Government introduces new regulations for imported medicines

In order to prevent the sales of unapproved or illegal medicines in Indian market, import registration and license have been made mandatory by The Central Drugs Standard Control Organization. On April 8, the apex drug regulatory agency of India said, “for import of drug into India, import registration and license are required to be obtained from CDSCO as per Drugs and Cosmetics Act and Rules made there under.”The circular signed by Rajeev Singh Raghuvanshi, drug controller general of India (DCGI) says, "In order to streamline the procedure for transfer of drugs manufactured in Special Economic Zone (SEZ) to domestic tariff area (DTA) for sale and distribution, the matter was examined and it has been decided that the following procedure should be followed for the transfer to DTA to ensure the drugs meet quality, safety and efficacy."

The rule says, "The Banned drugs manufactured at Special Economic Zone for export purpose are not allowed for transfer to Domestic Tariff Area for any purpose."

It also added that, "In case of unapproved and approved new drugs manufactured in SEZ, the requirements specified for manufacturing of new drugs under NDCT Rules 2019 and Drug Rules 1945 are required to be complied with."

In a scenario where, an active pharmaceutical ingredients (API) is being imported to SEZ for production of its formulation and the formulation is sought to be diverted to DTA for sale and distribution, Registration Certificate & Import License are needed for that API, the circular states regarding the new rule. API/semi-finished/ finished dosage forms in bulk packs imported without Import License and Registration Certificate will not be allowed for distribution and sale to the domestic market.