The industry can apply again from the zonal offices through online mode from May 15, said a notice issued by the Central Drugs Standards Control Organisation (CDSCO). It asked the industry to file fresh applications for NOC for manufacture of unapproved, approved new drugs and banned drugs solely for export purposes. “Accordingly, power delegated to state/UT licensing authority stands withdrawn w.e.f. May 15, 2024 and such NOCs shall be granted by head of CDSCO zonal office,” the notice said.
The regulator asked the drug controllers of the states and Union Territories to hand over all NOCs issued from August 2, 2018, to May 14, 2024, to the respective zonal offices of the CDSCO.
The move comes in the backdrop of multiple incidents where drugs and cough syrups manufactured in India have allegedly been found to be contaminated. Cough syrups imported by The Gambia were allegedly found to be contaminated with diethylene glycol (DEG) and ethylene glycol (EG), resulting in cases of acute kidney injury among kids.
An investigation led by the United States Centers for Disease Control and Prevention (CDC) and Gambian scientists in March “strongly suggested” that medications contaminated with DEG or EG imported into the country led to the cases among children. “A large cluster of acute kidney injury cases affecting children in The Gambia in 2022 was associated with case fatality rates of more than 80%,” it said.On October 5, 2022, the WHO announced that the deaths of dozens of children The Gambia from acute kidney injuries might be linked to contaminated cough and cold syrups made by an Indian drug manufacturer, Maiden Pharmaceuticals.
