Coimbatore: In a first, Union health ministry is working on proposal to designate Coimbatore based South India Textile Research Association (SITRA) as the nodal testing lab for bio-protective coveralls, surgical and medical face masks, gowns and drapes. The matter was discussed in the Drugs Technical Advisory Board (DTAB) meeting held recently which was chaired by the Directorate General of Health Services (DGHS) at the health ministry.
Even as the country faced the covid pandemic and growing threat of zoonotic disease such as Zika, Nipha, and Monkeypox; there is no central medical devices testing laboratory in India which also tests textile related medical items.
While covid cases have fallen to all time low, and the requirement of personal protective equipment (PPE) and other medical protective gears have reduced drastically, there are other zoonotic diseases which require medical professionals to wear such protective gears.
“The Board was apprised that representation was received from SITRA, Coimbatore, Tamil Nadu a not-for-profit research organization actively involved in carrying out research and development on conventional and technical textiles, requested the central government to recognize their lab as “Central Medical Device Testing Laboratory” for testing of Bio-protective coveralls, surgical/medical facemasks, surgical gowns, surgical drapes etc,” stated government minutes reviewed by Mint.
“Currently there is no central medical devices testing laboratory which is having facility for testing medical textiles such as coveralls, facemasks, surgical gowns, surgical drapes etc,” it said.
One of the officials who attended the meeting said that during covid-19 pandemic SITRA was approved by ministry of textile and accepted by the health ministry to test and certify (PPE) and coveralls to be used by frontline healthcare workers.
Prior to the pandemic, India used to import PPEs for its consumption. The company started to manufacture PPEs and coveralls to deal with pandemic situation and it is now considered as the world’s second largest domestic manufacturer of PPEs. The average market size of this newly created industry is around ₹7000 crores.
SITRA is empaneled by Bureau of Indian Standards (BIS) under group 2 category for testing medical textiles such as coveralls, facemasks, surgical gowns, surgical drapes etc. The lab is accredited by NABL and is largely being used by the textile industry.
“The board agreed in principle for the notification of SITRA for testing of medical textiles under the Medical Devices Rules, 2017,” said the official adding that adding that laboratory will be inspected by Central Drugs Standard Control Organization (CDSCO) officials to review the facilities available in the laboratory.
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