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Application for the grant or renewal of a [licence to manufacture for sale or for distribution of] drugs specified in Schedule X and not specified in Schedules C and C(1) - Form 24F

Dear user, you will be redirected to EODB portal for this service. If not already registered, please register first otherwise login to avail the service.

  1. If the applicant is a first time user, he/she needs to click the Register Tab provided in top right corner in this page and then get registered with the necessary fields such as Full Name, Mobile No., Email id (which is not mandatory), State and Password.
  2. Then the applicant needs to login with the credentials, by clicking the Login Tab.
  3. After the applicant has logged on to the system, he/she needs to click the Apply Online tab and select the service they want to apply for and click the apply button after going through the Requirements tab.
  4. Applicant has to fill up the form and upload the required supporting documents.
  5. On final submission of the form, applicant has to pay the requisite amount.
  6. Once the payment is successful it will be forwarded to the higher officials for further processes. An acknowledgement will be generated containing the application reference no., the same will be notified over SMS and Email id of the applicant.
  7. An SMS and Email alert is sent to applicant on completion of the service. The applicant needs to respond to the SMS and Email regarding completion of the service.
  8. After successful completion of the service, Application for the grant or renewal of a [licence to manufacture for sale or for distribution of] drugs specified in Schedule X and not specified in Schedules C and C(1) - Form 24F is generated. The applicant will be notified about this over SMS and Email and the applicant can download it from ARTPS portal.

LIST OF DOCUMENTS

List of products with compassion.

  • CDSCO / DCG(I) permission of Products.
  • Proof of CTS and educational qualification for Manufacturing Chemist.
  • Proof of CTS and educational qualification for Analytical Chemist.
  • List of Equipment’s.
  • Method of Preparation.
  • Specification & Standard testing procedure.
  • Label/Artwork of each product.
  • PAN Card of Firm.
  • Board resolution.
  • Authorization letter of Authorized signatory.
  • Pan card of Authorized signatory.
  • Address proof of Authorized signatory.
  • Memorandum & Article of Association.
  • List of Director.
  • AIDC lease agreement/land lease agreement proof/Copies of rent/lease deed in case of Rental premises.
  • Permission obtained from the Municipal Authorities/Panchayat Authorities/Certificate in conformity with Factory Act for construction and starting the unit.
  • Consent to established and operate from pollution control board.
  • Factory licence.
  • Approved Layout of Plant. (Blue Print)
  • Design and layout of HVAC systems, if applicable.
  • Site Master File.

TIMELINE

  • 20 days from the date of submission of application form, completed in all respect along with documents as per checklist.

FEES & PAYMENTS

  • License fees of Rs 10000/-

Mode of Payment:

Online: The requisite fees to be paid through EGRAS payment gateway only.

Offline: Head of Account is "0210-Medical and Public Health, 04- Public Health, 104-Fees and Fines".

PROCEDURE AND STAGE WISE TIMELINE

Click here to download : Procedure Details