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Manufacturing Licences

 

Different Forms of Licences for Manufacturing of drugs:

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.

Form 25A – Loan licence to manufacture for sale  ( or for distribution of) drugs other than those specified in Schedules C, C1 and X.

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).

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.

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.

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.

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

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.

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.

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.

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.

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.

 

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.

Form 3 2 – Licence to manufacture cosmetics for sale or for distribution.

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

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.

 

Documents required for grant/renewal of manufacturing licences.


Concerned Form (Refer statutory forms)

Original chalan receipt required  amount of fees.

Plan of the premises

Notarized affidavit in the prescribed form

Declaration of technical staffs on manufacturing  and testing.

Documents to prove their qualification and experience

Details of products applied with their master formula records & SOPs (In the case of renewal details of products approved is also to be submitted)

Details  of similar products in the market.

a )   In the case of renewal of licences the previous renewal certificate in original © of original Drugs Licences are to be attached. 

b )   By remitting Rs. 7500/- as the licence fee along with application of allopathic drugs (form 25,27) a maximum of   approval  of 10 products could be obtained.  For products beyond 10 numbers  additional  fee of Rs. 300/- is to be remitted.

 

 

The manufacture shall be conducted under the active direction and supervision of qualified person who is a whole-time employee and is-

 

A graduate in Pharmacy or Pharmaceutical Chemistry of a University established in India by law or has an equivalent qualification recognized and notified by the Central Government for such purpose) and has had at least  (eighteen months’  practical experience) after the graduation in the manufacture of drugs .  This period of experience may, however, be reduced by six months if the person has undergone training in manufacture of drugs for a period of six months during his University course; or

A graduate in Science or a University established in India by law or has an equivalent qualification recognized and notified by the Central Government for such purpose) who for the purpose of his degree has studied Chemistry as a principal  subject and has had at least three years  practical experience in the manufacture of drugs after his graduation; or

A graduate in Chemical Engineering or Chemical Technology or Medicine of  ( a University established in India by law or has an equivalent qualification recognized and notified by the Central Government for such purpose)  with general training and practical experience, extending over a period of not less than three years in the manufacture of drugs, after his graduation; or

Holding any foreign qualification the quality and content of training of which are comparable with those prescribed in clause
(a), clause
(b) or clause
(c) and is permitted to work as competent technical staff under this rule by the Central Government

 

Provided that any person who was immediately before the 29th June, 1957, actively directing and personally supervising the manufacture of drugs and whose name was accordingly entered in any licence granted in Form 25 (or Form 26-F) as it existed before that date shall be deemed to be qualified for the purpose of this rule:

For drugs other than those specified in Schedules C, C(1) and X and meant for veterinary use, the whole time employee under whose supervision the manufacture is conducted shall be a graduate in Veterinary Science or Pharmacy or General Science or Medicine of a University recognized by the Central Government and who has had at least three years’ practical experience in the manufacture of drugs.

In the matter of manufacture of disinfectant fluids ,insecticides, liquid paraffin, medicinal gases, non chemical contraceptives , plaster of Paris and surgical dressings the licencing authority may permit a competent technical staff who although not having any of the qualification mentioned above.

Before a repacking licence in Form 25-B is granted or renewed the following condition shall be complied with by the applicant :-

The operation should be carried out under the direct supervision of a competent person.

A person who satisfies the following minimum qualifications shall be deemed to be a “competent person”

A person who holds the Diploma in Pharmacy approved by the Pharmacy Council of India under the Pharmacy Act, 1948 (VIII of 1948) or a person who is registered under the said Act, or

 

A person who has passed the Intermediate examination with Chemistry as one of the principal subjects or an examination equivalent to it or an examination recognized by the licensing authority as equivalent to it, or

A person who has passed the Matriculation examination or an examination recognized by the licensing authority as equivalent to it and has had not less than four years practical experience in the manufacture, dispensing or repacking of drugs)

 

Before a licence in Form 25-C is granted or renewed the following conditions shall be complied with by the applicant-

(1)    The manufacture of Homoeopathic medicines shall be conducted under the direction and supervision of competent technical staff consisting at least of one person who is a whole time employee (and who is-

(a)

A graduate in Science with Chemistry as one of the Subjects with three years   experience in manufacture of Homoeopathic Medicines; or

(b) 

A graduate in Pharmacy with 18 months of experience in the manufacture of Homoeopathic medicines; or © Holds qualification as defined under sub-clause (g) of clause (g) of clause (1) of Section 2 of Homoeopathy Central Council Act, 1973 (59 of 1973) with 18 months of experience in the manufacture of Homoeopathic medicines:

 

Provided that the persons who are already in employment with five years experience in the manufacture of Homoeopathic medicines and whose name was accordingly entered in any licence granted in Form 25-C for manufacture of different classes of Homoeopathic medicines included in them shall be deemed to be qualified for the purpose of this rule.)