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Action Against Food and Medicine Adulteration in India: Legal Framework and Remedies
Introduction
Food and medicine adulteration represents a grave threat to public health in India, compromising the safety and well-being of millions of consumers. Adulteration involves the deliberate degradation of food or pharmaceutical products through the addition, substitution, or removal of substances, rendering them harmful or substandard. The Indian legal system has developed a robust regulatory framework to combat this menace, providing citizens with multiple avenues to seek redress and hold violators accountable. This article examines the legislative architecture governing food and drug safety, enforcement mechanisms, complaint procedures, and judicial interpretations that shape consumer protection in India.
Understanding Food and Medicine Adulteration
Adulteration fundamentally alters the natural composition and quality of consumable products. In the context of food, it includes mixing water in milk to reduce nutritional value, adding non-edible colors to vegetables to simulate freshness, or substituting cheap oils in ghee to compromise both safety and quality. For pharmaceutical products, adulteration can involve contamination with impure substances, storage under insanitary conditions, or the manufacturing of counterfeit medications that imitate genuine products.
The consequences of consuming adulterated products range from minor health complications to life-threatening conditions. Adulterated milk containing detergents can cause severe gastrointestinal disorders, while spurious medications lacking active pharmaceutical ingredients can result in treatment failure and disease progression. The magnitude of this problem is reflected in data from the Food Safety and Standards Authority of India, which indicates that food adulteration rates have increased significantly, underscoring the need for stringent regulatory oversight.
Legislative Framework for Food Safety
The Food Safety and Standards Act, 2006
The Food Safety and Standards Act, 2006 [1] stands as the primary legislation governing food safety in India. This comprehensive statute consolidates various food-related laws and establishes the Food Safety and Standards Authority of India as the apex regulatory body. The Act defines an adulterant as “any material which is or could be employed for making the food unsafe or sub-standard or mis-branded or containing extraneous matter” and prescribes science-based standards for food articles while regulating their manufacture, storage, distribution, sale, and import.
The Act mandates that all food business operators obtain either registration or license from FSSAI depending on their turnover. Food business operators with an annual turnover below Rs. 12 lakhs require registration, while those exceeding this threshold must obtain a license. Operating without valid documentation attracts immediate penalties and potential business closure. The licensing system ensures that food businesses maintain adequate infrastructure, follow proper hygiene practices, and implement food safety management systems.
Penalties Under the Food Safety and Standards Act
The Act prescribes graded penalties based on the severity of violations. For manufacturing, storing, selling, or distributing sub-standard food, violators face penalties up to five lakh rupees. Misbranded food attracts penalties up to three lakh rupees, while misleading advertisements can result in fines up to ten lakh rupees. The possession of adulterants carries penalties of two lakh rupees if the adulterant is not injurious to health, escalating to ten lakh rupees if it poses health risks.
For serious offenses involving unsafe food, the Act prescribes imprisonment alongside monetary penalties. Manufacturing or selling adulterated food not injurious to health results in minimum imprisonment of six months extending up to three years with a minimum fine of one thousand rupees. When the adulterant is injurious to health but does not cause grievous hurt, the punishment increases to minimum imprisonment of one year extending to six years with a minimum fine of two thousand rupees. The most severe punishment applies when adulterated food causes death or grievous bodily harm, prescribing minimum imprisonment of seven years extendable to life imprisonment with a minimum fine of ten lakh rupees [2].
The Act also establishes an adjudication mechanism where designated officers examine evidence of non-compliance and determine appropriate penalties. Food business operators can appeal penalties to the Food Safety Appellate Tribunal within specified timeframes, ensuring procedural fairness in enforcement actions.
Regulatory Framework for Medicines
The Drugs and Cosmetics Act, 1940
The Drugs and Cosmetics Act, 1940 [3] provides the regulatory framework for pharmaceuticals and cosmetics in India. This legislation defines adulterated drugs as those consisting wholly or partly of filthy, putrid, or decomposed substances, those prepared or stored under insanitary conditions leading to contamination, or those containing harmful or toxic substances that render them injurious to health. A drug is considered adulterated if any substance has been mixed with it to reduce its quality or strength.
The Act distinguishes between adulterated and spurious drugs. Spurious drugs are counterfeit products manufactured under names belonging to other drugs, imitations or substitutes that resemble genuine drugs in a manner likely to deceive, or products bearing labels claiming fictitious manufacturers. This distinction is crucial because spurious drugs carry more severe penalties given their deliberate deceptive nature.
