Service Code: DCA-404 | Department: Drugs Department

Purpose

The Licence to Grant or Renewal Specified in Schedule X Drugs (DCA-404) service enables eligible applicants to apply for a new licence or renewal to deal in Schedule X drugs through the Tamil Nadu e-District (e-Sevai) portal.

Schedule X drugs are subject to strict regulatory control under the Drugs and Cosmetics Act. This online service ensures regulated handling, proper documentation, and transparent approval through the Drugs Control Department.

This service is intended for:

- Applicants seeking a fresh licence to deal in Schedule X drugs
- Existing licence holders applying for renewal
- Businesses requesting Change of Premises
- Businesses requesting Change in Constitution
- Retailers or wholesalers authorized to handle Schedule X category drugs

Required Information

Mandatory for Renewal:
- Existing Schedule X Licence Number

Special Requirements

For Renewal Applications:
Upon entering the licence number, existing details are auto-populated in the application form.

For Change Requests:
In cases of Change of Premises or Change in Constitution, relevant sections become partially editable.

Competent Person Requirement:
Details of an approved Competent Person must be provided as per Schedule X norms.

Secure Storage:
Applicants must declare appropriate storage accommodation as required for Schedule X drugs.

Step-by-Step Application / Renewal Process

1. Visit the Portal
Login to the Tamil Nadu e-Sevai / e-District portal using valid operator credentials.

2. Navigate to the Service
Click Services → Drugs Department → DCA-404 Licence to Grant or Renewal Specified in Schedule X Drugs.

3. Select Application Type

- Licence Type: Grant or Renewal
- For Renewal: Enter the existing Licence Number
- Apply for: Fresh Licence / Change of Premises / Change in Constitution

4. Enter Applicant Details

- Enter applicant information using the available fields
- Multiple applicants can be added using Add Applicant
- Complete bio-data can be added using Add Bio Data

5. Enter Firm and Address Details

- Name of the firm
- Complete address details
- Ownership type (Owned / Rented)

6. Provide Competent Person Details

- Enter required qualification and approval details
- Add multiple competent persons if applicable

7. Enter Storage Accommodation Details
Specify storage facilities available for Schedule X drugs.

8. Enter Contact Details

- Phone number
- Mobile numbers
- Email ID

9. Submit Application
Click Submit to generate the application number.

Upload Required Documents

Applicants must upload the prescribed documents, including:

- Declaration Form
- Form 19C (where applicable)
- Proof of premises ownership or rental
- Authorization or constitution-related documents
- Competent Person qualification and approval documents
- Blueprint / layout of premises as required

Uploaded documents must follow the formats prescribed on the portal.

Payment Process

After document upload:

- Proceed to Make Payment
- Pay the applicable government fee and service charge as displayed on the portal
- Confirm payment to complete submission

Acknowledgement and Tracking

- Download and print the Acknowledgement Receipt
- Applications can be tracked under Submitted Applications
- Draft applications remain available under Saved Applications

Physical Submission of Documents

After online submission, applicants are required to submit physical copies of all mandatory documents to the concerned office of the Drugs Control Department.

Applicants must clearly mention the Acknowledgement Number on the document cover.

Downloading Licence Certificate

Once the application is approved and digitally signed:

- Go to Check Status
- Enter the Application Number
- Click Search
- Click Download Certificate when approval status is shown

The licence certificate can be downloaded and issued to the applicant.

Important Notes

- Schedule X drugs are governed by strict statutory controls
- Licence validity is subject to rules prescribed under the Drugs and Cosmetics Act
- Any change in competent person must be reported promptly
- Drugs must be purchased only from licensed manufacturers or dealers
- Certificates issued can be verified online through official verification mechanisms

Apply Online
https://tnedistrict.tn.gov.in

Assistance

Applicants may approach the nearest e-Sevai / CSC centre for guidance and s support.

This guide is based on the Tamil Nadu e-District User Manual (DCA-404). Government of Tamil Nadu, 2017.