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    Guide Book for retail and wholesale pharmacy
    Guide Book for retail and wholesale pharmacy
    Guide Book for retail and wholesale pharmacy
    Ebook224 pages2 hours

    Guide Book for retail and wholesale pharmacy

    By Sunny Sinha

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    About this ebook

    This book would be considered to be one of the valuable resource to all the offline and online pharmacies and pharmacists including medical devices business owner for the sake of knowledge gain related to sale, stock and distribution of the drugs and medical devices

    LanguageEnglish
    PublisherBlueRose Publishers
    Release dateAug 20, 2024
    ISBN9789364528771
    Guide Book for retail and wholesale pharmacy

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      Book preview

      Guide Book for retail and wholesale pharmacy - Sunny Sinha

      CHAPTER 1

      Introduction to the Drugs and Cosmetics Act, 1940 and Rules

      Evolution of the Drugs and Cosmetics Act, 1940

      The Drugs and Cosmetics Act was formed before Indian independence during British rule. It was under the Act 23 of 1940 under the Government of India Act, 1935 later known as the ‘Drugs Act, 1940’. Before independent India, the ‘Drugs’ was covered under the ‘List 2 of 7th Schedule of the Government of India Act, 1935’. All legislatures of provinces passed a resolution, wherein Central Legislature was authorized to legislate for regulating the import, manufacture, distribution and sale of drugs, that gave birth to the Drug Act, 1940.

      Chopra Commission (1930-1931): In 1930, an expert committee was formed after consulting with provincial governments and its people to learn and analyze the loop-holes in the quality of Indian drugs that were being sold in India. This committee was headed by Lt. Col. R. N. Chopra (Father of Indian Pharmacology). The Chopra Commission submitted its report in 1931 thereby recommending enactment of India legislation for the control of Drugs and Pharmacy either as a combined Act or a separate Drugs Act and Pharmacy Act. Finally, the ‘Drugs Act’ received assent of the Governor General in Council, on 10th April, Act 23 of 1940.

      Post Independence Era: After independence of India, the ‘Article 246’ of the Constitution of India gave law making powers upon some specific subjects to the Parliament and State legislatures. The ‘Seventh (7th) Schedule’ to the Constitution provides ‘Central list - List I’, ‘State list - II’ and ‘Concurrent list - III’. For any subject on the ‘Concurrent list’ both the Central and the State Government can legislate. Drugs are enlisted on SN. 19 of the ‘Concurrent list’ as ‘19. Drugs and poisons, subject to the provisions of entry 59 of List I with respect to opium’. Hence, both the Central and the State Government has power to legislate and amend this subject. In 1962, the word ‘Cosmetics’ was added in the ‘Drugs Act, 1940’ thereafter the Act was renamed as ‘Drugs and Cosmetics Act, 1940’.

      Provisions under the Drugs and Cosmetics Act

      All provisions under this Act are placed suitably in 5 Chapters for better understanding and enforcement by the regulators. Details under the Chapter includes:

      NOTE: **Chapter IV shall take effect in a particular State only from such notification as given by the State Government and *Chapter III shall come into as date of notification by the Central Government.

      Objectives of the Drugs and Cosmetics Act and Rules

      •  To regulate the import, manufacture, distribution and sale of drugs, medical devices and cosmetics through licensing.

      •  To ensure that manufacture, distribution and sale of drugs, medical devices and cosmetics is done under the supervision of the qualified persons (like registered pharmacists or competent persons).

      •  To prevent substandard in drugs, presumably for maintaining high standards of medical treatment.

      •  To regulate the manufacture and sale of Ayurvedic, Siddha, Unani (ASU) and Homeopathic (H) medicines.

      •  To prevent import of substandard or counterfeit drugs and prohibition of the manufacture of inferior or counterfeit drugs in the country.

      •  To establish Drugs Technical Advisory Board (DTAB) and Drugs Consultative Committees (DCC) for Allopathic and allied drugs, medical devices and cosmetics.

      •  To have drug inspectors visit licensed premises regularly.

      •  To control the standards of pharmaceuticals and cosmetics by collecting samples and studying them in recognised laboratories regularly.

      •  To make special regulations to govern the preparation, standardization, and storage of biological and special products, as well as to prescribe how various classes of medications and cosmetics should be labelled and packed.

      Important Definition covered under the Drugs and Cosmetics Act

      Difference between a ‘Drug’ and ‘Medicine’: The Drugs and Cosmetics Act and Rules thereunder, does not define or distinguish the terms ‘drug’ and ‘medicine’. In common understanding a ‘Drug’ is in the form of crude, raw or pure substance as such and is often called the active ingredient. When this drug is converted into a dosage form like ‘tablet’ or ‘syrup’ it becomes a ‘medicine’.

      For example ‘Paracetamol/Acetaminophen’ is a ‘Drug’ and when it is made in the form of a ‘tablet’ or ‘syrup’ then it becomes a ‘Medicine’ making it fit for consumption. However, in the Drugs and Cosmetics Act and Rules majority of the terminology used is ‘Drug’ only.

      CHAPTER 2

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