ADC NOC Certificate- Get the License in 1 Week

Eligibility to Obtain CDSCO ADC NOC for Export

The key eligibility criteria to obtain a CDSCO ADC NOC for export are as discussed below:

• Implement & document robust quality control measures to ensure consistent quality of pharma products
• Maintain facilities in compliance with Good Manufacturing Practices’
• Clearly define product specifications, including formulation, composition, and standards
• Ensure that personnel involved in pharmaceutical operations are adequately trained and qualified
• Keep all relevant licenses, CCDSCO registrations, and legal documents for inspection

Who Can Obtain an ADC Clearance Certificate?

The applicants eligible to obtain an ADC clearance certificate in India are as follows:

• Importers
• Indian Agents
• Traders
• Brokers
• Manufacturers
• Corporates
• Exporters
• Foreign Enterprises holding Indian Subsidiary
• Other entities involved in trading, manufacturing & processing of ADC NOC

Process to Obtain Online ADC NOC Certificate

The step-by-step process for obtaining an online ADC NOC certificate in India is as follows:

• Step 1: Pre-Application Assessment
  The first step in obtaining an online ADC NOC certificate is to initiate the application assessment, understand the specific NOC requirements, and prepare a document checklist.
• Step 2: Compilation of Documentation
  The next step requires the applicant to gather the required documents, such as a pro forma invoice, a copy of the export order, an affidavit under Annexure II, the company’s cover letter, etc.
• Step 3: Filing of Application Form
  The next step requires the applicant to submit the application form, along with the required payment, to the regulatory authority, typically the Assistant Drug Controller Office.
• Step 4: Inspection of Manufacturing Facilities
  In the next step, applicants must conduct an on-site inspection and audit to assess the current status of the manufacturing facility. These inspections further aim to assess compliance with regulatory requirements, including GMP.
• Step 5: Evaluation & Review of Clinical Trial Data
  After a thorough inspection, the relevant authority evaluates the clinical trial data and the mandatory documents required to obtain the ADC NOC certificate in India.
• Step 6: Issuance of ADC NOC Certificate
  Upon finalizing the evaluation, the regulatory authority issues the ADC NOC certificate to the concerned applicant. This certificate further signifies No Objection, as it authorizes the manufacturing unit to produce the goods.

Our Corpbiz Services for ADC NOC Certificate

• Pre-Application Consultation
  Connect with Corpbiz to assess product eligibility, exporter licensing, applicable drug authority, and export-specific regulatory requirements before initiating the ADC NOC application.
• Export Eligibility Verification & Preparation
  Our experts verify whether the proposed pharmaceutical products are permitted for export under the Drugs and Cosmetics Act, 1940 and the CDSCO guidelines.
• Export Labelling & Compliance Review
  We ensure compliance with export-specific labelling requirements, including For Export Only declarations, batch numbers, expiry dates, and destination-country norms, where applicable.
• End-to-End Documentation Support
  Our experts assist in preparing and reviewing all required documentation, including manufacturing licenses, product details, export invoices, and regulatory declarations.
• Coordination with CDSCO & Drug Control Authorities
  Connect Corpbiz to act as a liaison with the Assistant Drug Controller, CDSCO, and State Drug Control Departments to address queries and provide regulatory clarifications.
• Consignment-Specific ADC NOC Support
  Talk to our experts for assistance with preparing consignment-level details, including product quantity, destination country, port of export, and mode of shipment.
• Application Filling Support
  We at Corpbiz provide comprehensive support for online submission of ADC NOC applications, including accurate data entry and document uploads.
• Tailored Solutions for Pharma Business
  With Corpbiz’s expertise, we offer customised compliance and export support for manufacturers, exporters, traders, and contract manufacturers across the pharma sector.
• Post-NOC Compliance & Advisory Support
  We offer guidance on NOC validity, amendments, repeat export consignments, record maintenance, and ongoing regulatory compliance for pharmaceutical exports.