BENGALURU: In the backdrop of a series of maternal deaths in Ballari district, allegedly caused by substandard drugs, Karnataka Health Minister Dinesh Gundu Rao wrote to Union Health Minister JP Nadda on Thursday, urging immediate reforms in the central drug regulatory framework.
The minister highlighted the limitations of the Drugs and Cosmetics Act, 1940, and proposed measures to ensure stricter monitoring of drug manufacturing and distribution across states.
Gundu Rao emphasised that under the current regulatory system, pharmaceutical companies that were licensed and inspected only by their home states can sell their drugs nationwide, leaving states like Karnataka with limited control over substandard drugs entering their markets.
He pointed out that of the 894 drug samples tested in Karnataka over the past two years, 601 that failed quality checks were manufactured outside the state. He proposed the creation of a centralised database to address these gaps, suggesting that drug testing results from all central and state laboratories be made accessible.
In case of substandard drugs, the state are left with only one option -- to prosecute these companies, but criminal proceedings take time. Meanwhile, these manufacturers continue producing and selling drugs, posing a threat to public health, Gundu Rao said, pointing out that the creation of a centralised database would allow drug inspectors and procurement agencies, such as the Karnataka State Medical Supplies Corporation Limited (KSMSCL), to track a manufacturer’s history of quality failures across the country.