Penalties for Drug Adulteration
The Drugs and Cosmetics Act prescribes stringent penalties for violations. Importing adulterated or spurious drugs attracts imprisonment up to three years and fines up to five thousand rupees. Manufacturing or selling adulterated drugs that, when used for diagnosis, treatment, mitigation, or prevention of disease, are likely to cause death or grievous hurt results in imprisonment not less than ten years but extendable to life imprisonment, along with fines not less than ten lakh rupees or three times the value of drugs confiscated, whichever is higher [4].
For spurious drugs not falling under the most severe category, the punishment includes imprisonment not less than three years but extendable to five years with fines not less than five thousand rupees. The Act empowers courts to reduce sentences below the minimum for adequate and special reasons, which must be recorded in the judgment. This flexibility allows judicial discretion while maintaining the deterrent effect of stringent baseline penalties.
The compensation provision under the Act mandates that fines imposed on convicted persons must be paid as compensation to victims who used the adulterated or spurious drugs. This ensures that affected consumers receive financial redress for harm suffered due to pharmaceutical violations.
Regulatory Enforcement Mechanisms for Food and Medicine Adulteration
Food Safety Officers and Inspectors
Food Safety Officers appointed under the Food Safety and Standards Act possess extensive powers to ensure compliance. They can enter and inspect any premises where food is manufactured, processed, stored, or distributed. Officers are authorized to search premises with police assistance and search warrants, take samples of food for analysis, seize unsafe food products, and issue written warnings or stop production orders when food is found to be spoiled or unsafe.
The enforcement mechanism involves a structured process beginning with detection and sampling. Food Safety Officers conduct inspections and collect samples for analysis at accredited laboratories. If violations are detected through laboratory testing, notices of non-compliance are issued to the concerned food business operators. The Adjudicating Officer then examines evidence and determines appropriate penalties. Food business operators retain the right to appeal penalties to the Food Safety Appellate Tribunal, ensuring due process in enforcement actions.
Drug Inspectors and Controllers
Under the Drugs and Cosmetics Act, Drug Inspectors serve as the primary enforcement officers. They possess authority to inspect manufacturing facilities, storage premises, and sale outlets to ensure compliance with drug safety standards. Inspectors can take samples of drugs for testing, examine manufacturing processes, and verify licensing requirements. The Drugs Controller India oversees the implementation of the Act at the national level, while State Drug Controllers manage enforcement within their respective jurisdictions.
The enforcement framework includes provisions for emergency prohibition orders when immediate action is necessary to prevent health hazards. The Commissioner of Food Safety can issue such orders under the Food Safety and Standards Act when unsafe products require immediate removal from the market.
Consumer Complaint Procedures
Filing Complaints with FSSAI
Consumers who encounter adulterated food can file complaints through multiple channels established by FSSAI. The Food Safety Connect portal and mobile application enable online complaint submission from anywhere in the country. Complainants must provide detailed information including the product name, batch number, manufacturer details, nature of the complaint, and supporting evidence such as photographs, purchase receipts, or laboratory reports.
Upon receiving a complaint, FSSAI forwards it to the appropriate Food Safety Officer for investigation. The officer conducts an inspection, collects samples if necessary, and initiates action as per the provisions of the Act. Consumers can also contact the FSSAI helpline at 1800-11-2100 to report food safety concerns. For serious violations, consumers can directly approach the Designated Food Safety Court, which has jurisdiction to hear cases involving unsafe food.
Consumer Protection Act Remedies
The Consumer Protection Act, 2019 [5] provides an additional avenue for redress. Consumers can file complaints with District, State, or National Consumer Disputes Redressal Commissions based on the value of goods or services involved. District Commissions handle matters up to one crore rupees, State Commissions address claims between one crore and ten crore rupees, and the National Commission entertains complaints exceeding ten crore rupees.
The Act enables electronic filing of complaints through the eDaakhil portal, facilitating access to justice from any location. Consumer commissions can order replacement of goods, refund of prices paid, removal of defects, discontinuation of unfair trade practices, and payment of compensation for losses suffered. The Act prescribes penalties for non-compliance with commission orders, including imprisonment up to three years or fines up to twenty-five thousand rupees.
The Central Consumer Protection Authority established under the 2019 Act possesses suo motu powers to initiate action against unfair trade practices, misleading advertisements, and violations of consumer rights. It can recall products, order reimbursement, cancel licenses, impose penalties, and file class action suits on behalf of affected consumers.
