DRUGS AND COSMETICS
ACT
Contents of this chapter
•Definitions

•Administration of the act and rules

•Provisions related to Import

•Provisions related to Manufacture

•Provisions related to Sale

•Labeling and Packaging

•Schedules to the act and rules

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Learning Objectives
• At the end of this lecture, student will be able to

– Explain the provisions for drugs in Schedule X

– Describe the provisions for drugs for examination, test and analysis

– Discuss the provisions for manufacture of new drugs

– Discuss the provisions for loan and repacking licenses

– Discuss the provisions for penalties for manufacture of drugs

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Manufacture of Schedule-X drugs
Conditions

Accounts of all transactions regarding manuf. should be maintained in
serially.(Preserved for 5 years)
Have to sent invoice of sale to licensing authority every 3 months
Store drugs in direct custody of responsible person.

Preparation must be labeled with
Marketed in packings not exceeding
XRx XRx
100 unit dose –Tablets/Capsules
300 ml- Oral liquid
5 ml – Injection
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Manufacture of Drugs for Examination, Tests or Analysis
▪License is necessary for the manufacture of any drug in small quantity for the purpose
of examination, test or analysis.
▪If a person proposing to manufacture does not hold license i) to manufacture drugs
other than those specified in Schedule C, C1 & X, or ii) to manufacture drugs specified in
Schedule C, C1 in respect to such drugs; he should obtain license in Form 29.
▪If drug is not recognized as safe for use, license in Form 29 is only granted after
producing no objection certificate from LA appointed by Central Government.
▪License remains valid for a period of one year time
▪Drugs should 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.
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Conditions for License
1. Drugs should be used exclusively for the purpose for which they are
manufactured
2. Licensee should allow inspector to inspect the premises & satisfy himself
that only examination, test or analysis is being conducted.
3. Licensee should keep record of quantity of drugs manufactured and
supplied to any person.
4. Licensee should maintain inspection book to enable inspector to record
his impression and defects noticed.
5. Licensee must comply with any rules made subsequently and of which
the LA has given him NLT one months notice.

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Manufacture of New Drugs
▪Defined as a drug the composition of which is such that it is not generally recognized
among experts as safe for use under conditions recommended; or

▪Suggested on the label & includes any drug the composition of which is such that the
drug as a result of investigations for determining its safety for use under such conditions,
is so recognized but which has not otherwise than during course of such investigations,
been used to any large extend for any appreciable length of time under the said
conditions

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▪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 LA 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.

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Loan License
Definition:
A person(applicant) who does not have his own arrangements(factory) for
manufacture but who wish to manufacturing facilities owned by another licensee.
Such licenses are called Loan licenses.
Licence is obtained from licensing authority (FDA) on application in prescribed
forms (24-A , 27-A) with prescribed fees.
Loan licenses are issued for:
1) Drugs other than specified in C/C1 & X.
2) Drugs specified in Schedule-C/C1

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Loan Licenses
▪A loan license means a license which a LA may issue 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.
▪Issued for the manufacture for sale or distribution of drugs other than those specified in
Schedule C, C1 & X.
▪Application for license is made in Form 24-A & the license is issued in Form 25-A.
▪Before grant of license, the LA shall get the premises inspected by one or more inspectors.
▪Inspector shall check into all the portions of the plant & shall also inquire in professional
qualification for the technical staff employed.
▪For the manufacturing of additional items, an application must be made
to LA.
▪Licensee is required to test each batch of raw materials & finished products & the records
must be maintained for a period of 5 yrs from the date of manufacture. (2yrs in
case of drugs having expiry date, from the date of expiry)
▪Loan license is deemed to be cancelled or suspended if license owned by loan
licensee, whose manufacturing facilities is been availed by licensee is cancelled or
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Repacking Licenses
Repacking license are granted for breaking up of any drug other than those specified in
Schedule C, & C1, on application to LA in Form 24B & license is issued in Form 25B subject to
satisfying the following conditions:
1. The repacking operation must be carried out under hygienic conditions & under
supervision of competent staff namely,
a) A person who holds an approved Diploma in Pharmacy or is an Registered
Pharmacist.
b) A person who has passed intermediate examination with Chemistry as principal
subject.
c) A person who has passed matriculation & has at least 4 yrs. practical experience in
manufacturing, dispensing or repacking of drugs.
2. Factory conditions must specify conditions prescribed in Schedule M.
3. Applicant must have in his premises adequate facilities for the testing of drugs. Which is
separate from the repacking unit.
4. License must be kept at licensed premises & produced on request of DI www.DuloMix.com
5. Any change in competent staff must be reported to LA

6. For repacking of any additional items, application must be made to LA.

7. The label on repacked drugs should mention the name & address of the licensee
& his license number preceded by the word ‘Rpg. Lic. No.”

8. The license remains valid up to 31st December of the year following the year in
which it is grated.

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Repackaging license
Definition:

Process of breaking up any drug from a bulk container into small
packages and labeling with a view to their sale and distribution.

Repackaging of drugs is granted of drugs other than Schedule-C/C1 and X.

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Penalties Related to Manufacture
OFFENCES PENALTIES
Manufacture of any spurious drugs a) 1-3 years imprisonment and Rs.5000 fine
b) 2-6 years imprisonment & Rs.10000 fine on
subsequent conviction

Manufacture of adulterated drugs a) 1 year imprisonment & Rs.2000 fine
b) 2 years imprisonment & Rs.2000 fine for
subsequent conviction

Manuf. of drugs in contravention a) Imprisonment up to 3 months & Rs.500 fine
of the provisions b) Imprisonment up to 6 months & Rs.1000 fine
on subsequent conviction

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Manufacture of cosmetics
Prohibited for the following classes :

▪Misbranded or spurious cosmetics and of substandard quality

▪Cosmetics containing hexachlorophene or mercury
compounds

▪Cosmetics containing color which contain more than-

– 2 ppm of arsenic

– 20 ppm of lead

– 100 ppm of heavy metals

▪Eye preparations containing coal-tar color www.DuloMix.com
Summary
• Accounts of all transactions regarding manuf. should be maintained in serially.(Preserved for 5
years)
• Have to sent invoice of sale to licensing authority every 3 months
• License is necessary for the manufacture of any drug in small quantity for the purpose of
examination, test or analysis.
• If a person proposing to manufacture does not hold license i) to manufacture drugs other than
those specified in Schedule C, C1 & X, or ii) to manufacture drugs specified in Schedule C, C1 in
respect to such drugs; he should obtain license in Form 29.
• A person(applicant) who does not have his own arrangements(factory) for manufacture but
who wish to manufacturing facilities owned by another licensee. Such licenses are called Loan
licenses.
• Repacking license are granted for breaking up of any drug other than those specified in
Schedule C, & C1, on application to LA in Form 24B & license is issued in Form25B