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Overview of ADC NOC

In trade, if the export or import of any goods contains drugs or any related products, then such import or export is permitted with an ADC NOC. It is an approval given to manufacturers of such products authorised by Government Agencies of the manufacturing country. 

Many drugs are not manufactured globally, especially such drugs' right of manufacturing and marketing, which is with a single manufacturer. And these drugs or medicines are needed to be exported throughout the globe to cure people. And in India, the import of drugs is controlled and regulated by CDSCO.  

There is also a set of rules related to the export of drugs from India and set guidelines for the export of drugs issued by the Central Government's Ministry of Health and Family Welfare which all the Indian manufacturers must comply with.

The CDSCO provides authorisation of drugs and clinical trials and keeps a check on the standard and quality of imported drugs. It also coordinated with State Drug Organisation. This State Drug Organisation conducts the manufacturing, distribution, sale, lab testing, inspection and marketing of drugs. 

Legislation related to ADC NOC for import and export of Drugs

Following are the Acts or Rules that govern the manufacture, import, export, clinical trials, sale and aspects of drugs in India:

  • Drugs and Cosmetics Act 1940 with the Rules 1945 made thereunder
  • Narcotic and Psychotropics Substances Act 1985
  • Medicinal and Toilet Preparation Act 1956
  • Drugs and Magic Remedies Act 1994

Applicants who can obtain ADC NOC 

Applicants who can obtain NOC from the ADC are as follows:

  • Importers
  • Indian Agents
  • Foreign Enterprises holding Indian Subsidiary
  • Corporates
  • Exporters

Documents Required for ADC NOC

List of all required Documents for ADC NOC is as follows:

  • Covering Letter
  • Format of ADC sheet
  • Bond Declaration 
  • Manufacture's Letter Head
  • Quality Certificate
  • Analysis Certificate including batch code number and manufacturing and expiry date of product
  • Invoice Copy
  • Safety Statement
  • Certificate of Free Sales/FDA Report
  • Details of Manufacturer 
  • Purchase Order
  • Manufacturing License
  • Performa Invoice 
  • Registration Certificate from Ministry/NRA of importing Country (in case of banned drugs)
  • Export order on foreign buyer's letterhead with the quality and name of the drug to be exported
  • Special Code Number
  • Manufacturing License granted by State Licensing Authority, Product Permission for a specific product or No Objection Certificate (NOC) for export issued for specific product Prototype Packing material including Labels, Cartons, leaflets, Blister foil etc. with specific code.

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Procedure for ADC NOC

Step by Step procedures for obtaining ADC NOC are as follows:

  • Collecting Documents: 

All the required Documents are collected before filing the ADC NOC application.

  • Filling of Application: 

Application is filed along with the requisite fee. The Application is filed in the prescribed form with all the required Documents. 

  • Submission of Application:

The Application is submitted to the appropriate authority of CDSCO for the grant of ADC NOC.

  • Verification:

The appointed officer of the authority verifies the Application and the Documents, and after such verification, the officer approves the Application submitted along with all the Documents for ADC NOC.

  • Issue of ADC NOC:

After submission and verification of the submitted Application and all Documents, the appropriate authority (Assistant Drug Controller) issues the No Objection Certificate (NOC) to import or export drugs. 

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Frequently Asked Questions

CDSCO stands for the Central Drugs Standard Control Organisation, a statutory body under the Ministry of Health and Family Welfare.

The Central Drugs Standard Control Organisation (CDSCO) controls and regulates the whole trade of drugs, including their export and import.

A Special or Neutral Code is required by a manufacturer who does not want to mention its name and address on their product's label; such code is approved by Central Drugs Standard Control Organisation (CDSCO).

Dual use means that the same drug is utilised for two purposes; that is, it is used in pharmaceutical and industrial fields.

Dual Use NOC is granted for the import of drugs and items capable of dual use in pharmaceuticals and non-pharmaceutical industries. The permission is obtained from the Zonal Offices of CDSCO.

The validity period for an ADC granted No Objection Certificate is for one year.

The Drug Controller General of India (DCGI) with the CDSCO, under the Ministry of Health and Family Welfare, has the authority to approve Medical Devices in India.

Test License is granted for the purpose of test, examination or analysis of drugs in small quantities that are prohibited under Section 10 of Drugs and Cosmetics Act 1940 with the Rules 1945 made thereunder.

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