State Drug Regulators Should Be Merged With CDSCO: Bharat Biotech Founder
Bharat Biotech Executive Chairman Krishna Ella's comments came amid questions being raised about the quality of Indian drugs.
All state drug regulatory bodies should be merged with the Central Drugs Standard Control Organisation to ensure "one quality, one standard" for Indian drugs, Bharat Biotech International Ltd. Executive Chairperson Krishna Ella suggested on Sunday.
His comments came 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 Pvt. recalled its entire lot of eye drops, 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," Ella 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 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-Madison Global Health Institute (GHI) and the Ella Foundation in 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.