Adulteration & misbranding
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Adulteration & misbranding

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A brief description about adulteration and misbranding of Pharmaceutical and other substance with punishments and fines according to FDA

A brief description about adulteration and misbranding of Pharmaceutical and other substance with punishments and fines according to FDA

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  • 1. ADULTERATION & MISBRANDING
  • 2. CONTENTS  ADULTERATION OF DRUGS i. Definition ii. Conditions for adulterine drugs iii. Types of adulterants iv. Acts regulating adulteration  MISBRANDING i. Definition ii. Acts  Incidents  penalties
  • 3. ADULTERATION OF DRUGS  Definition : Adulteration is the practice of substituting the original crude drug either partially or wholly with other similar looking substances but the adulterated drug is free of or inferior to the parent drug in chemical and therapeutic properties
  • 4. ADULTERATION OF DRUGS  Adulteration involves different conditions:  Deterioration – It results in impairment in quality of drugs.  Admixture – Addition of one article to the other due to ignorance, carelessness or accidentally.  Sophistication – It is done intentionally or deliberately.  Substitution – In this a completely different substance is added in place of original drug.  Inferiority – A substituted drug is added.  Spoilage- Micro organisms attack the drug product
  • 5. ADULTERATION OF DRUGS  Types of adulterants: 1. Substitution with substandard commercial varieties(.Examples: Capsicum minimum replaced by Capsicum annuum. Indian sennareplaced by Arabian senna or Dog senna.) 2. Substitution with superficially similar inferior drugs(Examples: Bees wax is adulterated with Japan wax. Mother cloves and clove stalks are mixed with cloves.Saffron is adulterated with flowers of Carthamus tinctorius.) 3. Substitution with artificially manufactured substance. (Examples: Compressed chicory is used instead of coffee. Paraffin wax is made yellow and used instead of Bees wax.)
  • 6. ADULTERATION OF DRUGS 4. Substitution with exhausted drug: (Examples: Exhausted Gentian is made bitter with Aloes. Exhausted Saffron is artificially coloured) 5. Use of synthetic chemicals to enhance natural character(Examples: citral is added to citrus oils like lemon and orange oils.) 6. Presence of vegetative matter of same plant. (Examples: Moss, liverworts, epiphytes growing on bark portion is mixed with Cascara and Cinchona . Stem portions are mixed with leaf drugs like Stramonium, Lobelia and Senna.)
  • 7. ADULTERATION OF DRUGS 7. Harmful adulterants(Examples: Pieces of amber coloured glass is added to Colophony Limestones in Asafoetida. white oil in coconut oil.rodent faecal matter to cardamom seeds, which is harmful.) 8. Adulteration of powders(. Examples: dextrin is added in ipecacuanha, exhausted ginger in ginger, red sanders wood in capsicum powder and powdered bark adultered with brick powder.)
  • 8. ACTS REGULATING ADULTERATION  Federal food , drug & cosmetic act- early 1800’s  Pure food and drug act-1906  FFDCA-1938  Section 501 (a)(2)(B) Specifically declares that a drug is adultered unless it is manufactured in accordance with Cgmp  Section 301 FDA-adulteration and misbranding of drugs in interstate commerse  FDA-controls  -procedure and production results in proper identity , strength , quality and purity of drug  -identity deficiency  -ensure correction of deficiencies , sees for sub potency , particulates , lack of content uniformity , dissolution failures.
  • 9. MISBRANDING  Section 502 of the FFDCA contains provisions on misbranding and false or misleading labelling. A drug is misbranded if:  Its labelling is false or misleading in any particular:  It is in package form and its label fails to contain the name and place of business of the manufacturer, packer, or distributor; and an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count.  Its label does not bear adequate directions for use; including warnings against use in certain pathological conditions; or by children where its use may be dangerous in health; or against unsafe dosage, or methods, or duration of administration or application;  It is dangerous to health when used in the dosage or manner or with the frequency or duration prescribed, recommended or suggested in the labelling; or  It does not comply with the colour additives provisions listed under Section 706 of the Act.
