Prescribe Standards: Manufacturers allege govt keeps shifting goalposts for ventilators

Even now, requirements are arbitrary, and it is for this reason that objections have been raised against such products. (Representative image)

India didn’t have much ventilator manufacturing capacity at the start of the pandemic. So, it is commendable that, within a quarter, 60,000 ventilators are being manufactured by Indian companies. However, the achievement is clouded by the poor procurement process that has laid bare the challenges faced by medical device manufactures. The government, which commissioned the manufacture of 60,000 ventilators to various start-ups and corporate manufacturers, has changed the goalpost quite often; this has meant domestically-manufactured ventilators getting viewed as being of inferior quality. Ventilator manufacturers complain that HLL Life, a government entity tasked with procurement, has changed the requirements in the interim, leading to additional cost for manufacturers. Although HLL’s revisions were based on the urgent need for ventilators, acquisition would have been hassle-free if doctors from across the country were consulted before putting up a tender document. Even now, requirements are arbitrary, and it is for this reason that objections have been raised against such products.

But, given India has proven that it can excel in low-cost manufacture of medical devices like ventilators—Indian ventilators cost one-fourth or one-fifth of what international ones do—the government now needs to set standards and have a certification process in place. This will not only give impetus to the Indian device-making industry—only 20% of components for a ventilator are imported—but also help Indian hospitals in procurement. Once the pandemic passes, hospitals would still need ventilators. An absence of standards would mean low-quality products in the market.