DRUG AND COSMETIC ACT

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Drugs & cosmetics ACT & RULES (Import of Drugs)
Learning Objectives:
 To understand Drugs & Cosmetics Act & Rules
 Classes of drugs whose import is prohibited in India
 Classes of drugs which may be imported under License or permit
 Classes of drugs which may be imported without License or permit
 Concept of Misbranded drugs, Adulterated Drugs and Spurious Drugs
 Offences & Penalties related to the Import of Drugs
Description:
As we stated in the last module that Drugs & Cosmetics Act & Rules came in force 10th
April,1940
was having controls over operations related to Allopathic drugs only, Later amended to it was
having controls over operations related to Ayurveda, Unani , Siddha and Homeopathic drugs and
cosmetics. This Act kept amended till 2008. This act has various provisions related to Import,
manufacture, Sale, Labeling and Administration. A brief discussion of the Import of drugs and
provisions to it are covered in this chapter of PRISTYN RESEARCH SOLUTIONS.
IMPORT OF DRUGS:
Import of the Drugs, under D & C Act is defined as the process of bringing a material from a place
outside India to a place in India.

Classification:
1) Classes of drugs who’s 2) Classes of drugs which may 3) Classes of drugs can
Import is prohibited in India be imported under License be imported without License
(Misbranded drugs) (Schedule C & C1 Drugs)
(Schedule X Drugs) Drugs other than
(Adulterated Drugs) (Drugs for Analytical purpose) Specified in Class 1 & 2
(Drugs for Personal use)
(Spurious Drugs) (New Drugs)
1) Classes of drugs whose import is prohibited in India
The following classes of drugs are prohibited to be imported into India.
MISBRANDED DRUGS:
Example:
 Drugs colored,coated,powdered or
polished to conceal damaged or to
appear to be or better therapeutic
value than they really are.
 Drugs not lebelled in the prescribed
manner
 Drugs which are otherwise false and
misleading in claims
These are the drugs which are
prohibited to import in India
by law and if anybody comes
in contravention to the Act
related to the import of
misbranded Drug will be
punishable under the Act.

ADULTERATED DRUGS:
Drugs consisting of any filthy, putrid or decomposed substances
Drugs containing any harmful or toxic substances which may make them injurious to health
Drugs proceed or stored under insanitary conditions which may make them injurious to health
Drugs packed in container composed of poisonous or deleterious substances.
Drugs having color other than prescribed, and adulterated drugs are also those drugs admixed with
any substance which reduces their quality or strength.

SPURIOUS DRUGS:
Spurious drugs are those drugs which are imitations or substitute for other drugs
Drugs bears the name of other drug and drugs bear the name of manufacturer which are fictitious
& whose they are not the truly product.
Drugs containing ingredients in such quantities that there is no therapeutic justification
These all are those drugs which are not of standard quality and which do not comply with the
standard prescribed for them under the Act, Hence their import in India is prohibited. However
central Government by notification in official Gazette & in consultation with DTAB permit import of any
above listed class of Drug.
Case Study Related to drugs whose import is prohibited in India:
Indian pharmacologist charged with smuggling fake drugs
http://ibnlive.in.com/news/indian-pharmacologist-charged-with-
smuggling-fake-drugs/498492-2.html

2) Classes of drugs which may be imported under License:
There are five classes of drugs which can be imported into India after having a valid license or
permit, license is issued by licensing authorities it remains valid up to 31 Dec of the year following
the year in which it was granted, unless suspended or cancelled earlier. Licensing Authorities after
successful inspection grant a license for import of drugs for respective class. In any changes in the
constitutions of a license firm, the licensee should inform the licensing authority accordingly. A
separate license is necessary in respect of import of the drugs from each manufacturer.
A. IMPORT OF SCHEDULE C AND C1 DRUGS:
As stated a license is require for Import of schedule C and C1 drugs, It is granted with subject to
the following conditions:
The licensee must have adequate facilities for the storage of imported drugs so that
the properties of the drugs are preserved.
A record of the sale of imported drugs showing the particulars of the names of the
drugs and of the persons to whom they have been sold should be maintained.
The Licensee must allow the drug Inspector to inspect the premises where
imported drugs are stocked should be allowed, to check the record in respect of
their purchase and sale, and means employed to test the potency of the drug and to
take their samples for check analysis.
Licensee must, on request, furnish to the licensing authority sample of the drugs
from all batches or from such batches as the licensing authority may direct with
detail of the test if any carried out.
Licensee must not sell drugs from any batch from which samples have been
furnished to the licensing authority in case he is so advised by the said authority.
He may however dispatch the batch when a certificate has been issued to him by
licensing authority authorizing him to sell the drug from the batch. In case the
licensee is informed by the licensing authority that drug does not comply with the
prescribed standards. He should recall the batch from the sales as far as possible.
Must comply with the undertaking given in the form 9 and with such further
requirements has may be specified and of which he has been given not less than
four months noticed by licensing authority.
The import license or certain specified drugs, if the licensee or manufacturer fails
to observe any of the conditions of the license, after giving him an opportunity of
explaining himself. Person aggrieved by the decision of the licensing authority
may appeal to a court of law within 3 months of the date of order whose decision
shall be final.

