“It is to inform that presently, no permission is required for manufacturing of ventilators under the Drugs and Cosmetics Act and Medical Device Rules. Therefore, those who are willing to come forward and manufacture ventilators may start the production to tackle the situation arising out of Covid-19 outbreak in public interest," V. G. Somani, India’s Drugs Controller General, said in an email to the secretary, ministry of pharmaceuticals, on 23 March.
Companies generally need a license to make items listed as essential medical equipment under the Drugs and Cosmetics Act and Medical Device Rules. This rule has however been waived off considering the medical urgency but only if the manufacturer partners a licensed firm.
The Union government had on Tuesday reached out
to five automakers—Tata Motors Ltd, Mahindra and Mahindra Ltd (M&M), Hyundai Motor India Ltd, Honda Cars India Ltd and Maruti Suzuki India Ltd—to explore the possibility of making ventilators at their plants.
It also urged the automakers to partner nine companies who currently make ventilators in India and Tata Motors and M&M have already begun talks with some of them, said four people aware of the development.
“The government has asked us to partner with these auto companies like Maruti and Hyundai as well as any other manufacturers to make ventilators. Basically, we will share the technology and designs with them and they will manufacture it temporarily," said an official with a ventilator maker, requesting anonymity.
“Tata Motors might start production of such ventilators with one of the equipment manufacturing companies from next week. The developments are being monitored by the top management of the conglomerate Tata Sons, including the chairman. The challenge though will be reopening the plants for such a micro operation since permission will be required from local authorities," said a person directly aware of the development.
A senior government official said the automakers will have to talk to the existing ventilator manufacturers to reach an agreement on sharing of design and technology.
“It is only automobile manufacturers we had a meeting with, and they had only shown interest. But, if anyone else is also interested, they can partner with these ventilator makers and manufacture it," the official said, requesting anonymity.
The step is spearheaded by the Department of Pharmaceuticals, in consultation with the Central Drugs Standard Control Organization (CDSCO), a senior health ministry official said separately.
The health ministry has so far declined to give an estimate for the number of ventilators in India.
The latest move shows however that there may be an acute shortage of ventilators in India, especially considering that the total number of cases of novel coronavirus infection, or Covid-19, is expected to rise exponentially from nearly 700 now.
Amit Panday in Mumbai contributed to the story.
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