To Stop Entry Of Illegal Drugs In India, Govt Brings New Rules For Imported Medicines
According to the Drugs Rules 1945, companies located in Special Economic Zones (SEZs) don’t need to follow the usual import rules if they are importing drugs only to make products and export them outside India.
To prevent the sales or entry of unapproved or illegal drugs in the Indian market, the Narendra Modi government has decided to bring new rules for the sales and distribution of imported drugs. The apex drug regulatory agency of India, Central Drugs Standard Control Organization (CDSCO), has made “import registration and license" mandatory.
“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…," said the circular issued by Rajeev Singh Raghuvanshi, drug controller general of India (DCGI).
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A Domestic Tariff Area (DTA) refers to the part of a country that is outside special economic zones (SEZs) or export processing zones (EPZs) where normal customs duties and trade regulations apply.
It includes the mainland or internal part of the country where businesses operate under regular tax and trade laws.
According to the circular dated April 8, seen by News18, CDSCO has now formulated a procedure which will be followed for the transfer to normal domestic market “to ensure that the drugs meet quality, safety and efficacy
requirements."
Current Rules
According to the Drugs Rules 1945, companies located in Special Economic Zones (SEZs) don’t need to follow the usual import rules if they are importing drugs only to make products and export them outside India.
But there’s one important condition. These imported drugs must not be sold or used within India. They can only be used for making medicines that will be exported to other countries.
However, if imported drugs are permitted for sale and distribution in the Indian market, new rules have been formulated.
New rules
First rule clearly says that banned drugs made for export cannot be sold in India.
Secondly, in case of unapproved and approved new drugs manufactured in SEZ, the requirements specified for manufacturing of new drugs will be followed. Also, in case, an active pharmaceutical ingredients (API) is imported to SEZ for manufacturing of its formulation and the formulation is proposed to be diverted to Indian market for sale and distribution “a registration certificate and import license are required for that API."
Also, the API or semi-finished or finished dosage forms in bulk packs imported without registration certificate and import license will not be permitted for sale and distribution to the domestic market.
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