An overview of Dual-Use NOC

The simple definition of dual-use is drugs that can be utilised in the field of pharmaceuticals as well as in other areas of industries such as the textile industry, chemical industry, food and packaging industry, etc. For the purpose of importing drugs and for the dual usage of those drugs which can be used as a source of raw material for the purpose of fabrication of other drugs, it is mandatory to obtain permission from CDSCO Zonal Office.

Brief on CDSCO

CDSCO stands for Central Drugs Standard Control Organization which is a governmental National Drug Authority that is dedicated towards the distribution and handling of organisationson behalf of the Central Government that falls under the Drugs and Cosmetics Act, 1940 and Rules, 1945. This organisation has six Zonal Offices, which have four Sub Zonal Offices, which further has thirteen Port Offices and Seven Laboratories, all under CDSCO’s control. The essential responsibility of CDSCO is regulation over the importation of various drugs, authorisationof new drugs, clinical trials, conduct meetings for DCC, which stands for Drugs Consultative Committee and DTAB, which stands for Drugs Technical Advisory Board and over various licencing authentication by enacting as a Central License Approving Authority.

Why is Dual-Use NOC needed?

There are quite a number of drugs available in the market that are not used in pharmaceuticals but instead used in manufacturing industries such as the textile industry, chemical industry, food and packaging industry, etc. or used as a source of raw material for the purpose of fabrication of other drugs. For such drugs that are to be used for the purpose of Dual-Use and for the importation of drugs, NOC, which stands for No Objection Certificate, is mandatory.

Dual-Use NOC is required usually by the producers for the usage of drugs in bulk quantity. NOC for the purpose of Dual-Use, which is not to be used for medical purposes, shall be issued by the Deputy Drugs Controller, India,for the importers upon submission of the application and completing the required legal undertakings. The importer is then required to administer the provided NOC to either Assistant Drugs Controller – I or the Technical Officer present at the required port office for the clearance of such goods. The list of drugs mentioned in Schedule D from Chapter III of the Drugs and Cosmetics Act, 1940 and Rules, 1945 is an exemption in accordance with the conditions specified in the schedule. Although, the authorisation of NOC solely relies upon the Deputy drugs Controller, India, from any of the required Zonal Office.

Required List of documents for Dual-Use NOC Application

Required List of documents is needed for the Dual-Use NOC Application process –

• Covering Letter.
• Bills of either Invoice or Entry or Indent or Purchase Order or Sales Contract along with Analysis Certification of all importing packages.
• Copy of High Seas Sales Agreement, if any.
• Legal Undertakings with attached Rs. 100 stamp paper with mandatory notarization that is to be followed –

  - according to 3.1 of Annexure – I, in case of importation of drugs by the Actual User,

  - according to 3.2 of Annexure-II in case of importation of drugs by the Trader.

• If the drugs being imported are already registered with CDSCO, then information regarding the details shall also be enclosed.
• Declaration is required regarding the drugs will not be used for pharmaceutical or any other medical purpose.
• Submission of required documents, i.e., permission for the respective departments of the following situations mentioned below that shall justify the purpose of Dual Use –

  - Supplement for animal feeding,

  - As food supplements,

  - the purpose of fabrication of drugs from one drug to another along with the structural outline of the production process,

  - For the purpose of Cosmetic Use,

  - In any other industry except the pharmaceutical industry ormedical industry.

• Detailed information onthe previously permitted quantity of drugs.

Due Diligence

The producers that require Dual-Use NOC are required to perform a Due Diligence before submitting the application for importation of required drugs.

• The below-mentioned points are necessary for successful due diligence –

  - The drugs required for importation have to be already registered.

  - The drugs to be imported have to be approvedvia the laws of the country, whether it’s a single drug or a combination of multiple drugs.

  - Check-up on the international status of the drugs. For example, multi-vitamins are not recognised as drugs hence the laws applicable to their import and export are different.

  - Technical Survey by Martindale Extra Pharmacopeia, etc.

Necessary Facts for Filling of NOC for Dual-Use

The below-mentioned information is essential regarding the Dual-Use NOC procedure

• Before submission of the application, the applicant needs to make sure that the application is complete with no errors.
• The clearance needed for dual-use is advisable to be made by the manufacturer or the agent authorized before the technical review stage for the consideration process before the beginning of the import process to avoid penalisation, preferably before two months of applying.
• The required documents, such as bills, invoices, etc., should clearly state the purpose of the intention of usage.
• Master Formula Record has to be attested duly by Licensing Authority which is mandatory for the purpose of import application.
• Importation of other drugs required for purifying or sterilising of drugs being imported shall not be considered under Dual-Use NOC.
• The permission for importing drugs by the Actual User is limited to one year.
• In the event that an application is made to the Port Official, it will be forwarded with comments to the Zonal head of CDSCO for review and consideration, ideally via email/fax.The NOC from Zonal Head through email/fax will be adequate for discharge.
• The Zonal Officer maintains all required information in such cases.