Counterfeiting and Black Marketing of Essential Life Saving Drugs amidst the Crisis

I. Introduction

As the nation tussles with the biggest and most unfortunate health emergency after the rise in the number of Covid cases, counterfeiting and black marketing of essential life-saving² medicines has created life hard for both the patients as well as their families. Surprisingly, several people who have access to these drugs are attempting to make capital out of those in need by selling such medicines at exorbitantly high rates. Since the survival of these patients is at risk, the families of the patients are willing to give any amount to obtain the medicines. Besides, a majority are not able to afford them also. Recently in the state of Tamil Nadu, three people comprising a doctor were arrested for black marketing Remdesivir ampoules. The medicine Remdisivir, proposed for Covid-19 treatment, is being sold in the Indian black markets at rates six times more than its true rate. Even though Remdesivir is kept in stock at the requisite quantities in assigned public health establishments, their attainability to ordinary people is finite. This has brought about a scarcity, ushering to the formation of a ‘black market’ for this medicine. In another case in Uttar Pradesh, a 38-year-old man was demanded by a dealer to pay ₹40,000 for an oxygen cylinder which normally charge ₹6,000 only. Instruments like oxygen concentrators, which are utilized to supply oxygen in small concentrations is too being sold at fivefold the normal rate. There is literally no ceiling to this extortion. In Lucknow, a joint team of police and FSDA department has been organized to stop the sale of these medicines in black market; nevertheless it is yet to take any action. A 2017 WHO report states that 10.5% of medicines sold in the low and middle-income nations, which also includes India, are low quality and counterfeited.³ This is a grave menace to the welfare of the patients, with treacherous side effects and may steer to other health issues as well. The matter is indeed worst in rural places and small towns where the availability of these drugs and medical devices is very less, and private hospitals are continuing to take advantage of the helplessness of the poor people.

II. Right to health

Our Constitution does not explicitly acknowledge the fundamental right to health. However, the right to adequate health care and protection has been acclaimed in India since olden days. As per Article 21 of the Constitution – “No person shall be deprived of his or her life or personal liberty except according to the procedure established by law”. The word ‘life’ is not entirely only the physical display of inhaling and exhaling. It has a considerably more substantial significance. The Indian judiciary has in plethora of cases interpreted this right to life to incorporate various other rights such as the right to live with human dignity, right to livelihood, right to health, etc. In the case of State of Punjab & Ors v Mohinder Singh Chawla⁴, the court held that right to health is basic to the right to life and the government has a constitutional duty to deliver health care facilities to its population. In Paschim Bangal Khet Mazdoor Samity & Others v State of West Bengal & Others⁵, the court held that in a welfare state, the chief duty of the government is to assure the well-being of its population and furthermore it is their duty to provide sufficient medical services for its population. The Supreme Court in Vincent v. Union of India⁶ highlighted that a healthy body is the very basis of all human pursuits. Art.47, a Directive Principle of State Policy in this aspect heeds on the advancement of public health and banning of medicines dangerous to the health as one of the chief obligations of the state. In addition, the Constitution does not only compel the States to improve public health, it also equips the Panchayats and Municipalities to do so under Article 243G.

Health is a very important measure of human growth and human growth is the fundamental element of economic and social progress. The right to health should mean right to immediate quality and affordable health, especially during the time of this pandemic. Therefore it is the paramount duty of the states to see to it that their citizens have easy access to oxygen and other ELS drugs without any hindrance. Black marketing, hoarding and counterfeiting of these drugs are serious threats to the society and its people, which must be tackled with more severely.

