Loan license Agreement
A. Overview
A loan license manufacturing agreement is entered by a company that is the marketing
authorization holder of a drug duly licensed to manufacture and market.
Under a loan license agreement, product specification know-how and its trademark are
transferred to a manufacturing company to use manufacturing facilities and its staff. The
drug is manufactured under the supervision of a company that has got a Loan License. The
quality, efficacy and safety are responsibilities of the Loan license holder. The product label
clearly describes the product manufactured by the name of loan licensee with the place
where the product is manufactured by the licensee manufacturing company.
B. Regulations
The law related to loan license agreement can be found in Rule 69 A and 75 A of the Drugs and
Cosmetics rules, 1945.
Both of these provisions define the loan license agreement as “For the purpose of this rule a loan
licence means a licence which a licensing authority may issue to an applicant who does not have his
own arrangements for manufacture but who intends to avail himself of the manufacturing facilities
owned by another licensee.”
C. Authorities
Applications for the Loan licenses shall be made before the competent authority appointed by the
state government.
C. Application for Loan License Agreement
1. Forms
name of license Form in which given Form in which Regulations
application is
made
For the grant or renewal of Form 25-A. Form 24-A 69-A of DCR
loan licenses to manufacture
for sale or for distribution of
drugs other than those
specified in Schedule C,
Schedule C (1) and Schedule
X
Applications for the grant or Intending to avail the Form 27-A 75-A of DCR
renewal of loan of drugs facilities as under Form 28
specified in Schedules C and and Form 28-B
C(1)
For grant or renewal of loan Form 28-D Form 27-DA 75-A 1(A) of
license to manufacture for DCR
sale or distribution of drugs in
Large volume Parenteral,
Sera and Vaccine and
Recombinant DNA derived
2. Requirements for obtaining the License
As per the provisions of the DCR following are the requirement a manufacturer has to comply at the
time of applying for the license.
The manufacture will be conducted under the active direction and personal supervision of competent
technical staff consisting at least of one person who is a whole-time employee and who is
(a) a graduate in Pharmacy or Pharmaceutical Chemistry or
(b) a graduate in Science or
(c) a graduate in Medicine or
(d) a graduate in Chemical Engineering or
(e) holding any foreign qualification, the quality and content of training of which are comparable with
those prescribed in clause (a), clause (b), clause (c) or clause (d)
The applicant proposing to manufacture medical devices and in-vitro diagnostics shall comply with the
quality management system as referred to in Schedule M-III.
The applicant shall provide adequate space, plant and equipment for pharmaceutical products
The applicant shall provide and maintain adequate staff, premises and laboratory equipment for
carrying out such tests of the strength, quality and purity of the substances as may be required to be
carried out by him
The head of the testing unit referred to in condition (4) shall possess a degree in Medicine or Science
or Pharmacy or Pharmaceutical Chemistry of a University recognized for this purpose and shall have
experience in the testing of drugs, which in the opinion of the Licensing authority is considered
adequate
The applicant shall make adequate arrangements for the storage of drugs manufactured by him.
The applicant shall, while applying for licence to manufacture patent or proprietary medicines, furnish
to the Licensing Authority evidence and data justifying that the patent or proprietary medicines−
(i) contain the constituent ingredients in therapeutic/prophylactic quantities as determined in relation to
the claims or conditions for which the medicines are recommended for use or claimed to be useful;
(ii) are safe for use in the context of the vehicles, excipients, additives and pharmaceutical aids used
in the formulations and under the conditions in which the formulations for administration and use are
recommended;
(iii) are stable under the conditions of storage recommended;
(iv) contain such ingredients and in such quantities for which there is therapeutic justification.;] and
(v) have the approval, in writing, in favour of the applicant to manufacture drug formulations
3. Tenure
Loan License given by the state government shall be valid for 5 years from the date of issue.
4. Fees
The application made upto ten items for each category of drugs shall be accompanied by a
fee of rupees six thousand and an inspection fee of rupees one thousand and five hundred
for every inspection or for the purpose of renewal of licences. the application for manufacture
of more than ten items of each category of drugs on a loan license, shall be accompanied by
an additional fee at the rate of rupees three hundred for each additional item of drugs.
D. Documents Required
APPLICATION FOR GRANT OR RENEWAL OF MANUFACTURING LOAN LICENCE.
[FOR APPLICATION IN FORM 24-A /27-Al
SR. DOCUMENTS No. OF COPIES
No.
1 COVERING LETTER ALONG WITH PAYMENT OF 1 COPY
APPLICATION FEE
2 SELF ASSESED CHECK LIST OF DOCUMENTS 1 COPY
3 FORM 24-A & 27-A (MAXIMUM 10 PRODUCTS 1 COPY
SHOULD APPLY UNDER EACH FORM)
4 MANUFACTURING LOAN NO. 1, 2 & 3. (ORIGINAL) 1 COPY
5 COPY OF SELLING LICENCE 1 COPY
6 PRODUCT LIST. 2 COPIES
7 LIST OF EXCIPIENTS. 1 COPY
8 SIMILAR PRODUCT. 1 COPY
9 DRAFT LABEL. 1 COPY
10 METHOD OF ANALYSIS. 1 COPY
11 ADDITIONAL INFORMATION FORM. 1 COPY
12 COPY OF MEMORANDUM OF ARTICLES 1 COPY
13 LIST OF DIRECTORS WITH ADDRESS 1 COPY
14 COPY OF POWER OF ATTORNEY TO SIGN 1 COPY
THE DOCUMENTS.
