Hours before Nagpur bench of Bombay High Court began its emergent hearing on Sunday afternoon regarding non-compliance of its order to supply 20,000 Remdesivir vials to Nagpur, Akola, and Bhandara districts, the State Government dispatched 19,128 vials. By Sunday afternoon, the region received another tranche of 960 vials. Parimal Singh, Commissioner, Food and Drugs Administration (FDA), and Vijay Waghmare, Nodal Officer, informed a division bench consisting of Justice Sunil Shukre and Justice Avinash Gharote about this development during the special hearing. Nagpur did not receive a single vial in last two days.

 

The districts of Bhandara and Akola also did not get any vial. This forced the High Court to order release of 15,000 vials for Nagpur, 2,000 for Bhandara, and 3,000 vials for Akola as interim relief without disturbing the regular quota. But, till Saturday night, there was no word about Remdesivir allotment, after which Amicus Curiae Shreerang Bhandarkar moved an application seeking urgent hearing and action for breach of order. The machinery swung into action and before the hearing commenced, informed the High Court about receipt of 19,128 vials received for three districts and allotment of 960 more vials by Sunday evening.

 

The High Court made it clear that State FDA must ensure supply of allotted quantity as well as quantity not supplied during last 10 days to all districts every day and procure it from pharmaceutical companies while casting duty on companies to adhere to supply schedule given to them. Else, it warned, coercive action will be ordered against them for any deliberate default. The FDA Commissioner informed the court that as per revised allocation order of Centre dated April 24, the State should have received 4.35 lakh vials. If later amendment is added, then at least 4,73,500 vials should have been received by the State by April 30 night. But, the billed quantity of Remdesivir vials was 3.41 lakh by April 30 night and, as of May 1, a backlog of 1.43 lakh vials was created.

 

The High Court also expressed unhappiness over curtailment in State quota by Centre for next nine days. As per the latest order issued by Union Health Ministry, Maharashtra will cumulatively get 8,09,500 vials upto May 9 which includes the earlier 4.35 lakh vials. The High Court noted that such reduction was not consistent with reduction in number of active cases in the State, which still had the highest number of active patients (6.64 lakh on May 1 as against 6.72 lakh on April 30). There is marginal reduction of 1.2 per cent in number of cases while the Centre has reduced Remdesivir allocation by 14.35 per cent. As a result, Maharashtra will get 3,74,500 vials, or 60,500 less vials.

 

The High Court asked Assistant Solicitor General of India Ulhas Aurangabadkar to take immediate instructions and asked the Centre to reconsider this curtailment of Remdesivir allocation, particularly in the light of statement made by Central Drug Controller that all manufacturing firms were jacking up production, which might touch 88 lakh from existing 38 lakh capacity, in a few weeks. Since any order to restore or enhance allocation will have nationwide implications, the High Court refrained from passing any stern directions but firmly asked the Centre to appropriately reconsider the issue keeping in mind active patient load and actual production by Remdesivir manufacturers. 

HC directs CS to step in to end chaos n Asks pharma cos to furnish daily production figures to FDA Taking note of chaos prevailing due to multiple procurement methods, High Court directed the Chief Secretary (CS) to act immediately and remove the confusion leading to delay in getting Remdesivir vials from seven manufacturers. The High Court directed the Chief Secretary to immediately go for Centralised procurement, supply and distribution in fair and equitable manner to all the districts consistent with the order of Centre. Taking pharmaceutical companies to task for their failure to adhere to supply-schedule, the High Court made it clear that all the seven manufacturers of Remdesivir under duty to supply Remdesivir shall supply vials to State and only after the quota allotted to them ws fulfilled they could distribute remaining vials to private party. In case of any violation, the FDA has been directed to prosecute such erring pharmaceutical company for violating directions of the court and for jeopardising precious human life. All pharmaceutical companies have been directed to submit their daily production figures of Remdesivir and life-saving drugs to tackle COVID-19 to FDA Commissioner and upload on their own website. Any violation will attract criminal prosecution, the High Court warned. They have been asked to fulfil the obligation of supplying allotted quantity of Remdesivir as per Centre’s direction without waiting for formal order. The High Court has asked FDA to daily upload details about Remdesivir vials and other life-saving drugs received from pharmaceutical companies, district-wise distribution, backlog if any, to maintain utmost transparency. The High Court further asked the State to consider air-lifting of Remdesivir from company manufacturing unit to avoid delay and also to streamline procurement process.

 

 Give figure of COVID-19 medicines daily sales: FDA to wholesalers Food and Drug Administration (FDA) has stepped into address the shortage of medicines prescribed for countering effects of COVID-19 and asked wholesalers to provide daily data of sales. In a communication dated April 28, Dr P M Ballal, Assistant Commissioner (Medicine), FDA, Nagpur, also directed the wholesalers to seek additional stock considering the current viral load in Nagpur and other districts. The sellers should place orders with Carry&Forward Agents of respective companies and make advance payment after placement of orders so that no constraints remains in distribution cycle. Ballal mentioned that the said order was issued under powers conferred under Drugs and Cosmetics Act 1940. Nagpur is biggest market of entire region for medicine supply and companies these days are sending consignments through air route to cut down delays. As to Remdesivir, it is most sought after drug to counter infections in lungs due to onset of COVID-19, and High Court has taken cognisance and streamlined its supply to region. However apart from that Doctors are also prescribing Tocilizumab/Itiolizumab, Ivermectin and Favirapir to those afflicted by novel corona virus. While Tocilizumab and its alternatives are very costly drugs, these are in very short supply while demand is rising quite fast. As to Ivermectin and Favirapir, these drugs are prescribed for patients with mild infection and mostly they are in home isolation. Tocilizumab is used as a last resort when all other medicine fails to work. However the wholesalers say they are not getting enough supplies of these medicines whose demand has short up through out the country. The FDA communication has directed wholesalers to provide daily sales information about stock sold/distributed to administration on [email protected]. Also the administration has created WhatsApp group on which the names of dealers to whom the stock is distributed is to be provided promptly, states the documents with The Hitavada. While information about Remdesivir is to be provided to Swati Bharde, Drug Inspector; that of Tocilizumab/Itiolizumab, Ivermectin, Favipiravir is being compiled by Monika Dhawad, Drugs Inspector. Ballal in his letter further directed wholesalers to place week's anticipated demand in advance to the C&F so that they in turn can ensure proper supply. While Remdesivir is now arriving in steady quantity, the other four drugs have nearly disappeared from the market as people stocked-up on the same in state of panic. Government institutions itself cornered bulk of supplies and Ivermectin and Favipiravir was distributed by Nagpur Municipal Corporation health authorities during last two months on mass scale after positivity rates shot up considerably. Only after new guidelines were issued, supply of the pills to home quarantine patients was discontinued. A few days back city received supply of Tocilizumab but it was very few vials and same were sold in jiffy. It is learnt that people are placing advance orders with wholesalers and also deposit entire amount to ensure that they get the life saving injection. Curiously, companies have also increased the prices of Remdesivir and Tocilizumab injections. While the lowest cost of Rs. 700 of Remdesivir remains unchanged its availability in local markets is nil. The second lowest price was Rs. 900 and same has increased to Rs. 1400. Same is the case with Tocilizumab, it price earlier was Rs. 36,000 and now it is increased to Rs. 41,000, said a wholesaler. Also the companies have lowered the margin of wholesalers on Remdesivir from 5 per cent earlier to 4 per cent.