<p>The Karnataka Legislature’s recent Belagavi session introduced Section 19A in the Drugs and Cosmetics (Karnataka Amendment) Act, 2025. The provision states: “Where any drug or cosmetic is seized from any person on reasonable belief that such drug or cosmetic is misbranded or adulterated, the burden of proving that such drug or cosmetic is not misbranded or adulterated shall lie on the person from whose possession it was seized.” </p>.<p>This means that pharmacists and distributors, who receive products in sealed packaging from licensed manufacturers, are forced to prove their innocence, even if adulteration occurs upstream. This has sparked alarm amongst pharmacists, distributors, and small-scale traders. On paper, the law strengthens oversight. In reality, it risks punishing honest stakeholders whilst leaving the real violators untouched.</p>.<p>Traditionally, under both criminal and regulatory law, the burden of proof rests with the authorities, not the accused. The State Drug Control Authority ensures that medicines and cosmetics meet statutory standards for safety, quality, and labelling. Section 19A flips this principle, presuming guilt until innocence is established.</p>.<p>This is not just a legal quirk. Most adulteration and misbranding occur during the manufacturing stage, where compliance obligations are in place. Pharmacists and distributors act in good faith, relying on statutory assurances and regulatory oversight. Under Section 19A, they are required to prove the authenticity of every product, a task that is often practically impossible. Laboratory testing is expensive and inaccessible to small businesses, leaving them vulnerable to seizures, legal proceedings, and financial penalties, despite acting responsibly.</p>.<p>Internationally, regulatory frameworks differ. Both the US Food, Drug, and Cosmetic Act and European Union regulations place the burden of proof and oversight on manufacturers and regulators, not on retailers or distributors. They recognise that downstream stakeholders cannot verify every product, and penalising them for violations beyond their control is neither fair nor practical. Section 19A departs from these norms.</p>.<p>The practical implications are alarming. Section 19A could discourage legitimate trade, especially amongst small pharmacies and distributors. Many may avoid stocking certain drugs or cosmetics for fear of seizure or legal complications. This could disrupt supply chains, increase costs, and harm consumers, particularly in smaller towns and rural areas where pharmacies are essential for public health. Presuming guilt until proven innocent conflicts with Article 21 of the Constitution, which guarantees protection of life and personal liberty.</p>.<p>Economic repercussions are also significant. Small pharmacies may have to divert resources to compliance and testing, reducing profitability and limiting service to communities. Fear of legal action could drive traders out of business, consolidating the supply chain in the hands of a few large companies. As a result, costs will increase and access to essential medicines will be reduced.</p>.<p>Another serious concern is the potential for misuse by officials. Section 19A permits seizures based on “reasonable belief,” a vague and subjective standard. Coupled with the reversal of the burden of proof, officials could target specific pharmacies or distributors to settle personal or political scores or extract undue advantage. Honest businesses could face harassment, intimidation, or financial pressure, creating a climate of fear that undermines regulatory integrity and public trust.</p>.<p>Even more troubling is that lawmakers appear to have overlooked these practical realities. The provision does not reflect the complexities of pharmaceutical supply chains or the realities faced by small traders. There is no evidence that economic, legal, or operational impacts were seriously considered. Nor does it account for the possibility of misuse by officials. By ignoring these aspects, lawmakers have risked creating a law that punishes the innocent whilst failing to address the actual sources of adulteration —manufacturers.</p>.<p>Whilst the intent behind Section 19A is valid, the method is deeply flawed. A better approach would include strict oversight at manufacturing units, substantial penalties for offending manufacturers, procedural safeguards for downstream stakeholders, and support for verification and testing.</p>.<p>Section 19A represents a serious departure from legal norms, imposing undue burdens on pharmacists, distributors, and downstream stakeholders. Enforcement must target the actual source of violations — manufacturers — not those who merely possess the products. Policymakers must reassess this amendment, taking into account the legal, economic, and operational realities of the pharmaceutical sector.</p>.<p><em>(The writer is a former deputy director of boilers based in Mysuru)</em></p>
