Popular pharma products of GSK and Macleods face counterfeiting

Lately, India’s leading drug authority flagged almost 35 batches of medicines, including popular skin medication cream brands Betnovate and Panderm as they failed quality tests conducted last month. At the same time, companies that market these products in India said that the samples tested by the regulator were fake versions of their famous brands

Earlier this month, the Central Drugs Standard Organisation had marked specific batches of Betnovate C, Betnovate N & Panderm ++ failing in quality standards. According to the authority, the samples failed in tests conducted to determine their ingredients. The regulator also found that a batch of acidity drug Lupizole also failed in the tests.

While conducting the tests, CDSCO had identified batch number NG980 of Betnovate C cream for failing in identification tests along with tests of ‘assay’ of clioquinol- which means that the cream had fewer quantities of this ingredient. The batch number of EZ277 of Betnovate-N also failed in the identification test, whereas samples of Panderm ++ batch number PCF901A and Lupizole batch number T9004141 were declared substandard by the authority.

While commenting on the issue a spokesperson from GlaxoSmithKline which markets the product in India said that the two batches of Betnovate-N and Betnovate-C seized by Delhi Drug Control are counterfeits. He further added that the two batches were marked counterfeit by the company and the authority, after testing them at government labs and retesting at GSK sites. Meanwhile, GSK is coordinating with the regulator and providing its full support in the matter.

Macleods, which markets Panderm ++, has already filed a complaint with the drug regulator and Delhi Police over counterfeits of its skin treatment cream. A representative from the company said that the batch number listed by CDSCO is not correct and does not abide by the coding practices of Macleods Sikkim facility. Moreover, the details mentioned on the label are inaccurate which identifies the product as a counterfeit. Macleods had filed a complaint with the FDA and the Delhi Police in the month of August and September while an FIR has already been registered for the impugned counterfeit Panderm ++. Emailed queries to Lupin Ltd, which markets Lupizole in India, remained unanswered by press time Saturday.

Some quick facts:

  • In October 2019, Betnovate-C was the largest brand in the over Rs 210 crore betamethasone + clioquinol combination market, while Betnovate-N was the largest in the nearly Rs 195 crore betamethasone + neomycin combination market.
  • In October 2019, Betnovate-C was the largest brand in the over Rs 210 crore betamethasone + clioquinol combination market.
  • In October 2019, Betnovate-N was the largest in the nearly Rs 195 crore betamethasone + neomycin combination market.
  • According to AIOCD and PharmaTrac, Betnovate-C and Betnovate-C captured 100 percent and 98.78 percent of these markets.
  • Panderm ++ is also the top brand in its segment, capturing over 40 percent of the Rs 122.70 crore clobetasol + neomycin + miconazole combination market in October.

Source: Indianexpress.com

 

The impact of counterfeiting on the common man

Many people don’t take the crime of counterfeiting seriously, they think that counterfeiting will not impact their lives, however, the fact is that counterfeiting has many negative impacts on the common man and thus has been named as the ‘Crime of the 21st century by Federal Bureau of Investigation.

On the global scale, the value of counterfeiting has reached a high of approximately 1 trillion dollars whereas, in India, the figure has shot up to I lakh crore annually. These figures clearly show the grim scenario of the situation.

Counterfeiting not only impacts the global economy but is a challenge for the governments, business organizations and most importantly the consumers. Counterfeiting not just dupes the consumer of his hard-earned money but also affects his health, besides this, there are many far-reaching impacts of counterfeiting on consumers. Let’s discuss the same.

Negatively affects the consumer’s health: What could be more dangerous than a counterfeit life-saving drug. Counterfeit medicines have created havoc in the industry, and it has become increasingly difficult to control them. Counterfeit or substandard medicines can have serious side effects on the human body and in some cases can even lead to death.

Dupes the consumer financially: Consumers who unknowingly purchase fake goods have to pay an actual price for a counterfeit. While it may sound good to purchase an original product at high prices but for a counterfeit, it is not at all good in any sense as you have compromise on quality.

Creates unemployment: There is a clear link between the rise of counterfeiting and the rise in unemployment. The business of counterfeits leads to monetary losses for the manufacturers which in turn affects the expenditure on current and future employees.

