State drugs regulators should be merged with CDSCO to ensure "one quality one standard": Bharat Biotech MD
It is important to centralise the system, Krishna Ella said.
New Delhi: All state drug regulatory bodies should be merged with the Central Drugs Standard Control Organisation (CDSCO) to ensure "one quality one standard" for Indian drugs, Bharat Biotech's Executive Chairman Dr Krishna Ella has suggested.
His comments came on Sunday in the backdrop of questions being raised about the quality of Indian drugs over the past few months. The latest instance was on Friday, when the Tamil Nadu-based Global Pharma Healthcare recalled its entire lot of eye drop linked allegedly to vision loss in the US.
Before that, India-made cough syrups were allegedly linked to children deaths in the Gambia and Uzbekistan last year. The whole of Indian pharmaceutical industries cannot be sullied for a handful of cases, he said. "Even in Western countries, some of the companies are penalised on quality issues."
"There should be a single regulatory framework in India. All state drug regulatory bodies should be merged with the Central Drugs Standard Control Organisation(CDSCO) and that will solve the problem," Ella said.
"But somewhere a political decision and commitment is required for this," he said on the sidelines of an event in which an agreement was signed between the University of Wisconsin (UW)-Madison Global Health Institute (GHI) and the Ella Foundationin Delhi for establishment of the first ever "UW-Madison One Health Centre" in Bengaluru.
It is important to centralise the system, he said. "The licences for the cough syrups that were under question in the recent cases were given by state regulatory bodies, not by the Central (body".
"We have extremely good companies but because of some local agencies we are getting into trouble," he said.
A day after its plant was inspected by Indian drug regulatory bodies over allegations that its eye drop was linked to vision loss in the US, Tamil Nadu-based Global Pharma Healthcare on Saturday was asked to stop manufacturing all ophthalmic products till the inquiry is completed.
Read also: CDSCO suspends manufacturing of eye drops linked to 55 adverse events in US
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