Seven pharma firms to face criminal prosecution if they fail to submit Remdesivir data: HC

This comes while hearing a suo motu public interest litigation on the shortage of medications, oxygen, beds, and other essentials for COVID-19 in Nagpur and other neighbouring districts. A division bench comprised of Justices Sunil Shukre and Avinash Gharote was briefed about the various means to purchase the drug and the 1,43,000 lakh vial shortfall by Remdesivir manufacturers in order to satisfy the State's demand.

Vijay Waghmare, the state nodal officer, notified the court that Nagpur had received 20,000 vials of Remdesivir in response to the court's directive. However, the court stated that it wanted to assure a consistent supply and mentioned that there are concerns at the level of pharmaceutical companies.

Waghmare responded that the corporations are not fulfilling their commitments despite the fact that the State government has been in contact with them, as per a recent media report in The Hindu.

Accordingly, the court ordered the seven drug makers to supply vials to the State Government before catering to individual/pharmacist demands and to provide their daily production data to the Nodal Officer and State Commissioner of the Food and Drug Administration, adding that the production information should also be submitted on a daily basis to the manufacturer's and FDA's websites.

Shri Parimal Singh, Commissioner, F.D.A., State of Maharashtra informed the Court that the F.D.A. is making all-out efforts to ensure that pharmaceutical companies fulfil their quota of supply on a daily basis to the State of Maharashtra, but somehow or the other, there invariably remains a shortfall in the supply that all the pharmaceutical companies make.

He further informed the Court that as per the billed quantity of the supplies as of 1st May, 2021, the shortfall in so far as the State of Maharashtra is concerned is 143034 vials. He submitted that these pharma companies are required to clear this backlog of vials and also continue to supply vials in accordance with the quota already fixed by the Central Government by its two orders dated 24th April, 2021 and 1st May, 2021.

Following the hearing, the court ordered pharmaceutical companies to first supply Remdesivir vials to the State government and district authorities before providing them to private enterprises. The court noted,

"We would also direct that now no pharmaceutical company which is duty-bound to supply Remdesivir vials in accordance with the orders of the Central Government dated 24th April, 2021 and 1st May, 2021 to the State of Maharashtra, shall supply Remdesivir vials to private purchasers in the State unless the daily quota of the supply allocated to each of the pharmaceutical companies for Maharashtra is first fulfilled by every pharmaceutical company and if there remains any balance of Remdesivir vials thereafter, then only the concerned pharmaceutical company shall supply those vials to the private purchasers in the State in fulfillment of the orders that they have received from them."

The court further observed,

"We further direct the Secretary, Health of the State of Maharashtra and Commissioner, F.D.A., State of Maharashtra to ensure that these directions are scrupulously followed by every pharmaceutical company and in case it is seen that there is any violation committed by any of the pharmaceutical companies, we further direct that the erring company shall be prosecuted under the relevant provisions of law for violating the directions of this Court and jeopardizing the precious human life."

Subsequently, the court directed all the 7 pharmaceutical companies to submit production figures to the Commissioner, F.D.A., State of Maharashtra and also upload the same on their respective websites. It noted,

"It would also be necessary that each of the pharmaceutical companies submits on a daily basis its production figures to the State of Maharashtra and also upload those production figures on their respective websites."

It warned;

"Any violation committed in this regard would be viewed seriously and would be liable for prosecution under appropriate criminal law."

The bench further directed the F.D.A. and State of Maharashtra to upload on daily basis all the figures pertaining to the production of Remdesivir drug and also other drugs received by it from all the pharmaceutical companies, reports The Hindu.