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.


Reports & Data: Anti-counterfeit packaging market to reach USD 248.90 Billion by 2026

According to Reports & Data, the global anti-counterfeit packaging market is forecasted to reach a value of USD 248.90 billion by 2026. As per the report, the massive rise in globalization has increased the level of counterfeiting across the globe. Duplicate goods include jewellery, electronic items, apparels, medicines, tobacco products, liquor and much more. Due to this trend, secure packaging is witnessing high demand among different industries.

Anti-counterfeit packaging involves the action of assigning secure packaging to the product so as to minimize the incidents of counterfeiting and infringement. Currently, the market of fake products is growing across the globe at an alarming rate and manufacturers are finding it harder to counter the threat. Among the many sectors pharmaceutical is one of the worst-hit by counterfeits. Fake medicines include the proliferation of dangerous and illegal substance used in counterfeit drugs.

Organizations are using different anti-duplication packaging to counter the imitation and confirm the safety of items. Counterfeiting leads to a reduction in profits and loss in the brand image for the affected company.

In the year 2018, North America had the largest share at 31.4% in the anti-counterfeit packaging market. The report states that the high demand from healthcare products, electronics, food and beverages, and cosmetics is pushing the growth in this market. Moreover, awareness among consumers is leading to an increase in the demand for transparency which in turn is boosting traceability of the products. In order to cater to the rising demand, manufacturers are coming up with innovative technologies in equipment with specific functionalities for efficient identification and tracking of products.

Other key findings of the report:

  • Barcodes held the largest market share of 21.8% in the year 2018. The barcode is a series of numbers which, when decoded, identifies the product by date and place of manufacture. These codes are one-dimensional, and the information included in them is limited by the maximum available number of characters that can be scanned or printed at a time.
  • Overt Feature is forecasted to grow with the higher CAGR of 10.9% during the forecast period. This feature enables instant authentication of packaging via visual inspection by a layman. An optically variable feature like holographic devices within designs and color shift links are some of the most common and effective overt security features.
  • Counterfeit medicines in pharmaceutical are among the most lucrative sectors of the global trade. Fake drugs kill or harm millions across the globe and inflict some severe damage to the brand names of big pharmaceutical manufacturers. Lifesaving drugs are also included from the trade-in fake medicines. Healthcare & Pharmaceutical held the largest market share of 24.6% in the year 2018.
  • The Asia Pacific region is forecasted to grow with the highest CAGR of 10.7% during the forecast period, owing to the development of the anti-counterfeit packaging market in China and India. Increasing awareness among consumers has led consumers to check the product-related information before purchasing products, in turn, increasing the demand for anti-counterfeit packaging in this region.


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.

‘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.


The challenges posed by evil of counterfeit medicines in India

You take an antacid pill but, it doesn’t settle your heartburn. Your wife’s anti-allergic medicines are not curing her skin allergies, or your mother still complains of back pain, despite taking her medicines on time. Situations like these have become a common spectacle in India. It simply means that medicines are not working against diseases or most medicines you are consuming in everyday life are counterfeit and substandard.

Fake medicines have deeply penetrated into the Indian pharmaceutical market. Such dubious medicines can be found anywhere i.e. from government pharmacies to big pharma stores, local drug stores to small shops. People are highly susceptible to counterfeit or fake medicines due to lack of awareness and poor monitoring of drug supply chains.

A recent report by WHO (World Health Organisation) states that 1 in 10 medical products circulating in third world countries are either of low quality or are fake. These medicines not only fail to treat diseases but can also lead to serious implications.

The Department of Food Safety and Drug Administration says that 10% of the duplicate drugs have been introduced into the India pharma market whereas, 38% are of subpar quality, which do not work at all.

The above-stated figures point towards a worrisome situation in which it has become difficult to find an original medicine with ease.

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

1. Hampers business growth of pharma companies: It has been experienced time and again that counterfeits can lead to huge business loss and the gradual shrinking of the market share of real credible pharmaceutical companies. According to reports, fake medicines lead to an annual loss of $46 billion annually for pharma companies worldwide.

2. Blocks the use and promotion of low-cost generics: Almost 90 % 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 counterfeiting.

3. Increased pressure on national 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 counterfeits 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 is 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.

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NITI Ayog collaborates with Oracle to stop fake drugs

A WHO (World Health Organisation) report states that 35 % of duplicate drugs sold all over the world comes from India. This means that one out of ten medical products circulating in India are fake or of substandard quality. Approximately 20 % of the drugs sold across the nation are counterfeit or fake. The report further states that the fake drug market in India stands at Rs 4000 crore. The aftermaths of fake medicines are quite worrisome not just for India but for other countries as well. Duplicate medicines can promote antimicrobial resistance due to which the infection can be carried and passed on to people travelling to different countries. The mutated bacteria or virus is impossible to be treated with the same medicines as they become resistant to it.

Witnessing the looming danger, NITI Ayog which is government’s policy think tank has collaborated with Oracle and Apollo hospitals. Oracle will implement its block chain technology and a ledger system in the supply chain of pharmaceutical company. This will lead to creation of records cannot be altered with every transaction.

With the implementation of blockchain technology all kinds of medical and pharmaceutical products will be eliminated form the hospital chain’s inventory. The technology will help in reducing the distribution and sale of fake medicines. The system will also help in real-time monitoring of the production and export. The blocks of blockchain technology are continuous growing list of records that are linked using cryptography. In the pharmaceutical sector, blockchain will help in stopping the entry of fake drugs.

The collaboration of NITI Ayog and Oracle will help hospital chains across India to bring the entire inventory under the blockchain which will effectively check the intrusion of fake drugs. Moreover, government will also be able to keep a tap on the production and supply of the drugs. Besides big companies like Oracle many startups such as LinkLab, LifeCrypter, Chronicled and BlockVerify are also working to find solutions for the pharmaceutical sector through the use of blockchain technology.

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.