Amidst rising cases of coronavirus infection and limited treatment options, there are reports about supply shortage of remdesivir injections in the country. Members of the healthcare fraternity and public health activists have raised concerns about this situation and requested the government to intervene and resolve this issue at the earliest.

Prof Bejon Misra, Founder Director, Patients Safety and Access Initiative said, “Following the vision of accessibility and affordability, the NPPA and other regulatory authorities need to play a proactive role in such a situation to ensure that the medicines used for the treatment of COVID-19 are not in short supply. However, we are seeing that one of the ICMR recommended medicines, ‘Remedisivir’ is in shorter supply and creating a panic situation in the country.”

A medical practitioner from the Mumbai suburbs who is treating the COVID-19 patients informed, “We are seeing positive results after administrating remdesivir injection on patients. However, in the last couple of days, we have observed a shortage of supply, which is affecting treatment.”

He added, “The pharma companies and the government should ensure continuity in the supply of such medicines. Besides, there is also a need to reduce the price of each vial because in India affordability in itself an issue especially during the pandemic situation.”

The supply so far…

Last month, the Drug Controller General of India (DCGI) gave permission to Cipla and Hetero Labs to manufacture and market Gilead Sciences’ anti-viral drug remdesivir for “restricted emergency use” on hospitalised patients. Recently, it has also granted approval to Mylan Laboratories to manufacture and market the drug in India.

Hetero has already launched its product in the market, under the brand name ‘Covifor’. It is priced at Rs 5400 for each vial. The company’s first batch comprising over 30,000 vials have already been supplied, approximately 20,000 vials were delivered to the private hospitals and the remaining have been given to government institutions across the country.

Cipla is yet to launch its product, Cipremi, in the market. It is likely to launch it post July 9, 2020. A source from the company informed that Cipla is also now geared to supply remedisivir injection. It has the capacity to meet the growing demand.

Mylan has not announced a launch date for its product yet. Reportedly, the company’s consignments from China carrying some of the intermediates required to manufacture remdesivir was stuck at the Air Cargo Complex, Mumbai for a couple of days. It got clearances recently.

Measures to ramp up supply

A source from Hetero Labs informed that the Tamil Nadu Government has procured around 10000 vials of Covifor at Rs 4250 each. Other State governments have also approached the company these injections. For instance, through a tender, the Maharashtra Government has placed an order for 15000 vials. Each vial is priced at Rs 4144. The company’s second batch the drug will be available in the market post-July 9, 2020, and this time the company is planning to release approximately one lakh vials of Covifor.

An industry observer also informed that companies are trying their best to meet the demand, and new stock from Cipla and Hetero is likely to arrive in the market soon. 

Black marketing of remdesivir?

Recently, many have alluded to illegal marketing of remdesivir in the country. Reportedly, the drug is being sold at exorbitant prices per vial through an emerging black market.

Speaking against such practices, Misra stated, “It is the role of the regulatory authority to ensure affordability and accessibility so that patients are not compelled to purchase medicines at prices higher than the MRP. There should be a choice given to the patients by medical practitioners to play a proactive role, especially during the COVID-19 crisis.”

Express Pharma spoke to a few stakeholders to understand the situation better.

Mahesh Doshi, President, Indian Drugs Manufacturers Association (IDMA) said, “There is a short supply of the remedisivir injection in the market, but it is equally important to understand that black marketing of the said medicines is not by our member companies. Our member companies are trying their best to make the medicines available in the market on a priority.” 

Dharmesh Shah, CMD, BDR Pharmaceuticals, commented, “It is a very sad situation to know that some unethical marketing practices are taking place in the country amidst the pandemic situation. It is happening not from our industry but, through some unauthorised ways, it is taking place from the neighbouring country. However, I would like to inform you that in the next two to three days’ time there will be enough stock of the remdesivir injections in the market.”

KG Ananthakrishnan, Director General, Organisation of Pharmaceutical Producers of India (OPPI) said, “The global science-based pharma industry is focused on fighting the war against COVID 19.  This means that all our members are pushing the boundaries of science and using investments in new technologies to speed the development of safe and effective diagnostics,  treatments including vaccines.  One of our members-Gilead Sciences Inc has signed non-exclusive voluntary licensing agreements with domestic pharmaceutical manufacturers to further expand access and supply of Remdesivir only for “restricted emergency use” on Covid-19 patients.  As we understand, the product will be made available to serve patients in India and for several countries beyond India.  This is part of Gilead’s efforts to enhance global access to life-saving treatments for patients affected by the pandemic and we are certain that this product will be available soon for the patients.”