Guideline for Hand Sanitizer License

1. Application may be filled online through nivesh mitra, or in case of any difficulty it may be applied offline as under -

2. Application shall be made in Form 24 with fee of Rs. 7500.00 to the Drug Inspector, FSDA, Office of District Magistrate/Assistant Commissioner (Drug), FSDA, Office of Commissioner/Drug Licensing and Controlling Authority, Food Safety and Drug administration, Sector C, Aligannj Lucknow.

3. Drug Inspector/Assistant Commissioner (Drug) shall inspect the premises and forward application with inspection report to the Head Quarter, Lucknow within one day.

4. Head Quarter shall examine the application and issue the licence immediately. If application is not in order, applicant shall be informed to rectify the discrepancies within three days and further action shall be taken as per Rules.

Requirements

1. Documents:

i. Form 24

ii. Fee challan of Rs. 7500.00, Fee may be paid online through www.rajkosh.up.nic.in

iii. Map of premises

iv. NOC of pollution and Fire department/Undertaking of compliance of provisions of Pollution and Fire.

v. Water test report, (may be submitted before start of production)

vi. List of machinery and equipments

vii. Proof of building ownership

viii. Rent agreement, if applicable

ix. Constitution of the firm.

x. Affidavit of responsible/authorized person.

xi. Health fitness certificate of workers.

xii. Consent of outside laboratory for testing, if applicable.

2. Building:

i. Change room

ii. Solution preparation room – air conditioned with controlled envornment.

iii. Filling and packing room.

iv. Store room – raw material, packing material and finished goods

v. Quarantine area.

3. Machinery of production area:

i. Solution preparation vessel with suitable stirrer – SS

ii. Storage tanks – SS

iii. Filling and sealing machine

iv. Labelling machine, manual labelling may be done.

4. Technical Person:

i. Manufacturing chemist – B.Sc with experience in manufacturing

ii. Analytical chemist – B.Sc. with experience in analysis

5. Laboratory for the testing of raw material and finished products.

Application for External Preparation Section/Hand Sanitizer by existing manufacturer

1. Register on nivesh mitra (http://niveshmitra.up.nic.in) and fill common application form.

2. Select Food Safety and Drug Administration -> Additional Item

3. Complete profile on fsdaup.gov.in

4. Apply for additional items

5. Add product detail

6. Submit fee through nivesh mitra

In case of difficulty in online application

7. Submit offline application/hard copy to Drug Inspector, District magistrate office/Assistant Commissioner (Drug), divisional commissioner office/Office of Commissioner, Food Safety and Drug Administration, Aliganj, Lucknow.

8. In case of addition external preparation section Drug Inspector/Assistant Commissioner (Drug) shall forward application with inspection report/comment to the Head Quarters.

9. Applications shall be approved/disposed off at head quarters within three days