Introduction: Manufacturers of Unapproved or Approved New Drugs or Prohibited Drugs for Export

For manufacturers of unapproved or approved new drugs or prohibited drugs for export, ‘NOC’ is granted by the CDSCO on a 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 the 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.

The following procedures for granting NOC to Manufacturers of such Bulk Drugs/API and Manufacturers of formulations or export are required to be followed while processing such applications:

The formulation manufacturer should apply for NOC to the CDSCO Zonal office along with the purchase order and quantity required;
The applicant will also be required to submit a legal undertaking in the prescribed format from a bulk API Manufacturer;
Based on the applications and the legal undertaking submitted by the applicant, a NOC would be issued in the prescribed format with copies marked to State Licensing Authority, Zonal Office, DDC, if the bulk drug's manufacturer is situated in other zones and port offices.
The manufacturing site/unit of the formulation manufacturer will be regularly checked by Drug Inspectors/ADC to verify that API and formulation of unapproved drugs are not diverted or sale in the country.

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 the 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:

Covering Letter:

It is an integral part of the application and should clearly specify the intent of the same.
The list of the relevant documents and other details that are to be submitted (Should be indexed with Page Numbers) must be delineated in the cover letter. The covering letter must indicate the names of the drugs, dosage form, composition and strength pack size along with quantity and country to be exported duly signed and stamped by the authorized signatory, indicating the name & designation of the authorized signatory along with the name and address of the firm. The manufacturer should make each application only.

Purchase Order:

The order received from a foreign buyer either in the name of the manufacturer or in the name of the trader mentions the list of products to be exported clearly indicating the 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.

Manufacturing License:

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 purposes.

Performa Invoice:

A copy of a Performa Invoice from the importing country should accompany the application or import of unapproved Active Pharmaceutical Ingredients, used in the drug formulation.
A copy of the Performa invoice duly signed by the competent authority should be addressed to the manufacturer mentioning the required quantity of the bulk drug.

Procedure for grant of NOC for the purpose of export where the bulk drug is required to be obtained from another manufacturer

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Shamshad Alam