JNTU B.Pharmacy IV PHARMACEUTICAL JURISPRUDENCE Previous Question Paper (July-2021 - R17)

The primary objective of the Drugs and Cosmetics Act, 1940 is to regulate the import, manufacture, distribution, and sale of drugs and cosmetics in India. It ensures that the drugs sold to the public are safe, effective, and of high quality, while also preventing the circulation of substandard or spurious products.

Key objectives include:

• To regulate the import of drugs into India to ensure that only quality products enter the market.
• To establish uniform standards for the quality, purity, and strength of drugs and cosmetics manufactured and sold across the country.
• To control the manufacture, sale, and distribution of drugs through a system of licensing.
• To prevent the use of substandard, misbranded, or adulterated drugs that could pose health risks to consumers.
• To regulate the manufacture and sale of Ayurvedic, Siddha, and Unani drugs.
• To provide for the appointment of qualified inspectors and analysts to monitor compliance and test drug samples.

A patent or proprietary medicine is defined under Section 3(h) of the Act as a drug which is a remedy or prescription presented in a form ready for internal or external administration to human beings or animals, and which is not included in the edition of the Indian Pharmacopoeia or any other pharmacopoeia authorized by the Central Government. These medicines are typically marketed under a trade name or proprietary brand, and their composition is often specific to the manufacturer rather than being a standard pharmacopoeial preparation.

Under the Drugs and Cosmetics Act, 1940 and Rules, 1945, the import of certain categories of drugs is strictly prohibited to ensure public safety and quality standards. These prohibited classes include:

• Misbranded drugs: Drugs that are not labeled in the prescribed manner or bear misleading claims.
• Adulterated drugs: Drugs containing filthy, putrid, or decomposed substances, or prepared under unsanitary conditions.
• Spurious drugs: Drugs manufactured under a name belonging to another drug or substituted with another substance.
• Drugs of sub-standard quality: Products that do not meet the pharmacopoeial or declared standards of strength, quality, and purity.
• Drugs claiming to prevent or cure specific diseases: Drugs claiming to prevent or cure diseases listed in Schedule J (e.g., cancer, AIDS, blindness).
• Drugs with expired shelf-life: Products that have crossed their expiry date.
• New drugs without approval: Drugs not approved by the Licensing Authority for import or marketing in India.

To import drugs into India, the importer must obtain a license from the Central Licensing Authority (CDSCO). The conditions for the grant of an import license include:

1. The applicant must possess a valid wholesale license or manufacturing license under the Drugs and Cosmetics Act.
2. The importer must have adequate storage facilities, including cold chain management if required, to maintain the stability of the drugs.
3. The importer must maintain detailed records of the import, including batch numbers, dates of import, quantities, and distribution details, for inspection by the Licensing Authority.
4. The imported drugs must comply with the standards of quality, purity, and strength as specified in the Second Schedule of the Act.
5. The importer must ensure that the labeling on the imported drug container clearly displays the name of the drug, the manufacturer's name and address, the batch number, the manufacturing and expiry dates, and the import license number.
6. The importer must provide an undertaking that they will comply with all provisions of the Drugs and Cosmetics Act and Rules, and allow the Drug Inspector to inspect the premises and samples at any reasonable time.
7. Any change in the constitution of the firm or the premises must be notified to the Licensing Authority immediately.