Judicial Interpretation and Landmark Cases
Ram Nath v. State of Uttar Pradesh
The Supreme Court in Ram Nath v. State of Uttar Pradesh [6] addressed the critical issue of overlapping jurisdiction between the Indian Penal Code and the Food Safety and Standards Act. The appellant faced prosecution under Sections 272 and 273 of the Indian Penal Code for adulteration of mustard oil, edible oil, and rice bran oil. The Supreme Court held that Section 89 of the Food Safety and Standards Act gives overriding effect to its provisions over any other law concerning food-related matters. The Court stated that “the main Section clearly gives overriding effect to the provisions of the FSSA over any other law in so far as the law applies to the aspects of food in the field covered by the FSSA.”
The judgment emphasized that Section 59 of the Food Safety and Standards Act is more stringent than Sections 272 and 273 of the Indian Penal Code because it does not require proof of intention, which the IPC provisions contemplate. Consequently, the Court quashed the criminal proceedings under the IPC while clarifying that authorities remain free to act against violators under the Food Safety and Standards Act. This ruling established the primacy of specialized food safety legislation over general criminal law in adulteration cases.
Swami Achyutanand Tirth v. Union of India
In Swami Achyutanand Tirth v. Union of India [7], the Supreme Court addressed widespread concerns about adulterated and synthetic milk. The public interest litigation sought directions for the Union and State Governments to implement the Food Safety and Standards Act more effectively. The Court issued comprehensive directions requiring State Food Safety Authorities to identify high-risk areas and times for milk adulteration, collect samples from those locations, and ensure that all laboratories obtain National Accreditation Board for Testing and Calibration Laboratories accreditation.
The judgment mandated that dairy owners and retailers be informed that stringent action would be taken upon discovery of chemical adulterants in milk. The Court emphasized the State’s duty under Article 21 of the Constitution to protect citizens against hazardous and injurious food articles, affirming that food safety is a fundamental aspect of the right to life.
Centre for Public Interest Litigation v. Union of India
The Supreme Court in Centre for Public Interest Litigation v. Union of India [8] examined allegations of soft drink adulteration. The Court observed that people are protected under Article 21 against hazardous and injurious food articles and that the State bears a constitutional duty to ensure such rights. This judgment reinforced the principle that food safety is not merely a statutory obligation but a constitutional imperative flowing from the fundamental right to life and personal liberty.
Procedural Requirements for Taking Action Against Food and Medicine Adulteration
Evidence Preservation and Documentation
Successful action against adulteration requires proper evidence collection and preservation. Consumers should retain portions of adulterated food or medicine products whenever possible, keeping original packaging intact as it contains essential details like batch numbers, manufacturing dates, expiry dates, and manufacturer information. Photographic or video documentation of the adulterated product, its packaging, and any visible contaminants strengthens the complaint.
Purchase receipts, bills, and transaction records serve as proof of purchase and establish the consumer-seller relationship necessary for legal proceedings. Medical records documenting health complications resulting from adulterated products provide crucial evidence of harm suffered, supporting claims for compensation. Laboratory analysis reports confirming adulteration constitute definitive proof of violations and are essential for successful prosecution.
Notice Requirements and Limitation Periods
Before initiating formal legal proceedings, consumers should consider issuing a legal notice to the manufacturer, seller, or service provider detailing the complaint, relief sought, and timeframe for compliance. While not mandatory, such notices often facilitate amicable settlements and demonstrate good faith efforts at resolution.
Complaints under the Food Safety and Standards Act must be filed promptly after discovering adulteration. Under the Consumer Protection Act, complaints must be filed within two years from the date when the cause of action arises. However, consumer commissions possess discretion to condone delays beyond the limitation period if complainants demonstrate sufficient cause for not filing within the prescribed timeframe.
Integration of Multiple Remedies
Consumers possess the right to pursue remedies under multiple statutes simultaneously. While the Ram Nath judgment clarified that the Food Safety and Standards Act overrides the Indian Penal Code for food-related offenses, it does not preclude consumers from seeking compensation through consumer protection mechanisms. The Supreme Court has held that if an act constitutes an offense under two enactments prescribing punishment for the same, the offender may be prosecuted and punished under either or both enactments but shall not be liable to be punished twice for the same offense.
This principle enables consumers to file criminal complaints under the Food Safety and Standards Act or Drugs and Cosmetics Act for punitive action against violators while simultaneously pursuing civil remedies through consumer forums for compensation. The integration of criminal prosecution and civil compensation ensures both deterrence and restitution.
