Apply Online – Assam – Drugs License to Manufacture, Sale or Distribution

Apply Now for Drugs License to Manufacture, Sale or Distribution in Assam

Specified in Schedule X and not specified in Schedule C and C(1) (Additional Items)- Form 24 F

Eligibility Criteria

• The applicant must be a citizen of India
• The applicant must have a registered business in India
• The applicant must have a manufacturing unit in India
• The applicant must have a degree in pharmacy or pharmaceutical sciences

Documents Required for Drugs License to Manufacture, Sale or Distribution in Assam

• List of additional items to be approved
• Master Formula of additional item.
• Testing monogram of additional item.

Application Process

1. Registration (For First-Time Users):
   If the applicant is a first-time user, they need to click the Register tab located in the top-right corner of the page. The applicant should then complete the registration by filling in the necessary fields such as Full Name, Mobile Number, Email ID (optional), State, and Password.
2. Login:
   After registration, the applicant must log in using the credentials created during registration by clicking the Login tab.
3. Application Submission:
   Once logged in, the applicant must click the Apply Online tab, select the service they wish to apply for, and click the Apply button after reviewing the Requirements tab.
4. Complete the Application Form:
   The applicant must fill out the application form with the required details and upload all the necessary supporting documents.
5. Payment of Fees:
   After completing the form, the applicant must pay the required fee. The application cannot proceed without the successful payment of the requisite amount.
6. Acknowledgment:
   Once the payment is successful, the application will be forwarded to the higher officials for further processing. An acknowledgment will be generated, which includes the application reference number. The acknowledgment will be sent to the applicant via SMS and Email.
7. Service Completion Notification:
   The applicant will receive an SMS and Email alert once the service is completed. The applicant must respond to the SMS and Email to acknowledge the completion of the service.
8. Issuance of License:
   After the successful completion of the service, an Application for Grant of a License to Manufacture for Sale or Distribution of Drugs (as specified in Schedule X and not in Schedule C and C(1) – Additional Items, Form 24 F) will be generated.
   The applicant will be notified via SMS and Email, and they can download the license from the ARTPS portal.

Fees and Timeline

• Rs. 300/- for each additional item to be approved.
• Mode of Payment:
• Online: The requisite fees to be paid through EGRAS payment gateway only.
• Processing time: 20 days from the date of submission of application form, completed in all respect along with documents as per checklist.

Additional Resources

1. Central Drugs Standard Control Organization (CDSCO)
2. State Drugs Controller

Benefits

• Compliance with regulatory requirements
• Increased credibility and reputation
• Better market opportunities
• Protection of public health

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Frequently Asked Questions (FAQs)