Union Health Minister J P Nadda
Credit: PTI Photo
New Delhi: Union Health Minister J P Nadda on Wednesday asked the Central Drug Standards Control Organisation – India’s apex drug regulatory body - to follow the "highest standard of transparency" to improve the quality of medicines produced in India.
Public health campaigners for years have highlighted the opaque way of working of CDSCO, unlike some of the world’s top regulatory agencies like the US Food and Drug Administration.
Underlining the importance of transparency in the working of CDSCO, Nadda said, “In order to achieve global standards, our focus needs to be on transparency of procedures at CDSCO and within the drugs and medical devices industry."
“The drug regulatory body and the industry should work on the highest principles of transparency to ensure that the products manufactured and sold by India meet the highest indices of global quality standards,” he said.
Lack of transparency at CDSCO is one of the reasons that public health campaigners and a section of doctors have flagged over the years for India’s poor regulatory standards. Drug inspection reports are not made public and there is no centralised database to check the reports from all the 28 testing laboratories.
There is also no public database on the violation, inspection and history of a brand because of which drug inspectors in one state will not know the regulatory status of a medicine in another state.
The minister sought an update from CDSCO on the progress of a scheme to strengthen the state drug regulatory system with a budget of Rs 850 crore, launched in 2016 during his earlier tenure.
At a high level review meeting, Nadda asked the CDSCO to draw a roadmap with timelines of achieving global standards in its mandated activities.
For export of drugs and pharmaceuticals, the regulatory system should be designed for proper intervention to maintain the quality of drugs being exported, he said.
The quality of drugs exported by Indian companies came under international scrutiny following a few WHO alerts in recent months on contaminated cough syrups that were reportedly linked to children’s death in Gambia and Uzbekistan. Such contaminated Indian cough syrups were also found to be sold in other countries.
The US authorities also alerted Indian officials on the quality of certain eye drop brands and their link to bacterial infections in people.