<p>The Karnataka Legislature’s recent Belagavi session introduced Section 19A in the Drugs and Cosmetics (Karnataka Amendment) Act, 2025. The provision states: “Where any drug or cosmetic is seized from any person on reasonable belief that such drug or cosmetic is misbranded or adulterated, the burden of proving that such drug or cosmetic is not misbranded or adulterated shall lie on the person from whose possession it was seized.” </p>.<p>This means that pharmacists and distributors, who receive products in sealed packaging from licensed manufacturers, are forced to prove their innocence, even if adulteration occurs upstream. This has sparked alarm amongst pharmacists, distributors, and small-scale traders. On paper, the law strengthens oversight. In reality, it risks punishing honest stakeholders whilst leaving the real violators untouched.</p>.<p>Traditionally, under both criminal and regulatory law, the burden of proof rests with the authorities, not the accused. The State Drug Control Authority ensures that medicines and cosmetics meet statutory standards for safety, quality, and labelling. Section 19A flips this principle, presuming guilt until innocence is established.</p>.<p>This is not just a legal quirk. Most adulteration and misbranding occur during the manufacturing stage, where compliance obligations are in place. Pharmacists and distributors act in good faith, relying on statutory assurances and regulatory oversight. Under Section 19A, they are required to prove the authenticity of every product, a task that is often practically impossible. Laboratory testing is expensive and inaccessible to small businesses, leaving them vulnerable to seizures, legal proceedings, and financial penalties, despite acting responsibly.</p>.<p>Internationally, regulatory frameworks differ. Both the US Food, Drug, and Cosmetic Act and European Union regulations place the burden of proof and oversight on manufacturers and regulators, not on retailers or distributors. They recognise that downstream stakeholders cannot verify every product, and penalising them for violations beyond their control is neither fair nor practical. Section 19A departs from these norms.</p>.<p>The practical implications are alarming. Section 19A could discourage legitimate trade, especially amongst small pharmacies and distributors. Many may avoid stocking certain drugs or cosmetics for fear of seizure or legal complications. This could disrupt supply chains, increase costs, and harm consumers, particularly in smaller towns and rural areas where pharmacies are essential for public health. Presuming guilt until proven innocent conflicts with Article 21 of the Constitution, which guarantees protection of life and personal liberty.</p>.<p>Economic repercussions are also significant. Small pharmacies may have to divert resources to compliance and testing, reducing profitability and limiting service to communities. Fear of legal action could drive traders out of business, consolidating the supply chain in the hands of a few large companies. As a result, costs will increase and access to essential medicines will be reduced.</p>.<p>Another serious concern is the potential for misuse by officials. Section 19A permits seizures based on “reasonable belief,” a vague and subjective standard. Coupled with the reversal of the burden of proof, officials could target specific pharmacies or distributors to settle personal or political scores or extract undue advantage. Honest businesses could face harassment, intimidation, or financial pressure, creating a climate of fear that undermines regulatory integrity and public trust.</p>.<p>Even more troubling is that lawmakers appear to have overlooked these practical realities. The provision does not reflect the complexities of pharmaceutical supply chains or the realities faced by small traders. There is no evidence that economic, legal, or operational impacts were seriously considered. Nor does it account for the possibility of misuse by officials. By ignoring these aspects, lawmakers have risked creating a law that punishes the innocent whilst failing to address the actual sources of adulteration —manufacturers.</p>.<p>Whilst the intent behind Section 19A is valid, the method is deeply flawed. A better approach would include strict oversight at manufacturing units, substantial penalties for offending manufacturers, procedural safeguards for downstream stakeholders, and support for verification and testing.</p>.<p>Section 19A represents a serious departure from legal norms, imposing undue burdens on pharmacists, distributors, and downstream stakeholders. Enforcement must target the actual source of violations — manufacturers — not those who merely possess the products. Policymakers must reassess this amendment, taking into account the legal, economic, and operational realities of the pharmaceutical sector.</p>.<p><em>(The writer is a former deputy director of boilers based in Mysuru)</em></p>
