CDSCO issues Revised Export NOC Guidance document for Manufacture of Unapproved, Approved New Drugs

New Delhi: Through a recent notice, the Central Drugs Standard Control Organisation (CDSCO) has issued revised guidance documents for the issuance of no objection certificates for the manufacture of unapproved/approved new drugs for export purposes.

This document was made as per guidelines issued by the Ministry of Health and Family Welfare for export purposes and Rule 94 of the Drugs and Cosmetics Act, 1940.

This document is applicable for the manufacturer to obtain a No Objection Certificate for unapproved/approved new drugs from zonal offices of the Central Drugs Standard Control Organisation (CDSCO) for export purposes.

A manufacturer holding a valid license copy in Form -25/ Form-28/ Form 28 D and their respective loan licenses can obtain a No Objection Certificate from zonal offices of the Central Drugs Standard Control Organization (CDSCO) for export purposes only for unapproved/approved new drugs in India.

The requirement of online submission of an application for issuance of a No Objection Certificate for manufacture for export of unapproved/approved new drugs involves 2 steps, i.e., registration at the zonal office followed by procedure for release of consignments at port.

This procedure is applicable to unapproved drugs and approved new drugs, except for NDPS (narcotic drugs and psychotropic substances) and banned drugs.

Accordingly, an applicant is required to first apply to the concerned zonal office with all the requisite documents for the issuance of an Export NOC having 1-year validity/exhaustion of the sanctioned amount, whichever is earlier.

Thereafter, the applicant needs to fill out the reconciliation details in the prescribed format, along with the requisite documents, and obtain clearance for the consignments from the concerned port office for its release in Step II."

Step-I

One-time online registration process with zonal office: An applicant is required to fill online Integrated Registration Form (IRF) one time before the grant of the Export NOC, which is valid for 1 year. IRF needs to be verified by the concerned zonal office, and NOC may be issued with 1 year validity for the applied products within 7 working days from the date of application.

For the same, the applicant is required to submit documents as a part of the IRF with the following documents:

1. Export NOC Form /Integrated Registration form (IRF): This is an automatically generated form that requires the applicant to submit relevant details when filing an online application.

2. Legal Undertaking in Annexure -I /II: The Applicant shall submit legal undertaking in the prescribed format from the manufacturer of API as Annexure -I and from Formulation Manufacturer as Annexure -II digitally signed by the Applicant (attached at the End of the page)

3. Copy of Manufacturing License: A valid license issued by the State Licensing Authority in Form 25/Form 28/Form 28-D and their respective loan license shall be enclosed along with each application for the required location to manufacture the drug for export purposes. In case of issuance of a subsequent Export NOC after the first one, the firm is required to submit a quantityspecific export license as issued by the concerned SLA for the specific product, being applied for.

4. Reconciliation Data: The applicant is required to submit a history of reconciliation data of previously issued NOC in the online module in the following format.

5. NRA Approval Status of Importing Country: The applicant needs to submit a document of the applied drugs as issued by the NRA of the importing country.

In case NRA approval of the importing country is not available, the following documents may be submitted.

a) Active Pharmaceutical Ingredient (API):

 Approved New Drugs in India: The Approval status as issued by CDSCO may be submitted.

 Unapproved API’s in India: The API / Bulk drug’s Pharmacopeial status in IP/USP/BP/JP/EP may be submitted.

Further, if formulation of the said API is approved in any SRA country (United states/ European Union Member States/ Canada/ Japan/Australia/Switzerland) & (or) Importingcountry & (or) India may be submitted.

 Unapproved API of NDPS category in India & Banned API in India: NRA approval of the importing country is mandatory to submit.

b) Finished Formulation (FF):

 Approved New Drugs in India: In case of Approved New Drugs (FF) approval status as issued by CDSCO may be submitted.

 Unapproved Formulation in India: Approval status in SRA Country (United States/European Union Member States/ Canada/ Japan/Australia/Switzerland)/Importing country may be submitted.

 Unapproved (fixed dose combination) FDC in India, Unapproved NDPS Drugs in India & Banned Drugs in India: NRA approval of the importing country is mandatory to submit.

c) R & D Batches:

 API: The API / Bulk drug’s Pharmacopeial status in IP/USP/BP/JP/EP may be submitted.

Further, if formulation of the said API is approved in SRA country (United States/ European Union Member States/ Canada/ Japan/Australia/Switzerland) &(or) Importing country &(or) India may be submitted.

 Formulation: Approval status of any SRA Country (United States/ European Union Member States/ Canada/ Japan/Australia/Switzerland) and importing country may be submitted.

d) NCE Batches:

 NCE –Batches for Clinical trials, DMF/ANDA filings: The firm is required to submit IUPAC name details, COA & STP.

In case of third country exports all the above requirements are applicable to destination country/end use country

In case the pharmaceutical product (API or formulation) has been registered and approved by the National Regulatory Authority (NRA) of the destination country for a specific firm, such approval may be considered applicable for other applicants.

Step-II

Procedure for release of consignment at port office: In this step, after getting a valid export NOC from the zonal office, the applicant is required to submit the following details at the time of release of the consignment, which will be verified by the concerned port office.

During this step, an applicant is required to submit documents in online mode and requires submission of the following documents at the time of export:

1. Valid Export NOC: The applicant must select the EXPORT NOC for the intended export through the Auto Fetch system.

2. Reconciliation details for the quantity exported: Reconciliation data for each export at the time of release needs to be filled out by the applicant in the given online format and the same needs to be verified by the concerned port office. The reconciliation module will be open throughout the validity of the NOC for a repetitive release of consignment.

3. Test/Batch Release Certificate: The firm is required to upload a physical document of the COA (Certificate of Analysis).

4. Purchase order(PO) / Export Invoice (EI) / Shipping Bill (SB) details: The details of the PO/EI/SB number date/customer name, country and quantity are to be filled in the given format and the same needs to be verified by the concerned port office.

5. Label: The firm is required to submit the original label for the applied product.

6. Export License copy from SLA: The firm is required to submit an export license copy issued by SLA for the applied product.

Furthermore, the notice added,

1. Qty specific/PO Specific NOC is being discontinued except for NDPS And Banned drugs.

2. Issuance of Export NOC with 1-year validity from date of registration or exhaustion of the sanctioned amount, whichever is earlier.

3. In case of formulation, allowance of usage of un-exported quantity for next export order within 60 % residual shelf life. If the shelf life is below 60%, the same shall be destructed in the presence of the State Licensing Authority.

4. In case of API, allowance of usage of un-exported quantity for next export order within 3 months of residual shelf life. If the shelf life is below 3 months, the same shall be destructed in the presence of the State Licensing Authority.

5. Timeline of 7 days for Issuance of NOC (step – I - 5 working days & step – II - 2 working days).

6. "For the issuance of an export NOC for NDPS drugs and banned drugs, a quantity-specific and PO-specific NOC will be issued for each order/consignment.

To view the official notice, click the link below: