Dual-Use NOC

Out of many substances that are defined as drugs, there are many that we do not use for medicinal purposes. In some industries, the manufacturers use these drugs to produce chemicals, textiles, food or packaging. But they are unable to use them because of the restrictions applied by various drug rules and regulations. This can be because of the type of drug, the risks involved thereto, and the harmful nature of the drug or the amount of drug that is required by the manufacturing process. To resolve this issue, there is a provision for getting a Dual Use NOC from CDSCO Zonal office. It is provided by the Assistant Drug Controller online through the CDSCO Portal.

Dual use means the use of a drug for a purpose other than conventional medical use. In food, we use chemicals like preservatives to keep the food edible for a longer period. Other substances are used in the textile industry for cleaning clothes, dyeing and processing the fabric. Some of these substances are also covered under the definition of drugs. To produce chemicals, we use other chemicals that may be a drug according to the definition. In all these cases the manufacturer needs to obtain the Dual Use NOC from ADC to continue operating his manufacturing plant.

Dual Use NOC From CDSCO

This No-Objection Certificate allows the manufacturers to use some specified drugs for their respective work as needed by the manufacturing process. It gives written permission to use such drugs and bypass the restrictions imposed by other medical regulations. In this manner, industries run seamlessly and at the same time the Central Drugs Standard Control Organization (CDSCO) also gets the record which helps in monitoring and it can oversee these industries for any violation.

Who needs to get Dual Use NOC?

Any manufacturer or other business entity that has no connection with the pharmaceutical industry but they need to use medical drugs in their business for some other purpose then they should obtain the Dual Use NOC Registration. It can be a textile company, chemical industry or food company other business where there is such a requirement. Two factors need to be considered when deciding on the requirement of Dual Use NOC. These two factors are as follows-

• The entity is not involved in the pharmaceutical business.
• The entity is using a drug in its business for any purpose other than medical.

Dual Use NOC provides various benefits to all the involved stakeholders including the government, drug authorities, and the applicant manufacturers. These benefits are as follows-

• Benefits for the Issuer

The government has delegated the power to CDSCO to monitor and regulate drug standards in the country. The Central Drugs Standard Control Organization further divided the powers into its six zones across the country for better implementation of the drug rules. Assistant Drug Controller issues these Dual Use NOC Certificate from the zonal office of CDSCO. The government and these regulating authorities keep track of all the industries where such medical drugs are being used. And at the same time, the unauthorized and illegal use of these medical drugs is controlled.

• Benefits for the Applicant

The applicant manufacturers, industries and corporates get permission to use the drugs they need for their industrial processes. It allows them to import bulk amounts of these drugs when the restrictive laws are still in force. CDSCO Dual Use NOC differentiates between the purposes and allows the use of medicinal drugs for some specified business activities. It does not affect those who are in the pharmaceutical industry.

To apply for the grant of Dual Use NOC CDSCO, you need to prepare the following documents in advance and upload the soft copies of the same online when submitting the Dual Use NOC application. The list of these required documents is as follows-

