Pharmacy

1. UKA TARSADIA UNIVERSITY
MALIBA PHARMACY COLLEGE
SEMINAR ON
LOAN LICENCE
GUIDED BY:
Dr. Hetal P. Patel
Assistant Professor
PREPARED BY:
SHIVANGI SHRIVASTAV KAMTAPRASAD
EN.NO.: 202204100410010
SUBJECT :
COSMETICS AND COSMACEUTICALS.
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2. INTRODUCTION
 A person not having his own manufacturing facilities can get cosmetics manufactured from a
licensed cosmetics manufacturer under the loan licence system .
 It is issued by the licensing authority ,to a person who does not own, arrangement for
manufacture but intend to avail the manufacture facilities owned by another licenses.
 Application for loan licence in a prescribe (Form 31-A) along with a fee of Rs.3500.00 (at
present, may be revised together with other requisite document should be submitted to the
state regulatory authorities
 The license authorities of the state ,after examining that the licence manufacturer cosmetics
for applicant, will grant loan licence .
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3. 1. In the case of pharmacy business is operating in business in more then two state then it is
required to obtain a drug license in each state where the business is carrier on .A seprate
license shall be issued in case drug are sold at more than one place.
2. After the license in granted to the business ,the license must ensure that all the condition of
the drug license must be complied with during business .in the case of any changes or
modification in business activity authority must be informed and all the registers, record
,and forms must be maintained in a specified manner.
LOAN LICENCE FOR PHARMACY
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4. Sr. No. Classes of Drug
Form of
Application
Form of license
1.
Loan License (other
than schedule
C,C1,and X)
24-A 25-A
2.
Loan License (Only
schedule C, C1 27-A 28-A
3.
Repacking license
(other than
schedule C,C1,and
X)
24-B 25-B
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5. 3. The licensing authority shall ,before the grant of loan licence , satisfy him self that
manufacturing unit has adequate equipment ,staff , capacity for manufacture, and facilities for
testing ,to undertake the manufacture on behalf of the applicant for a loan license .
4. Application for manufacture of more than ten items for each category of drug on a loan
license shall be accompanied by a additional fee of rupees three hundred per item specified in
schedule M and M3.
5. The license shall allow inspector to inspect the premises and satisfy himself that only
examination is conducted .
6. The license shall maintain “Inspection book” in Form 35.
7. The license shall comply with further requirements specify by the authority .
8.The license shall test each batch of raw material and each batch of final product and also
maintain record of manufacture and testing of each batch as per schedule U.
9.Shall maintain the reference sample of each batch for the period of 3 years.
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6. 10. For schedule C and C1 drug ,the license shall furnish the data of stability and data of expiry to
the licensing authority .
11. Report to the licensing authority, regarding the changes in expert staff or change in the
manufacture or testing units .
12. If the licensing authority is satisfied that a loan licence is damaged or lost or otherwise
rendered useless ,he may, on payment of a fee of rupees one thousand ,issue a duplicate license .
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7.  It is granted for the purpose of breaking up any drug than those specified in schedule C and
C1.
REPACKAGING LICENSE
Sr.No. Classes of Drug
Form of
Application
Form of license
1
Repacking
License (other
than schedule
C,C1,and X )
24-B 25-B
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8. 1. Repacking of drugs should be conducted under hygienic conditions under personal
supervision of competent person, approved by the licensing authority.
2. The license must provide and maintain adequate arrangements for carrying out tests
of drugs repacked, in the specified place by the authority.
3. The licensee shall allow Inspector to inspect the premises and to take samples of
repacked drugs
4. The licensee shall test each batch of raw materials used and each batch of the final
product and also maintain the records of manufacture and testing of each batch as per
schedule U. Records must be retained for 5 years from the date of repacking.
5. Licensee must allow the Inspector to inspect all the registers and records maintained.
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9. 6. The license shall maintain Inspection Book" in Form 35
7. Shall maintain the reference samples from each batch of repacked drugs, for the
specified period.
8. License remain valid for a period of 5 years from the date its granted or renewed,
unless suspended or cancelled.
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10. OFFENCES AND PENALITIES
OFFENCES PENALITIES
Manufacture for sale/distribution or
stock/exhibit for sale/distribution or sale of a
cosmetic not of standard quality or
misbranded. Offence under section 18(a) (ii)
Imprisonment for a term which may extend to 1
year or fine which may extend to 1000 rupees.
Manufacture for sale/distribution or
stock/exhibit for sale/distribution or sale of a
cosmetic containing any ingredient which may
render it unsafe/harmful for use under
indicated direction. Offence under section 18 (a)
(v).
Imprisonment for a term which may extend to 1
year or fine which may extend to 1000 rupees.
Manufacture for sale/distribution or
stock/exhibit for sale/distribution or sale of a
cosmetic in contravention with provisions of
Chapter IV of the Act or any rule made there
under .Offence under section 18 (a) (vi).
Imprisonment for a term which may extend to 1
year or fine which may extend to 1000 rupees.
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11. Sale or stock/exhibit for sale/distribution of a
cosmetic imported or manufactured in
contravention with provisions of the Act or any
rule made thereunder, Offence under section 18
(b)
Imprisonment for a term which may extend to
1 year or fine which may extend to 1000
rupees.
Manufacture for sale/distribution of a cosmetic
except under, and in accordance with a
license issued for the purpose. Offence under
section 18(c)
Imprisonment for a term which may extend to
1 year or fine which may extend to 1000
rupees.
Manufacture for sale/distribution or
stock/exhibit for sale/distribution or sale of a
spurious cosmetic. Offence under section 18(a)
(ii).
Imprisonment for a term which may extend to
3 years and fine.
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Import of spurious cosmetic or a cosmetic
containing any ingredient which may render it
unsafe /harmful under indicate direction .offence
under section 13 (1) (a)
Imprisonment for a term which may extend to
three years and fine which may extend to five
thousand rupees.
Import of cosmetic ,import of which has been
prohibited under section 10-A.offence under
section 13(1) (c)
Imprisonment for a term which may extend three
years fine or which may extend to five thousand
rupees.
Import of cosmetic, other than the one mention
at S.No. 1,import of which is prohibited.
Offence under section 13 (1) (b)
Imprisonment for a term which may extend to six
months or fine which may extend to five thousand
rupees.
Repeated offence under S.No.1 or 3. Offence
under section 13(2) (a)
Imprisonment for a term which may extend to five
year or fine which may extend to ten thousand
rupees.

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Repeated offence under S.No.2 . Offence
under section 13(2) (b)
Imprisonment for a term which may extend to one
year or fine which may extend to one thousand
rupees.
Repeated offence under S.No.6 or 11. Offence
under section 13(2) (a). Respective section .
Imprisonment for a term which may extend to two
year or fine which may extend to two thousand
rupees.

14. REFERENCE
1. Sharma p.p.,” Cosmetics-Formulation Manufacturing and Quality Control,”4th Edition
2014, Published by-Vandana publication, Delhi ,Page no-32-34.
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