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A Bitter Pill to Swallow: The Pervasive Problem of Fake Pharmaceuticals in India

Posted by Tulip Mahaseth on Thursday, Dec 13, 2018

Counterfeit Indian pharmaceuticals

The Indian pharmaceutical market is inundated with counterfeits, which replace important active ingredients with dangerous, toxic replacement chemicals, and have been spreading to the rest of the world.

Fake pharmaceuticals are counterfeit drugs deliberately and fraudulently mislabeled with respect to identity and/or source.  They are sold under a falsified brand name or generic drug labels and packaging at a fraction of the genuine drugs’ price. The composition of such fake pharmaceuticals varies from containing no or less than optimal active ingredients to containing toxic substances such as poison.

India is the market leader in providing generic drugs globally and its pharmaceutical sector was estimated to be worth $33 billion (USD) in 2017.  However, due to widespread counterfeiting, the Indian pharmaceutical market is flooded by fake pharmaceuticals.

The exact extent of fake pharmaceuticals in India is hard to gauge because various studies using varying methodologies report widely differing numbers.  A 2009 study, published in PLoS One, analyzed 541 samples of drugs such as chloroquine, ciprofloxacin, erythromycin, rifampicin, and isoniazid collected from 52 pharmaceutical stores in Chennai and Delhi.  These samples were subjected to semi-quantitative thin-layer chromatography and disintegration testing to measure the amount of active ingredients in the samples.

This study found that approximately 12% of the samples from Delhi pharmacies and approximately 5% of the samples from Chennai pharmacies did not contain the required minimum amount of active ingredients in the drugs.  However, other studies, especially those sanctioned by the Indian government, severely underestimate the prevalence of fake pharmaceuticals in the Indian market. For example, the 2009 study conducted by the Indian Ministry of Health and Family Welfare analyzed over 24,780 samples collected from 40,000 Indian pharmacies over a period of 7 months found only 0.046 % to be counterfeit.

 

What causes the problem of fake pharmaceuticals?

Not only are fake pharmaceuticals prevalent in India, but about 75% of counterfeit drugs found globally have also been found to have originated in India.  The following are the primary driving forces behind the large fake pharmaceutical industry in India:


Lack of detection measures

India has not invested enough resources in agencies to supervise and assess the quality of drugs in its pharmaceutical market.  The 2003 Mashelkar Committee Report commissioned by the Indian Government noted, “the problems in the regulatory system in the country were primarily due to inadequate or weak drug control infrastructure at the State and Central level, inadequate testing facilities, shortage of drug inspectors, non-uniformity of enforcement, lack of specially trained cadres for specific regulatory areas, non-existence of data bank and nonavailability of accurate information.”  


Weak enforcement of legislation

India’s legal system is complex and overburdened, which prolongs litigation making enforcement of any legislation ineffectual.  The 2003 Mashelkar Committee Report stated that legal proceedings in India are “far too complicated and lengthy; the process moves slowly and the conviction rate is low.”


Lack of consumer awareness

India has a population of 1.3 billion and approximately 66% of the Indian population is rural.  Education and literacy rates are particularly poor in Indian rural communities.  The 2014 Survey conducted by the Indian National Sample Survey Office under the Ministry of Statistics and Program Implementation found that literacy rate among Indian rural population was 71%, while Indian urban population had a literacy rate of 86%.  As a result of poor literacy and education, Indian consumers also lag behind in general consumer awareness and lack education about the prevalence of fake pharmaceuticals and unwittingly buy them believing them to be the genuine drugs.


Lack of protection of patent rights

Genuine drug patent owners are not protected adequately by India’s weak patent laws.  In 2005, India purportedly made significant changes to its patent law to make it compliant with Trade-Related Aspects of Intellectual Property Rights (TRIPS), the World Trade Organization's (WTO) minimum standards for intellectual property protection.  However, cases such as Novartis AG v. Union of India, in which Novartis was denied protection for its chronic myeloid leukemia drug Gleevec, demonstrates that Indian patent law still has a long way to go when it comes to protecting patent owners.


Widespread corruption

Corruption is rampant among Indian politicians, bureaucrats, and judiciary.  Transparency International ranks India 81 among 180 most corrupt countries with a Transparency score of 40 out of 100.  Consequently, counterfeiters can escape punishment by paying off the right person.


Unaffordable genuine brand name and generic drug prices

Most of the Indian population survives on $1.9 (USD) per day. This makes genuine brand name and generic drug prices often unaffordable to a majority of the population unless the prices are subsidized.  Fake pharmaceuticals tend to be a significantly cheaper alternative making it more affordable for the average Indian citizen.

Conclusion

Fake pharmaceuticals not only pose a threat to Indian consumers’ health but also deter future investment in research and development of new drugs by cutting into profits of genuine brand name drug companies.  

Therefore, both Indian consumers and genuine drug companies need protection from fake pharmaceuticals. There is no easy solution to the problem of fake pharmaceuticals in India.  But providing better protection for drug patent owners by enacting stricter legislation that is strongly enforced, along with providing consumer education to increase awareness about the prevalence of fake pharmaceuticals would go a long way towards solving it.

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About the author

Tulip Mahaseth

Post Written by Tulip Mahaseth

Tulip Mahaseth, Ph.D., is a legal content contributor for Red Points. She is a Patent Attorney at Foley & Lardner LLP, Palo Alto, where she practices patent prosecution and counseling. Tulip is admitted to practice before the State Bar of California and the United States Patent and Trademark Office. Tulip received her JD, cum laude, from Northwestern University School of Law, where she was a George L. Quilici Scholar and Foley & Lardner Diversity Fellow. Tulip holds an M.S. and a Ph.D. in Microbiology from University of Illinois at Urbana-Champaign. She received her integrated M.S. in Biological Sciences with First Division honors from Birla Institute of Technology and Sciences, Pilani