Even as the Gujarat state task force of medical experts warned against indiscriminate prescription of Remdesivir and stressed on not resorting to panic buying and stocking up of the anti-viral, thus creating an “artificial scarcity”, some private hospitals in Vadodara have resorted to a peculiar prerequisite for patient admission – arrange for six doses of Remdesivir first.
Zydus Cadila, which had announced Friday night that it had run out of stock of the generic version of the drug, Remdac, put out a notice Saturday night that it would resume sale of the injection from Sunday on stricter documentation, purportedly to control hoarding.
Remdac, which was being sold at the Zydus Hospital in Ahmedabad at a price of Rs 899 since April 5, was planned to be sold until April 12, as the hospital had announced. However, stocks ran out by the night of April 9 and the hospital issued a public notice, stating that it “will not be able to dispense the drug till further notice.” On Saturday morning, Minister of State (Independent Charge) of the Ministry of Shipping and Minister of State in the Ministry of Chemicals & Fertilizers Mansukh Mandaviya tweeted, “I have spoken to Pankajbhai (sic)[Pankaj Patel, Chairman of board of directors at Zydus Cadila] regarding the resumption in sale of Remdesivir injection and very soon, the sale shall be resumed…It is my appeal to the relatives of patients to cooperate with the hospital administration. It is also an appeal to citizens to not purchase it if there is no need…” Mandaviya remained unavailable for details and comment “as he is busy with the election campaign in Bengal,” said his personal assistant. Pankaj Patel, too, was unavailable for comment. While the hospital would earlier sell the drug against a patient’s aadhar card, a physician’s prescription and recent RT-PCR test report, the Saturday notice allowed only one relative of a patient to buy it against an RT-PCR report that was not more than seven days old, a prescription from an allopathic physician with registration number, stamp and qualification on a hospital letterhead and the admitted patient’s aadhar card.
A senior official at Zydus Hospital, however, said, “We (Zydus Cadila) manufacture more than 30,000 units of Remdesivir every day. We also provided the Gujarat government with 85,000 injections in a span of three days, and apart from the government, we are also supplying to the open market… While earlier we had a supply of nearly 4,000-5,000 injections a week for retail sale, that has gone down given the increased demand from the government, to which we supply as well…We are seeing an artificial demand as well, with those not needing it, still purchasing it and hoarding it. We are doing the best to check this, by asking for Aadhaar, prescription etc, but we are still seeing (leakage)..we saw people coming from all over Gujarat, furnishing old prescriptions, old test reports. Given the rush, it becomes very difficult to check thoroughly…While we are seeing more demand, it is also a wrong (artificial) demand…”
Notably, Drugs Controller General V G Somani had written to all states and union territories, warning of “hoarding and black marketing” in light of the shortage being reported of the antiviral. Specifically mentioned were Ahmedabad, Surat and Rajkot from the state of Gujarat, along with mention of the states of Madhya Pradesh and Maharashtra. The communication had noted, “You are also requested to instruct your enforcement staff to keep continuous monitoring on the situation and to keep strict vigil so that any incidence of black-marketing and over-charging of the drugs is prevented.”
Gujarat State Druggist and Chemist Association president Alpesh Patel, who made several representations in March to the state government to regulate the prices of Remdesivir as it was freely available, says the stock has run out in no time. According to Alpesh, the availability of 3000 doses will remain insufficient for Vadodara, which has a daily demand of 5000-5500 doses of Remdesivi.
Alpesh said, “There was plenty of stock available in the beginning of this wave. But with the growing number of cases, the demand proportionally grew. It would still be manageable if not for the indiscriminate prescriptions by private hospitals. One of the pre-requisite conditions for admission of Covid19 patients in a private hospital is that the relative has to arrange six doses of Remdesivir. The problem is that despite there being enough advice for caution, private hospitals are making it mandatory for the patients to fetch the drug…Why a drug like Remdesivir with severe side effects, is being prescribed without any regulation is beyond baffling. Not every patient needs it but it is being prescribed like any other over the counter drug. While it is true that the supply has been short because the pandemic is on in the entire country and there are other states that are more badly hit than Gujarat in terms of statistics we know — the distribution is decided accordingly, it is also necessary for the state government to step in to regulate the prescriptions.”
The association’s pleas to the government to allow patients to procure the drug on their own instead of the mandatory purchase at a higher price from within the hospital where they are admitted went unheard and instead, Gujarat has used over one lakh doses of Remdesivir since the beginning of April, exhausting the stock. Remdesivir is one of the two most sought after drugs for Covid-19 patients, the other being Tocilizumab, sold as Actemra by Swiss pharmaceutical company Roche.
However, the state task force of medical experts, including infectious disease expert Dr Atul Patel, warned on Friday that Remdesivir “is not a life-saving drug” or a “miracle medicine”.and instead the steroid dexamethasone and immunosuppressive drug Toxilizumab can be termed as “life-saving drug”, in the case of patients who are on supplemental oxygen support.