B. IMPORT OF SCHEDULE X DRUGS:
C.IMPORT OF SMALL QUANTITIES OF DRUGS FOR EXAMINATION, TESTS OR ANALYSIS
Authority duly signed by the head of the institution where
the drug is to be used. The licensing authority has the right to call for such further particular as
may be considered necessary before the issue of the license of the prospective applicant. The
license is issued subject to the following conditions:
a) The licensee must use imported drugs exclusively for the purpose for which they are imported
and at the places specified in the license.
b) The license must keep the record of the substances imported under the license with respect to
their quantities, name of the manufacturer and the dates of their import and have to make report of
the details to the licensing authority.
c) Licensee must comply with such further conditions as may be prescribed and of which he has been given
at least one month’s notice by the licensing authority.
d) If the licensee fails to keep any conditions of the license the same may be cancelled by authority. The
licensee, however, has the right of appeal to the Central government within 3 months of the date of such
cancellation.
A license is necessary for the
import of small quantities of drugs
for analytical purposes. The
application for the license is
required to be made to the
licensing
A license is necessary for the import of schedule X drugs,
before granting the license the licensing authority ensures that
the licensee has proper facilities for storage of drug and may
also enquire into the occupation, trade or business ordinarily
carried out by the applicant.
The licensing authority may also refuse to grant the license if
the license granted previously to the applicant was suspended
or cancelled or in case the applicant fail to comply with any
provisions of the act and rules or has been convicted under a
drug and cosmetic act or narcotic and psychotropic substances
act however a person aggrieved by such decisions may appeal
to the central government within 30days whose decision shall
be final.

D. IMPORT OF DRUGS FOR PERSONAL USE:
In the normal course small quantities of drugs (up to average 100 doses) whose import is
otherwise prohibited ,may be imported without any permit ,provided they form part of
passenger’s bonafide luggage, are meant for his or her exclusive personal use and are declared
to the custom authorities. (In exceptional circumstances import of the drugs in excess of 100
doses may be sanctioned by the customs authorities).
If the drugs are imported for personal use and otherwise than as a part of passenger’s baggage
a permit is necessary to cover the import. The permit is granted by the licensing authority, if
the authority is satisfied that (a) the drug is for bonafide personal use and (b) the quantity
sought to be imported is reasonable and is covered by a prescription of a Registered Medical
Practitioner.
E. IMPORT OF NEW DRUGS:
No new drugs are allowed to be imported into the country without the sanctioned of the
licensing authority in writing. All drugs whose composition is not recognized as safe for the
use by experts and which have not been used to any large extent or for any appreciable
period of time are to be regarded as new drug.
Permission for the import of new drugs may be obtained from the licensing authority after
furnishing to him documentary evidence of the standards of quality, purity and strength of the
drug. The application for import of new drugs including their fixed dose combinations should
be accompanied as specified in schedule Y, provided that data on clinical trial for a drug may
not be submitted ,if the licensing authority decides to grant import permission without it in
public interest.
3) Classes of drugs which can be imported without License:
Drugs other than dose discussed above, may be imported without any permit or license.
However, before such drugs are imported into the country, their importers or manufacturers
should submit a declaration to the Customs Collector that they comply with all the
provisions of chapter 3 of drug and cosmetics act and the rules made under the same.

SOME OTHER PROVISIONS REGARDING IMPORT OF DRUGS
A. Custom collector’s authority over import:
The law letting to goods whose import is prohibited
under section 18 of the see customs act 1878 is
applicable to drugs whose import is prohibited. The
customs collector can detain any consignment of
drugs whose import is prohibited and report to the
drugs controller of India. Samples of any drugs
whose standards are suspected or whose compliance
with the act and rules in it doubt can be sent to
central drugs laboratory or any other laboratory
specified for analysis and report.
Consignment from which samples have been drawn
and sent for analysis may be detained by customs
collectors until receipt of reports on analysis.
however ,if the importer gives an undertaking in
writing to not to disposed of drugs from such
consignment without custom collector’s consent and
to return the same to him. If so required with 10 days
of notification the consignment may be released to
the importer.

