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.

Slide 8: 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) )
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16 October 2013 at 03:55

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