With collectors in-charge of allocating anti-viral drug remdesivir to Covid hospitals, and pharmacies prohibited from stocking it, several smaller nursing homes and non-Covid hospitals that are treating Covid patients are finding access to the drug difficult. The stringent allocation process has also forced several districts to opt for a tedious scrutiny of medical documents before approving the drug for a Covid-19 patient.
On Tuesday, Health Minister Rajesh Tope said he has requested the Centre to increase remdesivir allocation for Maharashtra. “There are only seven manufacturers and the entire stock is under the central government. We have demanded more stock and a price cap on this drug. The supply chain is closely monitored in all districts,” Tope said.
Maharashtra has been allocated 8.09 lakh vials for the period from April 21 to May 9, which is over 44,000 vials per day – about half of the state’s requirement of 75,000 vials.
Due to short supply, a team under the deputy collector scrutinises each application before deciding who gets vials in Osmanabad. In April, the district received 4,200 vials. It had 8000-9000 requests for remdesivir, and only 800 patients received it.
“We get requests from patients’ kin, hospitals and through war rooms. A team from civil hospital follows ICMR guidelines before approving. If a patient is on ventilator, we know remdesivir won’t help. After we began scrutiny, several hospitals reduced the tendency to over-prescribe,” said Collector Koustubh Diwegaonkar.
While the scrutiny has helped curb over-use, it has adversely affected smaller nursing homes and non-Covid hospitals that continue to treat Covid patients. In Mira Road, Sunrise hospital said it had put in a request to Food and Drug Administration for remdesivir for three days and got no stock for seven patients.
FDA Joint Commissioner G R Rokade said they are flooded with phone calls. “But supply is short, we too are helpless,” he said.
As per the latest SOP, the collector, FDA and health department have to together monitor remdesivir allocation to hospitals. Earlier, each district could have selected pharmacies to supply, now even pharmacies cannot stock. District officials said the new system has reduced panic among patients and controlled unnecessary prescription, but it has also made availability of the drug more difficult in some cases.
Doctors said that the distribution process criteria for the drug were not defined properly. Under the existing protocol, a particular hospital or nursing home is eligible to receive remdesivir for 10 per cent of active Covid patients under treatment. Each hospital raises their daily requirement with the area’s concerned health officer, who then forwards the same to FDA, which makes the doses available at the collector’s office. But if FDA does not direct the drug, patients’ kin start searching for it.
Raigad Collector Nidhi Choudhary listed the hurdles they face in the process. “The foremost problem is a gap between demand and supply. For instance, at a time there are 1000 patients on oxygen support in hospitals across the district who require remdesivir. The hospitals raise the demand for 2,000 vials as first dose and we are not able to get that kind of quantity in a day. There is also uncertainty related to the quantity that will be allocated to the district. There is no regular supply, which creates issues related to treatment management,” she said.
Each vial of remdesivir is 100 mg. Usually a six-vial course is prescribed, and irregular supply has left treatment of many midway.
In Raigad, there is no medical team to scrutinise each form. Distribution is based on hospital requests. Choudhary said planning for the distribution is difficult, “If we get 300 doses but demand is of 800, the question arises which hospitals should be given these 300 doses on priority. I don’t know which patient in which particular hospital needs it more than other patients. This call has to be taken by the physician from the hospital.”
In Mumbai, District Collector Rajiv Nivatkar said that allocation is done through the FDA. “FDA has created seven zones in Mumbai. Each zone has an assistant commissioner and drug inspector. If we get an inquiry at the control room, we forward it to the FDA. We don’t allocate remdesivir directly,” Nivatkar said.
In Aurangabad, a drug inspector said the biggest issue was black marketing, which they stopped by shortening the supply chain and removing retailers from it. In Gadchiroli, since private hospitals are few, demand is less than other districts. District officials said they have 3000 vials for a month, which is adequate.
The Maharashtra FDA has filed over 30 FIRs pertaining to remdesivir black marketing.