Mumbai : While the central government had allowed mask manufacturers to manufacture and then apply for registration within 18 months considering the ongoing pandemic, the state licensing authorities (SLAs) have asked the manufacturers to expeditiously register with Central Drugs Standard Control Organisation (CDSCO) for compliance.
CDSCO had earlier directed all approved mask manufacturers to voluntarily register at its medical device online portal—cdscomdonline.gov.in for quality compliance and to create a database of authentic manufacturers in the country.
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 personal protective equipment (PPE) kits meet certain standards of quality and efficacy.
The Maharashtra Food and Drug Administration (FDA), which has so far conducted more than 2,000 inspections on PPE kit manufacturers to ensure quality of these products, has directed the PPE manufacturers to test and certify PPE kits in Mumbai-based labs as per Union health ministry guidelines.
The Central government had notified EC Order 2020 to regulate production, quality, distribution and logistics of masks (2ply and 3ply surgical masks, N95 masks) for COVID-19 management. There are two types of masks which are recommended for various categories of personnel working in hospital or community settings, depending upon the work environment – triple layer medical mask and N-95 respirator mask.
The Drugs Controller General of India (DCGI) had also issued an advisory to the manufacturers to voluntarily register under the medical device rules, 2017. The registration will secure the manufacturers a registration number from the CDSCO, which will serve as a quality management system benchmark.
Maharashtra FDA earlier had directed its joint commissioners, assistant commissioners and district level drug control officers to review and oversee mask manufacturers in the state for quality compliance.
There are currently 9 labs in the country which test and certify PPE kits for quality assurance. Cases were detected in Maharashtra wherein unregistered manufacturers were using sub-standard lamination on the Coveralls or PPEs for blood penetration resistance just to meet WHO stipulated specification of 100 GSM thickness putting the users’ safety at risk.
WHO and the Union health ministry have also issued notifications in May 2020 to regulate the production of PPEs among Indian manufacturers in line with the global regulatory specifications.
Union ministry of textiles had designated Heavy Vehicles Factory (HVF), Avadi, Tamil Nadu and Small Arms Factory (SAF), Kanpur, UP under Ordnance Factory Board (OFB) in addition to notified labs earlier –SITRA and the Defence Research and Development Establishment (DRDE), Gwalior for testing and certifying PPE kits.
As of today, around 107 PPE manufacturers have been approved by the CDSCO for supplies in the government healthcare institutions.
As of today, 37 medical device categories have been notified. Earlier, 26 medical devices were notified between 2005 and 2017 which has under its ambit 364 products. In December, 2018 three new devices like nebuliser, glucometer and surgical gowns were notified.
In a notification, the Union health ministry brought all implantables along with eight new medical equipment like CT scan equipment, MRI equipment, defibrillators, dialysis machine, PET equipment, X-ray machines and bone marrow cell separator under the regulatory framework.
The notification stipulates to notify all the medical devices under sub-section (b) of section 3 of the D&C Act, 1940 to regulate them as per the provisions of the Act and MD Rules, 2017.