Poor infrastructure: Today’s common man needs beyond ‘roti, kapda, and makaan’. The government spends a good amount of money every year on rural and urban infrastructure. This money is collected from the taxes levied by the government on the business organizations and the common man. Since counterfeits evade taxes it leads to a drop-down in the money spent on infrastructure and development.

Counterfeit drugs creating a challenge for the regulators in India

According to Government-sponsored studies around 3% of medicines in the Indian market are of poor quality or are counterfeit. However, a report published by ASSOCHAM said that 25 percent of medicines sold in India re either counterfeit or of poor quality. Generic drugs like Crocin and Betadine have earned a bad name due to the menace of counterfeiting.

According to former International Pharmaceutical Federation vice president Prafull D. Shah, “Any study showing a higher percentage of Indian drugs as substandard or fake serves the interest of foreign pharma companies since Indian companies have always posed them a threat.” He also said that he had asked ASSOCHAM for the data based on which they provided the 25% figure however they never provided it to me.

The BJP government in 2003 had appointed an expert committee to assess the regulatory infrastructure and the scope of the problem of fake and cheap drugs in India. The panel admitted that there was an absence of scientific and detailed investigation to reveal the exact estimate.

The committee also said, “The Central government should provide assistance to undertake such scientific and statistically-significant study for a clear picture about the exact extent of spurious drugs in the country.”

In 2006-07 with the support of WHO around 7500 samples were collected and tested from across the country out of which 3.12% were of poor quality but the presence of spurious drugs was negligible.

In the second survey, conducted by the Central Drug Standards Control Organisation (CDSCO), a total of 24,780 samples were tested from around 40,000 pharmacies, of which 644 were “SALA (sound-alike and look-alike)”.

Going by raids conducted in the past few years, prominent places where counterfeit drugs are manufactured and sold in wholesale include Baddi in Himachal Pradesh, Agra, Aligarh, Bulandshahr and Muradnagar in Uttar Pradesh, Patna in Bihar and several places in West Bengal.

Source: OutlookIndia.com

The negative impact of counterfeiting in the pharmaceutical industry

There are many times when the medicines you take do not help you in relieving from the ailment. Sometimes these medicines may cause many unwanted side effects on your body. This simply means that such medicines may be of low quality or counterfeit.

The market of fake medicines has grown tremendously over the past few years. Such spurious medicines can be found at government pharmacies, big pharma stores, local drug stores to small shops. Nowadays, people have become highly susceptible to fake or spurious medicines. This is because of many reasons like lack of awareness, poor monitoring of supply chains and weak regulations.

Here are some shocking facts about counterfeiting in the Pharma industry.

  • Around 20% of all drugs sold in the Indian market are counterfeit- (Source: US Trade Representative Office Annual Report)
  • Up to 10% of drugs in developing countries are fake, costing an annual loss of $10bn to $200 Billion. (Source: American Journal of Tropical Medicine and Hygiene)
  • 35 percent of fake drugs sold all over the world come from India. (Source: WHO Report)

Now let’s discuss some of the challenges posed by counterfeit medicines.

1. Prevents the business growth of Pharma companies: One of the biggest impacts of counterfeiting in the pharma business is that it brings down the profits of legitimate manufacturers. Market reports state that fake medicines lead to an annual loss of $46 billion for pharma companies worldwide.

Hampers the use and promotion of low-cost generic drugs: A major share of India’s drug market is dominated by branded generics. To promote the use of less expensive branded generic medicines government is taking various measures but, the circulation of fake drugs blocks its promotion and sale. This is because medicine earns a bad reputation due to its duplication.

3. Increased pressure on health and economy: The use of counterfeit medicines increases unnecessary costs on public health. This is due to their unwanted side effects which leads to a host of other health complications and diseases subsequently creating a vicious circle.

4. The extra cost for resources: To tackle the issue of counterfeit government has created many regulatory bodies but, has failed to counter the problem due to lack of manpower, for more human resources increase in costs are quite evident. For instance, India’s Central Drugs Standard Organization which is the country’s drug regulator had just 233 employees in 2014. In order to increase the strength of employees will bring an extra burden on the government in the form of increased expenditures.

