Know Your Service
Grant of a Licence to manufacture for sale or for distribution of drugs specified in Schedules C, C (1) and X. Form 27 B
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.
- 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.
- Then the applicant needs to login with the credentials, by clicking the Login Tab.
- 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.
- Applicant has to fill up the form and upload the required supporting documents.
- On final submission of the form, applicant has to pay the requisite amount.
- 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.
- 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.
- After successful completion of the service, the certificate is generated. The applicant will be notified about this over SMS and Email and the applicant can download it from ARTPS portal.
Supporting Documents :
1. Copy of Partnership Deed/Memorandum and Articles of Association
2. Declaration of Proprietor/Partner/Director etc in affidavit
3. Copy of Ration Card/Passport/Electoral Card/Aadhar Card/Bank Passbook details in support of residential address & ID proof of the responsible person.
4. Copies of rent/lease deed in case of Rental premises.
5. Declaration of owner of the premises owned by the applicant firm or company with the documentary evidence of the ownership like registered sale deed etc and or proof of allotment of the site and or building along with latest property tax receipt.
6. Plan and layout of the premises showing the installation of Machinery and Equipment preferably a blue print approved by licensed engineer and sign by the applicant who sign in the statutory form.
7. Design and layout of HVAC systems, if applicable.
8. Detail list of manufacturing and analytical equipment with copies of purchase bills.
9. approval of technical staff in the prescribed format with enclosed with the consent letters, copies of qualification certificate, experience certificate, proposed technical staff along with earlier approvals if any, appointment letter of the technical staff.
10. Permission obtained from the Municipal Authorities/Panchayat Authorities/Certificate in conformity with Factory Act for construction and starting the unit.
11. Permission from the Health Authorities/Pollution Control Board/Clearance of the area for setting up the manufacturing facility in case of license for manufacture of API the Assam Pollution Control Board clearance of API is sought.
12. Clearance from Drugs Controller General (India), New Delhi in case of a New Drugs (either Bulk drug or formulation)
13. Site Master File (refer para 29 of Part 1 of the Schedule M)
14. Technical data in respect of the products of the manufacturer.
Technical document to be submitted for BULK DRUGS:
1. Manufacturing procedure of each product.
2. Flow Chart with structural formula of reaction as per Master Formula record and analytical procedure of the each applied product with mode of procurement of official reference standard or working standard.
3. Official Monographs copies.
4. Details of effluents generated and their treatment followed.
5. Specimen labels of all applied products.
Technical document to be submitted for Formulations:
1. Consolidated list of Formulations with packing particulars separately category wise viz. Tablets, Capsules,Injections etc.
2. Manufacturing and Analytical procedure of each product.
3. Specimen labels.
4. Labels of the similar products moving in the market for formulations not included in IP.
5. Declaration regarding the Brand Names of the product.
6. Copies of monographs of drugs which are not included in IP.
Stipulated Time Limit : 60 (Sixty) working days from the date of submission of application, complete in all respects along with documents as per checklist.
- Service charge (through PFC/CSC) - Rs. 30
- Printing charge (in case of any printing from PFC/CSC) - Rs. 10 per page
- Scanning charge (in case documents are scanned in PFC/CSC) - Rs. 5 per page.
- Application Fee-
Convenience fee-
License Fees of Rs. 6000 plus inspection fees of Rs. 1500 (Rs 7500)
OFFLINE:
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".
