Renewal of licence to manufacture for sale or for distribution of drugs

DepartmentDepartment of Medical Health and Family Welfare

TypeRenewal

StagePre-Operation

AppliedOffline

Unit sizeMicro, Small, Medium, Large, Mega, Ultra-Mega, Super Ultra-Mega

Business locationUrban-Plain, Urban-Hilly, Rural-Plain, Rural-Hilly

Risk / pollution categoryHigh, Medium, Low, Red, Orange, Green, White

Investor typeForeign, Domestic

Documents to submit

#	Document	Condition	Required
1	Application Form 24, 27, 24B & 31 etc	—	Required
2	Treasury Challan of requisite fees	—	Required
3	List of items to be manufactured	—	Required
4	Affidavit to the effect that so & so will be responsible for day to day conduct of the business of the firm or company etc	—	Required
5	Map of the premises approved by empanelled architect ( i f any changes )	—	Required
6	Owner ship documents of the premises	—	Required
7	L ist of present Directors, Resolution of Board of Directors	—	Required
8	Power of attorney & authorization letter to Authorized signatory	—	Required
9	List of manufacturing Equipment’s	—	Required
10	List of Lab. Equipment’s	—	Required
11	Appointment Letter s, Joining Letters, Approval Certificates & affidavit of Manufacturing & Analytical Chemists. (Three Photographs Per forms)	—	Required
12	NOC from Pollution Control Board	—	Required
13	Medical Examination report (Freedom from contagious diseases) from qualified Doctor along with his consent for regular periodical health check - up	—	Required
14	Portability test report of drinking water	—	Required
15	Consent letter from approved lab for sophisticated instrumental analysis	If applicable	If applicable
16	List of firefighting equipment’s	If any changes	If applicable