Introduction
Everyone wants to live a healthy life, but that's not always how things work out. Few people are lucky enough to never get sick, but most of us do at some point or another for different reasons.
When we are sick or not feeling well, we think about what we can do to get better. The illness could be short-term, long-term, or just happen sometimes. The solution may be something that already exists in nature, something that can be made chemically, or something that needs to be made. By using these products, the illness either gets better, goes away completely, or is kept under control. Pharmaceutical drugs can be used for a short time or regularly to treat long-term conditions. We also call these things “medicines”. From a layman's point of view, a drug is any substance other than food that keeps human functions from going wrong. A pharmaceutical drug, also called a medication or medicine, is a chemical substance used to treat, cure, prevent, diagnose, or find the cause of a disease or to improve health.
Drugs have been around since the beginning of human civilization. In its history, it has gone through a lot of changes that were very important. Drugs or medicines can be used with a doctor's prescription or they can be bought without a prescription over the counter. The history of prescription drugs shows that people have been writing prescriptions for medicines since the Sumerian era, around 2,000 BC[1]. Medicines and drugs are important parts of the healthcare system. The whole point of a drug is to help the person who takes it, whether it does so completely or only partially. In some unfortunate circumstances, the illness can't be cured. But there are many things about drugs that affect treatment and getting back to a normal life. They include using the right drug in the right amount. The sale and trade of fake drugs needs to be limited in every way. Several national laws have been passed to deal with the issue.
What is Drug?
Medicines or drugs are chemicals or compounds that are used to treat, stop, or prevent disease, ease symptoms, or help doctors figure out what's wrong with someone. Doctors have been able to save lives and cure many diseases because of how far medicine has come.
In psychology and sociology, a drug is a substance that makes you want to use it over and over again and has direct effects on the brain or nervous system.
In Hangamurti v. State of Orissa[2]The same Court said, "A drug is any medicine that can be used on humans or animals externally or internally, or any substance that is meant to be used to diagnose, treat, mitigate, or prevent disease in humans or animals." It also includes "substance" that is meant to be used to cure or treat diseases in people or animals. Even water and blood were drugs. In the case of Ram Chandra v. State of West Bengal[3]It was decided that water used to dissolve other medicines to be injected into people is a drug under Section 3(b) of the D&C Act.
Right to Healthy Life
In State of Punjab v. Ram lubhaya Bagga[4]The Supreme Court looked at the constitutional right to health care under Articles 21, 41, and 47 of the Constitution of India.
It found that a person's right corresponds to a duty on the part of another person, employer, government, or authority. So, the right of a citizen to live under Article 21 makes the state responsible. This duty is strengthened by Article 47, which says that the state's main job is to make sure its citizens are healthy. Without a doubt, the government is meeting this duty by opening government hospitals and health centers, but for them to be useful, they must be close to the people and have enough clean water. Since it is one of the most important and sacred rights of a citizen and one of the most important and sacred duties of the state, every citizen of this welfare state expects the state to make it a top priority to carry out this duty, including by giving enough money. This will help the state reach its social, political, and economic goals, as well as protect the rights of its citizens to their satisfaction.
Implication
When someone gets sick, they try to take medicine to feel better. Depending on what's wrong, a certain drug and dose are given. Patients sometimes take their own medicines without telling a doctor.
If the drugs or medicines taken are real, there will be relief. If it turns out to be false or fake, it could have anything from a small effect to a fatal one. The people who make, sell, distribute, and deal in these drugs are the ones who want to profit unfairly from their illegal actions. They don't care much about the health of the people. There are traders like this all over the world. Some countries have turned out to be paradise for people who don't care about other people. People use medicines that are against the law, even for small illnesses. Most countries have passed laws to stop this kind of abuse, but it turns out that these laws are not enough. The international community has asked the countries to keep their people safe from fake drugs. Several laws have been passed by Parliament and state legislatures to protect people from the dangers of fake drugs. Due to how serious the problem is, this study is looking into the legal aspects, administrative measures, and judicial interpretations that tend to control, limit, or stop the making or use of fake drugs.
