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According to the 1945 drug rules, companies located in Special Economic Zones (Sez) do not need to follow the usual import rules if they import medications only to manufacture products and export them outside India.
The first rule clearly says that prohibited medications made for export cannot be sold in India.
To avoid sales or entry of non -approved or illegal drugs in the Indian market, the Narendra Modi government has decided to bring new rules for imported drug sales and distribution. The Apex Medicines Regulatory Agency of India, the Central Medicines Standard Control Organization (CDSCO), has mandatory the “Import Registration and License”.
“To rationalize the procedure for the transfer of medicines manufactured in the Special Economic Zone (Sez) to the area of National Tariffs (DTA) for the sale and distribution, the matter was examined …”, said the circular issued by Rajeev Singh Raghuvanshi, general drug controller of India (DCGI).
A domestic tariff (DTA) area refers to the part of a country that is special economic zones of Outsid (Sez) or export processing areas (EPZ) where normal customs tasks and Apple trade regulations.
It includes the continental or internal part of the country where companies operate under regular tax and commercial laws.
According to the circular dated April 8, seen by News18, CDSCO has now formulated a procedure that will be followed for the transfer to the normal domestic market “to ensure that medicines comply with quality, safety and efficiency
Requirements. “
Current rules
According to the 1945 drug rules, companies located in Special Economic Zones (Sez) do not need to follow the usual import rules if they import medications only to manufacture products and export them outside India.
But there is an import condition. These imported medications should not be sold or used within India. They can only be used to make medications that will be exported to other countries.
However, if imported medications are allowed for sale and distribution in the Indian market, the new rules have been formulated bone.
New rules
The first rule clearly says that prohibited medications made for export cannot be sold in India.
Secondly, in the case of new medications not approved and approved manufactured in Sez, the specific requirements for the manufacture of new medications will be followed. In addition, in the case, an active pharmaceutical ingredients (API) are imported to Sez for the manufacture of its formulation and it is proposed that the formulation deviates to the Indian market for the sale and distribution “a registration certificate and an import license are required to depend.”
In addition, the API or the semi-finished dosage forms or finished in imported bulk packages without registration certificate and import license are not allowed for sale and distribution to the domestic market.