2. CONTENTS
1. INTRODUCTION
2. OBJECTIVES
3. CLASSES OF DRUGS PROHIBITED TO IMPORT
4. IMPORT OF THE BIOLOGICAL DRUGS(C/C1)
5. IMPORT OF THE SCHEDULE-X DRUGS(NARCOTIC & PSYCHOTROPIC DRUGS)
6. DRUGS IMPORTED FOR PERSONAL USE
7. IMPORT OF DRUGS WITHOUT LICENSE
8. PENALTIES RELATED TO IMPORT
9. THE PLACES OF IMPORT OF DRUG IN THE COUNTRY
10. CONCLUSIONS
11. REFERENCES
3. INTRODUCTION
1. Now a days foreign pharmaceutical companies have strict lawful foundation for releasing new
drugs in India.
2. The Indian medical regulatory system has become more muddled, and new drugs can required a
year or more to be approved for marketing.
3. In India the import of drugs is controlled by CDSCO. It exercises the regulation through its
eleven port offices which are situated all through the country.
4. The CDSCO give approval of new drugs , clinical trials and check the standard and quality of the
imported drugs.
4. OBJECTIVES
To regulate the import of drugs through licensing.
Import of drugs and cosmetics by qualified persons only.
To prevent Misbranded, Adulterated and substandard in drugs.
To regulate the import of Ayurvedic, Siddha and unani drugs.
To establish DTAB & DCC for allopathic and related drugs and cosmetics.
5. CLASSES OF DRUGS PROHIBITED TO
IMPORT
Misbranded drugs
Adulterated drugs
Spurious drugs
Drugs claiming to cure diseases specified in Schedule-J
Drugs whose manufacture, sale/distribution are prohibited in original
country, except for the purpose of test, examination and analysis.
Patent/proprietary medicines whose true formula is not disclose.
6. IMPORT OF THE BIOLOGICAL DRUGS(C/C1)
Conditions to be fulfilled:
Licensee must have adequate facility for the storage.
Licensee must maintain a record of the sale.
Licensee must allow an inspector to inspect premises and to check the
records.
Licensee must furnish the sample to the authority.
7. IMPORT OF THE SCHEDULE-X DRUGS
(NARCOTIC & PSYCHOTROPIC DRUGS)
Conditions to be fulfilled:
Licensee must have adequate storage facility.
Applicant must be reputable in the occupation, trade or business.
The license granted even before should not be suspended or cancelled.
The licensee has not been convicted any offence under the Drugs &
Cosmetics Act or Narcotic and Psychotropic Substances Act.
8. DRUGS IMPORTED FOR PERSONAL USE
Conditions to be fulfilled:
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 bonafide personal use.
The quantity should be covered by RMP prescription.
Drugs must be declared to the custom collectors if so directed.
9. IMPORT OF DRUGS WITHOUT LICENSE
Substances not used for medicinal purpose.
Drugs in Schedule-C1 required for manufacturing and not for
medicinal use.
Substances which are both drugs and foods such as:
Condensed/powdered milk
Malt
Lactose
Farex/cereal
Oats
Pre-digested food, Ginger, Pepper, Cumin, Cinnamon.
10. PENALTIES RELATED TO IMPORT
OFFENCES
• Imported of spurious or adulterated
drugs or drug which involves risk to
human beings or animals or drug not
having therapeutics values.
• Contravention of the provision
PENALTIES
a. 3 years imprisonment or 5000 Rs.
Fine in first conviction
b. 5 years imprisonment or 1000 Rs.
Fine or both for subsequent
conviction
1. 6 months imprisonment or 500 Rs.
Fine or both for first conviction
2. 1 years imprisonment or 1000 Rs.
Fine for subsequent offence
11. THE PLACES OF IMPORT OF DRUGS IN THE
COUNTRY
Firozepur cantonment and Amritsar Railway Stations: imported from Pakistan
Ranaghat, Bongaon and Mohiassan Railway Stations: imported from Bangladesh
Raxual: imported from Nepal
[Chennai, Kolkata, Mumbai, Cochin, Nhava Sheva and Kandla]: imported by sea port
into India
[Chennai, Mumbai, Delhi, Ahmedabad and Hydrabad]: imported by
airport into India
12. CONCLUSION
The process of Import of Drugs in any country including India is a lengthy
process involving the various reviewing and registration processes.
Drugs & Cosmetics rules (1945) prescribe various procedures for getting a
drug approved to be imported for human-veterinary use in the country. The
rules are very clear prescribing the procedure to be adopted in this regard.
Latest amendments are given by the CDSCO according to the current Laws
and Trading strategies for the approval for Import in India gives an outlook
on the entire process of getting a Drug Imported in India.
13. REFERENCE
The Drugs and Cosmetics Act,1940 and Rules,1945. By S.W.
Deshpande and Nilesh Gandhi.
