Gambiaj.com – (NEW DELHI) – India’s drug regulator, the Central Drugs Standards Control Organisation (CDSCO), has revoked the authority of state licensing authorities to issue no objection certificates (NOC) for the export of unapproved, banned, or new drugs. This decision follows reports of substandard Indian drugs causing health issues in several countries.
This regulatory change comes in response to instances where drugs and cough syrups manufactured in India were reportedly found to be contaminated.
Two years ago, cough syrups imported by The Gambia were allegedly contaminated with diethylene glycol (DEG) and ethylene glycol (EG), leading to cases of acute kidney injury among children.
Starting from May 15, the pharmaceutical industry will need to reapply for NOCs through zonal offices using online platforms, as per a notice issued by the CDSCO.
The notice specified that fresh applications are required for the manufacture of unapproved, approved new drugs, and banned drugs intended 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 “Accordingly, power delegated to state/UT licensing authority stands withdrawn w.e.f. May 15, 2024, and such NOCs shall be granted by the head of CDSCO zonal office,” the notice stated.
State and Union Territory drug controllers have been instructed to transfer all NOCs issued between August 2, 2018, and May 14, 2024, to the respective zonal offices of the CDSCO.
The results in March of an investigation by the United States Centers for Disease Control and Prevention (CDC) and Gambian scientists “strongly suggested” that medications contaminated with DEG or EG imported into The Gambia caused the acute kidney injury cases among children. The investigation noted that a significant cluster of acute kidney injury cases in Gambian children in 2022 had a case fatality rate of over 80%.
On October 5, 2022, the World Health Organization (WHO) announced that the deaths of numerous children in The Gambia from acute kidney injuries might be linked to contaminated cough and cold syrups manufactured by an Indian pharmaceutical company, Maiden Pharmaceuticals.