Challenges in Implementation
Despite robust Food and Medicine Adulteration Laws in India, implementation challenges persist. Inadequate testing infrastructure, especially in rural areas, hampers the detection of adulterated products. The shortage of Food Safety Officers and Drug Inspectors relative to the number of food businesses and pharmaceutical establishments limits enforcement capacity. Additionally, low consumer awareness about complaint mechanisms and available remedies reduces reporting of adulteration incidents.
Delays in laboratory testing and adjudication proceedings can undermine enforcement effectiveness. The Supreme Court has noted that delays in filing complaints after sample collection can prejudice defendants by preventing them from exercising their legal right to have samples analyzed by the Director of the Central Food Laboratory. Such procedural lapses can result in acquittals despite genuine adulteration.
Resource constraints affecting regulatory bodies limit the frequency and scope of inspections. Many food businesses, particularly small-scale operators, lack adequate knowledge of food safety standards and compliance requirements. Addressing these challenges requires sustained investment in testing infrastructure, capacity building for enforcement personnel, consumer education initiatives, and streamlined adjudication processes.
Preventive Measures and Consumer Vigilance
While legal remedies provide recourse after adulteration occurs, preventive measures can minimize exposure to unsafe products. Consumers should verify FSSAI license numbers on food products and check their validity on the FSSAI website. Examining expiry dates, manufacturing dates, and batch numbers before purchase helps identify potentially unsafe products. Purchasing food from licensed establishments with visible hygiene ratings reduces adulteration risks.
For pharmaceuticals, consumers should purchase medicines only from licensed pharmacies and verify the authenticity of products through the Drugs Authentication and Verification Application developed by the Central Drugs Standard Control Organization. Checking for proper sealing, manufacturer details, and batch numbers helps identify spurious drugs. Reporting suspicious products to regulatory authorities prevents their circulation and protects other consumers.
Consumer organizations play a vital role in raising awareness about food and drug safety, educating the public about complaint mechanisms, and filing class action suits on behalf of affected groups. Active consumer participation in food safety initiatives strengthens the overall regulatory ecosystem.
Conclusion
India’s legal framework for combating food and medicine adulteration encompasses comprehensive legislation, robust enforcement mechanisms, and accessible complaint procedures. The Food Safety and Standards Act, 2006, and the Drugs and Cosmetics Act, 1940, prescribe stringent penalties ranging from substantial fines to life imprisonment for serious violations. Regulatory authorities including FSSAI and Drug Controllers possess extensive powers to inspect premises, collect samples, and initiate prosecution against violators.
Consumers can seek redress through multiple avenues including direct complaints to regulatory authorities, criminal prosecution under specialized statutes, and civil remedies through consumer protection forums. Judicial pronouncements have clarified the primacy of specialized food safety legislation while affirming constitutional protections against hazardous consumables. Despite implementation challenges, the legal architecture provides a solid foundation for protecting public health.
Effective action against adulteration requires collaboration among regulatory authorities, enforcement officers, consumer organizations, and vigilant citizens. As the Supreme Court has emphasized, food and drug safety constitutes a fundamental aspect of the constitutional right to life. Strengthening enforcement capacity, enhancing consumer awareness, and ensuring timely adjudication will progressively realize this constitutional guarantee, ensuring that every citizen has access to safe and wholesome food and effective medicines.
References
[1] Food Safety and Standards Act, 2006. Available at: https://www.indiacode.nic.in/handle/123456789/2027
[2] IndiaFilings. (2025). FSSAI Penalty and Offenses. Available at: https://www.indiafilings.com/learn/fssai-penalty-and-offenses/
[3] The Drugs and Cosmetics Act, 1940. Available at: https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/acts_rules/2016DrugsandCosmeticsAct1940Rules1945.pdf
[4] Indian Kanoon. The Drugs And Cosmetics Act, 1940. Available at: https://indiankanoon.org/doc/1891720/
[5] Consumer Protection Act, 2019. Available at: https://byjus.com/free-ias-prep/consumer-protection-act-2019/
[6] LiveLaw. (2024). Food Safety and Standards Act Overrides IPC on Food Adulteration | Supreme Court. Available at: https://www.livelaw.in/supreme-court/food-safety-and-standards-act-overrides-indian-penal-code-simultaneous-prosecution-under-both-acts-not-possible-supreme-court-250555
[7] iPleaders. (2021). Role of judiciary in the implementation of food adulteration laws in India. Available at: https://blog.ipleaders.in/role-of-judiciary-in-the-implementation-of-food-adulteration-laws-in-india/
[8] iPleaders. (2021). Role of judiciary in the implementation of food adulteration laws in India. Available at: https://blog.ipleaders.in/role-of-judiciary-in-the-implementation-of-food-adulteration-laws-in-india/
