DRUG ADULTERATION AND COUNTERFEITING
DEFINITION: An adulteration means a process of addition of impure, cheap and filthy substances to genuine drug in order to get more profits. The adulterants may not have pharmacological or therapeutic properties.
FACTORS LEADING TO ADULTERATION:
Due to increased drug price; Due to scarcity of drug;
Due to improper knowledge; in order to get more profits;
Methods of adulteration:
A} Deterioration: impairment of quality of drug.
B} Admixture: in this method one type of drug is admixed with another one. this is mostly occurred due to improper knowledge.
C} Sophistication: in this type adulteration may done due to get more profits.
D} Substitution: in this method addition of completely different drugs in place of genuine drug.
E} Inferiority: in this the crude drug have less standard limit.
F} Spoilage: it occurs due to improper storage and also due to microbes.
“DIFFERENT TYPES OF ADULTERATION”
Adulteration may take place by two ways:
1} undeliberate or unintentional adulteration; 2} deliberate or intentional adulteration.
undeliberate or unintentional adulteration:
Unintended adulteration which sometimes occurs without bad intension of the manufacture or supplier.
- Faulty collection of crude drugs:
Certain drugs are collected in specific season only, if not then the conc. Of chemical constituents may be vary;
|Wild cherry bark||Autumn|
|Colchicum corn||Early summer|
|Male fern||Late autumn|
|Cinnamon bark||Rainy season|
With this parameter we should remember that the stage of drug collection from plant;
|DRUG||STAGE WITH MAX.ACTIVITY|
|linseed||when fully ripen|
|coriander||When fully grown and ripen|
|Solanaceous leaves||Flowering stage|
|Opium capsules||Maturing stage|
|Belladona root||At 3-4 years old|
|Wild cherry bark||Young stems|
- Imperfect preparation:
While preparation of crude drugs it should be considered the step of collection which reflects the economical state adulteration place by collection of undesirable and inert part instead of desired part;
|DRUG||OFFICIAL PART||UNDESIRED PART|
|ipecac||Roots and rhizomes||Arial stem|
|saffron||Style and stigma tops||Parts of corolla|
|pyrethrum||Flower heads||Stem & leaf|
- Improper drying:
Faulty inadequate drying may cause adulteration;
|DRUG||FAULTY TREATMENT OF DRYING|
|Digitalis leaves||When leaves dried enzyme degrades the glycosides content|
|Corn of colchicum||Above 65’c temp.,hydrolyses the drug|
|Cod liver oil||High heat for oil to saparate from liver lead to decrease the conc. Of vit.A
- Improper storage and maintenance:
Storage conditions also effect the quality of drug improper storage may leads to spoilage:
|volatile oil||In closed container stored in dark room|
|Cod liver oil||Stored in amberd colored bottles|
|Ergot||Protected from moulds|
|Belladona leaves||Moisture free containers|
|Sqill & digitalis||Any place|
|Male form||Dry place|
|Coffee||Avoid over heating|
Intentional or deliberate adulteration:
In this type, adulteration is done by mankind in order to get more profits.
- Substitution with inferior quality:
Ideal properties of substituent;
- It shows similar morphology with crude drug.
- It should cheaply available.
- Non toxic in nature.
- Compatible with crude drug.
|Indian senna||Arabian senna,dog senna|
|Trichunous nuxblenda,strichnous nuxblenda|
- Substitution with exhausted crude drugs:
Many drugs are extracted in large scale for the isolation of active constituent extraction process may doesn’t change morphology of drug and the extracted drug is called exhausted drug.there is a chance to adultrate crude genuine drug with it.
|Clove oil||With clove stem oil|
|Coriander||Oil from fruits|
|Cinnamon||Oil from leaves|
|Peppermint oil||Cornmint oil|
- Substitution with similar morphology: In this type drugs are sdultrated with similar morphology containing drugs;
|Saffron||Dried flowers of cartnomous tinctoris|
|Tragacanth gum||Sterculia gum|
|Stromonium||Leaves of xanthium|
|Bees wax||Japanees wax|
- Substitution with artifecially manufactured substances:
Some artificial agents are manufactured to get adultration with crude drugs.
|Bees wax||Yellow paraffin|
|Nutmeg||Pieces of vass wood|
|Balasum of peru||Addition of benzyl benzoate|
|Methyl salicylates||Gluteria oil|
- Substitution with harmfull substances:
In this method defective and harmfull substances are admixed with unorganized drugs;
|Colophony||Pieces of ambere colored glass|
|Cardamom seeds||Rodent fecal matter|
|Coconut oil||White oil|
|Asafoitida||Lime stone pieces|
- Substitution of powders:
Powdered verities of crude drugs nay be adulterated with the bellow;
|Capsicum||Red sandals wood|
|Powdered bath||Brick powder|
|Cinnamon||Hazel nut shells|
|Ginger powder||Exhausted ginger|
- Substitution with foregin & fictious materials:
Some times foreign matter is added to crude drugs;
|Myrrh||Quartz &mineral material|
|Black pepper||Seeds of papaya|
|Nuxvomica powder||Olive stone powder|
These are the different types of adulteration which leads to many complications;
DISADVANTAGES OF ADULTRATION:
- ADULTRATION causes denaturation°radation of product;
- Adulteration may leads to deterioration of product;
- Adulterants may completely destroy the active constituents;
- May cause artificial scarcity of drug;
- That leads to damage of dosage form;
- Adulteration leads to altering of drug nature;
- The adulterants may cause damage to patient;
- Adulterants may cause death of patient;
- They may cause un wanted side effects in patients;
- They lead to increase price of product;
- They cause to increase formulation price of dosage form;
- Adulteration leads to damage of containers also.
Fig 1: The difference between local and global prices in Nigeria can reach up to 400% in key drugs like Coartem, an anti-malaria medication.
A study conducted by a former Deputy Director of World Health Organization (WHO), Professor Adeoye Lambo in Nigeria for a pharmaceutical firm in Lagos in 1990, showed that 54 per cent of drugs in every major pharmacy shop were fake. The study also indicated that the figure had risen to 80 per cent in the subsequent years.
There were reported incidents of fake drugs that led to the death of innocent Nigerians. In 1989, poorly compounded chloroquine syrup killed children in UNTH Enugu, Enugu State. Also in 1990, the paracetamol syrup disaster occurred when 109 children died in Ibadan and just after the intake which was produced with toxic ethylene gycol solvent instead of propylene gycol. And in 2004, three Nigeria hospitals reported cases of adverse reaction from the use of contaminated infusion produced by four Nigerian companies. Consequently, the sampled infusions and water for infection from all over the country showed that 147 of the 149 brands of water for injection screened were also not sterile. It is disheartening to see men and women hawking drugs along the major streets of our towns and cities in Nigeria. This unwholesome practice is very rampant among the illiterates and semi-literates selling drugs in bags and trays, making wrong prescriptions that may be injurious to the health of the innocent members of the public.
In Nigeria, a counterfeiter is allowed to pay a fine option of N100, 000. Health watchers say the appropriate penalty for counterfeiting could be an effective deterrent, sadly, the penalty for manufacturing or distributing counterfeit drugs is rather lenient. Counterfeiting is punishable by imprisonment for between 3 months to 5 years or alternatively a fine of N100, 000 is imposed. Comparatively, in China, counterfeiting attracts the death penalty.
To avoid issues of fake drugs/substandard product patients are advised to purchase/obtain their medicines from accredited pharmacy and adhere to their dosage regimen in other to obtain excellent result.