The government of India has announced plans to establish a dedicated laboratory for testing personal protective equipment (PPE), masks, and coveralls. Despite the country’s battle with the COVID-19 pandemic and the increasing threat of zoonotic diseases such as Zika, Nipah, and Monkeypox, there is currently no central medical devices testing laboratory in India that tests medical textile-related items.
Although COVID-19 cases have reached an all-time low and the demand for PPE and other medical protective gear has significantly decreased, there are still other zoonotic diseases for which healthcare professionals need to wear such protective equipment.
The government minutes reviewed by Mint stated that the Southern India Textile Research Association (SITRA), a not-for-profit research organization based in Coimbatore, Tamil Nadu, had requested the central government to recognize their laboratory as the “Central Medical Device Testing Laboratory” for testing bio-protective coveralls, surgical/medical face masks, surgical gowns, surgical drapes, and other related items.
Currently, there is a lack of a central medical devices testing laboratory in India that has the necessary facilities to test medical textiles like coveralls, face masks, surgical gowns, and surgical drapes, according to the minutes.
Representatives from the health and textile ministries were approached for comments but did not respond. However, an official who attended the meeting disclosed that during the COVID-19 pandemic, SITRA was approved by the Ministry of Textiles and accepted by the Ministry of Health to test and certify PPE and coveralls for frontline healthcare workers.
Before the pandemic, India relied on imports for its PPE requirements. However, in response to the crisis, domestic production of PPE and coveralls was initiated, making India the world’s second-largest manufacturer of these products. The newly established industry has an average market size of around ₹7000 crores.
SITRA is already empaneled by the Bureau of Indian Standards (BIS) under the group 2 category for testing medical textiles such as coveralls, face masks, surgical gowns, and surgical drapes. The laboratory is accredited by the National Accreditation Board for Testing and Calibration Laboratories (NABL) and is primarily utilized by the textile industry.
The official mentioned that the board has agreed in principle to notify SITRA as a testing facility for medical textiles under the Medical Devices Rules, 2017. The laboratory will be inspected by officials from the Central Drugs Standard Control Organization (CDSCO) to assess its facilities.