This document summarizes regulations regarding the import of drugs and cosmetics into India. It defines key terms like drugs, cosmetics, misbranded drugs, adulterated drugs, spurious drugs, misbranded cosmetics, and spurious cosmetics. It outlines rules for importing drugs under a license, including for Schedule C, C1, and X drugs. It also discusses importing drugs for personal use, importing new drugs, and importing drugs by government hospitals. Exceptions to import rules are provided. Finally, penalties for contravening import provisions are stated.

1. SHALOM INSTTITUTE OF HEALTH AND ALLIED SCIENCES, FHS, SHUATS
ALLAHABAD
IMPORT OF DRUGS AND COSMETICS
Prepared By:
Name ID No.
Abhishek Kumar Karn 16BPH085
Md. Zaiem Ali 16BPH048
B.Pharmacy
6th semester
Submitted To:
Dr. Vikas Kumar
SIHAS, FHS, SHUATS

2. Import of drugs and
cosmetic

3. Definitions
Drugs :
a) substances used for the internal or external indented to be used for or in diagnosis, treatment
,mitigation or prevention of any disease or disorder in human beings or animals including preparation
applied for repelling mosquitoes
b) substances indented to affect any function of human body or indented to be used for the destruction of
vermin or insects that cause disease in human beings or animals
c) all substances indented for use as components of drug including empty gelatin capsules
d) Devices indented for internal or external use in the diagnosis, treatment, mitigation or prevention of
disease or disorder in human beings or animals.
Cosmetic :
Any article intended to be rubbed, poured, sprinkled or sprayed on, or otherwise applied to, the human body
or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and
includes any article intended for use as a component of cosmetic.
Misbranded drugs :
a) if it is not labelled in the prescribed manner; or
b) if its label or container or anything accompanying the drug bears any statement, design or device which
makes any false claim for the drug or which is false or misleading in any particular.

4. (a) if it consists, in whole or in part, of any filthy, putrid or decomposed substance; or
Adulterated drug :
(b) if it has been prepared, packed or stored under insanitary conditions whereby it may have been contaminated
with filth or whereby it may have been rendered injurious to health; or
(c) if its container is composed in whole or in part, of any poisonous or deleterious substance which may render the
contents injurious to health.
(d) If any substance has been mixed there with so as to reduce its quality or strength.
Spurious Drugs: A drug is deemed to be spurious –
(a) if it is imported under a name which belongs to another drug; or
(b) if it is an imitation/copy of, or a substitute for, another drug or resembles another drug in a manner likely to
deceive or bears upon it or upon its label or container the name of another drug . or
(c) if it has been substituted wholly or in part by another drug or substance.or
Misbranded Cosmetics: A cosmetic is deemed to be misbranded –
(a)If it contains color which is not prescribe; or
(b) If it is not labeled in prescribed manner; or
(c)If the label or container of anything accompanying the cosmetic bears any statement which is false or
misleading in particular.

5. Spurious Cosmetics: A cosmetic is deemed to be spurious –
(a)If it is imported under a name which belongs to another cosmetic; or
(b)If it is an imitation of, or a substitute for, or resembles another cosmetic in a manner likely to deceive or bears
upon it or upon its label or container the name of another cosmetic, unless it is plainly and conspicuously marked so
as to reveal its true character and its lack of identity with such other cosmetic; or
(c)If the label of the container bears the name of an individual or company purporting to be the manufacturer of
the cosmetic, which individual or company is fictitious and does not exist; or
(d)If it purports to be the product of a manufacturer of whom it is not truly a product.
New Drug
(a)A new substance of chemical, biological or biotechnological in origin, in bulk or prepared dosage form used for
prevention, diagnosis, or treatment of disease in man or animal; which except during clinical trials has not been uses
in the country to any significant extent and which has not been recognized in the country as effective and safe for
the proposed claims. or
(b)The drug which is first time introduced in country but previously it is used in other countries.
Import of Drug & Cosmetic
• Some drugs/cosmetics can be imported without any permit, providing they are of standard quality & statement that
they comply with the provisions relating to import has been given to the Customs Collector by manufacturer or
importer.
• Drugs/cosmetics may be imported to India under the authority of a license excepting those whose import is
Prohibited.
● Bring into a country from abroad for sale.

6. Prohibition of Import of certain drugs or cosmetics
• No person can import
1. Any drug/cosmetic which is not of standard quality
2. Any misbranded, spurious or adulterated drug
3. Any misbranded or spurious cosmetic
4. Any drug/cosmetic for import for which license is prescribed otherwise than under & in accordance with such
license.
5. Any patent or proprietary medicine unless there is displayed in the prescribed manner on the label the true
formulae or list of active ingredients in it.
6. Any drugs which purports to claim or mitigate any such disease or ailment specified in schedule j in the rules
7. Any cosmetic which contains an ingredient which may render it unsafe for use.
8. Drugs whose manufacture sale & distribution are prohibited in the country of origin,
9. Drugs not labeled & packed in prescribed manner
10. Biologicals & other special products after the date of their expiry as mentioned in label or those not complying
with the standards of strength, quality, purity as may be specified.
11. Any new drug expect with express permission of licensing authority.
12. Any drug/cosmetic, the import which is prohibited under the rules.

