IPC study reveals manufacturers not complying with guidelines in 64% cases in terms of distribution, testing and quality of PPEs

Shardul Nautiyal, MumbaiFriday, October 23, 2020, 08:00 Hrs  [IST]

The Ghaziabad-based Indian Pharmacopoeia Commission (IPC) which is the National Coordination Centre (NCC) for Materiovigilance Programme of India (MvPI) has revealed in its latest study that in 64% cases, manufacturers are not complying with the government guidelines and personal protective equipment (PPEs) are being sold and distributed in the market without proper testing and non-compliance to quality.

IPC has been keenly working on the development of resource material and reporting tools as the NCC for MvPI which was launched in 2015.

In 64% of the reported PPEs cases, the essential information including lot number/batch number, unique certification code (UCC), test standards, manufacturing date and expiry dates were not mentioned which indicates that in most of the PPEs manufacturing and quality norms are not being followed as per the Government of India guidelines, it stated.

Highest number of reported adverse events in 43% cases were associated with coveralls causing excessive sweating issue, dehydration, tearing of fabric material and skin allergies. In 58% of total reports, PPEs were manufactured indigenously. In 28% cases, the name of manufacturer was not mentioned on PPE kit.

Around 10% PPE devices were manufactured in China, 2% PPEs were manufactured in the US and 2% in Malaysia. It was also observed that 84 % of adverse events occurred within the healthcare facility including 11% in the emergency department and 36% in the other department of the hospital. Around 2% of all the events occurred during home quarantine whereas in 14% of the reports the location for the event was not mentioned.

To facilitate boost in adverse event reporting associated of PPEs, NCC- Pharmacovigilance Programme of India (PvPI) has also developed and rolled out one page electronically fillable adverse event reporting form specifically for PPEs so that Medical Device Adverse Event Monitoring Centres (MDMCs) and adverse drug reaction monitoring centres (AMCs) could actively participate in reporting of adverse events associated with PPEs.

In order to effectively implement the MvPI, the Union health ministry had in August 2019 directed medical device manufacturers to register at the launched Medical Devices Information Sharing Portal through hyperlink - for effective compliance to quality.

This portal would serve the purpose as an India specific tool to help IPC facilitate baseline study of products available with medical devices companies in India and assure patient safety. IPC in consultation with Central Drugs Standard Control Organisation (CDSCO) had developed the portal to ensure that safe medical devices are available in the country.

Other reporting tools and reference documents for manufacturers available on IPC website are an updated medical devices adverse event reporting (MDAER) Form (version 1.1), a field safety corrective action (FSCA) form, a reference manual for medical devices and a handbook for MvPI.