Se ha denunciado esta presentación.
Utilizamos tu perfil de LinkedIn y tus datos de actividad para personalizar los anuncios y mostrarte publicidad más relevante. Puedes cambiar tus preferencias de publicidad en cualquier momento.

Laws n drugs

2.291 visualizaciones

Publicado el

Laws regarding manufacture, marketing and prescription of drugs .

Publicado en: Salud y medicina
  • How to improve brain memory power naturally? Boost your brainpower with brain pill now... ♥♥♥ https://bit.ly/2GEWG9T
       Responder 
    ¿Estás seguro?    No
    Tu mensaje aparecerá aquí
  • //DOWNLOAD THIS BOOKS INTO AVAILABLE FORMAT ......................................................................................................................... ......................................................................................................................... //DOWNLOAD PDF EBOOK here { https://tinyurl.com/y8nn3gmc } ......................................................................................................................... //DOWNLOAD EPUB Ebook here { https://tinyurl.com/y8nn3gmc } ......................................................................................................................... //DOWNLOAD doc Ebook here { https://tinyurl.com/y8nn3gmc } ......................................................................................................................... //DOWNLOAD PDF EBOOK here { https://tinyurl.com/y8nn3gmc } ......................................................................................................................... //DOWNLOAD EPUB Ebook here { https://tinyurl.com/y8nn3gmc } ......................................................................................................................... //DOWNLOAD doc Ebook here { https://tinyurl.com/y8nn3gmc } ......................................................................................................................... ......................................................................................................................... ......................................................................................................................... .............. Browse by Genre Available eBooks ......................................................................................................................... Art, Biography, Business, Chick Lit, Children's, Christian, Classics, Comics, Contemporary, Cookbooks, Crime, Ebooks, Fantasy, Fiction, Graphic Novels, Historical Fiction, History, Horror, Humor And Comedy, Manga, Memoir, Music, Mystery, Non Fiction, Paranormal, Philosophy, Poetry, Psychology, Religion, Romance, Science, Science Fiction, Self Help, Suspense, Spirituality, Sports, Thriller, Travel, Young Adult,
       Responder 
    ¿Estás seguro?    No
    Tu mensaje aparecerá aquí

