Fake drugs in India: Points to Ponder

Dr Chandra M Gulhati,
    Two topics viz fake drugs and substandard medicines are separate subjects. For example:
    Regulatory framework (CDSCO) exists in India to deal with Fake and Substandard drugs.
    Production and sale of fake drugs is essentially a criminal act.
    Production and sale of substandard drugs can be deliberate or due to negligence.

Fault can also lie with distributors and retailers with regard to storage of temperature sensitive items that can render standard into substandard products e.g. Insulin.

Fake Drugs in India:
 

    Every now and then the mass media both in India and abroad carries stories on manufacture and sale of huge number of fake drugs in India.
    Figures quoted range from 20 to 25%
    Implication: Every 5th, if not 4th medicine being sold in over 600,000 retail chemist shops is fake.
    Based on this assumption, the total fake market business should be at least Rs. 6,500 crores every year!
     

Endless Repetition of Unreliable Data:
 

    “One widely quoted WHO statistic places India as the leader, with as much as 35% of world’s production (of fake drugs)”: news item in the Lancet, 2 June 2001.
    As part of the “evidence” the case of narcotic analgesics being smuggled by Uzbek carriers but seized at New Delhi airport was quoted.
    The fact: the narcotic analgesics were illegally produced for smuggling but were NOT FAKE.
    Despite repeated denials by WHO, this misinformation continues to be repeated by the media even today.
     

Confusion due to Different Definitions:
 

    In India, the descriptions fake, spurious and counterfeit convey the same meaning.
    However as per WHO definition counterfeit drugs are those that have “been deliberately and fraudulently mislabelled with respect to identity and/or source.”
    Despite such a wide definition between 2002 and 2004, not a single case of counterfeit case was reported to WHO.
    In America counterfeit drugs include genuine, foreign medicines/brands not approved by the

United States Food and Drug Administration (USFDA).
 

    No wonder according to USFDA, “Up to 25% of all drugs consumed in poor countries are thought to be counterfeit or substandard.”

(Ref: The Lancet, Vol. 362, 22 November 2003).

WHO “Fact Sheet” Without Data, Without Proof:
“There has been no full international survey but estimates from WHO and the pharmaceutical industry suggest that at least 5% of medicines in circulation (worldwide) may be counterfeit” (Ref: The Lancet, 5 October 2002)

“Counterfeiting in Peru is as high as 80% according to Merck, Sharp, and Dohme.” How come everyone is alive!

“In 2002, India’s pharmaceutical companies suggested that in India’s major cities, one in five medicines sold was a fake. They claimed a loss in revenue of between 4% and 5% annually. The industry also estimated that illegal drugs had grown from 10% to 20% of the total market.”
Ref: WHO Fact Sheet revised, 14 November 2006.
 

Figures Don’t Tally:
 

    If fake drugs are so much in abundance in India, then why does the industry claim that their “loss of revenue” is between 4 and 5%?
    It should be more like 20% or even more.
    It can be less ONLY if fake drugs fall overwhelmingly in the cheaper range.
    But why cheap fake drugs should be manufactured and sold since the profits are not be worth the trouble and risk.
     

Let us look at an illustration: Paracetamol v/s Ceftriaxone

    Bulk paracetamol costs Rs. 180 per kg (1000g).
    Cost of active ingredient in one dose comes to just 9 paise.
    The production cost of a strip of 10 tablets (without active ingredient) comes to Rs. 1.50. Thus production cost is higher than cost of medicine.
    Sale price varies from Rs. 4 to 10 per strip.
    Bulk ceftriaxone costs over Rs. 11,000 per kg.
    Cost of active ingredient in one dose (1g) vial comes to Rs. 11.20.
    The production cost without active ingredient is Rs. 4.40.
    Sale price is over Rs. 70
    Will fake drug maker produce paracetamol or ceftriaxone?
    Profits lie in expensive products with large market.
     

India: Fake v/s Spurious Drugs:

    In India, Fake is a commonly used word that means “Not Genuine.” This word is not specifically mentioned in our laws governing medicines.
    “Spurious”, as defined in the Drugs and Cosmetics Act (Section 17B) is not limited to fake products but also includes other cases such as products that use unauthorized names, manufacturers etc.
    Implication: A strip of 10 pure and genuine paracetamol tablets will be deemed to be “spurious” if it uses the name Crocin without permission from trade mark holder GSK.
    In many raids where the aggrieved informer is a manufacturer of the original product, primarily and at least initially the issue relates to unauthorized use of brand names.
    Thus manufacturers use the legal definition to their commercial benefit even when public health may or may not be at stake.
    How many of the “spurious” products were found to be fake as well?
    Is the definition exaggerating the figures of really fake drugs?
    Should the definition of Spurious drugs be amended?
     

Strange Silence on Fake Brands
 

    Large drug industry associations (IDMA, OPPI) provide estimated percentage figures of fake drugs.
    Methodology and conclusions are neither listed nor supported with evidence.
    Concrete examples are often not given.
    Why should the drug companies shy away from giving specific details?
    Recently duplicate copies of a popular and very widely used cough remedy flooded certain

markets in eastern India

    The company found that its product’s sale was either stable or going up all over the country except certain markets in eastern India.
    The Company took action with local police help but did not involve drug controller.
    The reason? Media coverage of the existence of duplicate products would have led to boycott of the brand by patients and doctors all over India!
     

Conclusion: Urgent Need of Credible, Correct Data:
 

    Currently fake drugs are discovered through random sample collections by state drug inspectors.
    On receipt of complaints by aggrieved manufacturers.
    Rarely by patients.
    These are inadequate measures to determine the correct prevalence of the problem.
    National level scientifically structured large sample collection and testing is urgently required.
    CDSCO has probably already started the process.