This article is written by Ms. Shivani Agarwal, currently pursuing B.Com.LLB (Hons) from the Institute of Law, Nirma University. This is a comprehensive article that provides an overview of the black marketing of Remdesivir drug and the action taken by the Bombay High Court to prevent the same.
Table of Contents
Introduction
Coronavirus disease 2019 (COVID-19) is a group of diseases characterised by severe acute respiratory syndrome, which includes major respiratory illnesses such as pneumonia and lung failure. Nations across the globe are continuously trying to tackle this pandemic by conducting large numbers of experiments and various other activities like developing formulas, conducting test-runs, etc. but no such viable solution has been developed.
Some people saw this harsh situation as a business opportunity and have started indulging in unfair practices in the vaccination market. While there is a shortage of vaccines in the hospitals, some people or ‘dealers’ are hoarding the vaccines and selling them at a much higher price to people. A black market is a kind of business that occurs outside of government-approved channels. Products and services sold in a black market might be unlawful, in the sense that their acquisition and sale are banned by law, or they might be legal but transacted to evade taxes. A black market is a platform and it can be physical as well as virtual where goods or services are unlawfully transferred. The illegal character of the products and services themselves, the unlawful character of the transaction, or both might constitute the black market. The local governments find it very difficult to regulate or operate these black markets because these markets are not easy to detect or see. The situation for a black market arises when a particular product/service has seen a rise in its market demand, when people want to avoid tax liabilities, etc.
For instance, a 10 dose vial of Covishield is being sold at approximately ₹20,000 while when we talk about the rate of Covaxin, it is being sold at around ₹25,000. These vials are carried in cold packs from Visakhapatnam and sold to individuals who want to administer them. After receiving the vial, it is placed in a refrigerator at home. The individual who obtains a vial of the vaccination organises a group of ten people to divide the 0.5 ml dosage and the entire cost of the vaccination. They hire a private health worker to deliver the vaccine to all ten people in one location, and they pay for the service as well as disposable needles and syringes. The middlemen’s strategy is to entice health staff with a lucrative offer of vaccination vials. At the Covid vaccination centre, health officials are drawing additional vials, alleging that more individuals are waiting for the vaccine. The vial should be thrown within four hours after breaking its seal, regardless of the number of doses delivered, according to the guidelines, but the health staff kept aside several full dosage vials and used the existing ones to give the dose.
The black marketers have not only limited themselves to the vaccination but they also have engaged themselves in the unfair practices of selling oxygen cylinders in black. Oxygen supply is a crucial part of every hospital and during these times of pandemic, the black market for oxygen cylinders have also started to grow in the market. While hospitals are running out of beds and oxygen, the black market for oxygen cylinders has substantially begun to develop. People are selling oxygen cylinders at a very high price and there have been many cases where people who were not able to afford the same are either facing critical health conditions or have died.
One of the crucial reasons for the rise in black market demand for the Covid-19 vaccine is the state government’s decision to finish administering the second dose of vaccination to persons over 45 years old first before commencing the first dose of vaccination for those aged 18 to 44 years old. This is because people over 45 years old who already have taken the first dose are compulsorily required to take the second dose so the effect of the vaccination continues to exist, it is because of this reason the vaccines are being diverted from the 18-44 age group to people over 45 years old (since the demand for second dose is high, it gives an opportunity to the black marketers to practice unfair trade practices in the market). Young people, on the other hand, are getting increasingly concerned as the incidents of Coronavirus illnesses and deaths rise. On the other side, the Covid-19 vaccine is being misused because health professionals are caving in to pressure from local politicians and other powerful individuals to administer the vaccine to children, despite the state’s unambiguous directive to use up all available doses of the vaccine by administering it solely to those over 45 years old as a second dose.
Covid-19 and Remdesivir injection
For the diagnosis of COVID-19, no treatments have been proven to be effective and safe. Given the disease’s experimental stage of care, Remdesivir has shown some promising benefits, and its compassionate use in the early stages of the condition is justified. Remdesivir may be a viable COVID-19 treatment, but it will need the findings of well-designed clinical trials to determine its efficacy, tolerability, and safety.