Laws n drugs

  1. 1. HARIPRIYA UPPALA DEPARTMENT OF PHARMACOLOGY S.V.M.C, TIRUPATI. DRUG LEGISLATION
  2. 2. SOURCES  Katzung – Basic and Clinical Pharmacology  CDSCO website  FDA website
  3. 3.  HISTORY  DRUG LEGISLATIONS IN USA  INDIAN DRUG LEGISLATION  US DRUG REGULATORY  INDIAN DRUG REGULATORY
  4. 4. In USA...  Pure Food and Drug Act of 1906 became law in response to revelations of unsanitary and unethical practices in the meat-packing industry.  The Federal Food, Drug, and Cosmetic Act of 1938 - a reaction to deaths associated with the use of a preparation of sulfanilamide marketed before it and its vehicle were adequately tested.  The Kefauver-Harris amendments of 1962 - the result of a teratogenic drug disaster involving thalidomide.
  5. 5. In INDIA...  Manufacture of modern drugs in India - end of 19th century.  Bengal Chemical and Pharmaceutical works at Calcutta - by Acharya P. C. Ray 1901  Alembic Chemical works at Baroda - by prof. T. K. Gajjar
  6. 6.  1920-1930 a number of reports of harmful substitutes and adulterants were identified to be marketed in place of genuine drugs.  According to Indian Medical gazette - no control over the manufacturing sale and distribution of drugs in India.  No restrictions on quality of drugs that are being imported.  Unscrupulous manufacturers abroad took advantage and flooded the Indian markets with adulterated & spurious drugs.  Lt. Col. H. A. J Gidney in the legislative council demanded for the control of adulterated drugs.  On september 4, 1928 he moved for leave to adjourn the house for the consideration of the "Gigantic Quinine fraud".
  7. 7.  Drugs enquiry committee constituted under the chairman ship of Col. R. N. Chopra as Chairman , Shri C. Govindan Nair as secretary and Dr. B. Mukharjee as assistant secretary. Objectives  To enquire & check the quality of drugs  To suggest remedial measures in preventing adulteration. The committee submitted its report in 1931.
  8. 8.  1937 – “Import of drugs” bill by EIC. Later withdrawn.  1940 - The Drugs Bill was introduced in the Parliament, based on the recommendation of D. E. C  The Drugs Act, 1940 was enacted which was latter amended to the Drugs and Cosmetics Act, 1940.  Later on, Drugs Enquiry Committee & Health Survey and Development Committee lead foundation for The Pharmacy Act, 1948.
  9. 9. DRUG LEGISLATIONS IN USA  Pure Food and Drug Act of 1906 - Prohibited mislabeling and adulteration of drugs.  Opium Exclusion Act of 1909 - Prohibited importation of opium.  Amendment (1912) to the Pure Food and Drug Act – Prohibited false or fraudulent advertising claims.  Harrison Narcotic Act of 1914 - Regulations for use of opium, opiates, and cocaine (marijuana added in 1937).
  10. 10.  Food, Drug, and Cosmetic Act 1938 - Required that new drugs be safe as well as pure (but did not require proof of efficacy). Enforcement by FDA.  Durham-Humphrey Act 1952 - Vested in the FDA the power to determine which products could be sold without prescription  Kefauver-Harris Amendments (1962) to the Food, Drug, and Cosmetic Act: Required proof of efficacy as well as safety for new drugs and for drugs released since 1938; guidelines for reporting of information about adverse reactions, clinical testing, and advertising of new drugs.
  11. 11.  Comprehensive Drug Abuse Prevention and Control Act (1970) :- Outlined strict controls in the manufacture, distribution, and prescribing of habit-forming drugs; drug schedules and programs to prevent and treat drug addiction.  Orphan Drug Amendments of 1983: Provided incentives for development of drugs that treat diseases with less than 200,000 patients in USA.  Drug Price Competition and Patent Restoration Act of 1984 –  Abbreviated new drug applications for generic drugs.  Required bioequivalence data.  Patent life extended by amount of time drug delayed by FDA review process.  Cannot exceed 5 extra years or extend to more than14 years post-NDA approval.
  12. 12. Dietary Supplement Health and Education Act (1994)  Standards with respect to dietary supplements  Prohibited full FDA review of supplements and botanicals as drugs.  Required the establishment of specific ingredient and nutrition information labeling  Allows unregulated advertising.
  13. 13. Bioterrorism Act of 2002 Enhanced controls on dangerous biologic agents and toxins. Seeks to protect safety of food, water, and drug supply. Food and Drug Administration Amendments Act of 2007  Granted FDA greater authority over drug marketing, labeling, and direct-to-consumer advertising; requiredpost-approval studies, established active surveillance systems, made clinical trial operations and results more visible to the public.
  14. 14. INDIAN DRUG LEGISLATION  The Drugs and Cosmetics Act, 1940  The Pharmacy Act, 1948  The Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954  The Narcotic Drugs and Psychotropic Substances Act, 1985  The Medicinal and Toilet Preparations (Excise Duties) Act, 1956  The Drugs (Prices Control) Order 1995 (under the Essential Commodities Act)
  15. 15. 1. The Drugs and Cosmetics Act 1940. Objective: Regulate the import, manufacture, distribution and sale of drugs. The Central Government appoints the Drugs Technical Advisory Board to advise the Central Government and the State Governments on technical matters arising out of the administration of this Act.
