Manufacturing Licences



1. Form 25 – Licence of manufacture for sale or for distribution of drugs other than those specified in Schedules C,C1 and X.

Application for grant of form 25 licence is made in form 24 is prescribed.
2. Form 25A – Loan licence to manufacture for sale ( or for distribution of) drugs other than those specified in Schedules C, C1 and X.
3. Form 25B – Licence to report for sale or distribution of drugs being drugs other than those specified in Schedule C and C1 (excluding those specified in Schedule X).
4. Form 25C – Licence to manufacture ( or for distribution) Homeopathic mediayurvedic drcines.

For the fresh or renewal application of the above licence form 24 C is prescribed.
5. Form 25D – Licence to manufacture for sale of Ayurvedic (including Siddha) or Unani Drugs.

For the fresh or renewal application of the above licence form 24 D is prescribed.
6. Form 25E – Loan licence to manufacture for sale Ayurvedic (Including Siddha) or Unani Drugs.

For the fresh or renewal application of the above licence form 24E is prescribed.
7. Form 25F – Licence to manufacture for sale (or distribution) of drugs specified in Schedule X and not specified in Schedules C and C1.

For the fresh or renewal application of the above licence form 24 prescribed.

a) Certificate of renewal of licence to manufacture for sale of drugs other than those specified in Schedule X is issued in form 26 and that of loan licence is form 26A.

b) Certificate of renewal of licence to manufacture for sale of homeopathic medicines is issued in form 26C and that of ayurvedic drugs are issued in form 26D.

c) Certificate of renewal of licence to manufacture for sale of drugs specified in Schedule X is issued in form 26F
8. Form 28 – Licence to manufacture for sale (or for distribution of) drugs specified in Schedules C and C1 (excluding thos specified in Schedule X)

Fresh/renewal application of the above licence form 27 is prescribed.
9. Form 28A – Loan licence to manufacture for sale ( or for distribution of) drugs specified in Schedul e C and C1 (excluding those specified in Schedule X).

For fresh/renewal application of the above licence form 27A is prescribed.
10. Form 28B – Licence to manufacture for sale (or for distribution of) drugs specified in Schedules C, C1 & X

For fresh/renewal application of the above licence form 27B is prescribed.
11. Form 28C – Licence to operate a Blood bank, processing whole human blood for components and/or manufacture of bloos peosuxra.

For fresh/renewal application of the above licence form 27C is prescribed.
12. Form 28D – Licence to manufacture for sale for distribution of Large Volume Parenterals/sera and vaccines specified on Schedules C and C1 excluding those specified in Schedule X

For fresh/renewal application of the above licence form 27D is prescribed.

Certificate of renewal of licence for the operation of blood bnk and/or processing of whole human blood fo component and/or manufacture of blood products is issued in form 26 D and that of Large Volume Parenterals/Sera and vaccines specified in Schedules C a and C1 excluding those specified in Schedule X is issued in form 26 H

1. Form 29 – Licence to manufacture drugs for purpose of examination, test or analysis.

For fresh/renewal application of the above licence form 30 is prescribed.
2. Form 32 – Licence to manufacture cosmetics for sale or for distribution.

For fresh/renewal application of the above licence form 31 is prescribed
3. Form 32A – Loan Licence to manufacture cosmetics for sale (or for distribution)

For fresh/renewal application of the above licence form 31 A is prescribed.

Certificate of renewal of licence to manufacture cosmetics for sale is issued in form 33 and that of loan licence is issued in form 33 A.

The approval for carrying out tests on drugs , cosmetics and raw materials is issued in form 37 and application for this purpose is made in form 36.

Certificate of renewal of form 37 approval is issued in form 38.

The Report of test or analysis by the approved institution is issued in form 39.

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