Because of its capacity to suppress SARS-CoV-2 in vitro, Remdesivir was recognised early as a possible therapeutic option for Covid-19. In addition, Remdesivir given 12 hours after MERS-CoV inoculation lowered lung viral levels and lung damage in non-human primates.
Remdesivir was discovered by Gilead Sciences, a pharmaceutical firm, to treat hepatitis C, but it later proved to be effective against Ebola and MERS. According to research published in the Lancet, Remdesivir was found to be effective against COVID-19 in vitro but did not demonstrate substantial clinical improvement in critically sick patients.
Remdesivir is intended to inhibit the stage of replication in which the coronavirus makes copies of itself, which then make copies of themselves indefinitely. Remdesivir attacks RdRp, which is its engine. The engine processes raw material from the viral RNA, which is broken down by another enzyme with that specific function, in order to replicate. When Remdesivir, the inhibitor, is given to a patient, it mimics part of this material and is integrated into the replication site. The virus can no longer multiply since Remdesivir has replaced the substance it requires.
The US FDA approved Remdesivir, a nucleotide analogue prodrug that inhibits viral RNA polymerase, an Emergency Use Authorization on May 1, 2020. After undergoing Ebola therapy studies, the attention has lately shifted to the use of Remdesivir in the treatment of COVID-19. Remdesivir, like most antiviral medicines, is more effective when given early in the course of the disease than when given later in the crucial stage. Remdesivir inhibits RNA-dependent RNA polymerases and causes RNA production to halt, most likely through delaying RNA chain termination, according to its broad range of action.
The World Health Organisation (WHO) also recommended the usage of Remdesivir for patients suffering from coronavirus. This recommendation was made by a group of clinical care experts. Remdesivir stops the coronavirus from generating a specific enzyme required for the virus’s replication. The virus will no longer be able to propagate throughout the body after this has occurred. According to studies, when individuals with mild Covid-19 are given Remdesivir, their symptoms recover faster. The medicine has also been demonstrated to reduce the length of time patients spend in hospitals. Remdesivir has been linked to decreased fatalities in critically unwell Covid-19 patients.
When given early in the course of the disease, Remdesivir appears to be more effective. Given the unpredictability of illness progression and large demographic variance, this makes it challenging to choose which individuals will receive the medicine. As a result, a significant number of people would need the medicine, which is difficult to obtain and also costly.
There are other vaccines in the market for the treatment of Covid-19 but Remdesivir has certain different and efficient results on the patients. The medication does assist patients in India reduce viral replication, but it has also been noted that moderate to severe Covid-19 patients are being treated with a mixture of oxygen treatment, vitamin supplements, steroids, and blood thinners at the right phases, which has been helping patients recover faster.
Remdesivir stops the virus from growing by interfering with one of the essential enzymes required for the virus to replicate RNA. The other medications help to alleviate the virus-induced inflammation.
Remdesivir’s hazards and benefits in individuals with severe COVID-19 who need high-flow oxygen or mechanical ventilation are unknown. The danger of Remdesivir causing damage is low, but it’s important to know if it has any additive effects when used with corticosteroids. Investigational drugs, such as immunomodulators and monoclonal antibodies, should be studied in critically sick patients using a placebo-controlled approach to see how they interact with Remdesivir.
Seeing the efficiency of Remdesivir, governments across the globe have started issuing certain guidelines for the usage of the vaccination. For instance, when we talk about the US, the government there has tested the dosage on various categories of patients like people having renal insufficiency, pregnant women, etc.
Despite all of the aggressive steps taken by the national and state governments, such as lockdown and social isolation, the number of COVID-19-positive patients in India continues to rise. As a result of the recent excellent developments with Remdesivir, authorities must be prepared to take steps to ensure that Remdesivir is available to such a large population at an accessible price.
