Indian Government’s Latest Weapon In The Battle Against Fake Drug – ‘Oracle’s Blockchain Solution’

Anti-Counterfeiting Menace and India
It is evident that counterfeiting of products continues to be a bane to the Indian economy as well as the world-wide image of the country. Globalization has brought the positives of increased commerce and opened India up for direct foreign investment, which is excellent for the country’s economy. However, India’s status as a low-cost manufacturing base also opens it up for use by counterfeiters as a prime location for the production of counterfeit goods both for domestic sale and export.

As per the global counterfeit goods ranking, counterfeited drugs are at the top of the list with a market value of $200 billion. World over India is a leading manufacturer and exporter of high-quality generic and patent drugs. However, the TAXUD statistics released by the European Commission a few years back showed us the dark side by stating that 75 percent of fake drugs supplied world over had some origins in India. The figures are bound to have increased considerably.

The owners being more aware of their rights have now become more prudent and are swift in taking action. Various government agencies in cases of counterfeiting have taken action both on their own accord as well as upon receipt of a complaint, either from the private sector, the right owners or the consumers themselves. The health ministry in India has also undertaken various steps to clamp down on the illegal trade such as launching a reward program, offering $55,000 to those who provide information about fake-drug syndicates amongst others. Important changes have also been proposed to the country’s IP laws such as the procedure stipulated by the Drug Controller General of India in January 2011, which required an amendment to Rule 96 (manner of labeling requirement) of Drugs and Cosmetics Act. The proposed amendment made it mandatory for every drug manufactured in India to bear on its primary label Unique Identifier Code and 2D bar code by which anyone can verify the drug through an SMS.

In the News
The Indian Government has become proactive in its fight against counterfeiting especially in case of medicinal drugs. The latest weapon in the battle against the fake drug is Oracle’s Blockchain Solution. NITI Aayog, has partnered with the technology giant Oracle and local chain of hospitals, Apollo Hospitals, where Oracle will integrate its blockchain technology and a distributed ledger solution in pharmaceutical supply chain, which will create records that are unchangeable for each pharma transaction.1

Footnote

1 https://www.indianweb2.com/2018/08/25/india-to-fight-fake-drugs-problem-using-oracles-blockchain-solution/

For further information please contact at S.S Rana & Co. email: info@ssrana.in or call at (+91- 11 4012 3000). Our website can be accessed at www.ssrana.in

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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Majority of the drugs found in India are either fake or ineffective

The drugs prescribed by the doctors to cure a person’s disease are unfortunately adulterated most of the times. According to the World Health Organisation (WHO), 35 percent of the fake drugs sold all over the world comes from India and it occupies the counterfeit drug market of nearly Rs 4,000 crore. 20 percent of the drugs sold in India are fake. Drugs prescribed for cold and cough or a headache are mostly either fake or of poor quality.

A patient receiving an authentic drug for his disease has become a challenge these days. The unfortunate thing is that the administration is mostly aware of everything that is happening. According to the data produced by the Department of Food Safety and Drug Administration, more than 10 percent of the counterfeit drugs have been introduced into the market and 38 percent of the drugs are not effective as they are of low quality.

According to the work report submitted by the Department of Food Safety and Drug Administration, Uttar Pradesh, in the year 2015, around 5,150 drugs and 301 cosmetics product samples seized in the raid conducted in the last eight months by them were sent to the laboratory for investigation. The examination report of 4,723 of these samples was astounding. 506 of these drugs were found to be fake which establishes that more than 10 percent of the drugs found in the market are fake. Apart from this, only 2,902 of these samples were found to be effective as per the standards.

National Institute of Biologicals conducted a study across the country during 2014-2016 following the orders of the Ministry of Health and Family Wel. During the survey, there were about 47,954 samples collected from the government hospitals, dispensaries, and pharmacies. More drugs of poor standards were found in the government hospitals as compared to the pharmacies in the market. While pharmacies in the market had 3 percent of the poor quality drugs, government hospitals had 10 percent. There were around 0.023 and 0.059 fake drugs found in the retail outlets and government hospitals respectively. According to the survey, there has been some improvement in the situation over the time.

Most of the fake drugs are made in extremely polluted atmosphere and the demand for these drugs is present all over the world, from South Africa and Russia to our neighbouring countries such as Myanmar and Nepal.

The standards created by the Pharmacy Council of India for setting up of pharmacy shops are also being regularly violated. One of the rules is that there should be a gap of at least 300 metres between two pharmacies. However, it is a common sight in India to spot two or three pharmacies right next to each other. The regular violations, which are the result of government’s apathy or corruption, are proving to be harmful to the common people of India.

https://yourstory.com/2017/06/india-fake-drugs/amp/

Can I fake your order?

