Import of drugs – mimprovement(1)

Import of drugs

The import of drugs encompasses the process by which pharmaceutical products are legally brought into a country from abroad. This involves ensuring compliance with regulatory guidelines and quality standards, as well as navigating customs procedures and documentation requirements.

It means to bring any drugs and cosmetics into India from foreign(any other country). Now, the import of drugs and cosmetics is regulated by the provision of this drugs and cosmetics act.

Classes of drugs and cosmetics prohibited from import

• Any drugs or cosmetic which are not of standard quality.
• Any drugs or cosmetic which are misbranded, adulterated and spurious.
• Any drugs or cosmetic which are require import licence and imported without such license.
• Any patent or proprietary medicines, the true formula or list of active ingredients with their true quantity is not display on the label or container in prescribed manner.
• Any drugs which claim to cure or prevent any disease described in schedule T.
• Any drugs or cosmetic for which manufacture, sale or distribution is prohibited in country of its origin.
• Any changes containing any such ingredient which may render it unsafe or harmful for use.

Import under license or permit

1. Drugs specified in schedule C & C1

• The license for the import of schedule C & C1 drugs requires following conditions:
• License must have suitable facilities for storage.
• License must maintain the records of sale of drugs, showing particulars of the names of the drugs and of the persons to whom they have been sold.
• License must allow an inspector to inspect the premises, where imported drugs are stored and to check the record and to take the sample for test or analysis.
• License shall supply the sample of drugs from all batches to the licensing authority for test or analysis.
• The import license may be cancelled or suspended, if condition is not satisfied.

2. Drugs specified in schedule X

Required following conditions:

• License is necessary and license must have adequate facilities for storage.
• The license granted ever before should not be suspended or cancelled.
• Applicant must be reputable in the occupation, trade or business.

3. Import of small quantities of drugs for examination, test or analysis

Required following conditions:

• The license must use imported drugs exclusively for the purpose for which they are imported and specified in the license.
• License must maintain the records of imported drugs, showing particulars of their quantities, names of manufacture & date of import.
• Imported under license in form-11.

4. Import of drugs for personal use

Required following conditions:

• The drugs must be Bonafide personal use.
• The quantity should be reasonable and covered by RMP prescription.
• The drug shall be declared to the customs authority.
• More than 100 doses are imported with license, applying in form no. 12A and 12B.

5. Import of drugs(new)

Required following conditions:

• License is required
• The license is required to provide the documents of standards of quality, purity and strength.

Procedure for imported of drugs

1. No drugs can be imported unless it is packed & labelled.

2. All consignments of drugs to be imported should be accompanies by an invoice or other statement showing the make & address of the mfg. & the name & quantities of the drug.

3. Before importing drug for which a license is not required a declaration signed by on or behalf of the mfg. or the importer that the drugs compile with the provision of the act & the rules should be supplied to the customer collector.

4. If the custom collector has a reason to doubt whether any drug comply with the provision of the act and rules or it required by an officer appointed for this purpose by the central government the custom collector shall take samples of any drugs in the consignment and forward them to the director of the lab appointed for this purpose by the central government.

5. Custom collector may also detain the consignment of drug of which sample has been taken until the report of analysis on such sample is received.

6. If the importer given on Undertaking in writing note to dispose of the drug without the consent of the customs collector may release the consignment to importer.

7. If the report of the analysis indicates that the drug in a consignment is not of standard quality or contrivance of the provision of the act & the rules & the contravention can’t be remedied by the importer and the customs collector made direct the importer to the export the consignment backed to the mfg. within 2 months or given the same to the central government for destruction.

8. The aggrieved importer representation of the customs collector, who sell forward the samples together with representation to the licensing authority whose decision shall be final.

Offences and penalties related to import of drugs

1. Any adulterated or spurious drug and cosmetics containing any ingredient who which may render it unsafe or harmful for use, shall be punishable with imprisonment of up to 3 years with a fine up to ₹5000 on first conviction and with imprisonment of up to 5 years or with the fine of ₹10000 or both on subsequent conviction.

2. Any drug or cosmetic other than that referred to above the import of which is prohibited, shall be punishable with imprisonment up to 6 month and find up to ₹500 or both on first convection and with imprisonment up to 1 year with a fine ₹1000 or both on subsequent conviction.