7. Import of Drugs under License
• The following classes of drugs can be imported under the license
1. Drugs specified in Schedule C C1
2. Drugs specified in Schedule X
3. Small quantities of drugs imported for the purpose of examination, test or analysis.
4. Drugs for personal use covered by the prescription of registered medical practitioner.
5. Any new drug
• An application for import license must be made to the proper authority in prescribed form & license remains
valid up to 31st December of the year following the year it was granted unless it was suspended earlier.
• Aggrieved party has the right to appeal in High Court against an order of the drugs controller of India
canceling the import license granted to him.
• A separate license is necessary in respect of drugs from each manufacturer
• A separate license is necessary in respect to drug manufactured in each premises when a single manufacturer
abroad has more than one factory.
• A single application may be made & single license may be issued in respect of import of more than one drug or
class of drugs manufactured by same manufacturer.

8. Import of Schedule C, C1 & X drugs
Licensee must have adequate facility for the storage.
Licensee must maintain a record of the sale, showing the particulars of the names of drugs and of the persons
to whom they have been sold.
Licensee must allow an inspector to inspect premises and to check the records.
Licensee on request shall supply sample of drug from all batches to licensing authority for test or analysis.
Licensee must not sell drugs from which sample is withdrawn.
Import of the Schedule-X drugs (Narcotic & Psychotropic drugs)
Licensee must have adequate storage facility.
Applicant must be reputable in the occupation, trade or business.
licensing authority may refuse to grant the license if the license granted to the applicant previously was
suspended or cancelled.
If the applicant is not satisfied with the decision may appeal to central gov within 30 days.
Drugs Imported for examination, test or analysis
License is necessary under form-11
Must use imported drugs only for said purpose and at the place specified in the license.
Must keep the record with respect to quantities, name of the manufacturer and date of import.
Must allow an inspector to inspect the premises and check the records.
Licensee must keep record of samples imported under the license together with their quantities, date of
importation &name of manufacturer.

9. Import of Drugs for Personal Use:
Up to 100 average doses may be imported without any permit, provided it is part of passenger’s luggage.
More than 100 doses imported with license. Apply on form no.-12-A,12-B
Drugs must be for personal use.
Drugs must be declared to the custom collectors if so directed.
Import of New Drugs:
No new drug can be imported except with the permission of the licensing authority. While applying for such
permission, all documentary & other evidence relating to standards of quality, purity & strength should be supplied to
the licensing authority
• Procedure for Import of New Drugs:
• The drugs should be labeled in conformity with the prescribed rules. All consignments of drugs to be imported
should be accompanied by an invoice or other statement showing the make & address of the manufacturer & the
names & quantities of the drugs. Before importing such drugs, declaration signed by the manufacturer on behalf of the
importer that the drugs comply with the provisions of the Acts & Rules ‘d be supplied to the customs collector.
• Customs Collector can take samples of any drugs in the consignment & forward to the director of laboratory
appointed for this purpose by the Central Government. If report of analysis indicate that the drug in a consignment is
not of standard quality the Customs Collector may direct the imported to export back the consignment to the
manufacturer within two months or forfeit the same to Central Government for destruction.

10. Import of drugs by Govt. Hospitals/Medical Institutions for the treatment of patients:
Small quantities of new drugs otherwise prohibited for import may be imported for the treatment of patients
suffering from life-threatening diseases or diseases causing serious or permanent disability by a medical
officer of Govt. Hospital or Medical Institution. Application for such import must be made in Form 12AA.
Exempted Drugs: the drugs specified in Schedule D are exempted from provisions of import of drugs as follows
Substances not used for medicinal purpose
Drugs in Sch-C1 required for manufacturing and not for medicinal use.
Substances which are both drugs and foods such as: Condensed/Powdered Milk ,Malt, Lactose ,Cereal, Oats
Predigested foods
Ginger, Pepper, Cumin, Cinnamon
Cosmetics prohibited to import
Misbranded cosmetics
Spurious cosmetics
Cosmetic containing harmful ingredients
Cosmetics not of standard quality
which contains more than-2 ppm Arsenic, 20 ppm lead, 100 ppm heavy metals

11. • Ferozpur cantonment & Amritsar
Railway station
• Ranaghat, Bongaon & Mohiassan
Railway Stations
• Raxaul
• Chennai, Kolkata, Mumbai, Cochin &
Kandla
• Chennai, Kolkata, Mumbai, Delhi,
Ahmedabad & Hyderabad
• In respect to drugs imported by rail across the
frontier with Pakistan
• In respect to drugs imported by rail across the frontier with
Bangladesh
• In respect to drugs imported by road & rail connecting India &
Nepal
• In respect to drugs imported by sea into India
• In respect to drugs imported by air into India
Places through which drugs may be imported in India

12. Penalties related to Import
Import of spurious OR
adulterated drug OR drug which
involves risk to human beings or
animals OR drug not having
therapeutic values
Contravention of the provision
OFFENCES PENALTIES
a) 3 years imprisonment and 5000 Rs. fine on first
conviction
b) 5 years imprisonment OR 10000 Rs. fine
OR both for subsequent conviction
a) 6 months imprisonment OR
500 Rs. fine OR both for first conviction
b) 1 year imprisonment OR 1000
Rs. fine for subsequent offence