Adulterated Drugs
A drug shall be deemed to be adulterated[5] :
(a) if it consists, in whole or in part, of any filthy, putrid or decomposed substance; or (b) if it has been prepared, packed or stored under insanitary conditions whereby it may have been contaminated with filth or whereby it may have been rendered injurious to health; or (c) if its container is composed in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or (d) if it bears or contains, for purposes of coloring only, a color other than one which is prescribed; or (e) if it contains any harmful or toxic substance which may render it injurious to health; or (f) if any substance has been mixed therewith so as to reduce its quality or strength. Adulteration, which is more accurately called "raw drug," looks real at first glance because it looks the same and sometimes has the same chemical makeup.
It is the deliberate or unintentional replacement of some or all of a crude drug with other substances that are either free or less effective as drugs or chemicals.[6] The bad thing about substitution is that it leads to conditions that aren't up to par which can sometimes be very dangerous. Adulteration led to a wide range of negative effects, from mild (allergies, fatigue, gastrointestinal upset, mood disturbances or muscle weakness, nausea, pain, and respiratory complaints) to moderate (confusion, convulsions, dermatitis, lethargy or seizures, leucopenia, sensory disturbances, vomiting) to severe (carcinomas, cerebral oedema, coma, intracerebral hemorrhage, poisoning, metabolic acidosis[7].
Problem and reasons:
It is clear that recycling old drugs goes against the spirit of the law. The recent changes to the Drugs and Cosmetics Act give the government the power to give a heavy fine and a 10-year prison sentence that can be extended to life in prison.
False drugs are a bigger crime than drugs that have passed their expiration date and are recycled. Drugs that are fake or have been tampered with are more likely to kill or cause serious side effects. In India, there is no law about "fake" drugs. Section 17 of the Drugs and Cosmetics Act says that a drug in India can be fake, tampered with, or mislabeled. It is against the law to make or sell such drugs, and doing so can get you in trouble (Sections 18 and 27 read together). If a drug is recycled after its expiration date, it may be considered "misbranded" or not of "standard quality," as defined by Section 16 of the Act. Rule 65(17) of the Act says that drugs can't be sold after their expiration date. People say that the prices of these drugs are part of the reason why they should be reused.[8]
Indian Drug Regulation
In order to reach its public health goals, the central government takes steps to make sure that the drugs available to the public are safe, effective, and meet quality standards. The system for regulating drugs is a classic command-and-control system, in which the regulator sets standards, gives out licenses, and then does inspections to make sure people are following the rules.
This has a lot of good things about it, like clear rules that make it easier to apply and find places where people aren't following the rules. The Drugs and Cosmetics Act of 1940 and the rules that go along with it are the main laws that control the quality, safety, and effectiveness of drugs in the country. In 1945, the Drug Rules were made to put the Act's rules into action. After that, both the Act and the Rules were changed many times, and different laws were passed to control the importing, making, distributing, and selling of drugs in India[9].
India is a major supplier of vaccines all over the world because its vaccines are used both in India and in 200+ other countries.[10] India has made progress in building up its pharmaceutical industry, which has made its role in both domestic and international markets more important.
The business world has grown faster than the regulatory system. India is committed to building a strong regulatory system that is on par with the best in the world. In the 12th five-year plan of the Government of India (2012–2017), the government spent a lot of money to strengthen the drug regulatory authority and drug testing laboratories. This made it possible for a number of initiatives and accomplishments in the regulatory sector. The government just put $275 million into the country's drug regulatory system to make it stronger. There will also soon be a national drug regulatory academy where regulators at the central and state levels will be trained.
India is a big part of the new South-East Asia Regulatory Network (SEARN), which is meant to make it easier for WHO members in the South-East Asia region to get high-quality medical products. In the next section, we'll take a look at India's regulatory system and the recent steps that have been taken to bring it up to international standards.
The main goal of the Drugs and Cosmetics Act of 1940 and the rules made under it is to control how drugs are made so that the quality of drugs that are sold and distributed as drugs stays the same.[11] It is also meant to control how drugs and cosmetics are imported, made, distributed, and sold.
Recent Observations
Anyone who isn't the maker of a drug or cosmetic or his agent for selling it can tell the Inspector the name, address, and other details about the person from whom he bought the drug or cosmetic. In Drugs Inspector vs. Kushalchand, Kushalchand[12]The accused was punished because he didn't give his name, address, and other information that was needed when he bought drugs. He also didn't give the correct purchase invoice, which was an offense under sections 18A and 18B.
Covid-19 and counterfeit drug challenges
The COVID-19 crisis has made the global trade in fake pharmaceutical products even more dangerous. When people order fake medicines online, they put their health and safety at risk.
