The type of licence required depends on whether the business manufactures, repacks, sells, stocks, distributes, imports or tests pharmaceutical products. Applications are generally submitted to the relevant State Licensing Authority or CDSCO, depending on the product and activity.
Pharmaceutical Manufacturing Licences
Licence form
Application form
Purpose
Form 25
Form 24
Manufacture of drugs other than those specified in Schedules C, C(1) and X
Form 25-A
Form 24-A
Loan licence for drugs covered under Form 25
Form 25-B
Form 24-B
Repacking of drugs other than those specified in Schedules C, C(1) and X
Form 25-F
Form 24-F
Manufacture of Schedule X drugs not specified in Schedules C and C(1)
Form 28
Form 27
Manufacture of drugs specified in Schedules C and C(1), excluding Schedule X
Form 28-A
Form 27-A
Loan licence for drugs covered under Form 28
Form 28-B
Form 27-B
Manufacture of drugs specified in Schedules C, C(1) and X
Form 28-D
Form 27-D
Manufacture of large-volume parenterals, sera and vaccines, excluding Schedule X
Manufacture for sale or distribution of homoeopathic medicines
Cosmetic Manufacturing Licences
The old Forms 31, 31-A, 32 and 32-A should not be presented as the current application route. Under the Cosmetics Rules, 2020, the applicable forms are:
Licence form
Application form
Purpose
Form COS-8
Form COS-5
Licence to manufacture cosmetics for sale or distribution
Form COS-9
Form COS-6
Loan licence to manufacture cosmetics for sale or distribution
Form COS-3
Form COS-12
Prior permission to manufacture a new cosmetic
The licences in Forms COS-8 and COS-9 remain valid perpetually, subject to payment of the prescribed retention fee every five years. See the official CDSCO Cosmetics Rules and guidance.
Blood Bank Licences
Licence form
Application form
Purpose
Form 28-C
Form 27-C
Operation of a blood bank for collection, storage and processing of whole human blood or blood components
Form 28-E
Form 27-E
Manufacture of blood products
Drug-Testing Laboratory Approval
Approval form
Application form
Purpose
Form 37
Form 36
Approval of a laboratory testing drugs, cosmetics or associated raw materials on behalf of licensed manufacturers
Retail and Wholesale Drug Licences
Retail Drug Licences
Licence form
Application form
Purpose
Form 20
Form 19
Retail sale of drugs other than those specified in Schedules C, C(1) and X
Form 20-A
Form 19-A
Restricted retail sale of drugs other than those in Schedules C, C(1) and X
Form 21
Form 19
Retail sale of drugs specified in Schedules C and C(1), excluding Schedule X
Form 21-A
Form 19-A
Restricted retail sale of specified Schedule C(1) drugs
Businesses exclusively stocking, selling or distributing medical devices generally require registration in Form MD-42 under the Medical Devices Rules, 2017. The applicable manufacturing forms depend on the device classification.
The precise requirements differ by licence, product and state, but commonly include:
Application form and government-fee receipt
Constitution documents of the firm
PAN, GST and business-registration documents
Proof of ownership or registered rent/lease agreement
Site plan and key plan of the premises
Details of manufacturing, storage and testing areas
List of machinery and laboratory equipment
Qualification and experience records of technical staff
Appointment, consent and joining letters of technical personnel
Product list with complete compositions
Testing arrangements and quality-control documentation
Affidavits or undertakings required by the licensing authority
Power of attorney or authorization letter
Applicable fire, pollution and local-body approvals
Important Clarification for Ayurvedic and Cosmetic Products
A separate retail drug licence is generally not prescribed merely for selling ordinary Ayurvedic medicines or cosmetics. However, this does not mean that every business can operate without registration.
Depending on the products and business model, the establishment may still require:
Business registration
GST registration
Shop and Establishment registration
FSSAI licence for food or nutraceutical products
Wholesale drug licence where allopathic medicines are stocked or sold
AYUSH manufacturing licence for manufacturing Ayurvedic medicines
Cosmetic manufacturing licence for manufacturing cosmetics
Disclaimer: Licensing requirements can vary according to product classification, business activity and state-level procedures. Applicants should confirm the current requirements with the applicable State Licensing Authority, State AYUSH Department or CDSCO before applying.
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I am from Pune and having a Medical Store. I wanted to expand the business and so looking for any kind of distributorship,Franchise or C&F.
Kindly let me know if you have any kind of business opportunity.
Mahesh Bachhav 9960461009
Hi.
I am from Pune and having a Medical Store. I wanted to expand the business and so looking for any kind of distributorship,Franchise or C&F.
Kindly let me know if you have any kind of business opportunity.
Mahesh Bachhav 9960461009
Dear sir we are —– LABS LTD KALA-AMB,HIMACHAL Pradesh. We need distributor and we want to open pharma franchises all India basis. So if you are interested please feel to contact : Manish kumar —— Labs Ltd.Kala-Amb.
Need Franchise pcd price list
Hello we are Offering Pharma Franchise on monopoly and PCD basis in all over india .if you are interested in Pharma PCD get in touch now.
Hi.
I am from Pune and having a Medical Store. I wanted to expand the business and so looking for any kind of distributorship,Franchise or C&F.
Kindly let me know if you have any kind of business opportunity.
Mahesh Bachhav
9960461009
Hi.
I am from Pune and having a Medical Store. I wanted to expand the business and so looking for any kind of distributorship,Franchise or C&F.
Kindly let me know if you have any kind of business opportunity.
Mahesh Bachhav
9960461009
Dear sir
we are —– LABS LTD KALA-AMB,HIMACHAL Pradesh. We need distributor and we want to open pharma franchises all India basis. So if you are interested please feel to contact :
Manish kumar
—— Labs Ltd.Kala-Amb.
Need Franchise pcd price list
Hello we are Offering Pharma Franchise on monopoly and PCD basis in all over india .if you are interested in Pharma PCD get in touch now.