When Suraj Daspattnaik, a resident of Kolkata, booked a Titan watch from a prominent e-commerce website, he wasn’t aware that a long battle was about to commence. The 28-year-old had purchased a men’s watch from the Titan Karishma collection for around Rs 2,500 from online retailer Snapdeal in June 2017. But within four months of the purchase, the watch stopped functioning. He took it to the Titan showroom, along with the guarantee card and invoice, but the shop attendant, after examining the watch, declared it to be a fake. “I wrote to Snapdeal about what the Titan showroom people told me, to which the online site responded that I would have to get the same in writing,” says Daspattnaik. He went back to the Titan showroom in Howrah and explained his predicament. The personnel at the showroom asked him to leave the watch with them, telling him they would send it to a workshop to get it verified further. “A week later, they returned the watch and confirmed orally that it was fake. But they refused to give it to me in writing, saying there was no such company policy,” says the disgruntled customer.

Daspattnaik then registered a complaint with the Consumer Online Foundation, an online consumer redressal forum, which tried intervening, but without any success. “Snapdeal refuses to refund my money without a written confirmation from Titan. On the other hand, Titan maintains that they aren’t entitled to give me anything in writing,” says Daspattnaik, a health and security officer at a construction firm in Mumbai now. “I got transferred to Mumbai and now I don’t have the time to follow up. But I intend to take my case to a consumer court,” he says.

Das pattnaik isn’t alone. In a survey conducted in April by Local Circles, a community social media platform, as many as 38% consumers polled said they received a counterfeit product at least once in the past one year. The survey, which polled over 12,000 customers across India, mentioned 17% people being unsure of whether they received any counterfeit goods, while 45% said it had never happened with them.

“The results were a surprise, as we did not expect so many people to be affected by counterfeit goods. When 38% people say they have received counterfeit goods, it is an alarming number. It shows that e-commerce platforms are not serious about tackling this problem,” says K Yatish Rajawat, chief strategy officer, LocalCircles. In the survey, around 29% people surveyed said they received a counterfeit product from one of the leading websites.

The break-up includes Snapdeal (12%), followed by Amazon (11%) and Flipkart (6%). “When more than one-third of consumers are getting fake products, it means it’s a major problem. Our survey shows that big marketplaces are not ‘safe havens’,” adds Rajawat.

Rampant issue

From branded footwear, apparel and personal care products to watches, fragrances and alcohol, fakes exist in almost all categories. With the number of people shopping on online platforms on the rise, consumers are more and more exposed to fake goods. Besides convenience, e-commerce sites offer consumers a wide choice, as well as discounted prices, from the comfort of their homes. As per market research firm RedSeer Consulting, India’s online shopping industry is estimated to grow at 60% to about $28.5 billion in terms of gross merchandise value (GMV) in 2018. But the ugly world of fakes is a big menace to this industry too. In December 2017, American footwear brand Skechers filed a case against Flipkart, and four sellers on its platform, for fake goods being sold under its label. The company, with orders from the Delhi High Court, raided seven warehouses in Delhi and Ahmedabad to recover fakes from several sellers.

In response, Flipkart has now filed a police complaint against one of its major suppliers and an employee for cheating, fraud, forgery and breach of trust. “As a responsible online marketplace, Flipkart has a robust system of checks to ensure that any instances of fake or spurious products are detected quickly and delisted,” says a Flipkart spokesperson. The complaint was filed last month after Flipkart conducted a third-party forensic audit, which revealed that the supplier, along with the Flipkart employee (designated to liaise with the supplier), was importing sub-standard products. Fake goods being sold online in India isn’t anything new however. There have been several stray incidents that have been reported against big online marketplaces over the years. In 2015, popular eyewear brand Ray-Ban took ShopClues to the Delhi High Court over complaints that it was selling fake products under its brand name. The same year, L’Oréal and Tommy Hilfiger, too, initiated action against ShopClues.

Over the years, though, these instances have only increased. So what makes online portals succumb to fakes? “Due diligence of suppliers has taken a backseat, meaning that counterfeit (products) and infringing goods have become increasingly common,” says Arun Agarwal, vice-president, Authentication Solution Providers’ Association (ASPA), a Delhi-based not-for-profit body that represents the authentication solutions industry. Agarwal explains that most e-retailers, including Amazon, Flipkart, Snapdeal and Jabong, use a marketplace business model, with suppliers storing goods on the e-retailer’s behalf and delivering them once orders have been placed, so as not to fall under the B2C category. “This model depends on e-retailers expanding their supplier base in order to provide goods at competitive prices. But the challenge is to ensure that the product shipped from an e-commerce authorised vendor to the end customer is genuine and reaches without any tampering and repackaging,” he adds.

