SALE OF DRUGS – Drugs and Cosmetic Act




Introduction of sale of drugs

The sale of drugs is a crucial aspect of healthcare and public safety, and it is regulated by various laws and regulations to ensure the quality, safety, and efficacy of pharmaceutical products. One of the primary regulations governing drug sales in India is the Drugs and Cosmetic Act. In this article, we will explore the key aspects of the Drugs and Cosmetic Act, its implications, and the challenges it faces.

Understanding the Drugs and Cosmetic Act

The Drugs and Cosmetic Act, 1940, is a comprehensive legislation in India that regulates the import, manufacture, distribution, and sale of drugs and cosmetics. The primary objective of this act is to ensure that drugs and cosmetics made available to the public are safe, effective, and of high quality. It also establishes the Central Drugs Standard Control Organization (CDSCO) to oversee and enforce these regulations.

The Importance of Regulatory Laws

Regulatory laws like the Drugs and Cosmetic Act play a pivotal role in safeguarding public health. They help in controlling the quality of drugs, cosmetics, and medical devices available in the market. These regulations set standards for manufacturing, labeling, and distribution, ensuring that consumers receive safe and effective products.

  • Classes of drugs prohibited to be sold
  • Wholesale of biological (C/C1)
  • Wholesale of other than those specified in C/C1 and X

Class of drug prohibited to sale

       Misbranded, spurious, adulterated and drugs not of standard quality

       Patent/Proprietary drugs with undisclosed formula

       Sch-J drugs

       Expired drugs.

       Drugs used for consumption by government schemes such as, Armed force.

       Physician’s samples

Wholesale of biological (C/C1)

·        Adequate premises, with greater than 10 M2 area, with proper storage facility

·        Drugs sold only to retailer having license

·        Premises should be in charge of competent person who is Reg. Pharmacist.

·        Records of purchase & sale

·        Records preserved for 3 years from date of sale

·        License should be displayed on premises

·        All the conditions as discussed in for biological.

·        Compounding is made by or under the direct and personal supervision of a qualified person.

Retail Sale

For retail sale, two types of licenses are issued:

                                i) General licenses

                                ii) Restricted licenses

Restricted license:

Granted to those dealers who do not engage the services of a qualified person and only deal with such classes of drugs whose sales can be effected without qualified person and vendors who do not have fixed premises


  1. What is the primary objective of the Drugs and Cosmetic Act? The primary objective is to ensure that drugs and cosmetics made available to the public are safe, effective, and of high quality.
  2. How are drugs classified under the act? Drugs are classified into categories like prescription drugs, over-the-counter drugs, and controlled substances.
  3. What is the role of the Central Drugs Standard Control Organization (CDSCO)? The CDSCO oversees and enforces the regulations specified in the act.
  4. What are the challenges in drug regulation in India? Challenges include a lack of resources, the emergence of new drugs, and the evolving pharmaceutical industry.
  5. How can consumers protect themselves from counterfeit drugs? Consumers should purchase drugs from licensed pharmacies and authorized dealers and be cautious when buying online.

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