A week back, a retired professor from Panjab University suffering from coronavirus was admitted to Dayanand Medical College and Hospital (DMCH) in Ludhiana after his oxygen levels plummeted. Doctors advised tocilizumab injection. His family had to go all the way to Delhi as chemists both in Ludhiana and Chandigarh did not have the injection.
This is no isolated incident. Dr Rajesh Bhaskar, nodal officer of Covid cases in Punjab, said, “We have learnt that the pharmaceutical company, which manufactures tocilizumab has stopped supplying this drug, leading to its shortage.”
A call to one of the patient support helpline numbers publicised by pharmaceutical firm Cipla Ltd to check for the availability of the drug they offer for Covid-19 treatment confirmed that the supply of Tocilizumab – sold under the brand name ‘Actemra’ by Cipla through its tie up with Swiss biotech firm Roche – has been “a little low” lately. Several facilities have been prescribing tocilizumab, a rheumatoid arthritis drug, to mitigate a severe immune reaction known as the ‘cytokine storm’, which could cause inflammation that may be life threatening.
A Delhi-based supplier of the injection told The Indian Express on condition of anonymity that the vendor had been observing instances of shortages over the last two weeks, when calls had begun coming in from patients across the country.
“I got queries from Hyderabad, Baroda and parts of Uttar Pradesh,” said the supplier, adding that due to contractual obligations towards a specific hospital in the national capital, the vendor was unable to divert supply towards fulfilling these requirements. “We are also helpless. Our orders are limited to the hospital we supply to,” the supplier said, adding that the vendor was experiencing a delay of 2-3 days in receiving the quantity of Actemra required by the hospital.
“Whatever the hospital’s order is, we get only that quantity…We can’t divert this supply to any other patient,” the supplier said. “This is an injection given under strict conditions to specific patients after filling a form and receiving their consent, and these details are closely monitored by regulators”.
Others have been observing the drop in supply for longer, “especially” in metro cities.
For instance, only six of 10 patients recommended by Dr Manoj Goel, Director-Pulmonology, Fortis Memorial Research Institute, Gurgaon, for treatment with tocilizumab were actually able to get the drug. “Over a period of time, in the last month, we have found a decrease in supply of tocilizumab. I think (one of the reasons is) because the number of cases have increased,” said Goel.
“The interest of the medical fraternity using it is still there. Naturally, the demand is much more compared to the supply and so there is a scarcity of this medicine,” he added.
Sales of tocilizumab saw a spike after it was included in India’s revised guidelines on clinical management of Covid-19 in June. Pharmaceutical market research firm AIOCD Awacs PharmaTrac recorded at least 4,790 units of the drug sold across the country in July, up from 60 in June. Estimates from some states hint that the actual number of injections sold would be higher.
For instance, The Indian Express earlier reported that over 11,800 injections of tocilizumab were sold in Maharashtra alone until July 12 since the pandemic began.
On July 29, however, Roche had released findings of phase III clinical trials it had been conducting on the drug in relation to its effectiveness in Covid-19 treatment. According to the firm, the study of the drug “did not demonstrate a benefit for patients in either clinical status or mortality”.
Some medical professionals claim that supplies of the injectable drug began drying up around the time these results were published.
For instance, towards the end of July, Dr LH Hiranandani Hospital in Mumbai found that its distributors did not readily have the drug available, prompting the hospital to check with Cipla.
“We asked Cipla as to what had happened and they informed us there was some problem with Roche, and then Roche came out with the paper,” Dr Sujit Chatterjee, the hospital’s CEO told The Indian Express. “I’m not going to be buying all of this in the black market…Since we’ve got an alternative, we’re focusing on what’s available,” he said, adding that the hospital was now focussing on plasma and early plasma therapy.
“Tocilizumab on its own is not available in the market from our dealers, so we are as good as not using it,” he added.
In Punjab, doctors are now opting for pulse steroid therapy. “In this therapy, high dose steroids are administered intravenously for short duration to handle cytokine storm. AIIMS Bhopal is using this therapy. Initial results reported by doctors from different institutes in Punjab have shown promising results. Looks like, it can be an alternative to tocilizumab injection,” said Dr Bishav Mohan, cardiologist at DMCH and convenor of management of Covid update in Punjab.
The tocilizumab injection is priced at Rs 29,000, but due to shortage it was found being sold in the black market for upto Rs 60,000 per vial.
A Roche India spokesperson said they are constantly monitoring the evolving situation and coordinating with the global supply chain teams to ensure that the demand requests for tocilizumab are met. “We have already received a few consignments in the last couple of weeks and are expecting more to reach India in the coming weeks,” said the spokesperson.
The spokesperson said that Roche is closely working with Cipla “to provide unrelenting support” to patients in India during these unparalleled times. “In addition, Roche urges all health system participants to refrain from stockpiling. This will help enable timely adjustments which in turn will support us in meeting the needs of patients around the world,” the spokesperson added.
According to Cipla, the shortage is also because of an “unprecedented” demand for the drug here.
“We will continue in our endeavor to support patient access to the drug. There has been an unprecedented demand for tocilizumb within the country. We are moving expeditiously and working closely with our global partners to ensure supplies. The situation has stabilized with the receipt of consignments in the last week and we are expecting more stocks in the coming weeks,” stated a spokesperson for Cipla.
There was an international briefing last week where this question was asked. “There is sufficient supply globally to provide Actemra for its main indication, which is rheumatoid arthritis. Of course, physicians, if they wish so and if they feel that Actemra can also help Covid-19 patients in this specific setting, should be able to receive it. So, we can supply worldwide. There might be a specific issue with a specific customer in India, but please let us know so that we can follow up. Overall, there is enough supply of Actemra,” said Dr Severin Schwan, CEO, Roche Group during a global pharma press briefing on Covid-19 treatments organised by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) on Thursday.
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