Regulatory Guidelines for Drug Manufacturing Under the Drugs and Cosmetics Act, 1940 & Rules, 1945

MANUFACTURE OF DRUGS
Manufacture in relation to any drug includes any
process or part of a process for making, altering, finishing,
packing, labelling, breaking up or otherwise treating or
adopting any drug with a view to its sale and distribution, but
does not include compounding or dispensing of any drug or
packing of any drug in ordinary course of retail business.
Manufacture of drugs is a blend of art and science, to be
achieved strictly in accordance with the provisions of Good
Manufacturing Practices (GMP).

 A person who is interested in starting manufacturing of drugs is
required to fulfill several conditions laid down in DCA and Rules.
 The conditions to be fulfilled before license is granted are
collectively called as "Conditions Precedent" and conditions that
are required to be fulfilled after the license is obtained for
manufacturing are called "Conditions Subsequent".
 The Licensing Authority is both in States and at Central
Government.
 The Central Government is empowered to prohibit
manufacturing and sale of any drug formulation in public
interest.
 License valid up to 5 years from the date of grant or renewal
unless otherwise suspended or cancelled.

Licenses are required for the manufacturing of following
categories of drugs.
Manufacturing of drugs belonging to Schedules C and C1
Manufacturing of drugs belonging to Schedule X
Manufacturing of drugs belonging to Schedules C, C1 and
X
Manufacturing of drugs other than Schedule C, C1, and X
Manufacturing of drugs for examination, test or analysis
Loan licenses
License for Repacking

THE FOLLOWING CATEGORIES OF DRUGS AND COSMETICS ARE PROHIBITED TO BE
MANUFACTURED OR SOLD IN OUR COUNTRY
 Any drug or cosmetic which is substandard, misbranded, adulterated or spurious.
 Any patent or proprietary medicine without clear indication of ingredients.
 Any drug claiming for accurate cure or prevention of diseases listed in Schedule J.
 Any manufacturing of formulation containing drug or cosmetic which has been
imported into our country in contravention to the provisions of the Act and Rules.
 Manufacturing for sale of any drug or cosmetic containing any harmful ingredient.
 Manufacturing for sale of any drug or cosmetic in contravention to the provisions
of the Act and Rules, provided that manufacture of small quantities of any drug for
the purpose of examination, test or analysis is permitted, subject to prescribed
conditions.

MANUFACTURING LICENSE:
Issued to person or organization who has their own
arrangements for the manufacturing and standardization of
drugs. Different license are issued for different classes of drugs.
LOAN LICENSE:
Issued to person who does not have his own arrangements
for manufacture but who intends to avail himself of the
manufacturing facilities owned by another license.
REPACKING LICENSE:
Granted for the purpose of breaking up any drug from a
bulk container into small packages and labelling of each
packages for sale and distribution (does not include the
compounding or dispensing or packing of any drug).

Type of
License
Classes of Drugs Forms
Manufacture
of Drugs for
Sale or
Distribution
Application for the grant of or renewal of a license to manufacture for sale or
for distribution of drugs other than those specified in [Schedule C, C (1) and
X]
Form 24
Application for grant or renewal of a license to manufacture for sale or for
distribution of drugs specified in Schedule X and not specified in Schedule C
and C(1).
Form 24F
distribution of drugs specified in Schedule C and C (1) excluding those
specified in part XB and Schedule X
Form 27
distribution of drugs specified in Schedules C, C (1) and X.
Form 27B
Application for grant/renewal of license for the operation of a Blood Bank for
processing of whole blood and / or preparation of blood components.
Form 27C
https://drugscontrol.tn.gov.in/download_application.html

Type of
License
Classes of Drugs Forms
Manufacture
of
Homeopathic
Drugs for Sale
or
Distribution
Application for the grant or renewal of a license to manufacture for sale [or
for distribution] of Homoeopathic medicines or a license to manufacture
potentised preparations from back potencies by licensees holding license in
Form 20-C
Form 24C
Loan License
Application for grant or renewal of a loan license to manufacture for sale or
for distribution of drugs other than those specified in Schedule C, C (1) and X
Form 24A
Application for grant or renewal of a loan license to manufacture for sale or
for distribution of drugs specified in Schedule C and C (1) excluding those
specified in part XB and Schedule X
Form 27A
Manufacture
of Cosmetics
Application for grant or renewal of a license to manufacture cosmetics for
sale or for distribution
Form 31
Application for grant or renewal of a loan license to manufacture cosmetics
for sale [or for distribution]
Form 31A
Repackaging
Application for grant or renewal of a license to repack for sale or distribution

