Two Notified Labs To Test And Certify Huge Quantum Of PPE Procured In The Country
Mumbai, 10 April 2020:
Even as the Indian healthcare system is grappling with the rising demand for personal protective equipment (PPE) in the country, the Union health ministry has a big challenge in terms of testing and accrediting a huge quantum of PPE manufactured and imported in the country by only two notified labs – South India Textile Research Association (SITRA), Coimbatore as well as the Defence Research and Development Establishment (DRDE), Gwalior.
There is a demand of 1.57 crore of PPE in India as of today which stood at 3 lakh PPE in the first week of March 2020, according to official sources. State owned HLL Life Care Ltd has also floated a global tender to procure 1 crore PPE kits.
PPE is indispensable at the point of care with healthcare workers at most risk of infection as they are in direct contact with COVID-19 patients. With a global shortage of PPE that is supposed to protect healthcare workers, the demand for PPE has grown exponentially in hospitals and among sanitation workers.
To tide over the crisis, the government has also already got 1.70 lakh PPEs from China and 2 lakh PPEs from Singapore. A total of 1.4 crore PPEs are being planned to be imported from both the countries.
This move of the government however comes at a time when issues have been raised that unapproved PPEs are being sold in the market due to lack of regulation and standards. This is in light of the fact that manufacturers can rely only on two notified labs for quality control and certification.
To regulate the production of PPEs among Indian manufacturers in line with the specifications of the World Health Organisation (WHO) and the Union health ministry, Government issued a notification on April 6, which stipulated a Unique Certification Code (UCC-COVID19) to be applied to PPE garments and fabric which pass the laboratory tests laid down by the SITRA as well as DRDE. The Code will record the type of garment, its test procedure, date of test.
Another directive was that in the case of coveralls, the manufacturer will print in indelible ink or in a tamper-proof sticker details such as name of producer, code, test standard, batch number and order details.
WHO has also issued guidelines for the rational use of personal protective equipment in healthcare and community settings, as well as during the handling of cargo. PPE also includes gloves, medical masks, goggles or a face shield, and gowns, as well as for specific procedures, respirators (i.e. N95 or FFP2 standard or equivalent) and aprons.
It is intended for those involved in distributing and managing PPE, as well as public health authorities and individuals in health care and community settings, and it provides information about when PPE use is most appropriate.
Precautions are required by health care workers to protect themselves and prevent transmission in the healthcare setting. Precautions to be implemented by healthcare workers caring for patients with COVID-19 include using PPE appropriately. This involves selecting proper PPE and being trained in how to put on, remove and dispose of it.
PPE is only one effective measure within a package of administrative and environmental and engineering controls, as described in WHO’s infection prevention and control of epidemic- and pandemic-prone acute respiratory infections in health care.
“Going forward, India needs to import PPE or at least the raw materials and rope in garment exporters, manufacturers, army uniform and PPE manufacturers in making these as per the Union health ministry specifications considering now that these specifications are available. The new manufacturers need to be educated on medical safety and design requirements, standards and specifications, in-house Quality Assurance (QA) and Quality Control (QC) checks and systems to augment the imports,” explains Rajiv Nath, forum coordinator, Association of Indian Medical Device Industry (AiMeD). Pharmabiz