III. Existing laws in india

In India, there are certain legislations that are already in existence, to deal with the issues of black marketing and counterfeiting of drugs. As per Drug and Cosmetic Act 1940⁷, under sections 17, 17A and 17B, substandard quality drug encompass misbranded, spurious and adulterated drugs, respectively. After the amendment of the D and C Act in 2008, the Central Drugs Standard Control Organization classified the not so standard quality (NSQ) products into three heads A, B and C that is useful in classifying the products in the course of their quality assessment. Similarly, the Essential Commodities Act, 1955 is a legislation which was passed to guarantee the conveyance of specific products or commodities, the supply of which if blocked due to black marketing or hoarding would have an effect on the ordinary life of the citizens. This Act was passed to secure the comfortable attainability of indispensable products to the public and to safeguard them from unfair treatment by unethical dealers. This legislation authorizes the Central Government to manage and control manufacture, distribution, supply, storage, conveyance, etc. and regulate rates of products which have been stated under the legislation as indispensable. Another Act, The Prevention of Black Marketing and Maintenance of Supplies of Essential Commodities Act, 1980 is being enforced across the States and Union Territories for prohibition of illicit and unscrupulous trade activities of black marketing of essential products. The Act gives power to the Central and State Government officials as stated to detain people whose practices are established to be detrimental to the preservation of distribution of the products indispensable to the public.

It is reckoned that 75% of counterfeit drugs manufactured world-wide emanate from India⁸. Almost all counterfeit drugs are bought by the people unwittingly, since distinguishing counterfeit drugs is hard, even for health care executives. Counterfeit drugs can not only have an unfavorable consequence on the altogether well being of a person but also destroy our country’s prestige in the international pharmaceutical market. To prevent and curb this situation in our country, the government had ordered to make sure solid watch on black markets and also upon those who have access to these drugs, but this so far has had only limited impact.

What can be done?

Some of the measures which have to be implemented to curtail this issue of bogus/wrongly-branded /counterfeit medicines include:

• Increasing community understanding –enlightening patients and raising awareness is a right area to begin. Health executives, medical professionals and pharmaceutical companies all have a part to be engaged in apprising patients and their families and preparing them to be aware of the existence of counterfeit drugs. There is a necessity to familiarize the method for buying these ELS drugs from health care institutions and not from local unscrupulous traders.
• Carrying out contemporary anti-counterfeiting actions - insufficient anti-counterfeiting steps by pharmaceutical companies mark their drugs prone to counterfeiting. All companies must adopt global measures such as mass serialization in which machine-readable codes comprising of a serial number are affixed to each pack of medicines, allowing the product to be tailed and detected. Pharmaceutical companies can resist the increase in counterfeit drugs by executing contemporary anti-counterfeiting technologies, like the application of forensic markers, cloud-based supply chain data repositories, and block chain technology in supply chains.
• Ameliorating the pharmaceutical industry of India - To preserve the sufficient supply of life-saving drugs and oxygen in different health care facilities both private as well as Government to care the people infected by Covid-19 virus.
• Advancing more austere legislations - In India, the D and C Act, enlarged the punishment to wrongdoers, however there are nevertheless many hardships, such as varying execution of laws across states, feeble drug quality examination methods and incapacitated prosecution of counterfeit drug producers. Stricter obedience to existing legislations and at the same time adopting more unbending legislations would also help fight against counterfeiting.
• Special Task Force – The Special Task Force shall be chiefly accountable for examining, investigating and halting the production and distribution, and thereby prevent the black marketing and hoarding of ELS medicines which are used for tending COVID-19 patients.

Altogether there is an urgent requirement of more stringent regulation and legal action against the problem that we are dealing today. It is now the exact time to explore this matter more vigorously in order to safeguard the interests of the patients at large. It is very much necessary to initiate measures to deter such unethical people who indulge in black marketing of ELS drugs.

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Footnotes

1. Author is a student at Government Law College, Ernakulam, India

2. Hereinafter ELS

3. 1 in 10 medical products in developing countries is substandard or falsified, WHO(April 30, 2021, 10:05 AM) https://www.who.int/news/item/28-11-2017-1-in-10-medical-products-in-developing-countries-is-substandard-or-falsified

4. (1996) 113 PLR 499

5. SCC (4) 37, JT 1996 (6) 43

6. AIR 990, 1987 SCR (2) 468

7. Hereinafter the D and C Act

8. S Verma, Countering the Problem of Falsified and Substandard Drug, NCBI (May 1, 2021, 11:09 PM) https://www.ncbi.nlm.nih.gov/books/NBK202531/