Battle for e-tailers

For e-commerce portals, the battle against fake products is even bigger. Most have ‘zero tolerance’ for counterfeit products. Amazon India maintains that it removes suspected counterfeit items as soon as the company becomes aware of them. “We suspend or block bad actors suspected of engaging in illegal behaviour or infringing others’ intellectual property rights (IPR). We have taken independent legal action against bad actors and will continue to do so,” says an Amazon India spokesperson. But the company did not divulge any details on how many sellers have been barred from the marketplace over fake goods in the past years or how many consumers have gotten refunds for such goods. “To preserve customer trust, we are investing heavily in protecting the integrity of the Amazon marketplace for consumers, sellers and manufacturers. We are also working closely with rights owners to strengthen protection for their brands on Amazon,” adds the spokesperson.

As per a report by RedSeer in April, the Indian e-commerce industry lost $3.4 billion in GMV due to product returns in 2017. As per Snapdeal, the problem of unscrupulous sellers attempting the sale of fake products is a generic one that impacts buyers, brands and marketplaces all over the world. Experts maintain that what should be worrisome is the increasing number of people falling prey to fakes, leading to trust deficit for online sites. “By 2020, over two billion e-shoppers—60% of the target global population—will be transacting 13.5% of their overall retail consumption online, equivalent to $3.4 trillion. So the biggest challenge today for e-commerce is trust. According to Edelman’s 2015 Trust Barometer report, trust in business and other institutions is at an all-time low,” says Agarwal of ASPA.

Rajat Chetia would agree. The 27-year-old from Sivasagar in Assam swore never to return to online sites for shopping after a bitter experience in February this year—he received duplicate Amway Nutrilite supplements from Snapdeal. “Since I had been using the product for a few months, I could spot the difference in packaging and realised it was fake. I sent a mail to Snapdeal and they asked me to send proof. I clicked pictures of the original box and the fake one, and sent them to the e-tailer. After a month or two, I was refunded the complete amount of `1,422 by Snapdeal,” says Chetia, who runs an automobile business in Sivasagar. “But what if I was a first-time user? Or someone who didn’t know how to pursue the case in a consumer forum?” he says. Most online portals might seek refuge in the fact that they are a marketplace, which acts as an intermediary, connecting buyers and independent third-party sellers.

But with brands threatening to pull out, and many having already done so, e-commerce giants are now working towards weeding out counterfeiters. In the past three years, Snapdeal has delisted/restricted 45,319 sellers from accessing the platform for non-compliance with the company’s terms of use. “Every seller listed with us is required to enter into a legal agreement to sell only new and genuine items. Sellers of a branded product are required to submit a brand invoice or a brand authorisation letter before they are allowed to list products on the marketplace. A seller found indulging in any malpractice is investigated and strict action is taken, which may include, amongst other measures, permanently barring the seller from using the platform. In the case of an IPR infringement, we take down the listing and support the brand by providing seller information to enable the brand to pursue legal remedies. Snapdeal acts against verifiable and actionable complaints, as per the applicable laws of the marketplace,” says a Snapdeal spokesperson.

The company maintains that it protects the interests of the buyer through the ‘Trust Pay’ policy, wherein buyers can return the product and get 100% refund in case they are dissatisfied with it. “Besides the image-recognition system that helps identify apparent violations, we are in the process of developing and deploying additional AI-based tools, which will help analyse and correlate product, price and image-related information to flag suspicious listings for further analysis,” the spokesperson adds. India is not the only country that faces the problem of fake goods in online retail. Top retailers such as Alibaba and eBay have also struggled to weed out counterfeits. Alibaba had, in fact, fired several of its employees in 2011 when it discovered that they had granted special status to more than 2,000 sellers who had cheated customers. “The survey by LocalCircles revealed that more than 50% customers don’t trust product reviews on e-commerce sites. A majority of them even said e-tailers don’t publish negative product reviews at all times. So all the stakeholders must take collective responsibility,” says Agarwal of ASPA.

Need to get tough

Consumer activists maintain that it’s time that stringent laws are put into practice. “The penalty and liability for selling fakes should not just be on the seller, but also on the marketplace,” says Bejon Mishra, an international consumer policy expert, founder of the Consumer Online Foundation and author of the Jago Grahak Jago consumer awareness programme. “Currently, what we have in place are laws for when you are cheated. But what about telling these marketplaces to follow good practices and put in stringent norms that registered sellers have to follow?” says Mishra. Brands, too, can’t shy away from taking the onus. Queries sent from Financial Express to many brands went unanswered. L’Oréal India legal director PL Mishra told FE: “We work closely with law enforcement agencies to take legal action against counterfeiters. Also, we have registered our brands as right holders under IPR rules 2007, as a result of which we are able to block fakes at the customs end itself.”