In India, Cipla is the manufacturer of Remdesivir and the company has stated that after the business pushed to accelerate production amid a major second wave of coronavirus infections in the nation, manufacturing of the COVID-19 Remdesivir medicine was beginning to catch up with demand. Cipla’s monthly Remdesivir production is now 5 times more than the 200,000 to 300,000 vials produced in the last wave of the pandemic last year. In addition, the business has secured licencing arrangements with Merck and Eli Lilly in India to manufacture and distribute Merck’s investigational COVID-19 medicine Molnupiravir and Lilly’s arthritis medicine Baricitinib, which is also used to treat COVID-19.
Remdesivir, being a novel medicine in India, must go through a clinical trial before being approved for sale. According to the Clinical Trial Rules-2019, if it is approved by the US-FDA, the Drugs Controller General of India (DCGI) reserves the ability to give local clinical trial waivers in unusual situations while keeping a careful eye on its safety. Cipla and Hetero Labs Ltd., the two Indian pharmaceutical companies have recently applied to DCGI for a clinical trial waiver.
Remdesivir is a strong and viable option in the vaccination market. The medical authorities in India have observed the effect of Remdesivir and along with the local governments, the usage of Remdesivir is recommended by the medical experts. Though the vaccination market is showing various new products such as Sputnik V that have been developed in Russia, Pfizer vaccine, etc. the usage of Remdesivir along with certain different combinations of medicines holds a probability that the disease can be reduced.
Black marketing of Remdesivir injections
As discussed earlier, a black market is a market where people are engaged in illegal trade. In black markets, either the product or service that is being purchased and sold is illegal or the channel through which the goods or services are offered in the market is illegal or both things can take place. The black market of Remdesivir has also started growing in the country.
Gilead Life Sciences, the company that created the repurposed medication, has licenced six Indian firms to make it. To create the goods, the majority of them relied on contract manufacturers and their subsidiaries. After the initial wave of the epidemic hit the country in January, demand was essentially non-existent. Most firms ceased taking new orders for production because there was no demand. Neither the producers nor policymakers anticipated a second wave and so failed to stockpile the life-saving medicine.
In March-April, Remdesivir was produced at full capacity, with 25-30 lakh vials manufactured every month. India was producing 38.8 lakh vials of Remdesivir per month as of April after the government permitted companies to raise capacity. Hetero Drugs was the largest producer, accounting for 33% of total capacity (13 lakh vials a month). Cipla had 20% of the market, or 7.6 lakh vials, while Zydus Cadila had 16%, or 6.1 lakh vials. Mylan Labs was producing 5 lakh vials, which accounted for 13% of total capacity. Dr. Reddy’s Labs, Syngene, and Jubilant Ingrevia each produced 2.4 lakh vials every month, accounting for 6% of the total.
The current production in the month of May 2021 is at around 85 lakhs and it is expected further to grow. Many states like Maharashtra, Gujarat, Uttar Pradesh are currently facing or are running out of the Remdesivir drug stock. The government at the centre has started planning for the same. According to government statistics, all seven businesses would supply Maharashtra: Zydus Cadilla, Herero, Mylan, Cipla, Syngene/Sun, Jubilant, and Dr Reddy’s. Gujarat would receive the second-largest allotment of 1,82,500 vials after Maharashtra. Except for Dr Reddy’s, Gujarat would be supplied by six firms. With 1,79,300 vials, Uttar Pradesh is the third-largest allotment, with supply coming from all firms except Dr Reddy’s. While there are states such as Maharashtra, Gujarat and Uttar Pradesh that are facing a shortage of Remdesivir injection, states like Karnataka have mentioned that they have sufficient stock of the medicine.
The Indian government has also begun importing critical Remdesivir medicine from other countries in order to alleviate the country’s medicine deficit. Meanwhile, the government has increased Remdesivir production capacity in the nation. As of April 27, the seven approved domestic producers’ monthly manufacturing capacity had grown from 38 lakh vials to 1.03 crore vials. On April 11, the daily supply increased from 67,900 vials to 2.09 lakh vials on April 28. The Ministry of Home Affairs (MHA) issued a recommendation to states and UTs to help with the seamless transfer of Remdesivir supply.
