Close on the heels of reports that unapproved personal protective equipment (PPE) kits are being sold in the market due to lack of regulations and standards, cases of overcharging have also been detected in Maharashtra and Uttarakhand wherein PPE kits were sold at three times its current cost to government and private healthcare institutions.
“A PPE kit which usually costs not more than Rs. 330 is being unethically sold at exorbitant costs ranging from Rs. 900 to Rs. 1,500 even in bulk orders,” said the All India Drug and License Holders Foundation (AIDLHF) president Abhay Pandey. A letter has been sent by AIDLHF to the National Pharmaceutical Pricing Authority (NPPA) and the Union health ministry to frame an apt policy for timely action as it is poised to create a big economic and disease burden on the healthcare infrastructure of the country.
As of today, only surgical masks have been brought under price control by the Centre. As per health ministry guidelines, components of PPE are goggles, face-shield, mask (both surgical and N95 mask), gloves, coverall/gowns (with or without aprons), head cover and shoe cover.
A firm based in Dehradun reportedly sold unapproved poor quality 1,000 PPE kits to a prestigious healthcare institution in Haldwani in Uttarakhand at a huge cost of Rs. 9 lakh which was rejected by the hospital’s quality control committee due to quality flaws. Similar kind of cases related to quality and pricing were also reported in Maharashtra as well. This comes at a time when China has admitted that they need to strictly comply with standards to export high quality PPE kits required by India for preventing COVID-19. An order of 80 lakh PPE kits has been finalized as of today and around 70 lakh PPE kits are also awaited from China.
India 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. 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.
Association of Indian Medical Devices Industry (AiMeD) has also cautioned the Central Government about the harmful effects of duty free imports while considering government’s decision to import ventilators, face masks, surgical masks, PPE kits and COVID-19 test kits in view of the immediate requirement due to COVID-19 crisis.
According to Rajiv Nath, forum coordinator of AiMeD, “We are not against imports. We have apprised Government about capacity limitations and to arrange imports of PPE till Indian manufacturing gear up but that doesn’t mean that imports should come in to undermine ‘Make in India’ efforts. It is shocking to learn that Government will be reducing duty on import of masks, ventilator and PPE kits to Nil and it was already nil for gloves.”
Government of India needs to take policy decisions towards ending over 80 to 90% import dependence forced upon us and an ever increasing import bill of over Rs. 38,837 crore, expedite steps for patient’s protection, stronger quality and safety regulations, judicious price controls to make medical devices and quality treatment accessible and affordable. 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.
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 has also issued a notification on April 6, 2020, 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 and 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.