BIS Retracts New Guidelines For Coveralls In PPE Kits

New Delhi, 18 April 2020:

The Bureau of Indian Standards (BIS) on Friday withdrew the specifications for coveralls – one of the components of the personal protective equipment (PPE) – just three days after they were released because they were found to be too stringent.

The new specifications said that in addition to being fluid-resistant, the coveralls or body suits also had to be viral resistant. They were part of a set of specifications put together by the national standards body for PPE including gloves, masks, and eye protectors to be used by health care workers while treating Covid-19 patients.

The specifications were first put up on the BIS website three days ago and were removed on Thursday.

On Friday, the organisation tweeted: “As per some media reports, confusion has arisen about standards of coveralls in the Personal Protective Equipment (PPE). As of now standards specified by the ministry of health and family (welfare) are applicable. It is clarified that BIS has not notified any standard for coveralls.”

A senior official from BIS said on condition of anonymity hat while the specifications were released, “there were administrative and inter-ministerial issues. For the time being, manufacturers have to keep following the specifications as released by the health ministry.”

The reason for the withdrawal is that none of the manufacturers in India are currently geared up to make coveralls as per these specifications, not even the ones that have been approved by the textile ministry, according to an industry expert who asked not to be named.

The industry expert, who was part of the discussions regarding the specifications, said, “The specifications must have been withdrawn after requests from the textile ministry. Although companies are working towards developing breathable viral-barrier materials and technology that can be used for sealing the seams, it is not available for now. The textile ministry knows this and they cannot afford to stop the production of the much-needed PPEs.”

Indian manufacturers could not meet the new standards that required the coverall be made from viral-barrier materials that are not available in India, which is also short on machines needed for sealing the seams to prevent leakage.

While the specifications have been withdrawn, most manufacturers agree that some standard ones are necessary.

“What the ministry of health had released were buyer specifications, but not national standards that were to be followed by all manufacturers. These BIS standards are a very important first step towards creating uniformity in products that are being manufactured across the country. So far, the procurer for central government, HLL, institutes such as AIIMS, and different state governments all have different specifications for procurement,” said Rajiv Nath, founder and forum coordinator of the Association of Indian Medical Devices Industry (AiMeD).

BIS organised a meeting on April 3 with manufacturers and industry bodies to seek feedback on the draft of the specifications that were uploaded to its website earlier this week after the organisation decided to fast-track the adoption of the specifications.

“The committee decided that due to novel coronavirus pandemic and for uniform product requirements and test methods to be followed by stakeholders, the wide circulation of the draft standard be waived off and draft standard be held to have been finalised for publication,” read the minutes of the meeting, a copy of which has been seen by HT.

“We were initially about to start our production with fluid-resistant material, but we stopped even before we began because there were talks of viral-barrier suits. Now the challenge is availability of the raw material and the taping machines. These are dampeners when it comes to scaling up production in the country. Now, we have finally managed to source some material for the viral-barrier suits, but our product is yet to be certified. . Our PPE kits should reach the market next week,” said Dr GSK Velu, Chairman and Managing Director, Trivitron Group. Hindustan Times