Assistant Drug Controller (ADC) NOC

India is among the biggest countries in the world for the manufacturing of pharmaceutical products. Not only manufacturing but India is also ranking high for pharmaceutical exports in recent years. The Covid pandemic shook the world economy but provided a boost to the pharmaceutical industry and it increased the pharmaceutical export of India by a huge margin. Such growth attracted new entrepreneurs to the pharmaceutical industry but for such establishment and operations, they need to comply with the rules as prescribed for the pharmaceutical manufacturers, importers and exporters.

The exporters and importers cannot perform any import or export without the permission of CDSCO (Central Drugs Standard Control Organization). It monitors and ensures that drug manufacturing companies and importers only deal in standardized safe drugs which further benefits the end consumer. Such standardization and monitoring are extremely necessary because in various circumstances a drug can be fatal to someone’s health. A drug should be safe and stakeholders in the health sector should administer it with due care and diligence.

ADC NOC Full Form

You need to obtain ADC NOC if you are manufacturing, exporting or importing a pharmaceutical drug. Here ADC stands for Assistant Drugs Controller of India and NOC is the abbreviation for No-Objection Certificate. Assistant Controller General acts under the subordination of the Deputy Controller General. CDSCO has divisions in six Zones situated in Ahmedabad, Chennai, Ghaziabad, Hyderabad, Kolkata and Mumbai. The Deputy Controller General administers these zonal offices. While the Drugs Controller General of India chairs the CDSCO on the central level.

NOC Given by Assistant Drugs Controller

The Assistant Drugs Controller provides a No-Objection Certificate to the manufacturers, exporters and importers. This NOC from ADC acts as permission granted to the applicant for exporting pharmaceutical drugs. As the ADC governs drug-related matters on behalf of CDSCO in their respective jurisdiction, you can not import or export pharmaceutical drugs without their nod. Apart from the Export NOC, the Assistant Drug Controller also provides a no-objection certificate for the dual use of drugs. In other words, the ADC provides the export license to a defined set of pharmaceutical products in the form of ADC NOC.

Who needs No-Objection Certificate from ADC?

The business entities involved in the import and export of medical drugs need to get this no-objection certificate from the Assistant Drugs Controller of respective zones. The following entities need to obtain NOC from ADC-

• Importers
• Exporters
• Trade Members
• Brokers
• Agents
• Manufacturers
• Enterprises
• Corporates

The Assistant Drugs Controller’s no-objection certificate gives a written nod to businesses to import or export pharmaceutical drugs from one country to another. It helps businesses in the following ways-

• It assists the custom clearance after the shipment arrives in the importing country.
• It assists in the shipping of the consignment from the exporting country.
• It mitigates any legal implications that you may have faced if attempted the import or expert without this non-objection certificate.
• It helps to prove the legality of your shipment.
• It allows you to reach out to new markets and generate profits by selling your pharmaceutical drugs manufactured in India.

You must have all the requisite documents available with you when applying for the ADC NOC online through the CDSCO portal. After applying for the Export NOC and submitting the given documents, the ADC NOC Registration gets completed. These documents are as follows-

• Covering Letter

The cover letter mentions the purpose of this export. It should justify the application and provides an overview.

Purchase Order

This is the order you receive from the importing country. You should export the drugs in consonance with the items mentioned in the purchase order only. This acts like evidence and proves that your shipment is legit and reasonable.

• Copy of Manufacturing License

A copy of the manufacturing licence shall be provided when applying for the grant of NOC by the Assistant Drugs Controller. It proves that the drugs are coming from a legit source and the manufacturer holds a valid manufacturing license.

• Performa Invoice

Performa Invoice is kind of a dummy invoice for the shipment. The shipment requires an invoice to pass through customs but the buyer does not execute the payment until he receives his goods. This is where the proforma invoice kicks in and takes the drugs from customs to the buyer and then he receives an actual invoice which he pays for.

• Registration Certificate

Whatever drug you are exporting, it should be first registered in the importing country if it contains any amount of a banned drug. Such registration certificates should also be provided when applying for ADC NOC Import.

• Previously Issued NOC

If you are regularly shipping your drugs internationally, you may have previous NOCs and the same should also be provided on the portal. It can help you by expediting the processing of your application.

• Application Form

Lastly, you need to upload the application form for NOC with all the requisite details filled in. The portal uses the term ‘Export NOC Form’ for this application.

To apply for the Assistant Drugs Controller (ADC) NOC online, you can follow the steps given below-

Log into the Portal

• First, log on to the CDSCO Portal using any browser to apply for the ADC NOC for export.
• On the homepage of this portal, you can either log in or sign up. If you have previously used this portal then log in with your credentials and if you are submitting an application on this portal for the first time then sign up by providing your basic details.
• After logging into the portal, click on the ‘switch role’ button and choose the appropriate role as per your need.
• You will find the ‘submit application’ button on the dashboard. Click on this link and it will start the form submission process.

Fill in the Details

• On the next screen, choose the respective zone and the form for your respective purpose. In the present case, we will choose the ‘Export NOC’ option. Then check the tick mark alongside the declaration and click on ‘Proceed’.
• On the next screen, you will need to enter the type of manufacturing, shipment and manufacturing license number from the drop-down menu. If the license number is not available in the drop-down list, you may need to enter it on your dashboard and then again start the application submission process.
• After entering the licence number, you should move forward to the next step and enter the drug details which is going for the export. On this page, you need to enter the details like drug name, brand name, class of drug, shelf life, quantity, export country, strength, composition etc.
• After saving one drug, you can add more drugs to the list one by one if you are exporting more than one drug in the shipment.
• After this step, the portal will generate an application that you need to download, sign and upload back to the portal as an Export NOC form.

Submitting the Application

• Before downloading the application, ensure that there are no mistakes as it won’t be possible to edit the details later. Now you can click on the ‘save and continue’ button. It will take you to the checklist section where you need to upload all required documents along with the downloaded and signed application.
• After uploading the documents, click on the ‘submit’ button and your application will be submitted. Note down the reference number provided to you at this stage which you may need later on.

Review of Application

• The Assistant Drugs General will scrutinise the documents and review the application and if the details are valid, it will issue the ADC NOC to the applicant. The issuance may take approximately 20 to 25 days.

You need to pay a minimal fee for the issue of ADC NOC for export through the online CDSCO portal. The fee is paid through the same portal. All you need to have is a valid user account on the SUGAM portal, an internet-enabled device, an internet browser and a debit or credit card to execute the payment. After successful payment, you will receive a receipt which you can use to track the payment status. Once the payment is processed, you get a payment challan which you need to upload during the application process for No-Objection Certificate from the Assistant Drug Controller (ADC).

The NOC provided by the Assistant Drug Controller (ADC) allows the exporter to export the mentioned drugs only. This No-Objection Certificate remains valid only for the consignment, you obtained it for. The consignment should be shipped within six months from the issuing date of NOC. After the execution of such shipment, you cannot use this No-Objection Certificate provided by the ADC to ship another consignment.

Running a business on the track of growth not only demands infrastructure or capital but also compliance with the rules and regulations of the country. And that’s not optional as their violation can bring legal troubles to your door. This is where Corpseed comes into the picture. With years of experience and extensive knowledge of various drug regulations and export laws applicable in India and abroad, our team at Corpseed understands the procedures involved in obtaining the No-objection certificate (NOC) from the Assistant Drug Controller (ADC). To assist our clients in their businesses and comply with applicable rules, we conduct desk-based research, documentation, and coordination. Corpseed is a one-stop solution for all your business needs.