ADULTERATION & MISBRANDING

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

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

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

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.)

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.)

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.)

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.

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.

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.

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)

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

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

IDENTICAL BRAND NAMES, ONE WITH AN ADDITIONAL LETTER, SAME GENERIC

NAME INDIFFERENT COMBINATION, SAME MANUFACTURER (CATEGORY III)

Brand name Generic name Manufacture

Acnesol Erythromycine Systopiclab ltd

Acnesol-T erythromycine+tretinoin

Systopic lab ltd

Novolid Nimesulide Vrown and vurk pharm ltd

Novolid-s Nimesulide+serratiopeptidase

Brown and bruk pharm ltd

Aamin Amlodipine Targof pure drugs ltd

Aamin-A Amlodipine+atenolol

Targof pure drug ltd

IDENTICAL BRAND NAMES, SAME GENERIC NAME, DIFFERENT MANUFACTURERS,

DIFFERENTDOSAGE FORMS (CATEGORY IV)

Brand names Generic names Manufaturer

Oflorin(tablet) Ofloxacin Indoco Remedies Ltd.

Ofllorin(eye drops) Ofloxacin Warren Pharma Pvt. Ltd.

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.

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

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.

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

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.

REFERENCE

WWW.GOOGLE.COM

FDA OFFICIAL SITE

Government of india (ministry of health of health and family welfare) drugs and cosmetic act 1940

THANK YOU