Coronavirus | Bombay HC orders Centre to include Remdesivir in list of scheduled drugs

Court asks govt. to regulate pricing, do away with tender process

The Nagpur Bench of the Bombay High Court on Friday asked the Centre to include Remdesivir in the list of scheduled drugs and to regulate its pricing. The direction came while the Bench was hearing a suo motu public interest litigation (PIL) on shortage of oxygen, non-availablity of Remdesivir, Tocilizumab injections, and hospital beds in Nagpur district.

When Ulhas Aurangabadkar, assistant solicitor general of India, told a Bench of Justice Sunil Shukre and Justice Avinash Gharote, that it would be difficult to include Remdesivir in the scheduled drugs, the Bench noted, “Prima facie, we are of the view that it is possible to regulate the pricing if a liberal interpretation is given to the provisions of Drugs and Cosmetics Act (DCA).”

The Bench went to state that the provisions of the DCA did allow restriction or regulation of prices of a drug that was essential during a natural calamity or epidemic. “The laws empower the Union government to take such steps,” said the Bench and noted that even the Drugs Control Act provides for fixing rates of essential drugs.

Both the Drugs Control Act and DCA enable the central government to issue a notification to fix rates of essential drugs during an epidemic, noted the Bench. Till now, not a single drug has been added to the scheduled drugs, and “the Central government can now do so and fix the rates of Remdesivir” it noted.

“If the powers conferred on the Central government are exercised, it will go a long way. It will stop extortion of money from families of COVID-19 patients, and will also put a full stop to the black-marketing of the drug. The Centre should perform its fundamental duty by fixing the prices,” the Bench said.

The court also came down heavily on Maharashtra for not having a proper mechanism to procure and distribute Remdesivir vials across various districts of the State, and directed it to exercise its powers under the Disaster Management Act and the Epidemic Diseases Act, to centralise purchasing of all COVID-19 related medications at an appropriate price and to do away with the time consuming tender process. “If the State doesn’t rise to the occasion of this disaster, then it would be failing in its duty to protect human life,” noted the Bench.

The hearing began with the court asking for a district-wise allocation of Remdesivir from the Food and Drugs Administration (FDA). And when the joint commissioner of FDA told the court that he did not have the order copy for distribution, it irked the Bench. Justice Shukre said, “This isn’t a drama going on. This is a real life issue. This is another example where there is no assistance from the State. It is a very sorry state of affairs. How can it happen that a senior officer like you has no idea about the allocation order for life saving drugs?”

“Be a bit more sensitive and serious,” Justice Shukre said, adding, “You shouldn’t mislead us. In fact, we are sorry for having trusted you and going by your word.”

The State nodal officer for COVID-19 Vijay Waghmare then submitted a district-wise chart that spelled out Remdesivir requirement and the number of COVID-19 cases to which Justice Shukre questioned on how the State was planning to distribute the drug among various districts. Mr. Waghmare said the vials would be distributed as per requirements pertaining to the percentage of patients in each district. Justice Shukre then sought to know the number of Remdesivir vials Nagpur would require in the next seven days. Mr. Waghmare, after calculations, told the court that Nagpur would need 8,100 vials.

The Bench then sought to know if the State had placed purchase orders for the remaining vials and what the procedure was, and found that it would take at least 15 days to procure Remdesivir vials. Justice Shukre then noted that the private purchasing of the drug should be stopped and said that the State must also know the demand of private hospitals, and the purchase and distribution of the drug should be brought under a centralised mechanism.

The Bench then asked the State to do away with the tender process so that the drugs could be procured faster.

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