The amended law introduces a major shift in how drug-related offences are prosecuted. If a drug or cosmetic is seized on suspicion of being fake, adulterated or misbranded, the person in possession will have to prove its authenticity.
Published Dec 19, 2025 | 9:32 AM ⚊ Updated Dec 19, 2025 | 9:32 AM
Drugs. (iStock)
Synopsis: The Karnataka Assembly passed the Drugs and Cosmetics (Karnataka Amendment) Bill, 2025, which tightens penalties, shifts legal responsibility, and empowers enforcement agencies with sharper powers to act against spurious drugs and cosmetics. Public health experts noted that while the Bill is welcome, its real impact lies in proper implementation.”
In a move that could dramatically change how fake and unsafe medicines are policed, the Karnataka Assembly passed the Drugs and Cosmetics (Karnataka Amendment) Bill, 2025, which tightens penalties, shifts legal responsibility, and empowers enforcement agencies with sharper powers to act against spurious drugs and cosmetics. The Bill aims to amend the Drugs and Cosmetics Act, 1940 (a Central Act).
Piloting the Bill, Health Minister Dinesh Gundu Rao told the House on Wednesday, 17 December, that the amendment was meant to protect citizens from “inferior, dangerous and fake drugs and cosmetics,” stressing that the changes came after extensive deliberations.
The government, he said, could no longer afford weak enforcement when public health was at stake.
The amended law introduces a major shift in how drug-related offences are prosecuted. If a drug or cosmetic is seized on suspicion of being fake, adulterated or misbranded, the person in possession will have to prove its authenticity. Until now, that burden largely rested on the state. The government argues that this will prevent offenders from exploiting legal loopholes and delaying cases for years.
“If you are selling medicines, you must be able to show where they came from and that they meet standards,” said a government official. “The responsibility cannot always lie with the state,”
Another key change is the steep escalation in punishment. For repeat offences involving fake or harmful products, courts can now award life imprisonment or long jail terms, a significant increase from earlier limits. According to the government, stronger penalties are essential to deter organised networks involved in manufacturing and distributing spurious medicines.
“Selling fake drugs is not a paperwork error,” a public health expert told South First. “It can kill people. The punishment now reflects that reality.
In addition, offences under the Act have been made cognizable and non-bailable, allowing police to act without waiting for court permissions.”
“Speed matters in public health,” said a senior police officer. “If a harmful drug is in circulation, delays can cost lives.”
The amendment also makes offences under the Act cognizable and non-bailable, allowing police to arrest suspects without a warrant and limiting the possibility of immediate bail. Officials said this will enable quicker action and reduce the chances of offenders slipping through the cracks during investigations.
Speaking in defence of the Bill, Gundurao said the state had a responsibility to act decisively. “This is not about harassment,” he said, adding that unsafe medicines were a direct threat to lives and public trust in the healthcare system.
The law also allows the Karnataka government, with central approval, to assign certain testing and enforcement functions to state authorities. This could speed up drug testing and reduce delays caused by dependence on overburdened central laboratories.
Calling it an interesting move, Akhila Vasan, a public health activist, expressed concern about vacancies in the Drug Controller’s office. She said, “The state drug controller’s office is full of vacancies. There are only a handful of drug inspectors. What is the government doing about that?”
She questioned why the department’s structure for enforcement was so weak: “When you are not even in a position to conduct routine inspections of drug manufacturing sites, storage centres, and retailers, what’s the point of this Amendment?”
Vasan pointed out that these are typical knee-jerk reactions to incidents of deaths due to drug adulteration!
Speaking to South First Dr Gopal Dabade, the leader of the Drug Action Forum Karnataka and the Samagra Arogya Andolan Karantaka, said, “Whatever the laws may be, it is their implementation that matters the most.”
He explained that in the Ballari maternal deaths case, the company that was alleged to supply spurious drugs is still not on the black list. “Why is that so? “ Dr Gopal asked.
(Edited by Muhammed Fazil.)