In Ahmedabad, Dhruvi Pharma, a distributor of Cipremi (Cipla’s generic Remdesivir) sold out 5,000 vials within the first 10 days of April and managing director Rupesh Shah has been fielding calls with ‘we do not have stock’ since Saturday. This paper too found relatives of a home isolating patient and another critical patient admitted at a private hospital, turned away on Saturday evening. Shah says, “We expect the stock to arrive by Monday, but we do not know how much since it depends on Cipla and country-wide demand,” he says. Shah says, between March 1 and 15, 100 injections were sold by them and between March 16 and 31, 2,400 vials were sold. Dhruvi pharma has both a wholesale license, thus being the go-to distributor for several private hospitals and retail pharmacies, as well as a retail license that permits them to sell to individuals.
When The Indian Express visited the Gujarat Medical Education and Research Society (GMERS) Sola in Ahmedabad, which has been appointed as one of the four nodal centres by the state government to purchase Remdesivir, on Saturday, staff there said that it is not providing Remdesivir to ‘outside’ patients.
Commissioner of Food and Drugs Control Administration Dr HG Koshia told this newspaper that the availability of Remdesivir is adequate but it is being used thoughtlessly and has resulted in artificial scarcity. There is limited manufacturing in the country – only around 3.5 lakh injections a day – but Gujarat is getting the highest number of injections per day. There are other states… so the injections can be sent to states only on the share they need.”
Rupesh says Zydus Cadila’s Remdac takes up the largest chunk of the Gujarat market. Cipla, which is manufacturing Remdesivir at its Daman and Goa plants, too supplies to Gujarat. Alpesh says that although the majority of the Remdesivir stock in Gujarat comes from Zydus, companies like Hetero and Jubilant Life Sciences have also supplied batches of Remdesivir to the state and Sun Pharma has pumped in its first batch on Saturday. Vadodara received a total of 3,000 doses of Remdesivir on April 8 and 9, after the appointment of the nodal officers for the distribution of the drug. These doses were distributed to 57 private hospitals until Friday.
Private hospitals, however, deny that there are “bulk prescriptions”. The head of a private Covid empanelled hospital, which is also heading a cluster of smaller hospitals in Vadodara, said, “Private hospitals are definitely prescribing more Remdesivir because there are also more admissions to private hospitals. We are not only counting those who have tested positive on RT-PCR but also the suspects, who are awaiting reports but whose laboratory tests have shown lung involvement are immediately treated in line with the Covid19 protocol. One cannot call it indiscriminate use.”
Dr Sheetal Mistry, former nodal officer and Assistant Professor of the GMERS-run Gotri Covid19 hospital, who is now the advisor to the Covid19 disaster management team in the city, says that patients too are pressurising doctors to use the drug, a sentiment also echoed by the state task force of medical experts. Mistry told this newspaper, “It is true that the consumption of the drug in private hospitals is more. But it is a two-way cycle. Because of the popularity among common people and due to fear among patients of the mortality they see around them, patients insist on taking the drug. Private practitioners have to also safeguard themselves because it is difficult to tell which critical patient will make it or if anyone is likely to develop a cytokine storm. In case the doctor feels Remdesivir is not needed and advises so but then something goes wrong with the patient, there will be a ruckus and the hospital will be blamed for negligence. It is also true that if patients insist, the hospitals also prescribe because it is profitable. We use Remdesivir in moderate to severe patients and all those who are on oxygen support. Our protocol for hospitalisation notified in Vadodara has made it mandatory for Remdesivir to be administered only after hospitalisation and not in home isolation. But according to research, Remdesivir should be given in addition to Dexamethasone, a corticosteroid that has been found to improve survival in patients, who see a drop in oxygen saturation. There is no conclusion yet on whether Remdesivir alone or in combination with the steroid works better.”
On Saturday, in Vadodara, 90 percent of the 1701 ICU beds were occupied and over 80 percent of the 3,923 oxygen supply beds were taken. Vadodara District Collector Shalini Agarwal said, “The admission of critical patients is so high that there is a natural demand for the Remdesivir drug. The nodal officers are trying their best to distribute the drug in rounds to each private hospital. So the hospitals that were not covered in the rounds on Thursday and Friday will get the doses in the next round. The drug is being given on a pro-rata basis based on the requisition from the hospitals. The hospitals can then decide which patients they want to administer it to.”
Koshia added that the non-availability of Tocilizumab is because the manufacturing company, Roche, has not dispatched its stock. Koshia said, “Tocilizumab is not the official protocol for treatment medicine for Covid19. The Ministry of Health and Family Welfare and ICMR have already removed Tocilizumab from the line of treatment. The company has already communicated that it should not be used for treatment of Covid19. Instead, Dexamethasone and methylprednisolone are available in adequate numbers.”
However, on April 7, AIIMS, New Delhi, in a document outlining the interim clinical guidance for management of Covid 9 mentioned Tocilizumab usage, subject to fulfillment of specific clinical conditions.
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