  16. 16. 2. The Pharmacy Act 1948 The Pharmacy Act was passed in 1948 and was amended in 1959, 1976 and 1984. Aim - To regulate the profession of Pharmacy in India. The Central Government constitutes a Central Pharmacy Council of India consisting of following members: a) Six members from the Teachers of pharmacy. b) Six members from practicing pharmacists or Pharmaceutical Chemists holding degree of diploma. c) One member elected by the Medical Council of India.
  17. 17. d) The Director-General of Health Services. e) The Director of the Central Drugs Laboratory. f) The Chief Chemist, Central Revenues. g) One member to represent each state elected by members of State Councils who shall be a registered pharmacist. h) One member to represent each State Government who shall be either registered medical practitioner or a registered pharmacist.
  18. 18. 3. The Drugs and Magic Remedies (Objectionable Advertisements) Act 1954 To control the Advertisements regarding drugs Prohibits the advertising of remedies alleged to possess magic qualities and to provide for matters connected therewith.
  19. 19.  The Drugs and Magic Remedies Act prohibits a person from taking part in publication of any advertisement referring to any drug which suggests use of the drug for: a) the procurement of miscarriage in women or prevention of conception in women; and b) the maintenance or improvement of the capacity of the human being for sexual pleasure; c) the correction of menstrual disorders in women; d) the diagnosis, cure, mitigation, treatment or prevention of any venereal disease. It is prohibited to directly or indirectly give a false impression regarding the true character of a drug or make false claim for it or to convey any false or misleading information in any material particular about it.
  20. 20.  Whoever contravenes the provisions of this Act shall, on conviction, be punishable with imprisonment which may extend to six months, with or without fine. The prohibition under this Act does not apply to: a) any signboard or notice displayed by a registered medical practitioner including the treatment for any of the disease b) any treaties or book dealing with any of the matters from a bonafide scientific standpoint c) any advertisement related to any drug sent confidentially to any registered medical practitioners or to chemists for distribution among registered medical practitioners or to a hospital or laboratory d) Government advertisements.
  21. 21. 4. The Narcotic Drugs and Psychotropic Substances Act, 1985  To consolidate and amend the law relating to Narcotic Drugs  To make stringent provisions for the control and regulation of operations relating to Narcotic Drugs and Psychotropic Substances and for matters connected therewith.  Includes: 1. Narcotic drugs 2. Psychotropic substances 3. Controlled Drugs
  22. 22. NDPS ACT 2014 amendment  To relax restrictions placed by the Act on Essential Narcotic Drugs (Morphine, Fentanyl and Methadone), making them more accessible for use in pain relief and palliative care.  Contained measures to improve treatment and care for people dependent on drugs.  Removed the NDPS Act's imposition of a mandatory death sentence in case of a repeat conviction for trafficking large quantities of drugs.  Increased the punishment for "small quantity" offences from a maximum of 6 months to 1 year imprisonment.
  23. 23. There are some other laws which have a bearing on pharmaceutical manufacture, distribution and sale in India. The important ones being:  The Industries (Development and Regulation) Act, 1951  The Trade and Merchandise Marks Act, 1958  The Indian Patent and Design Act, 1970  Factories Act
  24. 24. REGULATORY BODIES  Regulatory authorities are bodies having the power to regulate.  In the ICH-GCP guidelines, the regulatory authorities includes the authorities that review submitted clinical data and those that conduct inspections.  These bodies are sometimes referred to as competent authorities.
  25. 25. US DRUG REGULATORY  The FDA is the administrative body that oversees the drug evaluation process in the USA and grants approval for marketing of new drug products in USA.  To receive FDA approval for marketing, the originating institution or company (almost always the latter) must submit evidence of safety and effectiveness.
  26. 26. INDIAN DRUG REGULATORY  Medicines in India are regulated by CDSCO - Central Drugs Standard Control Organization under Ministry of Health and Family Welfare.  Headed by Directorate General of Health Services CDSCO regulates the Pharmaceutical Products through DCGI - Drugs Controller General of India at Chair.
  27. 27.  Under Retail and Distribution: - Drugs classified under 5 heads 1. Schedule X drugs – Narcotics 2. Schedule H and L – Injectables, Antibiotics, Antibacterial 3. Schedule C and C1- Biological Products-example Serums and Vaccines  Under Manufacturing Practice 1. Schedule N - List of the equipment for the efficient running of manufacturing wing, qualified personnel 2. Schedule M
  28. 28.  Functions of CDSCO: 1. Approval of new drugs and clinical trials 2. Import Registration and Licensing 3. Licensing of Blood Banks, LVP’s, Vaccines, r- DNA products & some Medical Devices 4. Amendment to D &C Act and Rules 5. Banning of drugs and cosmetics 6. Grant of Test License, 7. Personal License, 8. NOCs for Export 9. Testing of Drugs

×