Assistant Drug Controller | ADC NOC Certificate

Overview

ADC (Assistant Drug Controller) NOC (No Objection Certificate) is a significant document that helps to ensure the quality, efficacy and safety of the pharmaceutical industry. In the pharmaceutical industry, the export of medicines and related products is easily circulating in the global economy. Due to this multifaceted landscape of the pharmaceutical industry where the health of the public is the topmost priority, this document helps the products (drugs) to stay compliant with regulatory standards. This article will provide you complete insights on how to obtain the ADC NOC certificate, documents and eligibility criteria to obtain it for drug productions in India.

What is meant by the term ADC?

The full form of ADC is Assistant Drug Controller. The ADC refers to the government authorities and is responsible for regulating the pharmaceutical industry. This organisation helps to meet the highest quality, safety and efficacy. For pharmaceuticals and other drug related products and take actions against violence.

What is the ADC NOC Certificate?

The term ‘NOC’ connoted to No Objection Certificate. This certificate is the legal document that declares the organisation’s ‘no objection’ and complies with the legal standard.

Within the pharmaceutical industry, the ADC NOC is the document that complies with legal standards and is an important element for governing the overall framework for pharmaceutical activities. This document ensures to protect the market from the unsafe drugs circulation in the market.

Benefits of ADC NOC Certificate

Here’s the benefits of ADC NOC Certificate:

• Helps in clearing customs for pharmaceutical exports
• The ADC NOC certificate provides legality of your shipment
• This helps to get the efficient consignment shipping
• This validates the exporting of pharmaceuticals across different companies

Who requires to get NOC from ADC?

As the name suggests, ADC NOC certificate bound for pharmaceuticals industry. Yet, you’re still required to know about which entity is required to apply for ADC NOC certificate under pharmaceutical industry. Here’s the list of eligibility criteria listed for the application of ADC NOC certificate:

1. Exporters
2. Manufacturers
3. Traders
4. Brokers
5. Agents
6. Importers
7. and other entities that involves in trading, manufacturing and processing ADC NOC Certificate

Documents required for ADC NOC Certificate

Here’s the list of documents required for ADC NOC Certificate, which are as follows:

• Manufacturing license
• Status of the applied product (Approved New Drug/ Unapproved New drug/ Banned drugs)
• Covering letter of company’s letter head duly stamped and all required details such as name and address of foreign buyers, purchase order, list of products to be exported, etc.
• Copy of valid Export Order
• Proforma invoice
• Source of approved New Drug (API) (in case of domestic manufacturers holding Form 46A) used in drug formulation;
• Affidavit (on non-judicial stamp paper and notarized) as per Annexure-II
• Undertaking by the manufacturer on Company’s Letter Head duly signed and stamped by the authorized signatory (with name & designation) as per Annexure-I
• Challans regarding User Charges of Rs. 500/- and Act fees of Rs. 300/- per product

ADC NOC Certificate Process

Here’s the step-by-step procedures for obtaining NOC from ADC within pharmaceutical industry:

• Step 1: Pre-Application Assessment
  In the initial process to initiate the application, this application involves reviewing the requirements, understanding the specific NOC requirements and preparing the checklist of documents.
• Step 2: Documentation
  For obtaining the ADC NOC certificate, an applicant needs to gather required documents such as proforma invoice, copy of export order, affidavit under annexure-II, covering letter of company, etc.
• Step 3: Submission of Application along with Payment
  Once the required documents are furnished you need to submit the application form along with the concern payment to the regulatory authority, typically the Assistant Drug Controller Office. Make sure that the documents that you've provided should be free from any errors and discrepancy.
• Step 4: Inspection of Audit
  Once the applicant submitted their documents to concerned authorities, the Assistant Drug Controller (ADC) may conduct on-site inspections and audits for the current status of the manufacturing facility. These inspections may aim to assess compliance with the regu;latory compliance including GMP.
• Step 5: Evaluation and Review
  After the inspection is done by the concerned authority, the authority may check to submit documentation, inspections and review the application thoroughly.
• Step 6: Issuance of ADC NOC
  On finalising the evaluation, the regulatory authority will issue the ADC NOC Certificate to the concerned applicant. This certificate signifies ‘No Objection’ since it frees the manufacturing unit to freely produce the goods.

Validity and Renewal of ADC NOC Certificate

The validity of ADC NOC Certificate lasts for 6 months from the date of issuance.

After the validity of the ADC NOC Certificate, you need to renew the certificate by reapplying to the online CDSCO SUGAM portal.

Time Taken to Obtain ADC NOC Certificate

The time taken to obtain the ADC NOC certificate takes around 10-15 days from the date of application. However the date of obtaining could vary because of several factors such as:

• Complexity of applications
• Regulatory authority workload
• Timelines of Response
• Completeness and accuracy of Documentation

Why choose Bizfoc for the ADC NOC Certificate?

Here are the top five reasons why you should choose Bizfoc for registering themselves under ADC NOC Certificate Online:

• Hassle-free procedures
• Cost-effective solution
• Respond to all your queries and doubts via communication mediums
• Free assistance of experts
• Proven success

We, the team of Bizfoc experts, will help you to overcome the problems via communication mediums regarding ADC NOC Certificate online. You can either contact us by way of email or direct phone number to get connected to our experts without any hesitation. So, for registering under the ADC NOC Certificate for trading pharmaceuticals industry, get free assistance today to proceed with your application successfully by undergoing hassle-free procedures.

Conclusion

Assistant Drug Controller is the vital authority to facilitate and regulate the Indian pharmaceutical sector. Under this nodal body of CDSCO, the NOC is issued to the manufacturing unit to the concerned authority to freely manufacture their drug related products. This certificate also helps to stay compliant during the manufacturing process of drugs related products. For registering your certificate, you need to know the required documents, procedures, fees and the total time taken to obtain the certificate.

Frequently Asked Questions