  • 10.  If the device's established name (if it has one) its name in an official compendium, or any common or usual name is not prominently printed in type at least half as large as that used for any proprietary name  If the establishment is not registered with FDA as per Section 510, has not device listed as per section 510(j), or obtained applicable premarket notification clearance as per Section 510(k)  If the device is subject to a performance standard and it does not bear the labeling prescribed in that standard  If there is a failure or refusal to comply with any requirement prescribed under the FFDCA, Section 518 on notification and other remedies, or failure to furnish any materials or information requested by or under Section 519 on reports and records or under Section 522; or  If there is any representation that created an impression of official approval because of the possession by the firm of an FDA registration number.
  • 11. TYPES OF MISBRANDING  False or Misleading labelling(sec.502(a))  Habit forming drugs(502)  Established names of drugs(502(e))  Adequate directions for use(502(f))  Imitation drugs(502(i)(2))  Batch certification(502)
  • 12. LOOK ALIKE DRUGS(LOOK-ALIKE BRAND NAMES, DIFFERENT, GENERIC NAMES, DIFFERENT MANUFACTURER (CATEGORY I)) Brand name Generic name manufacturer Tibitol Etambutol PCI tobitil tonixicam Ranbaxy PRONIM Nimesulide Unichem lab ltd PRONIL flouxeetine PIL pharmacia india ltd. celib Celecoxib Unichem lab ltd. celin Vitamine C Glaxo smithkline
  • 13. LOOK-ALIKE BRAND NAMES, DIFFERENT, GENERIC NAMES, DIFFERENT MANUFACTURER (CATEGORY II Brand names Generic names Manufaturer PD-Mox Amoxicilline Parenteral PD-Mox Roxithromycine Parenteral Colmine Clomipramine PIL Clozine Clomipramine PIL Bioclox Clarithromycine Biochem biodoxi Doxycylline Biochem )
  • 14. IDENTICAL BRAND NAMES, ONE WITH AN ADDITIONAL LETTER, SAME GENERIC NAME IN DIFFERENT COMBINATION, SAME MANUFACTURER (CATEGORY III) Brand name Generic name Manufacture Acnesol Erythromycine Systopiclab ltd Acnesol-T erythromycine+treti Systopic lab ltd noin Novolid Nimesulide Novolid-s Nimesulide+serratio Brown and bruk peptidase pharm ltd Aamin Amlodipine Aamin-A Amlodipine+atenolo Targof pure drug ltd l Vrown and vurk pharm ltd Targof pure drugs ltd
  • 15. IDENTICAL BRAND NAMES, SAME GENERIC NAME, DIFFERENT MANUFACTURERS, DIFFERENT DOSAGE FORMS (CATEGORY IV) Brand names Generic names Manufaturer Oflorin(tablet) Ofloxacin Indoco Remedies Ltd. Ofllorin(eye drops) Ofloxacin Warren Pharma Pvt. Ltd.
  • 16. INCIDENTS  Contaminated heparin from china 2007-2008,149 deaths  In panama,2006,many more disabled after receiving cough syrup prepared with incorporation of diethylene glycol masquerading as the proper and more costly excipient glycerin  In 2008, significant portions of China's milk supply were found to have been contaminated with melamine. Infant formula produced from melamine-tainted milk killed at least six children and were believed to have harmed thousands of others  In 2012, a study in India conducted by the Food Safety Standards Authority of India (FSSAI) across 33 states found that milk in India is adulterated with detergent, fat and evenurea, as well diluted with water.
  • 17. INCIDENTS  In gujarat state-total brands=19367 misbranded drugs=367 S.A.L.A brands=3847  In maharastra state-total brands=18630 Misbranded drugs=201 S.A.L.A brands=2582
  • 18. PENALTIES  Any person who violates a provision of section 301(prohibition act) shall be imprisoned for not more than one year or fined not more than $1,000, or both.  if any person commits such a violation after a conviction of him under this section has become final, or commits such a violation with the intent to defraud or mislead, such person shall be imprisoned for not more than three years or fined not more than $10,000 or both.  knowingly distributing drugs in violation of section 503(e) (2)(A),shall be imprisoned for not more than 10 years or fined not more than $250,000, or both.
  • 19. PENALTIES  Violation of SEC. 301(t)be subject to the following civil penalties:  (A) A civil penalty of not more than $50,000 for each of the first two such violations resulting in a conviction of any representative of the manufacturer or distributor in any 10-year period.  (B) A civil penalty of not more than $1,000,000 for each violation resulting in a conviction of any representative after the second conviction in any 10-year period  If a person provides information leading to the institution of a criminal proceeding against, and conviction of, a person for a violation of section 301(t) ), such person shall be entitled to one-half of the criminal fine imposed and collected for such violation but not more than $125,000
  • 20. CONCLUSION  Detecting adulteration and misbranding is important to avoid damage to the consumers like loss of healthy life  In some cases death May occur hence it is a important study to control those activities.
  • 21. REFERENCE  WWW.GOOGLE.COM  FDA OFFICIAL SITE  Government of india (ministry of health of health and family welfare) drugs and cosmetic act 1940
  • 22. THANK YOU