JNTU B.Pharmacy IV PHARMACEUTICAL JURISPRUDENCE Previous Question Paper (September - 2022 - R17)

Under the Drugs and Cosmetics Act, 1940, the import of certain drugs and cosmetics is strictly prohibited to ensure public safety. Prohibited items include misbranded drugs, adulterated drugs, spurious drugs, drugs of sub-standard quality, and drugs claiming to cure diseases specified in Schedule J. Additionally, any drug or cosmetic whose manufacture, sale, or distribution is prohibited in the country of origin, or which does not comply with the standards prescribed under the Act, is prohibited from import.

Import under license is required for all other drugs and cosmetics intended for sale or distribution. The licensing process involves:

1. Submission of an application in the prescribed form to the Licensing Authority (CDSCO).
2. Payment of the required fees.
3. Compliance with the conditions of the license, which include maintaining records of imports, ensuring proper storage conditions, and allowing inspection by the Drug Inspector.
4. The license is granted only if the premises and the products meet the quality standards specified in the Second Schedule of the Act.

The primary objectives of the Drugs and Cosmetics Act, 1940 and the Rules 1945 are to regulate the import, manufacture, distribution, and sale of drugs and cosmetics in India. The key objectives include:

• To ensure that the drugs and cosmetics sold to the public are safe, effective, and conform to prescribed standards of quality.
• To prevent the manufacture and sale of sub-standard, misbranded, adulterated, or spurious drugs.
• To regulate the import of drugs and cosmetics to prevent the entry of substandard products into the Indian market.
• To establish a uniform regulatory framework across the country through the Drugs Technical Advisory Board (DTAB) and the Central Drugs Laboratory (CDL).
• To ensure that the manufacture and sale of drugs are carried out only by qualified persons and under the supervision of competent technical staff.