JNTU B.Pharmacy IV PHARMACEUTICAL JURISPRUDENCE Previous Question Paper (July/August-2022 - R17)

The import of drugs into India is regulated under the Drugs and Cosmetics Act, 1940 and Rules, 1945. Drugs allowed for import are broadly categorized into: (1) Drugs for sale or distribution, (2) Drugs for personal use, (3) Drugs for examination, test or analysis, and (4) Drugs for clinical trials.

The procedure for the import of drugs involves the following steps:

1. An application for an import license must be submitted to the Central Licensing Authority (CLA) in the prescribed form along with the required fees.
2. The applicant must provide details of the manufacturing site, a list of drugs to be imported, and a certificate of registration for the premises.
3. The licensing authority verifies the compliance of the manufacturer with Good Manufacturing Practices (GMP).
4. Upon satisfaction, the license is granted in the appropriate form (e.g., Form 10 for sale).
5. At the port of entry, the importer must present the license and a bill of entry to the Assistant Drug Controller.
6. Samples are drawn for inspection and testing if required, and the consignment is released only after the customs clearance and verification of quality standards.

i) Ayurvedic, Siddha or Unani Drug: Includes all medicines intended for internal or external use for or in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, exclusively in accordance with the formulae described in the authoritative books of Ayurveda, Siddha and Unani systems of medicine.

ii) Spurious drug: A drug is deemed to be spurious if it is manufactured under a name which belongs to another drug, if it is an imitation of or a substitute for another drug, or if it has been substituted wholly or in part by another drug or substance, or if it falsely claims to be the product of a manufacturer who does not exist.

iii) Manufacture: In relation to any drug or cosmetic, this includes any process or part of a process for making, altering, ornamenting, finishing, packing, labelling, breaking up or otherwise treating or adopting any drug or cosmetic with a view to its sale or distribution, but does not include the compounding or dispensing of any drug in the ordinary course of retail business.

iv) Chemists and Druggists: These are persons or entities licensed under the Drugs and Cosmetics Rules to sell, stock, exhibit or offer for sale, or distribute drugs by retail. A 'Chemist and Druggist' specifically refers to a retail pharmacy establishment where a registered pharmacist is present to dispense medicines.