Export NOC, Special Code/Neutral Code For NOC

Export NOC, Special Code/Neutral Code For NOC

 

EXPORT NOC

Under the Drug and Cosmetics Act, the regulation of manufacture, sale and distribution of drugs is primarily the concern of the State authorities while the Central Authorities are responsible for approval of New Drugs, Clinical Trials in the country, laying down the standards for drugs, control over the quality of imported drugs, coordination of the activities of State Drug Control Organisations and providing expert advice with a view to bring about the uniformity in the enforcement of the Drugs and Cosmetics Act.

A manufacturer holding valid license copy as per the Form-25 and Form-28 can obtain No Objection Certificate from Zonal/Sub Zonal offices of Central Drugs Standard Control Organisation (CDSCO) for export purpose only for approved / unapproved new drug / banned drug in India.

The guidelines are issued by Ministry of Health and Family Welfare for Export purpose and Rule 94 of the Drugs and Cosmetic Act, 1940.

The application for Export NOC is filled as per checklist issued by the CDSCO.

The Following documents are required to be submitted in the following manner and order for issue of the No Objection Certificate for export of drugs from India

  • Covering Letter
  • Purchase Order
  • Manufacturing License
  • Performa Invoice
  • Registration Certificate (Applicable for banned drug)

There are set rules related to export of drugs from India and set guidelines for the export of drug issued by Ministry of Health and Family Welfare which the manufacturer has to comply to.

SPECIAL CODE/NEUTRAL CODE FOR NOC

Special Code and Neutral code are synonyms. Both are approved by CDSCO, when a manufacturer does not want to reflect name & address on the label. For export of finished formulation and bulk drugs, the manufacturer fill an application to get a special code for the finished formulation or bulk drugs with the required documents.

Special code is given by the manufacturer who is approved by the regulatory authority in the application to CDSCO.

Following documents required for the application for grant of permission to the use of Special Code for Export of Finished Formulation/Bulk Drug.

  • Application for Export NOC on company’s letter head duly signed.
  • Valid export order on the foreign buyer’s letter head clearly mentioning Quantity and Name of the drug to be exported.
  • A letter from foreign buyer on his letter head mentioning the specific requirement of special code number.
  • A copy of valid Manufacturing License issued by State Licensing Authority A copy of Product Permission for specific product or No Objection Certificate for export issued by this office for specific product Prototype Packing material including Labels, Cartons, leaflets, Blister foil etc. mentioning the specific code.
  • In the case of the export of banned drugs valid registration certificate from the Ministry of Health of the importing country is to be provided

 

References

  1. Guidance document on common submission format for issuance of no objection certificate for export of unapproved/approved new drugs/banned drugs. Central drugs standard control organisation, directorate general of health services, Ministry of Health and Family Welfare Government of India. Available at- http://www.cdsco.nic.in/writereaddata/guidane_documents_export_noc.pdf. Accessed on: 17th March 2016.
  2. Checklist for the application for grant of permission to the use of Special Code for Export of Finished Formulation/Bulk Drug. Available at- http://cdsco.nic.in/writereaddata/prescreening%20special%20export.pdf. Accessed on: 17th March 2016

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