This article is written by Abinas Kaur Gill of Lovely Professional University, an intern under Legal Vidhiya.
ABSTRACT
A major global health concern is the selling of counterfeit medicines, and India, one of the biggest manufacturers and exporters of pharmaceuticals, has a difficult time regulating this threat. The deliberate mislabelling of counterfeit or spurious medications, which frequently contain hazardous, insufficient, or wrong substances, poses serious concerns to patient safety. These medications cause antimicrobial resistance, erode public confidence in healthcare institutions, and frequently result in treatment failures or deaths.
This article outlines important judicial interpretations, assesses the efficacy of existing legislation and regulatory agencies such as the Central Drugs Standard Control Organization (CDSCO), and looks at the extent of the counterfeit pharmaceutical issue in India. It also highlights the main obstacles to compliance, including inadequate interagency coordination, delayed testing, and technological shortcomings in supply chain surveillance. In order to counter this expanding threat, the study concludes with recommendations for technological, administrative, and legislative reforms. In order to protect public health, the essay advocates for a comprehensive strategy that includes strict law enforcement, sophisticated tracking systems, and extensive consumer education.
Keywords
Counterfeit medicines, Spurious drugs, Public health law, Drugs and Cosmetics Act of 1940, Pharmaceutical regulation, Central Drugs Standard Control Organization (CDSCO), Legal enforcement, Drug safety, Consumer protection.
INTRODUCTION
As the cornerstone of contemporary healthcare systems, medications are essential to public health since they both prevent and cure illnesses. However, the growing number of fake or counterfeit medications has turned into a worldwide problem with potentially fatal consequences for both patients and medical professionals. According to estimates from the World Health Organization (WHO), one out of ten pharmaceutical items in low- and middle-income nations is either faulty or fraudulent. In addition to posing a threat to human life, this expanding threat also fuels antibiotic resistance, erodes public confidence in healthcare organizations, and prolongs suffering.
India, which has a significant domestic pharmaceutical market and is a major supplier of reasonably priced generic medications, is especially susceptible to the infiltration of fake medications. Counterfeit medications frequently reach unwary consumers, particularly in semi-urban and rural areas, due to a convoluted and disjointed supply chain, insufficient surveillance, and variations in regulatory enforcement among states.
The problem is not merely legal; it also includes ethical, economic, and public health aspects. This article explores the extent of the issue in India, assesses the current legal system, highlights difficulties with enforcement, and suggests extensive reforms meant to improve regulation and protect consumer health.
LEGAL & REGULATORY FRAMEWORK
The Drugs and Cosmetics Act of 1940, which establishes essential legal standards intended to differentiate between pharmaceutical items that are compliant and those that are not, is India’s main legislative instrument for regulating the quality, safety, and authenticity of medications. According to Section 17 of the Act, “misbranded drugs” are those that are falsely labelled or coloured to seem like they have more medicinal value. Section 17A deals with “adulterated drugs,” which are tainted, made in an unhygienic manner, or contain harmful ingredients. Most importantly, “spurious drugs” are defined by Section 17B as those that are purposefully made to mimic another drug or fraudulently claim to be made by a respectable producer. India’s legal attempts to combat counterfeit drugs are based on these provisions. [1]
The Ministry of Health released updated guidelines in 2008 that classified Not of Standard Quality (NSQ) medications into three risk-based groups: Category A (drugs that were intentionally deceptive or falsified), Category B (drugs that had potentially harmful quality deviations), and Category C (minor defects unlikely to impact safety or efficacy). This was a significant policy development. These legislative distinctions provide a systematic framework for addressing the spread of inferior and counterfeit medications in the nation by assisting regulators in prioritizing enforcement and criminal actions according to public health risk.[2]
LEGAL ENFORCEMENT AND JUDICIAL RESPONSE TO COUNTERFEIT MEDICINES IN INDIA
India’s regulatory architecture for combating counterfeit and substandard medicines is primarily structured around a dual system comprising central and state-level authorities. At the apex stands the Central Drugs Standard Control Organization (CDSCO), the national regulatory authority responsible for approving new drugs, issuing manufacturing and import licences, and coordinating national enforcement actions. Complementing it are the State Drug Control Authorities, which undertake regional inspections, sample collection, prosecutions, and monitoring of retail and wholesale drug establishments. Under the Drugs and Cosmetics Act, 1940, empowered Drug Inspectors have the authority to inspect premises, seize suspected drugs, and launch prosecution proceedings.
However, a number of structural issues still threaten enforcement. The regulatory reaction is significantly weakened by a persistent lack of qualified inspectors, inadequate facilities in government drug testing labs, and a lack of interstate coordination. Since there are only 47 National Good Laboratory Practice (GLP)-compliant labs in the country, prompt chemical analysis and reporting frequently act as roadblocks to getting criminals convicted.[3]
The seriousness of the counterfeit drug problem has been recognized by the Indian judiciary. Trafficking of counterfeit medications is a serious public health issue that requires strict legal measures. The Supreme Court reaffirmed in Drugs Inspector v. Fizikem Laboratories that although procedural protections like appropriate sample testing and evidence are crucial, the greater goal of saving lives must not be sacrificed.[4] However, real conviction rates in cases involving fake medications are still dreadfully low in spite of these findings.
However, real conviction rates in cases involving fake medications are still dreadfully low in spite of these findings. Acquittals or drawn-out trials are frequently the consequence of procedural errors, forensic testing delays, and the unavailability of expert witnesses. Because of this, a large number of criminals carry on with impunity, undermining public confidence in the legal and regulatory systems. Legal experts and parliamentary committees have frequently called for better bail guidelines, better prosecutorial coordination, and special tribunals for drug offenses in order to solve this. Therefore, it is essential to strengthen both enforcement agencies and court procedures to make sure that the legal system acts as a reliable deterrent to the production and distribution of fake medications.[5]
CIVIL AND CRIMINAL REMEDIES AGAINST COUNTERFEIT MEDICINES
In order to combat counterfeit pharmaceuticals, Indian law provides consumers and rights holders with a variety of civil and criminal remedies. The Drugs and Cosmetics Act and other pertinent penal provisions are used to enforce criminal penalties, while intellectual property laws are the main tool used for civil relief.
Civil Remedies
According to the Trade Marks Act of 1999, brand owners can file civil lawsuits against counterfeiters on the grounds of passing off and trademark infringement. Interlocutory injunctions, discovery, delivery of infringing goods, and damages for lost profits or goodwill are some examples of remedies. By proving false likeness or misrepresentation, these clauses enable manufacturers to safeguard their brand identification and reputation in the marketplace. Courts have highlighted the need to avoid consumer confusion in healthcare settings, where brand trust is crucial, in seminal rulings such as Cadila Healthcare Ltd. v. Cadila Pharmaceuticals Ltd. and Allergen Inc. v. Sun Pharmaceuticals Industries Ltd. Proof of infringement and product-related goodwill are usually required in civil proceedings.[6]
Criminal Remedies
Indian law establishes criminal culpability under both drug safety and intellectual property laws, in addition to civil routes. Applying fraudulent trade descriptions or marks can result in penalties and imprisonment of up to three years under the Trade Marks Act. The production or sale of “spurious drugs” is illegal under the Drugs and Cosmetics Act, 1940 section 17B, and it carries severe penalties, such as life in prison or large fines, when it endangers the public’s health. Furthermore, depending on the seriousness of the offense, criminal prosecutions may be brought under the Indian Penal Code, citing Sections such as section 420 (cheating), section 274 (adulteration), and section 120B (criminal conspiracy).[7]
Hybrid Approach
An integrated enforcement strategy combining civil and criminal remedies is viewed as most effective. Civil actions afford rapid interim relief and brand protection, while criminal prosecutions serve as a strong deterrent against larger-scale counterfeiting operations affecting public health. Industry experts and jurists advocate for a harmonized approach: civil lawsuits can quickly halt counterfeit distribution, while criminal cases pursue lasting justice and penal consequences.[8]
SUGGESTED REFORMS
There is an urgent need for a series of focused legal, technological, and administrative reforms in order to successfully address the growing threat of counterfeit medications in India. All medications should be tracked from the manufacturer to the final consumer using a required track-and-trace system that includes digital barcoding and serialization. In addition to increasing openness, this would make it easier for authorities to spot and recall faulty or counterfeit batches.[9] Furthermore, the government needs to make sure that online pharmacies rigorously follow licensing requirements, prescription verification, and product validity. ² Public awareness campaigns are crucial to educating people about the hazards of counterfeit pharmaceuticals and how to recognize authentic products, especially in rural and semi-urban areas where there is a lack of consumer awareness. Investing in new facilities and equipping current ones with more advanced machinery and quicker processing speeds will also increase the capacity of drug testing labs.[10]
Promoting incentive programs and whistleblower protection would aid in exposing illicit activity in the pharmaceutical supply chain. Finally, in order to exchange intelligence and coordinate enforcement measures against transnational counterfeit drug networks, India has to strengthen international collaboration by working with international organizations such as the World Health Organization and Interpol.[11] India’s pharmaceutical regulatory system might be greatly strengthened if these improvements were applied comprehensively. Success will also depend on political will, interagency collaboration, and consistent investment in capacity building, in addition to institutional and legislative improvements. To keep ahead of counterfeiters, regulatory bodies need to take a proactive approach rather than a reactive one, utilizing data analytics and real-time surveillance tools. Furthermore, India can preserve and rebuild its standing as a trustworthy pharmaceutical leader by implementing worldwide best practices and adhering to international drug safety regulations. In the end, protecting the public’s health from the dangers of fake medications is not only required by law, but also by morality.
