NPPA not to bring PPE kits under price control
The national drug pricing regulator National Pharmaceutical Pricing Authority (NPPA) has refused to bring personal protective equipment (PPE) kits under price control citing that only scheduled medical devices which are included in National List of Essential Medicines (NLEM)-2015 prescribed by the Union health ministry are brought under price control.
In a letter addressed to the All India Drug and License Holders Foundation (AIDLHF), the NPPA stated that it fixes ceiling prices or brings under price control only scheduled medical devices which are included in National List of Essential Medicines (NLEM)-2015 prescribed by the ministry. Further, it stated that it also needs to be included in Schedule -1 of Drugs Price Control Order (DPCO)-2013, as per DPCO Rules for the purpose of price control.
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. This comes soon after Prime Minister Narendra Modi in his recent speech on Lockdown 4 said that today we are in a situation to produce 2 lakh PPE and 2 lakh N-95 masks daily turning the COVID-19 pandemic crisis into an opportunity while announcing the Rs. 20 lakh crore economic package to revive Indian economy badly impacted due to COVID-19. Prime Minister announced a package worth Rs. 20 lakh crore under ‘Atmanirbhar Bharat Abhiyan’ to deal with the current economic crisis.
Cost of PPE
Reports of unapproved PPE kits being sold at exorbitant costs ranging from Rs. 900 to Rs. 1,500 in the open market due to lack of effective price control policy and standards had earlier prompted health activists and experts to suggest to the government to bring PPE kits under price control to curb unethical marketing.
A PPE kit usually costs not more than Rs. 330. Cases of overcharging were also detected in Maharashtra and Uttarakhand wherein PPE kits were sold at three times its current cost to government and private healthcare institutions.
As a major step towards indigenization and ensuring compliance to quality, government has kick-started indigenous manufacturing of PPE kits in the wake of rising cases of COVID-19 globally and in India. As per official estimates, around 107 PPE manufacturers have been identified who have raised their daily production to about 1.87 lakh PPE kits. The total projected demand of PPE kits till June, 2020 is estimated to be 2.01 crore.
Department of Pharmaceuticals
Department of Pharmaceuticals (DoP) secretary PD Vaghela has also stated that out of the total 2.49 crore N-95 masks ordered, 1.49 crore of these masks have been ordered from domestic manufacturers. The total projected demand of N-95 masks till June, 2020 has been estimated to be 2.72 crore. As of now, about 49.12 lakh N 95 masks have been received and additional domestic supply in the next two months would be more than 1.40 crore. Union health minister Dr. Harsh Vardhan also informed that 29.06 lakh PPEs and 62.77 lakh N-95 masks have been distributed among the States/UTs/Central Institutions. India imported 1.70 lakh PPEs from China and 2 lakh PPEs from Singapore.
Indian Medical Devices Industry
Association of Indian Medical Devices Industry (AiMeD) has however has 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, “Government of India needs to take policy decisions towards ending 80 to 90% import dependence and an ever increasing import bill of over Rs. 38,837 crore, and expedite steps for patient’s protection, stronger quality and safety regulations and judicious price controls to make medical devices and quality treatment accessible and affordable.”
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 eight notified government testing labs in the country. 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.