The Central government should, if necessary, invoke its powers under the Patent Act to direct compulsory licensing of the drugs to deal with the COVID-19 situation, the Delhi High Court said on Tuesday in view of the shortage of several drugs that are used for saving the lives of COVID-19 patients (Rakesh Malhotra vs GNCTD).
The Court nonetheless said that the “best course” would be to “encourage” the existing manufacturers to ramp up their production on a war footing, as was done in the case of Remdesivir, and to grant “voluntary licenses” to others to manufacture.
“If such efforts do not fructify, the Government/Drug Controller should not hesitate to invoke their power under Patent Act (to direct compulsory licensing) since lives of the people which are being lost at a very fast pace take priority over everything else. Such patent holders can be compensated by fixing a fair licence fee,” the Court said.
The order was passed by a Division Bench of Justices Vipin Sanghi and Rekha Palli in a petition concerning the COVID-19 situation in the city.
Taking note of the presence of hoarding and black-marketeering of COVID-19 related drugs, the Court also directed the Central government and its agencies, particularly the Drug Controller, to issue necessary directions and undertake checking on regular basis to unearth all such cases.
“You need to take out a whip, raid people,” the Court said.
During the course of the hearing, the petitioner, Rakesh Malhotra, highlighted that Delhi was facing an acute shortage of Remdesivir on account of the drug being given to other States.
Senior Advocate Rahul Mehra for Delhi government added that Delhi was in a “very alarming situation” and there was a need to divert resources to it.
To this, the Court responded,
“We can hope and expect that this distribution is on the number of cases in other places and there is no politics. Every life is important… We assume the (government official) is applying its mind to the need of the area and seriousness of the situation otherwise people will have blood on their hands… Then we are doomed.”
The Court accordingly directed that the Central government to “dynamically review” the distribution of Remdesivir to States and Union Territories, on the basis of the need/serious active COVID patients.
“This is essential to maximize efficient use of the life-saving drug,” the Court added.
The Central government told the Court that it has banned the export of Remdesivir and manufacturing has been ramped up.
The Court proceeded to record the Central government’s submission that it was “endeavouring to make more beds available” to Delhi in its hospitals.
Considering that number of COVID-19 patients needing hospitalisation is higher than last year, the Court asked Centre to urgently look at allocating more beds from amongst their hospitals.
The Court was informed that the Centre’s hospitals were occupied by non COVID patients who also require critical care.
Further, to ramp up COVID-19 testing, the Court directed Central government to issue necessary directions for top-priority-clearance of imported machines by Customs authorities.
It also directed ICMR to give top priority to clearances for setting up/expanding RTPCR test labs.
The matter would be heard next on April 22.