To increase Remdesivir’s availability in India, the Indian government has banned its export. To guarantee that the injection is affordable to the general public, the National Pharmaceutical Pricing Authority (NPPA) lowered the maximum retail price on April 17, lowering the cost of all major brands below Rs 3,500 per vial. The Centre has also exempted Remdesivir injection, its API, and beta-cyclodextrin used in its manufacture from customs duty until October 31 in order to enable increased production and availability. One of the main causes of the present supply shortage is the cutting back or halting of medicine production in January and February of 2021 due to a lower number of patients in the nation.
When we talk about the shortage, Remdesivir is not the only medical aid that is currently not available at many places. Various other crucial medical equipment and such associated things are facing a shortage in the market like oxygen cylinders. One example that can be taken is the betadine solution for gargle purposes, earlier people used to buy one bottle for their usage but seeing the current scenario, those people who can afford it are now buying 4-5 bottles of the same.
There have been many instances where people are found in the illegal trade of the Remdesivir injection and some of the following are:
- In a decoy operation, officers from the Drugs Control Administration (DCA) apprehended two people accused of black selling Remdesivir injections in Visakhapatnam. Three Covifor injections (Hetero) and three Redyx-L injections (Dr. Reddy’s) were recovered from them, along with ₹44,000 in cash.
- Bengaluru police stated that they had detained five people on two different occasions for selling Remdesivir injections at rates eight to ten times higher than the drug’s recommended dosage. These five people were apprehended by Bengaluru North division police in two different instances. The accused bank manager utilised a naive vegetable seller to sell these vials by convincing buyers that he had them since one of his relatives had recently died of Covid and the family had these drugs, and all he wanted to do was sell them for the money he had allegedly paid for them.
- An anonymous tip was received by Delhi Police regarding illegal trade of the Remdesivir drug. Five persons were detained in different sections of Delhi for allegedly black-marketing Remdesivir injection, which is in high demand due to an increase in coronavirus infections, according to police. The initial arrests were made in south Delhi where three persons were apprehended, and two more were apprehended in west Delhi.
These are some cases that were reported, however, the shortage of Remdesivir drug still is a big concern for the local authorities and the government amid the time of the pandemic.
The Central government has taken various measures to deal with this problem of shortage of Remdesivir drug in the market and one such measure is a direct supply of the vaccine to the hospitals. The government is strictly monitoring the channel through which Remdesivir drug is supplied to the hospitals. The primary focus is to eliminate the middlemen from this channel. Middlemen are one of the significant factors through which shortage of the vial takes place and even the unfair trade practices start taking place.
Actions taken by Bombay High Court
The Bombay High Court, in Court on its own motion v. the State & Ors., took suo motu cognizance on the supply of oxygen and Remdesivir drug. A two-judge bench, consisting of Justice Sunil Sukre and Justice SM Modak, heard the case. The hearing in the High Court was mainly about two issues: the availability of the life-saving medication “Remdesivir” and the provision of oxygen to patients infected with the Coronavirus.
On April 19, 2021, the court ordered the authorities to send more than 10,000 vials of the drug to Nagpur. However, the order was not fully complied with, and only a small number of vials were delivered. The Division Commissioner of Nagpur submitted details on drug supply between April 19th, 2021 and April 21st, 2021, which is half of what the Court ordered. Furthermore, it was said that a nodal agency will distribute 6752 vials of Remdesivir Drugs to government and private hospitals by the next day. The Court was also given information in which seven pharmaceutical companies stated the number of Remdesivir vials that would be available by April 22, 2021. The court ordered the Joint Commissioner, Food and Drugs Administration, Nagpur, to gather information about Jubilant Company‘s supply and present it to the court because no data about the company’s supply had been provided in court. All seven pharmaceutical companies have the capacity to manufacture 88,00,000 vials of the drug Remdesivir in one month, according to experts in the field of medicine who testified in court. This is enough for serious covid patients in the country. To eradicate the drug’s black market, the court can order the companies to streamline the delivery process to all the states, ensuring that there is no shortage of drugs across the country. The Court ordered the Additional Solicitor General of India to take orders from the Central Drug Controller on the measures to be taken and to exercise power under the Drug Control Act of 1950 to ensure a fair and equal supply throughout the country, as well as to use other applicable and relevant laws to avoid excessive stocking and black marketing of the drug. In its order, the HC also claimed that in times of crisis, it is important to take such unprecedented measures to prevent certain unscrupulous people from engaging in life-saving drug black marketing. It went on to say that the courts cannot sit on the sidelines and that in order to send a clear message to people who might engage in black marketing of life-saving drugs, the investigation and trial of those accused of black marketing of life-saving drugs must be brought to a conclusion, with one of the most successful approaches being to ensure that the trial is concluded swiftly.
