For manufacturer of unapproved or approved new drug or prohibited drugs for export, ‘NOC’ is granted by the CDSCO on case-by-case basis against valid export order. The office has examined along with the Ministry of Health and Family Welfare on the issue of manufacture of such drug for export by the manufacturer of drug formulation after obtaining the Active Pharmaceutical Ingredient (API) from other bulk drug manufacturers in our country.
It has been decided that along with the NOC to the formulation manufacturer or export of its drug formulation, a NOC to the API manufacturer of the said bulk drug required for the manufacture of formulation my also be granted to the API manufacturer or manufacturing the specific quantity of API for the sole supply to the formulator.
Note: Both the manufacturers of such API/Bulk Drugs and the manufacturers of the formulations who would use such Bulk Drugs would be required to furnish legal undertakings in this regard. In the event of non-materialization of export for some reason, the same would be intimated to the State licensing Authorities concerned and the manufacturers shall ensure physical destruction of such drugs in the presence of State Licensing Authorities.
The list of the documents that are mandatory to be submitted in the following manner and the order for the issue of the No Objection Certificate for Export of Drugs from India:
The order received from foreign buyer either in the name of the manufacturer or in the name of the trader mentioning list of products to be exported clearly indicating name of the drug, dosage form, composition and strength pack size duly signed by the competent authority with specific destination point of the importing country.
The document must be signed by the competent authority /person with a valid purchase order number and recent date being not more than 6 months prior to the application made by the firm.
The license, which is issued by the State Licensing Authority, must be enclosed along with each application for the required location to manufacture the drug for export purpose.
A copy of a Performa Invoice from the importing country should accompany with the application or import of unapproved Active Pharmaceutical Ingredients, used in the drug formulation.
A copy of Performa invoice duly signed by the competent authority should be addressed to the manufacturer mentioning the required quantity of the bulk drug.
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