• Covering Letter:- The covering letter provides a brief overview and explanation of the purpose of the application, as well as any additional supporting information or documents that are being submitted.
• Purchase Order/Bill of Entry/Invoice/Indent/Sales Contract:- A purchase order is a document that a buyer sends to a seller when they want to buy something. It's like a contract between the buyer and seller, and it shows what the buyer wants to purchase. There can be a requirement for other similar documents from case to case instead of the purchase order.
• Certificate of Analysis of all the Batches Imported:- To ensure the quality of the products thus produced, it requires submitting the report of product analysis for all the batches.
• Copy of Highseas Sales Agreement:- A high seas sales agreement is a special contract for buying and selling things while they are being shipped on the ocean. It's a legal agreement between people or companies involved in international trade. It requires only when a multinational deal is involved.
• Legal Undertaking:- A legal undertaking refers to a commitment made by the applicant to fulfil certain legal obligations involved with the issuance of Dual Use NOC CDSCO. It should be drafted on Rs. 100 Notarised Stamp Paper. There are different formats prescribed for the actual user and the trader.
• CDSCO Registration Details:- If the drug is imported and registration for the same is obtained from the Central Drugs Standard Control Organisation (CDSCO) then these registration details shall also be submitted along with the CDSCO Dual Use NOC Application.
• End-Use Declaration:- You need to provide the end-user declaration. In this declaration, you should write how you going to use the drug so acquired.
• Manufacturing Process or Flowchart:- If you will use the drug to convert into any other drug then such conversion process should be submitted in the form of a flow chart.
• Permission:- If there is involvement of other departments then you also need to take the permissions and NOCs from them too and submit them along with the application for Dual Use NOC.
• Justification for Dual Use:- In this document you need to justify the use of the drug. You should include the necessity and lack of alternatives to convince CDSCO officials for the grant of CDSCO Dual Use NOC.
• Reconciliation Data of Previous Usage:- If you have previously acquired the same drug, you also need to provide information about that. You need to enter the reconciliation data of the quantities previously issued by the ADC and used by your business.

The application process for Dual Use NOC is online and can be completed through the CDSCO portal which is also known as SUGAM Portal. The applicant needs to go through the following steps to apply for the grant of Dual Use NOC-

Sugam Portal for Dual Use NOC

• Go to the CDSCO Portal using this link https://cdscoonline.gov.in/ through any web browser.
• If you have previously used the portal then login with the same credential or if you are using it for the first time then choose the option to sign up.
• After you are logged in, you will see a dashboard. On this dashboard choose the option to start the application.
• When you sign up, you need to choose the purpose of registration from a dropdown menu. Choose the Dual Use NOC in this menu.
• On the next screen, the registration form will appear, fill in all the necessary details and submit.
• It will verify your identity using the provided email address and mobile number. Enter the OTP received on this page and complete the verification.

Application for CDSCO Dual Use NOC

• After successful registration and login, you can move forward to submit the application for Dual Use NOC. Click on the ‘Submit Application’ tab.
• On the next screen, choose the applicable zone for your location and tick the option of Dual Use NOC.
• Now you will see a three-step process for the submission of this application.
• The first step is to fill out a form where you need to enter details regarding your business and the drug you are applying for etc. Fill in all the details carefully.
• In the second step, you can preview all the submitted details. Check the mentioned details carefully at this stage as the edit option may not be available later.
• If any information is wrongly entered then edit it by going back and come back to the next step of previewing.
• After the final check, submit the form which will take you to the third step - the checklist.
• In this step, you need to check all the documents required and upload the same according to the given checklist.

Dual Use NOC CDSCO Application Submission and Review

• Once all the documents mentioned in the checklist are uploaded, you can submit the application. This will be the final submission and you will receive an application number which may be used later for reference.
• The Assistant Drug Controller will issue the Dual Use NOC Certificate if he is satisfied with your application and the documents submitted by you do not have any discrepancies.

The Dual NOC is provided by the Central Drugs Standard Control Organisation without any fee while they charge a minimal amount for other No-Objection Certificates. Unlike other NOCs, you do not need to go through the Sugam Online Payment System. Also in the process of application submission, you do not get any step to upload the payment challan.

Validity of Dual Use NOC CDSCO

The CDSCO provides Dual Use NOC for only one year. After the expiry of this time period, you need to renew the NOC or apply for the issuance of a new NOC. To continue using the medical drug in the manufacturing process and operating your plant, you must have a CDSCO Dual Use NOC at all times hence the renewal is necessary after the validity of the NOC.

The CDSCO provides Dual Use NOC for only one year. After the expiry of this time period, you need to renew the NOC or apply for the issuance of a new NOC. To continue using the medical drug in the manufacturing process and operating your plant, you must have a CDSCO Dual Use NOC at all times hence the renewal is necessary after the validity of the NOC.