A death due to the consumption of a drug not conforming to the prescribed quality cannot be ignored as a singular incident.
Published Dec 01, 2025 | 1:41 PM ⚊ Updated Dec 01, 2025 | 1:41 PM
Dinesh Gundu Rao.
Synopsis: In India, despite being one of the world’s largest producers and exporters of generics, the mandate of bioequivalence studies for generic products sold in the domestic market was implemented only in 2017, with the amendment to the Drugs and Cosmetics Act.
Karnataka’s Health Minister, Dinesh Gundu Rao, has called for continuous reforms in the health sector, stating that the system is flawed.
“Our systems are flawed; it is a reality. But we must continuously reform, ensure accountability and administrative transparency,” he said in the light of deaths linked to Coldrif paediatric cough syrup in Madhya Pradesh and Rajasthan.
He urged pharmaceutical firms to standardise themselves according to the Revised Schedule M regulations. Rao said his department would support the transition.
Further addressing a workshop on Bioequivalence Studies in Bengaluru recently, he said drugs, affordable to both the rich and the poor, should have the same efficiency. A death due to the consumption of a drug not conforming to the prescribed quality cannot be ignored as a singular incident.
“Whether a person is rich or poor, the quality and efficacy of the drugs they can afford must be the same. There must be no variation. Even if one person dies because of the NSQ (Not of Standard Quality) drug, it is just as critical as a hundred or a thousand. It is not just a statistic, it’s a human life,” the minister said.
He added that critical incidents should not be the reason for society to wake up. “Those who are aware of corners being cut must come forward to the authorities,” he said.
Rao further pointed out that the Government had notified the Revised Schedule M to modernise India’s Good Manufacturing Practices (GMP) in alignment with global standards.
These reforms, he said, were essential for robust quality systems, manufacturing efficiency, improved documentation and stronger environmental and contamination controls. He urged manufacturers to view these changes “not as burdens, but as investments in the credibility and sustainability of your businesses”.
The National President of the Indian Pharmaceutical Association, Dr RN Gupta, urged the drug control authorities to keep a tab on the levels of Diethylene Glycol solvents used in the food and herbal nutraceutical industries.
“The drug control authority is strict about the levels of Diethylene Glycol solvents, but these solvents are used in the food and the herbal nutraceutical industry as well, which has weaker regulations for their levels. I request our health control administration to consider these other aspects too and save the masses,” he said.
Since 1988, BE studies have been mandatory for all products classified as ‘new drugs’.
Countries like Fiji, Thailand, Malaysia, etc, with far smaller pharmaceutical markets than India, made Bioequivalence studies for generic products mandatory years ago. Yet in India, despite being one of the world’s largest producers and exporters of generics, the mandate of bioequivalence studies for generic products sold in the domestic market was implemented only in 2017, with the amendment to the Drugs and Cosmetics Act.
Dr Premnath Shenoy, former president of IPA-KSB, said, the regulatory gap has had consequences not just for public health, but for trust, credibility and global reputation.
“Bioequivalence is not just a regulatory formality; it is a scientific and ethical safeguard that companies need to adhere to,” he said.
“We must use the Revised Schedule M as our roadmap and eliminate all NSQ drugs by adopting BA/BE studies in our formulation. The FDA will show zero tolerance for NSQ drugs. Any suboptimal efficacy drugs on the market are a public health concern,” said Dr Umesh S, Additional Drugs Controller, FDA.
“The image– the trust built on a pill– is the most important thing. And that image can come from systems, and the systems can only come from a scientific background,” said Jatish Sheth, President of the KDPMD.
Dr Gupta also requested the Minister to strengthen the present drug control commission by appointing more inspectors and conducting timely drug testing.
“The Indian pharmaceutical market stands at $66.6 billion, and is predicted to advance to $88 billion in five years, with 5.92% as the compound annual growth rate,” Dr Umesh S said.
Globally, oral solid forms make up 84 percent of the best-selling pharmaceuticals and 68 percent of the overall contract manufacturing market. Oral dosage forms have a major market share due to patient preference, ease of use, cost-effectiveness, manufacturing capacities and ease of handling and transportation.
