For any type of Pharma Business, we require a license or registration from Drug Department. Here we are discussing about brief detail about licenses required to start a particular type of pharma business
Different types of Licences are issued by the Drug Department for Manufacture of Drugs/Cosmetics:
List of Licenses Require for Manufacturing of Drugs are as below:
- Licence on Form 25 is issued for the manufacture for sale/distribution of Allopathic drugs other than those specified in schedule C, C(I) and X (Form 24)
- Licence on Form 25-A is issued, for Loan Licence to manufacture for sale distribution of drugs in clause (a) above. (Form 24-A)
- Licence on From 25-B, for re-packing for sale/ distribution of drugs mentioned in (a) above. (Form 24-B)
- Licence on Form 25-C is issued for manufacture for sale/distribution of Homoeopathic Medicines (Form 24-C)
- Licence on Form 25-F is issued for manufacture for sale/distribution of schedule X drugs other than those specified in schedule C & C (1). (Form 24-F)
- Licence on Form 28 is issued for manufacture for sale/distribution of Allopathic drugs specified in schedule C & C (1) excluding those specified in schedule X (Form 27)
- Licence on Form 28-A is issued for Loan Licence to Manufacture for sale/distribution of drugs mentioned in clause (f) above. [Form 27-A]
- Licence on Form 28-B is issued for manufacture for sale/distribution of drugs specified in schedule C, C(1) & X, (Form 27-B.)
- Licence on Form 28-C is issued to operate a Blood Bank for processing of Whole Human Blood and / or Preparation of Blood Components (Form 27-C)
- Licence of Form 28-D is issued to manufacture for sale or for distribution of Large Volume Parenterals, Sera and Vaccines excluding those specified in schedule 'X' (Form 27-D)
- Licence on Form 28-E is issued to manufacture for sale/distribution Blood products (Form 27-E)
License Required for Manufacturing of Cosmetic Products are:
- Licence on Form 32 is issued for manufacture to sale/distribute of cosmetics. (Form No. 31) b) Licence on Form 32-A is issued for Loan Licence for Manufacture to sale/distribute cosmetics (Form No. 31-A)
License for Laboratory:
- Laboratories which carry out tests on drugs, cosmetics and raw materials used in their manufacture, on behalf of licensees for manufacture for sale of drugs/cosmetics, are granted approval in Form 37, (Form No. 36)
General Documents and requirements for applying for above mention licenses are as below:
- Prescribed Fee Deposit Receipt
- Manufacturing Premises Site Plan providing detail of layout with dimensions in meters
- Key-plan that provide accurate knowledge about location of the manufacturing unit including land marks and other specifications nearby manufacturing unit.
- Proof of constitution of Firm e.g. Proprietor' affidavit/partnership deed/Memorandum and Article of association which is applicable.
- Power of Attorney in the name of one or more than one partner / Director / Manager/Secretary or any person who is competent to correspond with the Drugs Control Authorities with regard to grant/Renewal etc. of licence(s).
- List of Equipment and Machinery installed for manufacturing and testing of drugs with complete detail.
- Attested photo copies of qualified certificates, experience letter, letter of approval, Bio data, consent affidavit and joining report of the whole time technical staff employed for the manufacturing chemist and analytical chemist.
- List of products intended to be manufactured with detailed formula, (including Pharmaceutical aids, excipients) in proforma prescribed by drug department duly signed by authorized signatory and manufacturing chemist.
- Proof of ownership/Rent Agreement
- An affidavit/undertaking to the effect that neither the owner nor the firm had been convicted under the Drugs & Cosmetics Act 1940.
- All the photocopies of documents should be self attached
List of Licenses Require for Exhibition, Sale and Distribution of Drugs are as below:
- Licence on Form 20 is issued for the sale of Allopathic drugs by retail other than those specified in Schedule C, C(1) and X. Application is to be submitted on Form-19.
- Licence on Form 20-A is issued for the sale of restricted Allopathic drugs by retail other than those specified in schedule C, C(1) and X. Application is to be submitted on Form-19-A.
- Licence on Form 20-B is issued for wholesale of Allopathic drugs other than those specified in Sch C, C(1) and X. Application is to be submitted on Form-19.
- Licence on form 20-C is issued for sale of Homoeopathic medicines by retail. Application is to be submitted on Form-19-B
- Licence on Form 20-D is issued for sale of Homoeopathic Medicines by wholesale. Application is to be submitted on Form - 19-B.
- Licence on Form 21 is issued for retail sale of Allopathic drugs specified in Sch C & C(1). Application is to be submitted on Form-19.
- Licence on Form 21-B is issued for wholesale of Allopathic drugs specified in Sch C & C(1). Application is to be submitted on Form-19.
- Licence on form 21-A is issued for retail sale of restricted Allopathic drugs specified in Schedule C (I). Application is to be submitted on Form-19-A.
- Licence on Form 20-F is issued for retail sale of drugs specified in Schedule 'X'. Application is to be submitted on Form-19-C.
- Licence on Form 20-G is issued for wholesale of drugs Specified in Schedule 'X'. Application is to be submitted on Form-19-C.
For sale and Distribution of Ayurvedic and Cosmetic Products, No License is required
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