If the report of the analysis indicates that the sample of any drug in the consignment does not come
up to the prescribed standards or contravenes any of the provisions of chapter 3rd
of the act and the
rules in any manner and the defects are such that they cannot be remedied by the importer, the
custom collector may ask the importer to export the consignment bag to the manufacturer within 2
months of the receipt of information from the custom collector or forfeit it to the central
government for destruction . If the importer is aggrieved by the report of analysis, he may make
representation against the report to the custom collector who shall forward the samples together
with representation to the licensing authority. The decision of the licensing authority shall be final
in the matter. In case the report of analysis indicated that the contravention is such that it can be
remedied by the importer ,the customs collector may permit the import provided the importer gives
an undertaking not to dispose of the without the permission of the officer authorized in this behalf
by the central government.
B. Place at which Drugs may be imported:
Import of drugs in India is allowed only through the following places:

Places in India where Drugs can
be imported under D&C Act.
PRISTYN RESEARCH SOLUTIONS
Mumbai
Madras
Calcutta
Cochin
Vishakhapatnam
Delhi
Ahmadabad
Amritsar
Ranaghat
Raxaul
Bongaon

C. Offences and penalties Related to import of Dugs:
Summary:
In this session of PRISTYN RESEARCH SOLUTIONS we have learnt about the provisions of
Drugs & Cosmetics Act related to the import of any drug into India, where you can now better
explain about the Misbranded, Adulterated and Spurious Drugs. Also about the License and permit
required for import of drugs. Now you have better understanding about the various places & routes
at which drugs are imported. Offences & Penalties related to import of drug should keep in the
mind while dealing with import related activities in India as Drugs & Cosmetics Act has strict
regulations and rules over it.
OFFENCES PENALTIES
Anyone who imports a spurious or
adulterated drug or drugs which involve any
risk to human beings or animals or drugs
not having claimed therapeutic value
Shall be punished with imprisonment up to
3 years or fine up to Rs. 5000 on first
conviction and imprisonment up to 5 years
& fine up to Rs. 10000 for any subsequent
offence
Persons importing drugs in contravention of
other provisions
Punishable with imprisonment up to 6
months and/or fine up to Rs. 500 on first
conviction and imprisonment up to 1 year
&/or fine up to Rs. 1000 for any subsequent
conviction.
These punishments shall be in addition to any punishment that may
be imposed under Sea customs Act. The offence cannot be tried in
courts inferior to that of a Metropolitan Magistrate or Judicial
Magistrate of the First class.

Note: Other oral description and case studies are detail explained in attached video.
Competitive Exam Possible Practice Questions:
1. Correct the following, if necessary:
I. The drugs may be imported by air at Bombay, Calcutta, Delhi, Madras and Cochin.
II. A drug which claims to cure a disease specified in schedule X cannot be imported.
III. Drugs other than chose in schedule C and C1 and X can be imported without
license.
IV. In the normal course a passenger coming from any foreign country can be bring up
to 500 average doses of a drug meant for his /her/personal use.
V. No drug license is required for quinine and other antimalarial drugs.
VI. By sea, drugs can be imported at Delhi, Calcutta, Bombay, Madras and Cochin.
VII. Drugs can be imported by air at Bombay, Delhi, Madras, Calcutta and Allahabad.
VIII. A patent medicine for cure of diabetes whose true formula is disclosed can be
destroyed.
IX. Consignments of substandard medicine not collected by importers can be destroyed.
2. Explain:
I. How consignment of imported drugs is found to be substandard required to be
disposed off?
II. Whether homeopathic drugs may be imported into India without any license.
3. What types of preparations are exempted from duty?
4. What is underlying reason for:
I. Ban on import of drugs which claim to cure diseases specified in schedule J.
II. Discuss whether a person importing the drug such as (3) insulin, antibiotics, drugs
for appendicitis, cancer, insanity etc. is contravening the law? If yes, how?
III. Why complaints about non-standard drugs cannot be filed in courts directly by
individual citizens.

5. Fill in the blanks:
I. Imported drugs declared to be substandard should be
_________________________ or ____________________________.
II. From Pakistan import of drugs by rail is allowed at
__________________________ or ___________________________.
III. Proprietary drugs _______________________ is not disclosed cannot be imported.
IV. No license is necessary for _______________for __________________ used
solely __________________ of drugs.
V. By sea drugs can be imported at _______________, ________________,
_______________, and __________________.
VI. Patent medicines cannot be imported unless there ________________________ is
given.
VII. No license is needed for import of drugs other than _______________________.

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DRUG AND COSMETIC ACT

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