Single Drug Regulatory Framework

BHARAT BIOTECH’S Executive Chairman, Dr Krishna Ella, has called for a unified drug regulatory framework with the merging of all state drug regulatory units with the Central Drugs Standard Control Organisation (CDSCO) to ensure one quality and one standard in pharmaceuticals. 

He said, “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.” His comments come in the wake of the quality of Indian drugs having come under scrutiny around the world over the past few months.

Recently Chennai-based drug firm, Global Pharma Healthcare, voluntarily recalled its whole batch of eye drops after the United States Foods and Drugs Administration (USFDA) notification alleged that they had caused a death and 55 instances of eye infections and permanent loss of vision. 

Earlier Made in India cough syrups from two companies had allegedly led to the death of 90 children in Gambia and Uzbekistan. Speaking on the sidelines of an event in Bangalore, Dr Ella said the entire Indian pharmaceutical sector should not be tainted because of a few cases. “We have extremely good companies but due to some local agencies we are getting into trouble,” he said, adding, “The licences for the cough syrups which were under question in the recent cases were provided by state regulatory units and not by the Central regulator.”