 The Bangalore District Chemists and Druggists Association (BDCDA) has called for reconsideration and appropriate inclusion of certain rules in the amendments to Rules under the Drugs and Cosmetics Act (Karnataka Amendment) Act, 2025. This bill was presented in December 2025 at Legislature session at Belagavi by Karnataka health & family welfare minister, Dinesh Gundu Rao.
The Drugs and Cosmetics Act (Karnataka Amendment) Act, 2025 is a commitment by the state government to strengthen the regulatory framework, safeguard public health and ensure access to genuine, quality-assured medicines. At the same time, there are certain critical aspects requiring ratification and reconsideration in the amendment, said B Thirunavukkarasu, president, BDCDA.
These concerns will be formally presented at an appropriate forum. We see rules regarding regulatory lapses and operational shortcomings have not been adequately brought out, he added.
For instance, the Drugs and Cosmetics Act (Karnataka Amendment) Act, 2025 Rule 19A states: ‘Burden of Proof’. This is when any drug or cosmetic is seized because it is tested to be misbranded or adulterated. The burden of proving that it is not misbranded or adulterated will be on the person from whose possession such drug or cosmetic was seized, he said.
Now we need to view this Burden of Proof as a protective resolution for ethical practice. Rather than regarding compliance as a liability, we must look at the Burden of Proof as a professional shield, said Thirunavukkarasu.
Based on this, BDCDA proposes a resolution Retail Pharmacists’ Ethical Commitment. A key aspect to this is physical presence of qualified-registered pharmacists in pharmacies throughout all business operating hours. Verification of every batch and expiry date must match the invoice before stocking or dispensing. Retail pharmacists should ensure every supplier is fully compliant by periodically verifying their valid drugs license & GST registration certificate. There is a need to maintain Authorized Stockiest Appointment Certificates from each supplier as a legal safeguard, said Thirunavukkarasu.
From a consumer perspective, medicines and cosmetics should be sourced only from locally licensed, and authorized wholesale distributors. Under any circumstances, it should never be purchased from unauthorized semi-wholesalers, sub-stockists, procuring agents, unverified sources, he noted.
For Scheduled Drugs in the H, H1 including antibiotics, it is mandatory to endorse the prescription with dispensed, pharmacy details, bill number, and date. And for habit-forming or narcotic medicines, a copy of the original prescription must be retained along with complete patient contact information for legal traceability and accountability, Thirunavukkarasu told the retailers in his communication note.
All pharmacy retailers must install 24×7 CCTV surveillance to enhance patient and staff safety, ensure transparency, accountability, and legal protection. Retailers should not view the burden of proof as a tool for harassment or corruption, said Thirunavukkarasu.
Shifting enforcement failures onto compliant pharmacists lets real offenders escape and increases malpractices. Without uniform accountability across the supply chain and regulators, the amendment will worsen problems. Regulations should strengthen justice and protect ethical pharmacists, not instil fear. The government must recognize that retail pharmacists are the last line of defence for patients and the backbone of safe healthcare services, said Thirunavukkarasu.
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