Dr. Arindam Basu, Director General of the Northern India Textile Research Association (NITRA), tells TIC Council how the industry is helping the Government of India facing the Covid-19 pandemic.
It has been about two years since Coronavirus reached India, with the first case being reported on 30 January 2020. Since then, the entire country, along with the world, have struggled to battle against the pandemic whilst looking for solutions. The first and the second wave in India have ruined the health system and have highlighted the fact that the country has yet to do a lot of work in augmenting health facilities across the nation, irrespective if in urban or rural areas. Many lives were been lost during the second wave, with a lot of people losing their relatives and/or dear ones. Not only has COVID-19 impacted society, it has also affected the economy, putting a severe strain on livelihoods, and badly restricting economic activities.
The journey of PPE kits since February 2020
As Coronavirus started spreading from one country to another, the government of India started making preparations in order to face any adverse situation. A committee was formed, comprising medical experts including the Northern India Textile Research Association (NITRA) to understand the availability of personal protective equipment (PPE) in the country. It was found that India was entirely dependent on imports of medical kits. During that time, countries had imposed export restrictions on medical kits to fulfill their domestic requirements.
With almost zero capacity, India wanted to become self-sufficient in the manufacturing of PPE kits. The government was very anxious about the safety of people, doctors and healthcare workers, and started making efforts to avoid the collapse of the healthcare sector due to a shortage of these kits. The Ministry of Textiles of the Government of India approached various textile mills and suggested them to start producing PPE kits. Both the Ministry of Health and Family Welfare and the Ministry of Textiles jointly worked in order to understand the existing resources, infrastructure, testing production, and packaging of PPE kits as per the quality standards set up by the WHO.
Their research revealed that local manufacturers in India did not have the capability to produce PPE kits that could be used during the pandemic. As per World Health Organisation (WHO) guidelines, PPE kits, coveralls and shoe covers in particular, should pass the requirements set by the ISO 16603:2004 standard (class 3 protection level) or ASTM F 1670, which tests resistance against synthetic blood penetration. The majority of local manufacturers were not able to manufacture PPE kits in conformity with these requirements. Another hurdle was due to the unavailability of the required number of laboratories to carry out these tests.
The South India Textile Research Association (SITRA) was the only organisation equipped with the right tools to test synthetic blood penetration as per ASTM F 1670. Thus, the Ministry of Textiles approved SITRA for the testing and certification of prototype test samples of PPE kits.
Considering the vast demand, SITRA alone could not cope with the testing and certification requirements of pilot test samples of PPE kits. Therefore, the Ministry of Textiles authorised the Institute of Nuclear Medicine and Allied Sciences (INMAS) to conduct synthetic blood penetration tests. With the increase of further demand for testing facilities, the Ministry of Textiles added some more laboratories, including NITRA, to take up the challenge and grow to meet demands, all while acheiving the objectives set out with the “Make In India” programme. The Ministry has since taken steps to ensure that only certified manufacturers, across the entire supply chain, are permitted to supply PPE kits to governments. Authorised laboratories have to issue a Unique Certification Code (UCC) to each passed prototype sample submitted by the manufacturer of PPE kits. This UCC has to be embossed or printed on each PPE kit along with other details. The manufacturers were also required to submit an affidavit along with their submitted samples giving details regarding their manufacturing unit, GSTIN number, company registration number, Udyog Adhar number/DIC registration number and other relevant details. Government procurement agencies and private hospitals were advised to procure PPE kits from certified agencies. They were also requested to verify the certificates using a specific weblink, provided on the website of the Ministry of Textiles.
Since then, things have changed drastically, and today laboratories no longer have to issue a Unique Certification Code (UCC) to each passed prototype sample submitted by the manufacturer. If a manufacturer wants to get a license from BIS for the manufacture and supply of PPE kits, a sample needs to be tested by a BIS-approved lab with a synthetic blood penetration resistance test. This ensures safety of the product.
Today, India has become the second largest manufacturer of PPE kits across the world with more than 450.000 units being produced daily by over 1.100 manufacturers. It is reported that the supply of India-produced PPE kits had surpassed the domestic demand, and India has exported to the US, the UK, Senegal, Slovenia, and UAE. This has been made possible due to the remarkable collaboration between the government and industries, an achievement of which any citizen of the country would be proud of.
The contribution of NITRA in fighting COVID
NITRA understands that nothing is more costly than life. Everyone should be protected. Since June 2020, NITRA has joined hands to fight the coronavirus, and has set up testing facilities for PPE kits and coveralls.
The Ministry of Textiles has approved NITRA’s testing facilities for conducting testing and certification services via synthetic blood penetration test for body coveralls for COVID-19 on June 8, 2020. NITRA has facilities for testing of fabric and body coveralls in accordance with required standards such as ISO 16603:2004, IS 16546:2016 and ASTM F1670/F1670M - 17a:2017.
The Bureau of Indian Standards (BIS) also recognized NITRA for the testing of “Coveralls Meant for COVID-19 Healthcare Workers to ensure Quality and Patient Safety” as per IS 17423:2020.
NITRA has testing facilities for medical devices such as masks, surgical gowns and surgical drapes. NITRA inspection services have been accredited against ISO/IEC 17020:2012 by NABCB. Reputed companies like HLL Lifecare and many more organizations have availed themselves of inspection and testing services for PPE kits when they were most needed.
NITRA always has close relations with manufacturers, making the utmost efforts to deliver the test reports in time. Apart from testing, NITRA also advises maufacturers about the products and factors responsible for quality problems.
Finally, NITRA has implemented the guidelines of COVID-19 prevention as directed by the government, taking steps to ensure that its testing services are not impacted by the pandemic, be it be vaccination of laboratory staff, sanitization of the workplace, use of masks and washing of hands with soap and maintaining minimum safe distance.
The contribution of the TIC Sector
The TIC (testing, inspection and certification) sector has contributed immensely, by ensuring that PPE kits are produced with the highest quality, working day and night to ensure that there are no delays.
This sector has provided assurance and confidence through testing, inspections and certification services that products and services offered by their customers meet fundamental safety and health requirements. Finally, the sector makes all-out efforts in providing the best quality of service possible, helping and supporting its customers in maintaining their operations and delivering the desired quality products.