Barcoding to become mandatory for drugs in India

The Union Health Ministry in India is going to make barcoding necessary for drugs after an alarming report by US Trade Representative (USTR) which revealed that India was one of the largest producers of fake medicines in the world.

The Drug and Technical Advisory Board (DTAB) had earlier recommended that an Indian law should be made that makes barcoding mandatory for all medicines. This would allow pharmacists, customers and the government to trace medicines across the supply chain and identify where a drug was manufactured

The barcoding would help pharmacist, consumers and government bodies to track and trace medicines across a supply chain. The Indian government is taking the measure after a USTR report which mentioned that up to 20% drugs sold in India are fake and could pose a serious risk to the health and safety of the patient.

As of now barcoding is mandatory for medical devices and exported medicines but for drugs sold domestically, it is voluntary. Raja Selvam, Managing Attorney, Selvam and Selvam said that barcoding would help in preventing the infiltration of fake drugs in the supply chain which will ensure the safety of patients.

DTAB said that mandatory barcoding would help in preventing the problem of false labelling and thus will help the manufacturer in identifying the falsely labelled product. Vikrant Rana, Managing Partner at SS Rana & Co in New Delhi, said that the change was timely, but it will be challenging in the village areas where there is hardly any internet connectivity and electricity making it tough for scanning to be possible.

How counterfeiting affects pharmaceutical industry?

Medicines are boon for human life. Be it a life-saving drug or something as simple as a cold pill, the importance of each of the medicines can only be understood by the patient, and his or her loving ones.

Healthcare industry is being pumped due to the increasing number of diseases and people’s shift towards health care. In this fast-moving world, nobody can afford to stay ill for a long period of time. With the easy availability of medicines and advanced health care facilities, today’s generation is far more safe and secure against chronic diseases.

No wonder, the pharmaceutical industry is booming worldwide bolstered by constant innovations and research. However, on the flip side, the pharmaceutical industry is facing the wrath of counterfeit drugs. Lately, the manufacturing of fake drugs has become a thriving business in third world countries-India being one of them.

According to the World Health Organization (WHO), 10 to 15% of the global drug supply is counterfeit and Africa accounts for up to 30% of the counterfeit medicine in circulation. A per another statistic it is estimated that 1 in 10 drugs sold worldwide is counterfeit.

One of the worrisome situations created by counterfeit medicines is their threat to human lives. According to a news published in The Guardian, “A surge in counterfeit and poor-quality medicines means that 2,50,000 children a year are thought to die after receiving shoddy or outright fake drugs intended to treat malaria and pneumonia alone.”

In order to fight the menace of counterfeiting the Indian government is taking various measures. The Union health ministry will make barcode compulsory for all pharmaceutical ingredient packages so that it may help to track spurious drugs and also monitor imported and domestically produced raw materials. Besides the use of digital authentication, physical anti-counterfeiting technologies can play an important role by adding an extra layer of security to the product.

Health Ministry preparing a draft to counter USTR report

The Indian Health Ministry is preparing a draft to refute US trade representatives (USTR) report that accuses India as one of the main sources of fake medicines across the globe. Arun Singhal, Additional Secretary Health Ministry has dismissed the report and has termed that the Ministry is in the process of preparing a draft to counter USTR report which mentions that India is a global supplier of fake drugs.

The USTR report claims that India and China are the leading hubs for the supply of counterfeit medicines globally. The report states, “While it may not be possible to determine an exact figure, studies have suggested that up to 20% of the drugs sold in the Indian market are counterfeit and could represent a serious threat to patient health and safety.”

Surprisingly, the report is in complete contrast to the government’s own report of 2016 which states that only 3% of the drugs are not of standard quality and 0.0245% are spurious drugs. According to S Eswara Reddy, Drug Controller General of India, “The claim made by USTR tarnishes the image of India which is one of the leading global producers of low-cost generic medicines and hence it’s important to get documentary evidence from them that they used to support their claim.” Leena Menghaney South Asia head of the Access campaign by Médecins Sans Frontières also supports India’s point and says, “MSF supports the health Ministry’s position that the USTR report is a scathing attack on India’s capability of manufacturing large scale affordable generic drugs.”

