The document summarizes the regulation of drug imports under the Drugs and Cosmetics Act of 1940 in India. It outlines that certain drugs cannot be imported if they are not of standard quality, misbranded, spurious, adulterated, or do not have an import license. Drugs specified in Schedules C and C1 can be imported under license, excluding those in Schedule X. An import license application requires a fee and must be accompanied by information about the drug. Licenses are valid until the end of the year issued and can be suspended or cancelled for non-compliance. Personal imports of drugs are allowed if for exclusive personal use and declared to customs.

1. Regulation of Import of
Drugs Under the Drugs and
Cosmetic Act 1940
SABYASACHI MAITY
Roll no:19301920045
5TH SEMESTER,3RDYEAR
B.PHARM
PHARMACEUTICALJURISPRUDENCE
PT-516

3. INTRODUCTION
• The Central Legislative Assembly passed the Drugs and
Cosmetics Act 1940 and rules 1945 with an objective to
regulate the import, manufacture and distribution and sale
of drugs and cosmetics. It is applicable on Allopathic,
Homeopathic, Unani and Siddha drugs as well on
contraceptives, mosquitoes repellents, creams, lotions,
cosmetics and devices used for internal and external use for
diagnosis.

4. OBJECTIVES :
1.The Drugs and Cosmetics Act 1940 provides the Central legislation, which regulates
import, manufacture, distribution and sale of drugs and cosmetics in the country.
2.The main objective of the Act is to ensure that the drugs available to the people
are safe and efficacious and the cosmetics marketed are safe for use.
3.The D and C Act regulates the manufacture and import of drugs into India so that
no substandard or spurious drugs get manufactured and imported in and into India
respectively.

5. IMPORT OF DRUGS :
• Prohibition of Import of Certain Drugs or Cosmetics:
Following Drugs and cosmetics cannot be imported:
1. Any drug or cosmetic which is not of standard quality;
2. Any misbranded or spurious or adulterated drug or cosmetics;
3. Any drug or cosmetic without import license, for the import, for which an
import license is prescribed.
4. Any patent or proprietary medicine, which has not displayed the true
formula or list of active ingredients with their quantities as per the label.

6. 5.Any drug which claims to cure or prevent any disease or ailments specified in
Schedule J.
6. Any cosmetic or drug containing any ingredient, which is unsafe or harmful.
7.Any drug or cosmetic whose manufacture, sale, distribution and import of
which is prohibited by rule made under this act
8. Drugs not labelled in the prescribed manner
.
9. Drugs after the expiry, and those which does not meet the standards, quality
and purity specified in the schedule-F

7. Import of Drugs under License:
The following classes of drugs can be imported under the license or permit
granted by the licensing authority:
• 1. Drugs specified in schedule C andC1 excluding those specified in schedule X.
• 2. Drugs specified in schedule X.
• 3. Minor quantities of drugs imported for the examination, test or analysis.
• 4. Drugs for personal use covered by a prescription of RMP.
• 5.Any new drug.

8. .
• 6. An application for an import License shall be made to the licensing
authority by the manufacturer or by the manufacturer’s agent in India and
shall be accompanied by a License fee of ` 1,000 for a single drug and ` 1,000
for each additional drug, duly signed by or on behalf of the manufacturer
7. The License remains valid upto 31st Dec of the year following the year in
which its granted unless cancelled or suspended earlier.

9. Registration Certificate:
‘Registration certificate’ means, certificate issued under Rule 27-A, by
the licensing authority in Form-41, for the registration of premises and
drugs manufactured by the manufacturer for import into and use in
India.
Suspension and Cancellation:
Both the Import License and Registration Certificate will be suspended or
cancelled, if the manufacturer or licensee fails to comply with any of the conditions
1.The drugs in the schedule C and C1 are prohibited for import into the country
after the expiry of potency of the drug product.
2. If the drug is banned in the country of origin then it is prohibited from
importing into the country except for the purpose of examination, test or
analysis

10. Import of New Drugs:
1. An application for an import License for small quantities of a new drug, as
defined in rule 122-E for the purpose of treatment of patient
2.A License for import of small quantities of a new drug, defined in rule 122-E, for
the purpose may be cancelled by the licensing authority for the conditions subject
to which the License was issued. If so, the licensee may appeal to the Central
Government within three months of the date of the order of cancellation.
Import of Drugs for Examination,Test or Analysis:
1.The drug is imported under a license in Form-11.
2.The drug must be exclusively examined in the place specified in the license by the
licensing authority

11. Import of Drugs or Cosmetics for Personal use:
Import of drugs which are otherwise prohibited under section 10 of the act can be imported
on following conditions:
1. Drugs or cosmetics must be a part of a passenger’s bonafide baggage and must be intended for the exclusive
personal use of the passenger.
2.They must be declared to the custom collector, if so directed

12. REFERENCES:
1.A Text Book of Pharmaceutical Jurisprudence; Sandeep D.S. , Sandeep D.S., Shabana
S. By NIRALI PRAKASHANI , First Edition 2019
2.Pharmaceutical Jurisprudence ; Neerja Gandhi, Harvinder popli , by CBS Publishers
& Distributors Pvt Ltd.,Reprint:-2015

13. THANK YOU
• .