What is the CDSCO Dual Use NOC?
The drugs that are used for dual purposes are the ones that are used for pharmaceutical uses as well as raw materials in other industries. Such drugs which serve the ‘dual’ purpose need the permission of the CDSCO’s zonal offices. Certain drugs are specified in Schedule D and shall be exempted from the provisions of Chapter III of the Act. Some of the drugs mentioned in the schedule have purposes in the textile, food and chemical industry or are used as part of synthesising other drugs. For this, No-Objection Certificate is required for the import of drugs from the Deputy Drugs Controller of the respective zonal office.
What is CDSCO?
CDSCO – Central Drugs Standard Control Organisation is the National Authority for Drugs in the country. It is an entity that deals with the import and distribution of drugs that fall under the ambit of the Drugs and Cosmetics Act 1940. CDSCO has about six zonal offices, four sub-zonal offices, 13 port offices and seven laboratories in the country. It is the responsibility of the CDSCO to conduct clinical trials, authorise drugs and conduct clinical trials.
Purpose of CDSCO Dual Use NOC
All the drugs in the schedule are not used for pharmaceutical purposes instead, they are used in different industries such as the textile industry, chemical industry and food industry. In some cases, they are used in the manufacturing of other drugs. For this type of drug, Dual-use NOC is mandatory for the import of the drugs.
When drugs are imported to fulfil alternative purposes, the manufacturers need to obtain the Dual-Use NOC from the Deputy Drugs Controller of India. This NOC is granted to the importer upon successfully submitting the application and fulfilling all the legal requirements.
Due diligence to be completed for CDSCO Dual Use NOC
There is certain due diligence that an importer needs to do before applying for a CDSCO Dual use NOC:
- The drugs that are required to be imported must be registered.
- The drugs being imported must be approved by the Drug department of the country. This is applicable both for single drugs and a combination of drugs.
- The importer must check the international status of the drug he needs. For example, the multi-vitamin does not fall under the category of ‘drugs”; hence stringent laws are not imposed on their exports and imports.
Documents required for CDSCO Dual Use NOC
The following documents are required for CDSCO Dual Use NOC:
- Covering letter
- Documents related to the import of packages; this shall include invoice, entry, purchase order, sales contract and import certificate
- Copy of High Seas Sale Agreement (if any)
- The importer needs to have an undertaking duly made on a stamp paper of value of Rs.100 with the following :
- As per 3.1 of Annexure-1, if the importation of drugs by actual user
- As per 3.2 of Annexure-2, in case the trader imports the drugs.
- If CDSCO has already registered the drug, then details regarding it should be enclosed.
- A declaration is to be made by the importer that the drug shall not be used for any pharmaceutical purposes.
- Supplementary documents is to be attached that shall state the purpose of dual use, the respective department should grant permission before the use. This can be:
- Drugs to be used as a supplement for animal feed
- Drugs that are to be utilised as a food supplement for humans
- If the drug is utilised for the synthesis of some other drugs, then a detailed document explaining the process of production must be attached.
- Drugs for cosmetic use
- In any other manner, the drug is being used apart from the medical/ pharmaceutical industry
Process for to obtaining CDSCO Dual Use NOC
- The applicant must log in to the CDSCO Sugam portal.
- Next, the applicant must sign up at the portal and create a login id.
- If the applicant does not hold a Drugs or cosmetic license under the Drugs and Cosmetic Act rules as a corporate, importer, Indian agent, manufacturing, cosmetic. He may log in with the Id and password and submit the application with the respective segment.
- Once the applicant has logged into the SUGAM, the applicant must head on to the Sugam portal to select the purpose of registration.
- The applicant needs to fill in the details carefully and upload the documents mentioned on the form (NMT 10 MB) and click on submit.
- The portal shall generate an OTP that will be sent to the registered mobile number and email id for verification purposes. The user and the password shall be activated for the application.
- Once logged in, the user dashboard shall appear. Click on the submit application tab.
- Choose the department, head over to the NOC- zone now and mark the Dual Use NOC and then click on proceed.
- Next, fill in the details carefully, cross-check and verify the details under the preview tab. Make any corrections if required by clicking on the edit form button.
- If no corrections are required then click on proceed to a checklist.
- The applicant needs to upload a scanned copy of all the documents as mentioned before, and place a digital signature on it.
- A unique application number shall be generated that should be used by the applicant if any communication is to be carried out.
- The application process shall be completed, and in case the applicant faces any technical glitch, he may reach out to the IT help desk in the portal itself.
CDSCO is responsible for the import and use of drugs in India. It has a CDSCO Dual Use NOC certificate that is required by the Importers who wish to import drugs for purposes other than that of medical use. to obtain this certificate, the importer has to get himself registered under the CDSCO’s SUGAM Portal. The process can be completed online. The importer must ensure that the drug is not utilised for any medical or pharmaceutical purpose.
Read our Article:What is FORM-42 and FORM-43