Adulteration Of Drugs And Food
1. Overview: Adulteration of Drugs and Food
Adulteration refers to the act of making a substance (food or drugs) impure or unsafe by adding inferior substances or by removing valuable ingredients, making it harmful, substandard, or dangerous for human consumption.
Legal Framework:
The Food Safety and Standards Act, 2006 (FSS Act): Governs food adulteration.
The Drugs and Cosmetics Act, 1940 (D&C Act): Governs adulteration of drugs.
The Prevention of Food Adulteration Act, 1954 (repealed but foundational).
Relevant Sections:
Section 2(1)(b) of FSS Act defines adulteration.
Section 27 of D&C Act penalizes manufacturing/selling adulterated drugs.
Section 52 of FSS Act provides penalties for adulteration.
2. Important Aspects of Adulteration Law
Presumption of Adulteration: Courts often presume adulteration if samples test positive, shifting the burden to the accused.
Strict Liability Offense: Often treated as strict liability; intent may not always be necessary.
Public Health Concern: Adulteration is considered a grave offense due to risk to life and health.
Burden of Proof: Largely lies on the manufacturer or seller to prove innocence.
Seizure and Testing: Samples are taken and tested in government-approved labs.
3. Key Case Laws on Adulteration of Drugs and Food
Case 1: R.K. Sharma v. Union of India, AIR 1979 SC 1369
Facts: The case involved adulteration of medicines where the manufacturers were accused of selling spurious and substandard drugs.
Issue: Whether the manufacturer is liable even if adulteration was unintentional.
Judgment: The Supreme Court held that strict liability applies in cases of adulterated drugs. A manufacturer cannot escape liability by claiming ignorance or unintentional adulteration.
Significance: Established that for drugs, due to the impact on health and life, strict liability applies. This ensures high accountability in the pharmaceutical industry.
Case 2: Mohd. Sadique v. Union of India, (2006) 9 SCC 700
Facts: The issue was adulteration of milk with harmful chemicals.
Issue: The Court examined the sufficiency of evidence for adulteration and the standard of proof required.
Judgment: The Court reiterated that in cases of adulteration, if samples show contamination, the accused must prove the absence of adulteration. Mere technical irregularities in the collection or testing of samples cannot lead to acquittal.
Significance: Reinforced the presumption of guilt in adulteration cases once laboratory tests confirm contamination.
Case 3: Dr. Rafiq Zakaria vs. State of Maharashtra, AIR 1963 SC 881
Facts: This case involved adulteration of food items and selling them as pure.
Issue: Whether adulteration amounts to an offense under Prevention of Food Adulteration Act.
Judgment: The Supreme Court held that adulteration involves a clear violation of statutory standards and amounts to an offense punishable by law.
Significance: Affirmed the protective purpose of food laws and that any tampering with food quality is a punishable offense.
Case 4: Union of India v. Parmar Oil Mills, AIR 1979 SC 1021
Facts: The case related to adulteration of edible oil.
Issue: Whether technical defects in the sample or minor deviation can lead to conviction.
Judgment: The Court ruled that minor deviations or procedural lapses in sample collection should not absolve the accused if the sample conclusively proves adulteration.
Significance: This ruling strengthened the protection of consumer rights over procedural technicalities.
Case 5: Gopal Bhargava v. Union of India, AIR 2002 SC 1614
Facts: The case involved adulterated drugs supplied in a government hospital.
Issue: Whether public servants can be held liable for negligence in procurement leading to adulteration.
Judgment: The Supreme Court held that all persons involved in the supply chain can be held accountable, including officials responsible for quality checks.
Significance: Expanded liability beyond manufacturers to include government agencies and intermediaries.
Case 6: State of Punjab v. M.S. Chopra, AIR 1959 SC 662
Facts: Involved adulteration of food products with hazardous substances.
Issue: Whether knowledge and intention are necessary to convict for adulteration.
Judgment: The Court held that knowledge and intention are not essential elements; selling adulterated food or drugs itself is sufficient for conviction.
Significance: Affirmed the doctrine of strict liability in food and drug adulteration cases.
4. Summary of Legal Principles
Strict liability applies in adulteration cases — no need to prove mens rea.
Courts rely heavily on scientific laboratory tests to prove adulteration.
Burden of proof shifts to the accused once adulteration is established.
Public health and safety take precedence over commercial interests.
Procedural irregularities in sample collection do not necessarily absolve liability.
Government officials, intermediaries, and manufacturers can all be held liable.
Severe penalties including imprisonment and fines are imposed to deter adulteration.
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