Consider doing away with registration of private importers willing to bring raw materials for Black Fungus drug from other countries: Bombay HC to Centre

The Bombay High Court bench of Justices Sunil Shukre and Avinash Gharote at Nagpur seat on Tuesday ordered the Drug Controller General of India (DGCI) to consider doing away with the registration process of private players, who are willing to import the raw material to be used for producing Amphotericin-B, the essential drug to treat Mucormycosis aka as Black Fungus.

This comes after two private entities petitioned the bench seeking directives to the Union government and the DGCI to expedite the registration process of private players.

"During such a serious and alarming situation pertaining to Black Fungus, some public spirited importers from Nagpur have come forward to extend their helping hands. However, they have highlighted their problem in importing of the raw material required for manufacturing of the drugs," the judges noted in their order.

According to the two importers, if these hurdles are cleared, they

being the private importers, who are willing to make the raw material available to the Indian manufacturers, "our society will substantially save itself from its present crisis."

One of the two importers - Unijules Life Sciences Limited, had sent a letter to the bench on May 31, detailing their grievances. The other importer is M/s Arco Lifesciences (I) Pvt. Ltd.

"On going through this letter, it appears that major hurdles that

these interested importers are facing are in respect of the delay occurring at the level of DCGI in granting registration to the private players," the bench noted.

The judges further noted that the Union government has actively coordinated with all the stakeholders holders for importing raw material.

Also Read: Mucormycosis: Act as if this is a war like situation, Bombay HC to Centre and State

"But the Union's note does not say anything about the expeditious grant of registration to the Indian importers," the bench noted.

The judges further took into account the request made by the private importers that the procedure for obtaining registration of DCGI for making import of the drugs or raw material required for production of drugs within India should be done away with, atleast during the pandemic situation and the Authority to grant permission for import of the drugs and/or raw material for drugs be delegated to the Food and Drugs Administration (FDA) of individual states.

"We request the Central Government to actively consider the prayers made in the letter by these private players. A decision in this regard, we direct, be taken on or before the next date. We are hopeful that some solution will be found out by the Central government as the goal of this Court is in communion with the object of the Central government, with the patient being at the centre of focus," the judges said while adjourning the hearing till June 9.

Also Read: Apprise Centre about rising Mucormycosis cases, Amphotericin B shortage: Bombay HC tells Maha govt

source https://www.freepressjournal.in/mumbai/consider-doing-away-with-registration-of-private-importers-willing-to-bring-raw-materials-for-black-fungus-drug-from-other-countries-bombay-hc-to-centre