 "CDSCO brings new rules for drugs transfer from SEZ units to domestic mkt")
To prevent the sale and distribution of illegal and unapproved drugs and formulations in India, the Central Drug Standard Control Organisation (CDSCO) has issued new rules mandating import registration and licence for drugs meant to be transferred from special economic zones (SEZ) into domestic tariff areas (DTA).
Under the current provisions, units located in the SEZ are exempt from mandatory import registrations required for importing a drug into the country, subject to the condition that these drugs shall not be diverted for sale within the country and must be used solely for export purposes.
In a circular dated April 8, the CDSCO mandated a new procedure in order to streamline the transfer of drugs manufactured in SEZ to DTA for sale and distribution to ensure that the drugs meet quality, safety and efficacy requirements.
According to the new rules, for Active Pharmaceutical Ingredients (APIs) imported into SEZs for the purpose of manufacturing formulations that are subsequently proposed to be diverted to the DTA for sale and distribution, a registration certificate and import licence from the regulator are mandatory.
“In the case of both unapproved and approved new drugs manufactured in SEZs, the manufacturers must comply with the requirements specified under the NDCT Rules, 2019, and the Drugs and Cosmetics Rules, 1945,” the circular added.
The new guidelines also state that banned drugs manufactured at SEZs for export purposes are not permitted to be transferred to the DTA for any reason.
The apex drug regulatory body has directed all its port, zonal, and sub-zonal offices to review the documents submitted on the ICEGATE portal for the clearance of drugs intended for sale in India.
Additionally, officials have been instructed to maintain data on bills of entry, and ensure that the details of such bills are communicated to the DCGI as and when required.