Source: Live Mint

20% medicines sold in India are fake, says US trade body

India is one of the leaders in producing low-cost generic medicines due to high local demand and low-cost manufacturing. Despite being ranked as the third largest pharmaceutical market in terms of volume, it is ranked on 13th when it comes to quality. It has been discovered that even the most popular drugs like Crocin and Betadine are adulterated to a certain degree.

The rise of low-cost pharmaceuticals has come under the light of United States Trade Representatives under its ‘Special 301 Report’. The organisation has blamed India for violating the IP protection for its growing problem on fake medicines.

The report states that 20% of the drugs manufactured in India are adulterated. With its claim of being the home to most ancient medicine and one of the foremost pharmacy hubs of the world, figures like this can be disparaging for India.

Such fake drugs are not only affecting India’s local population but also the massive populations of Indian pharmaceutical exporters like Africa, Canada, the Caribbean, the E.U, South America, and the United States. The officials are looking seriously into the matter aim to combat it with the use of advanced anti-counterfeiting technology.

Source: Trak.in

Why pharma companies must take counterfeiting seriously?

Pharmaceutical products are of vital importance to the healthcare system of every country. However, high incidents of counterfeiting in the pharmaceutical business has hampered the growth of the pharma industry and has wreaked havoc on the healthcare systems. According to the World Health Organization (WHO), 10 to 15% of the global drug supply is counterfeit and Africa accounts for up to 30% of the counterfeit medicine in circulation. A per another statistic it is estimated that 1 in 10 drugs sold worldwide is counterfeit.

One of the worrisome situations created by counterfeit medicines is their threat to human lives. According to a news published in The Guardian, “A surge in counterfeit and poor-quality medicines means that 2,50,000 children a year are thought to die after receiving shoddy or outright fake drugs intended to treat malaria and pneumonia alone.”

Lately, the problem of fake medicines has grown manifolds with the rise of e-commerce platforms. This has led to a growth of illegal online pharmacies as well as online marketplaces distributing them. Amidst this grim scenario, pharmaceutical companies must take product and brand protection seriously due to the following reasons:

To protect their consumers

An estimated 116,000 deaths have occurred in Sub-Sharan Africa due to counterfeit malaria pills. Whether the counterfeit is a placebo containing sugar or has been laced with cheap and dangerous chemicals, it is putting human lives at risk.

To secure their return on investments

The global pharmaceutical industry loses millions due to the sale of fake and sub-standard medicines every year. The EUIPO (European Union Intellectual Property Office) estimates that the EU pharmaceutical industry loses the equivalent of nearly 7% in sales per year due to counterfeit drugs which accounted for 26,9 billion Euros annually. No wonder, the pharmaceutical industry invests billions in R&D and counterfeiting badly affects their return on investments.

To safeguard their brand reputation

Counterfeit drugs ruin the image of pharmaceutical brands. Fake medicines also affect the reputation of generic medicines which are meant for the masses. Pharmaceutical companies must strictly ensure that their products are not being counterfeited.

‘Fake drugs cause death of 2,50,000 children every year’ warn US doctors

Doctors have asked for an urgent international effort to combat the harmful effect of bad drugs that are thought to kill hundreds of thousands of people around the world everywhere.

The doctors cautioned that an increase in counterfeit and cheap grade medicines means that 2,50,000 children are thought to die because of them.

A large number of children are thought to die due to cheap grade vaccines and antibiotics which are meant to treat acute infections and diseases such as hepatitis, yellow fever and meningitis.

“The penalties are a slap on the hand, but we are talking about murder by fake medicine here,” said Joel Breman, a senior scientist emeritus at the US National Institutes of Health in Maryland.

Writing in the American Journal of Tropical Medicine and Hygiene, doctors from the US government, universities, hospitals and the pharmaceutical firm Pfizer warn that the rise in “falsified and substandard medicines” has become a “public health emergency”. On top of the direct harm they cause, bad drugs are a major driver of antimicrobial resistance, which fuels the rise of superbugs. “This is an urgent public health issue and we need to take action,” Breman said.

Source: theguardian.com