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.

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.


Low quality drugs are a bigger challenge for India than counterfeits

The US government has blamed India for being a hub of counterfeit drugs globally. However, for pharma companies in India low-quality drugs are a bigger threat than fake drugs.

As per the US Trade Representative office’s annual report on IP protection and review of markets notorious for privacy and counterfeiting, 20% of all drugs sold in the Indian market are counterfeit. On the contrary, India has shunned the report claiming it is an attack on its capability to supply cheap generic drugs.

Recent surveys show that the proportion of cheap or substandard drugs at about 3 per cent of the overall drugs sold, while about 0.28% were found to be counterfeit. This hints toward the scenario that India has a bigger problem of cheap quality drugs which is overshadowed by the focus on controlling the production of duplicate ones.

According to a report released by the World Health Organization in 2017, about 10.5 per cent of medicines sold in low and middle-income countries, including India, are substandard and falsified.

The surveys and reports point the need for handling of the problem of substandard and fake drugs with a heavy hand, as low-cost medicines manufactured in the country should not end up being labelled as being low in quality.

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.

Pharmaceutical anti-counterfeiting technologies market analysis (2018-26)

Pharmaceutical products are one of the most vulnerable goods for counterfeiting practices worldwide. Counterfeiting practices involve substitution of original medicine with a substandard drug containing toxic substance or no active ingredient at all. Anti-counterfeiting technologies are applied to nullify adverse impact on the health of patients, which may lead to the death of the patient in extreme cases. Unlike other products in which counterfeiting practices could be identified with the visual appearance of the product by the end user, pharmaceutical products could not be identified for their spurious content by the end user or other stakeholders.

Anti-counterfeiting technologies consist of different types such as track and trace technologies, cohort technologies, overt technologies, and forensic technologies. Although there is a rapid change in the technology landscape due to the availability of smartphones.

According to the International Trade Administration Top Market Reports on Pharmaceuticals published in 2016, the global market for counterfeit drugs valued at number of US$ 75 – 200 billion, which is a serious threat to the health of people worldwide. According to the estimate by the International Criminal Police Organization, (Interpol) counterfeit drugs causes more than 1 million death every year. Increasing intervention by government and other health authorities such as WHO, OECD, and Interpol to tackle the problem of counterfeit drugs is also expected to drive the growth of pharmaceutical anti-counterfeiting technologies market size over the forecast period (2018-26).

Access the full report:

Source: business herald

‘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.


Raids conducted at different locations in UK on fake medicines

During a sting by UK police more than £2million worth of illegal and ‘potentially harmful’ medicines have been seized by officials. The confiscated medications include diazepam also known as Valium and another stimulant drug modafinil which were found inside clothes and video games cases. Government agents arrested a person after raids on a semi-detached house and lock up a unit in Manchester along with this they also found packages at airports and mail delivery centres.

The Medicines and Healthcare products Regulatory Agency (MHRA) found more than one million doses of medications as part of a coordinated international operation. The raids were part of Interpol’s Operation Pangea which took place in 116 countries and uncovered worth £10.9million of medicines.

The officials carried out the raids between October 9 and 17 and have warned people from buying medicines online and also self-medicating. Alastair Jeffery, MHRA’s head of enforcement said that criminals who sell medicines over the internet have no regard to the health of the people.

Alastair also stressed on that fact that falsified or unlicensed medicines puts the life of consumers at risk. This is just a small part of the overall problem and they are taking action against illegal partners to stop illegal medicines. Alastair also said that in order to protect your health


AICDF wants anti-counterfeiting technology for essential medicines

The CDSCO (Central Drugs Standard Control Organization) is on the verge of implementing a track and trace mechanism for prominent drug manufacturing companies which are most susceptible to counterfeiting. But, the step can only reap benefits if the move extends to NLEM (National List of Essential Medicines) products as well says, AICDF (All India Chemists & Distributors Federation).

CDSCO has identified top 300 drug companies based on the moving annual data. The organization wants top 300 drug brands to print a 14-digit number on the labels of the product along with their contact number. This will help the consumer to check the authenticity of the drugs by sending a text message on the number provided on the label. One would receive information like batch number or the expiry date of the product with other details verifying the product’s genuineness.

However, the AICDF has disagreed with the current move and has stated that counterfeiters concentrate more on the brands which have been popular for more than a decade- the brands well known to common people. Joydeep Sarkar General Secretary of AICDF stated that any new molecule included in NLEM, post-DPCO-2013, can churn out huge profits. In 1995 the NLEM brands had a profit margin of 100 % which has now grown up to 500 to 800 %.

Sarkar also said that government should take proactive measures to banish counterfeiting from the pharma industry but, production of fake medicines starts with the availability of basic ingredients imported by companies. It’s the negligence of the concerned authorities who are quite liberal in allowing easy import of salts rather clearing them through a stringent check. Moreover, no restriction on proper disposal of expired medicines has also encouraged the sale of counterfeit medicines as manufacturers show reluctance to take back expired medicines from stockists. He also pointed out that instead of taking measures against the real offenders who are the manufacturers, authorities consider traders as the prime culprits.

Expressing his doubt on the efficacy of unique code to be printed on dug packs to counter duplication he said that the use of a code, QR-code or a special mark will not be able to restrict counterfeiting. In the past counterfeiters have been able to replicate labels and with time they would also find ways to replicate special codes thus diminishing the line between fake and real product.

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