The following conditions must be fulfilled by the licensee
 Use manufactured drug exclusively for the purpose for which
they are manufactured.
 Drugs would be kept in containers bearing labels indicating
the purpose for which it has been manufactured.
 If the drugs are to be supplied, it should bear label stating
name & address of manufacturer, scientific name of
substance & purpose for which it has been manufactured.
CONDITIONS FOR LICENSE

 The application for manufacturing a new drug including their fixed dose
combinations should be supplemented along with the data mentioned in
Schedule Y.
Provisions applicable for the manufacture of new drugs:
 Whether classifiable under schedule C&C1, or otherwise: No new drug can
be manufactured unless prior approval of the Licensing authority has been
taken.
 Applicant should produce all documentary & other evidence relating to the
standards of quality, purity, strength & such other information as may be
required including the results of therapeutic trials carried out on the new
drug.
 While applying for a license to manufacture a new drug, or its preparations
an applicant should produce along with his application evidence that the
drug has already been approved.
CONDITIONS FOR MANUFACTURE OF NEW DRUGS

 It means a license issued by the 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 licensee.
 Application for grant of loan license should be supported by
documentary consent of the licensee whose facilities he is going
to use.
Loan licenses are issued for:
 Drugs other than specified in C/C1 & X.
 Drugs specified in Schedule-C/C1
LOAN LICENSE

 Before granting a license the authority may satisfy himself that
the person, whose facilities applicant wishes to use must
possess necessary staff, equipment & space for manufacture of
drugs.
 The loan license shall be deemed to be cancelled or suspended,
if the license owned by licensee whose manufacturing facilities
have been availed by the licensee is cancelled or suspended.
 The licensee must test each batch of raw material & finished
product & Maintains records of the tests for at least 5 years
from the date of manufacture.
CONDITIONS FOR LOAN LICENSE

 It means the process of breaking up any drug from a bulk
container into small packages & the labelling of such package
with a view to its sale & distribution, but does not include the
compounding or dispensing or the packing of any drug in the
ordinary course of retail business.
Person licensed to repack drug should observe the following
condition
 Licensed premises must conform to the requirements of GMP
specified in schedule M.
 Licensee must provide adequate arrangements for testing the
strength & quality of drugs.
REPACKING LICENSE

The manufacture of drugs must be carried out under active direction & personal supervision of 'competent person'
 a) person who either holds diploma in pharmacy or Registered pharmacist under pharmacy act. OR
 b) Have passed the intermediate examination with chemistry as principal subject. OR
 c) Have passed matriculation examination & have not less than 4 years of experience in manufacturing or
dispensing or repacking of drugs.
Licensee must follow these conditions
 Adequate facilities for the storage of drugs, so that the properties of drugs are preserved.
 Repacked drug should bear the no, of license with words "Rpg. Lic. No." on its label.
 Inform to the licensing authority about any changes in the technical staff or any material changes in the
 plant or premises since the date of last inspection
 on request, shall supply the samples of drugs from all the batches to the licensing authority for test or analysis.
 The license should be kept on the licensed premises & should produce before an inspector on demand
 Should comply with the provisions of the act.
CONDITIONS FOR REPACKING LICENSE

COMMON CONDITIONS
TEST, EXAMINATION &
ANALYSIS
LOAN LICENSE REPACKAGING LICENSE
Maintain the records of the
manufactured drugs,
showing particular of their
quantities & names of the
persons to whom they have
been supplied.
Licensee should maintain
manufacturing & analytical
records of drugs.
Maintain the records for
the repacking of drugs.
Licensee must allow the
inspector to inspect the
premises where drugs are
kept & to check the record
& to take the samples for
test or analysis.
kept & to check the record
& to take the samples for
test or analysis.
repacked & to check the
records & to take the
samples for test or analysis.

OFFENCES PENALTIES
Manufacture of adulterated
OR spurious drugs
Imprisonment for a term which shall not be less than ten years but
which may extend to imprisonment for life and shall also be liable to
fine which shall not be less than ten lakh rupees or three times value
of the drugs confiscated, whichever is more.
Cosmetic deemed to be
spurious
Imprisonment for a term which may extend to three years and with
fine which shall not be less than fifty thousand rupees or three times
the value of the cosmetics confiscated, whichever is more.
Not keeping documents and
for non-disclosure of
information
Imprisonment upto one year or with fine may be extended to Rs. 1000
or both.
Non-Disclosure of the
Manufacturer Name
Imprisonment upto 1 year or with a fine which is not less than Rs.
20,000 or with both.
For the use of Government
Analyst's Report for
Advertising
Punishable with a fine which may be further extended to Rs. 5,000
OFFENCES AND PENALTIES

Regulatory Guidelines for Drug Manufacturing Under the Drugs and Cosmetics Act, 1940 & Rules, 1945

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Regulatory Guidelines for Drug Manufacturing Under the Drugs and Cosmetics Act, 1940 & Rules, 1945