CONCLUSION
The sale and distribution of fake medications in India is a complicated and extremely worrisome problem that impacts not just public health but also the integrity of the country’s pharmaceutical sector and its reputation abroad. These fake medications, which frequently include dangerous or inaccurate components, directly endanger human life, lessen the efficacy of real therapies, and play a major role in the escalating issues of antibiotic resistance. Even though India has a robust legal system thanks to laws like the 1940 Drugs and Cosmetics Act and other provisions in the Indian Penal Code, systemic flaws, disjointed regulatory oversight, and inadequate infrastructure still make it difficult to effectively enforce these laws.
India needs to take a comprehensive approach to address this problem, which involves updating enforcement procedures, reforming laws, and implementing digital tools like track-and-trace systems to keep an eye on the flow of pharmaceuticals across the supply chain. Raising public awareness and improving collaboration between federal and state regulatory agencies are equally crucial. Being one of the top producers of pharmaceuticals worldwide, India bears the burden of establishing international standards. India can safeguard public health and rebuild trust in its drug supply system by strengthening its regulatory framework and making sure that only authentic, secure, and efficient medications are delivered to consumers.
REFERENCES
- Ministry of Health and Family Welfare, Govt. of India, Risk-based Classification of NSQ Drugs (2008).
- The drugs and Cosmetics Act, 1940.
- Journal of Social Sciences, Combating Counterfeit and Substandard Medicines in India: Legal Framework and the Way Ahead, 6 J. Soc. Sci. (2024), available at https://journalofsocialsciences.org/vol6no1/combating-counterfeit-and-substandard-medicines-in-india–legal-framework-and-the-way-ahead/
- World Health Organization, Substandard and Falsified Medical Products, available at https://www.who.int/news-room/fact-sheets/detail/substandard-and-falsified-medical-products (last visited July 22, 2025).
- S.S. Rana & Co., The Counterfeit Conundrum: Civil And Criminal Remedies For Spurious Medicines In India, 2021 (discussing civil IPR remedies and case law).
- Ministry of Health and Family Welfare, Govt. of India, “Annual Report on National Drug Testing Laboratories,” (2023).
- Drugs Inspector v. Fizikem Laboratories, AIR 2008 Supreme Court 1932
- Ministry of Health and Family Welfare, Govt. of India, Risk-based Classification of NSQ Drugs (2008).
[1] The drugs and Cosmetics Act, 1940, s.17, 17A, 17B
[2] Ministry of Health and Family Welfare, Govt. of India, Risk-based Classification of NSQ Drugs (2008).
[3] Ministry of Health and Family Welfare, Govt. of India, “Annual Report on National Drug Testing Laboratories,” (2023).
[4] Drugs Inspector v. Fizikem Laboratories, AIR 2008 Supreme Court 1932
[5] Journal of Social Sciences, Combating Counterfeit and Substandard Medicines in India: Legal Framework and the Way Ahead, 6 J. Soc. Sci. (2024), available at https://journalofsocialsciences.org/vol6no1/combating-counterfeit-and-substandard-medicines-in-india–legal-framework-and-the-way-ahead/
[6] S.S. Rana & Co., The Counterfeit Conundrum: Civil And Criminal Remedies For Spurious Medicines In India, 2021 (discussing civil IPR remedies and case law).
[7] Id. at 4.
[8] Id. at 4.
[9] Journal of Social Sciences, Combating Counterfeit and Substandard Medicines in India: Legal Framework and the Way Ahead, 6 J. Soc. Sci. (2024), available at https://journalofsocialsciences.org/vol6no1/combating-counterfeit-and-substandard-medicines-in-india–legal-framework-and-the-way-ahead/
[10] Id. at 3.
[11] World Health Organization, Substandard and Falsified Medical Products, available at https://www.who.int/news-room/fact-sheets/detail/substandard-and-falsified-medical-products (last visited July 22, 2025).
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