Fake medicines are often not made correctly and may contain dangerous ingredients. During a public health crisis like the current COVID-19 pandemic, it is even more important and urgent to fight this global scourge.
According to the World Health Organization, more and more fake medicines linked to coronavirus are being sold in developing countries, and Interpol has also seen a rise in fake COVID-19 medicines[13]. The US CBP[14] and customs from other member countries, as well as the World Customs Organization[15], have found fake COVID-19 tests and personal protective equipment like facemasks and hand sanitizers.
As treatments and, eventually, a vaccine is made, fakes of these products could cause both more illness and death and unsafe behavior by making people think they are safe when they are not. So that people can trust the medicines they buy, both online and in stores, governments need to make sure that pharmaceutical products come from legal and safe sources. The OECD and the European Union Intellectual Property Office (EUIPO) have joined forces to help governments fight the trade in fake medicines. They will do this by giving policymakers solid empirical evidence about the value, scope, and trends of the trade, which does a lot of damage to the economy and puts people's health and safety at risk.
Conclusion
An e-Pharmacy model would help with better buying margins, better inventory management, more customers, lower prices, and more services that give customers more value.
On August 28, 2018, the Indian government announced in the Gazette that Part VI, "Sale of Drugs by e-Pharmacy," would be added to the Drugs and Cosmetics Rules of 1945[16]. When dealing with problems related to the online sale of medicine in India, the Indian Judiciary and regulatory authorities on E-pharmacies should look at the steps taken by the US and EU, such as a common logo mark, an online tracking system, and E-Prescriptions for some drugs. Fake drugs are a problem for public health around the world. It has been a problem in both developing and developed countries[17]. The problem of counterfeiting is also not new; it has been around for a long time. What's different about this problem now is that it affects people all over the world and that the people who make and sell fake drugs are getting smarter and better at what they do.
-- [1] Ali Venosa , “History of the Pharmacy: How Prescription Drugs Began and Transformed Into What We Know Today”, https://www.medicaldaily.com/pharmacy-prescription-drugs-378078 March 16, 2016 [20-12-18]. [2] (1973) 1 CWK 308 [3] 1971 Cri. LJ 1369(Cal) [4] (1998) 4 SCC 117 [5] Drug and Cosmetic Act, 1940, Section 9A. [6] Kumar Doni Prakash et al; ―Current Trends in Regulatory Authority Actions against Misbranded and…..1513 [7] Posadzki P, Watson L, Ernst E. Contamination and adulteration of herbal medicinal products (HMPs): an overview of systematic reviews. Eur. J Clin Pharmacol., 2013; 69: 295-307. [8] S Srinivasan, ‗Spurious drugs‘, Indian Journal of Medical Ethics: https://ijme.in/wp-content/uploads/2016/11/1555-5.pdf. [9] The Drug Rules were amended recently in 2016 and in 2019. [10] Indian Pharmaceutical Industry Report 2022, https://www.ibef.org/download/1650607741_Pharmaceuticals-March_2022.pdf [11] Medley Pharmaceuticals Limited V. Commissioner of Central Excise and Customs, Daman, (2011) 2 SCC 601. [12] https://services.ecourts.gov.in/ecourtindia_v4_bilingual/cases/display_pdf.php?filename=/orders/2009/201200004442009_11.pdf&caseno=C.C./444/2009&cCode=5&appFlag=web&normal_v=1 [13] https://www.interpol.int/News-and-Events/News/2020/Global-operation-sees-a-rise-in-fake-medical-products-related-to-COVID-19 [14] https://www.cbp.gov/newsroom/national-media-release/cbp-officers-seize-fake-covid-19-test-kits-lax [15] http://www.wcoomd.org/en/media/newsroom/2020/march/covid_19-urgent-notice-counterfeit-medical-supplies.aspx [16] For details see the Notification issued by CDSCO under the Ministry of Health and Family Welfare (Department of Health and Family Welfare) Notification New Delhi, on the 28th August, 2018. Rules 67 I to W provides wide rules, guidelines and procedure for online pharma sale. [17] Dr. Paul B. Orhii Director General NAFDAC, Vice-Chair IMPACT, in his Foreword to a Handbook on ‗International Medical Product Anti-Counterfeit Taskforce‘, 2010, ISBN 978-88-481-2646-5, Italy. https://apps.who.int/medicinedocs/documents/s20967en/s20967en.pdf
This article is written by Kunal Keshri of Bennett University.
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