Classes of drugs and cosmetics prohibited from import into India and Offences. Pharmacy Law and Ethics.

IMPORT OF DRUGS

An import license will be required to import drugs into India. While certain classes of drugs and cosmetics are prohibited from being imported into India. Chapter III of the Drug and Cosmetic Act 1945 and Part IV Rule Number 21 to Rule Number 43 deal with provisions of drugs and cosmetics to be imported under Drugs and Cosmetics Rule 1945 (amendment 2013).

Classes of Drugs or Cosmetics Prohibited from being imported into India:

(Section 10 of Drugs and Cosmetics Act 1940).

The central government prohibits the import of certain categories of drugs and cosmetics by notification in official Gazettes. No person can import the following category of drugs and cosmetics. However central government may allow the import of any one category of drug for special purposes after consultation with the Drug Technical Advisory Board (DTAB)

• 1. Substandard drugs or cosmetics

• 2. Adulterated Drugs or Adulterated cosmetics

• 3. Misbranded Drugs or Misbranded Cosmetics

• 4. Spurious Drugs or Spurious Cosmetics

• 5. Drugs purport or claim to cure or prohibit diseases or disorders mentioned in Schedule J of Drugs and Cosmetics Rules 1945.

• 6. Patent and proprietary medicines' true formula or name of active ingredients is not disclosed on the label of the container.

• 7. Drugs that have been prohibited to manufacture, sell, and distribute are prohibited in the country of origin.

• 8. Drugs harmful likely to be harmful or risky for human beings or animals.

• 9. Drugs that do not claim their therapeutic value.

• 10. Drugs containing active ingredients with no therapeutic justification

• 11. Any cosmetic that has ingredients harmful or unsafe to be used under the direction recommended.

• 12. Drugs have less than sixty percent residual shelf-life period as of the date of import:

• 13. However in special conditions licensing authority can allow the import of drugs with a lesser half-life period

• 14. No drug shall be allowed to be imported if not labeled as a prescribed condition of labeling in the Drug and Cosmetic Rules 1945.

• 15. No drugs shall be imported after its expiry date.

Customs officers have the power to detain any such drugs that have been prohibited from being imported. They shall send a report to the drug controller of India regarding such detention. If necessary, they also send samples of detained drugs to the central drug laboratory in Kolkata for testing and analysis of such drugs.

Offenses

(13 of drugs and cosmetics act 1940)

• 1. Import of adulterated (under section 9A) or spurious drug (under section 9B) or any spurious cosmetic ( in section 9D) or any substandard cosmetic i(in section 10) shall be punishable with imprisonment up to three years and a fine up to five thousand rupees

• 2. Import of drugs or cosmetics prohibited to be imported under section 10, shall be punishable with imprisonment up to six months, or with a fine of up to five thousand rupees or both

• 3. Import of any special drug or cosmetic prohibited to be imported by central government (section 10A), shall be punishable by up to three years, or with a fine up to five thousand rupees, or both;

• 4. Subsequent offense to the Import of drugs or cosmetics mentioned in point number 1 and point number 3 shall be liable to imprisonment and a fine up to 10 years or both.

• 5. Subsequent offense to Import of drugs and cosmetics mentioned in point number 2 shall be liable to imprisonment up to 1 year or a fine up to 5 years or both

• 6. The above punishments shall be in addition to the punishment awarded by the Sea Customs Act, of 1878.

• Consignment of drugs or cosmetics shall be confiscated.

Alok Bains.