally. The whole licensing ecosystem by its costs and burdens would eliminate the competition in the market and only few big players would remain and then they would monopolise and raise prices for their products leaving the patients high and dry. Further for devices and models sold in smaller quantities this is total death as the cost of product for an item costing 5000 would become 10000 without even a single paisa profit by the importer.”