Conclusion
The antiviral Remdesivir, which was widely discussed during the initial wave of the new coronavirus epidemic in India last summer and monsoon, has resurfaced. As the country fights the second wave of illnesses, medicine is in short supply, and the government has barred its export. Remdesivir is one of the experimental medications approved for use in treating hospitalised Covid-19 patients, according to the national treatment protocol. As the number of instances rises, so does the demand for medicine.
As the number of Covid-19 cases in India increased, so did the demand for Remdesivir, which led to indiscriminate use, hoarding, and black marketing, resulting in an artificial scarcity that drove up costs. Before it was prescribed for Covid-19 therapy last year, the antiviral dosage was used to treat patients with Severe Acute Respiratory Syndrome (SARS). To prevent illicit stockpiling, the minister urged all district authorities to guarantee that every injection is utilised wisely and that prices be capped.
In recent days, India’s drug regulator, the Central Drugs Standard Control Organisation (CDSCO), and various state governments expressed alarm over Remdesivir hoarding and black marketing, which is being marketed at over 10 times the maximum retail price in certain cases. On Sunday, social media images revealed long lines of people in Gujarat, waiting to get Remdesivir injections for Covid-19 sufferers. People queued outside medical stores in Madhya Pradesh as well, with some of them, enraged at not being able to buy the medicine, obstructing a road in Indore for a brief period on April 9.
Gilead Sciences has licenced the medicine for local use to seven Indian firms, with an installed capacity of around 3.9 million units per month.
The Centre announced on Sunday that the export of Remdesivir and its Active Pharmaceutical Ingredients (API) has been blocked until the situation in the nation improves, citing increasing demand for the antiviral injection owing to a spike in Covid-19 infections. A scarcity of the antiviral medicine or injection used to treat new coronavirus illness was observed in numerous jurisdictions just days before the decision. People are queuing outside medical stores for medicine in many places across a few states, as coronavirus cases in the country have reached daily highs in recent days.
The government is forced to take such harsh measures to tackle the problem of shortage of Remdesivir drug. The Centre has increased its efforts to address Remdesivir shortages in response to rising demand. Several states have expressed worry about the developing Remdesivir scarcity and have contacted the Centre. As a result, the Centre has tried to deal with the situation. There are various measures that the government has adopted to deal with the shortage of Remdesivir such as:
- Prohibition of export of the vaccine to other nations
This measure is to be continued till the situation of the country improves.
- State governments to tackle the problem of black marketing
The shortage of the vaccine is being seen as a business opportunity by various people and as a result, an illegal market of the same has been born. The local governments are taking strict actions against the problem of black marketing of various medicines, especially Remdesivir.
- Display of stock list and distributors
The local authorities have asked the drug-producing companies as well as manufacturers to provide information regarding the details of availability of the medicine.
The suo motu cognizance taken by the Maharashtra High Court (Nagpur Bench) is one of the appreciable work done by the authorities. The High Court also stated that in such a harsh time of crisis, it is very important to take such actions to prevent people from engaging themselves in unfair trade practices.
The concerned authorities need to be more active to eliminate the problem, especially during such harsh times. The government at the State and at the Centre level need to adopt more strict monitoring regulations so that the black market of any potential thing that would help to fight the virus is eliminated from its roots. This is a battle that the government has to fight using all its required resources so that a national tragedy can be avoided.
References
- https://indianexpress.com/article/explained/from-glut-to-shortage-story-of-remdesivir-the-drug-of-hope-in-covid-surge-7272095/
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