LOAN LICENCE DEFINATION: ‘ A licence issued by a licensing
authority to a applicant who does not have his own arrangements for
manufacture but who intends to avail himself of the manufacturing
facilities owned by another licence’’ Condition of a loan licence under
the rules :71 B ,74B, 76B.78 B.
LICENSING AUTHORITIES :
LICENSING AUTHORITIES Each state government appoints licensing
authorities To issues licence for manufacture,distribution and sale of
drugs or cosmetics for a specified area and also having empowered to
cancel or suspend the licence
Slide 4: FORM 24 A: Application
for grant or renewal of a loan licence to manufacture drugs other the
schedule C , C1and X drugs FORM 24E: Manufacture for sale of ayurvedic
or unani drugs FORM 25 E: loan licence to manufacture for sale ayurvedic
or unani drugs FORM 25A: loan licence to manufacture for sale or for
distribution or drugs other than those specified n schedules C,C1 and X
drugs FORM 28A: licence to manufacture for sale or for distribution of
drugs specified in schedules C and C1
Slide 5: FORM27A:
Application for grant or renewal of a loan licence to manufacture for
distribution of drugs in schedules C&C1 FORM 32 A: loan licence to
manufacture for sale or for distribution
Slide 6: PROCEDURE
FOR GETTING LOAN LICENCE : Application for a grant of loan licence
should be made in the prescribed forms 24A,27A with Rs-200/- or 600/-
respectively The applicant has to obtain & submit a letters from the
licence holder which facilities are to be availed for the manufacture.
The licence authority must be satisfied that the licence holder should
posses the necessary equipment ,staff capacity for manufacture
&facilities for testing for a loan licence.
Slide 7: In
case the licence of the person (i.e the licence holder) whose facilities
are being utilised by the licence is cancelled or suspended the loan
licence will also be deemed cancelled or suspended. Licence authority
should inspect the each bath ,maintain the records or not for a period
of 5 years from the date of manufacturing The licence should maintain
control samples of each bath of drug manufactured.
PROCEDURE TO OBTAIN DRUG MANUFACTURING LICENCE IN LOAN PREMISES Stage 1 :
Application for grant of Loan Manufacturing Licence(application form in
Form 24A , 27A, 24E respectively )
Slide 9: Documents to be
attached along with the application form : Receipt of payment of Fees.
Documents such as partnership-deed, Memorandum and Articles of
Association. List of Drugs/Cosmetics to be manufactured in duplicate.
Copy of the letter written to the manufacturer whose premises, machinery
equipments are to be taken on loan. Copy of consent letter of the
manufacturer who gives his premises, Machinery and equipments on loan.
Labels and cartons of the Drugs to be manufactured. In case, the
application is for the products covered under C and C (1) category, then
the details of stability data are required.
Slide 10: Stage2
Inspection The application is scrutinized and premises inspected . Stage
3 Grant of Licence If all conditions as prescribed by the act are
complied license is granted
Slide 11: PROCEDURE TO RENEWAL
DRUG MANUFACTURING LICENCE IN LOAN PREMISES (Licenses in Forms 25A, 28A,
25E can be renewed. ) Stage 1 Application for renewal of Loan
Manufacturing Licence (The applicant has to make application in the
requisite form( 24A,27A,24E) )