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Govt needs to align regulatory regime as per global standards to make Indian PPE manufacturers competitive

Shardul Nautiyal, Mumbai
Tuesday, November 10, 2020, 08:00 Hrs  [IST]

New York headquartered GlobalPPEMart.com has recommended for an urgent need for government to align regulatory regime as per existing global standards to enable Indian Personal Protective Equipment (PPE) manufacturers to enhance competitiveness, scale and become export friendly.  

PPE coverall is an important medical device for healthcare workers handling COVID-19 patients.

GlobalPPEMart.com is a technology and marketing B2B platform that bridges the gap between manufacturers and buyers of PPE. It has the distinction of being the first global online marketplace to address the shortage of COVID-19 gear across the world during the ongoing pandemic.

Experts have also advocated that developed countries have their own certification requirements. Therefore, Indian PPE manufacturers will need to meet the requirements of the countries where they export.

According to Harjiv Singh, Board member, GlobalPPEMart, “The global PPE market, estimated to be $54 billion globally, is a huge opportunity for Indian PPE manufacturers. Quality certifications are important for exporters and for them to be successful in markets like the US and Europe they need to adhere to local certifications like ISO, FDA and CE.”

He further added, “Leading manufacturers globally are helping us create a wide inventory of protective gear and medical products. Any supplier that manufactures products to treat COVID-19 can find the right buyers at GlobalPPEMart.com.”

Drugs Controller General of India (DCGI) has been asking all stakeholders and associations for suggestions on classifying non-notified medical devices for its effective regulation under the New Medical Device Rules (MDR-2017). As per a DCGI notice, stakeholders suggestions have been sought with reference to gazette notification, published on February 11, 2020 which stipulated that the medical devices will be regulated in phase-wise manner.

This is with reference to gazette notification, published on February 11, 2020 which stipulated that the medical devices which are covered under the definition will be regulated in phase-wise manner. In accordance to medical device rules (MDR-2017) Chapter II, Rule 4 (3) the Central Licensing Authority (CLA) needs to classify such medical devices as per risk based approach. In order to facilitate the process to classify all such medical devices including IVD medical devices, the devices are divided into 03 categories like IVD analyzer, IVD Instrument and IVD software and examined as per the classification followed internationally and First Schedule of MDR-2017.

DCGI had recently issued an advisory to the manufacturers to voluntarily register on Central Drugs Standard Control Organisation (CDSCO)’s medical device online portal---cdscomdonline.gov.in. The registration will secure the manufacturers a registration number from the CDSCO, which will serve as a quality management system benchmark.
According to industry sources, as of today barely 25 manufacturers have ISO 13485 certification.

Union health ministry on February 11, 2020 had notified all medical equipment used on humans or animals as "drugs" under Section 3 of the Drugs and Cosmetics (D&C) Act, with effect from April 1, 2020 to ensure that all medical devices including PPE kits meet certain standards of quality and efficacy.

In order to ensure patient safety at the point of care, experts had earlier also recommended that gloves, coveralls and masks intended for medical use should conform to Bureau of Indian Standards (BIS) as per MDR 2017. As of today PPE which include gloves, coveralls, goggles and masks are not being effectively regulated as medical device manufacturers have yet to get themselves registered voluntarily on the portal-cdscomdonline.gov.in. as per the mandate of MDR- 2017.

To promote the supply of quality PPEs during the ongoing pandemic, BIS has also permitted relaxation in its norms of having in-house testing facilities for the following PPEs like filter half masks to protect against particles of Class FFP2 as per IS 9473:2002, surgical face masks as per IS 16289:2014 and eye protectors as per IS 5983:1980.

Those domestic manufacturers who are interested in applying for a BIS licence may register themselves and submit their application online through BIS website ‘www.bis.gov.in’.


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