Rajawat of LocalCircles warns: “Brands need to realise that fakes sold online will have a major impact on their reputation. If consumers experience counterfeit (products), they will not be potential consumers in the future. And the growth for these brands will taper of. It is very important for the brand to take action and prevent counterfeit products from being sold online.” If we talk about the West, there are stringent laws in place there. “In the US, cheating with fake goods can lead to sellers and retail giants being sued for millions, besides having their licences cancelled. But in India, we have neither an aware consumer nor stringent laws,” Mishra laments.

Measures to tackle the menace, however, are underway. E-commerce platforms selling consumer products will be held liable for unfair trade practices under the new Consumer Protection Bill, 2018, which was introduced in Parliament in January this year. “It provides for the establishment of an executive agency to be known as the Central Consumer Protection Authority, which will deal with unfair trade practices and misleading advertisements,” says Agarwal of ASPA. There will, however, always be some loopholes in laws. And with counterfeiters becoming smarter by the day, it’s a problem that needs to be looked into more seriously. “The key is to be ahead of them. The biggest loophole is awareness amongst consumers towards the importance of the issue. The more they are aware, the more they will be vigilant before buying any product,” sums up Agarwal.

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https://www-financialexpress-com.cdn.ampproject.org/c/s/www.financialexpress.com/industry/can-i-fake-your-order/1165093/lite/

WHO: 10% of medicine in developing countries fake or substandard

An estimated 10% of medicines and medical products in low- and middle-income countries are either falsified or substandard, killing hundreds of thousands of patients and wasting billions of dollars each year, according to new research published by WHO.

Driven by demand, falsified or substandard medical products including antibiotics, cancer treatments and diabetes medication make their way onto the market in countries around the globe, meaning that many patients are taking medicine that cannot treat or prevent disease, WHO said.

The agency said it has received 1,500 reports of these products through a global surveillance program established in 2013, split almost evenly between generic and patented products.

Two British universities used WHO data to estimate that up to 169,000 children die each year from pneumonia and as many as 158,000 more die from malaria due to falsified or substandard antibiotics or antimalarials. These medications not only lead to treatment failures, but also contribute to antimicrobial resistance.

In a telebriefing, WHO experts said fixing the problem will take more political will in the form of human and financial resources to translate policies and strategies that have been agreed upon at the global level to sustainable actions on the ground.

“Substandard and falsified medicines particularly affect the most vulnerable communities,” WHO Director-General Tedros Adhanom Ghebreyesus, PhD, MSc,said in a statement. “This is unacceptable. Countries have agreed on measures at the global level — it is time to translate them into tangible action.”

WHO published data on reports filed through the Global Surveillance and Monitoring System for substandard and falsified products from July 2013 through June 2017. Most of the reports — 42% — came from sub-Saharan Africa, with another 42% originating in either the Americas or Europe. More than 36% of the reports involved either antibiotics or antimalarials, the two most commonly reported drugs.

WHO said the data likely represent only a small fraction of the overall problem. For example, it said, only 8% of the reports came from the Western Pacific, 6% from the Eastern Mediterranean and just 2% from the Southeast Asia region.

Michael Deats, WHO expert on medicine safety and diligence, said access and affordability are two factors that allow fake medical products to make their way to patients. He noted a 2015 outbreak of meningitis C in Niger that resulted in a vaccine shortage, leading to supplies of fake drugs when the country turned to wholesalers in neighboring countries to fill the gap.

“If there’s insufficient product on the market, within days the vacuum is filled with falsified versions,” Deats said during the briefing. “Sometimes it’s about access and sometimes it’s about affordability, but not always. Sometimes it’s about governance.”

Malaria medication made up nearly 20% of all products reported through the WHO surveillance program, and antibiotics accounted for almost 17%. Anesthetics and painkillers, lifestyle products including cosmetics, erectile dysfunction drugs and bodybuilding or diet products, and cancer medications were also commonly mentioned.

Deats said the problem of falsified and substandard medical products is widespread in Africa but can be found in most places. “The equivalent of a street market in Africa is an unregulated website in a high-income country,” he said. “This affects all parts of the world.”

The financial toll is also significant. A WHO study based on more than 100 published research papers estimated a 10.5% failure rate in all medical products used in low- and middle-income countries at a cost of around $30 billion.

“These are approximations because we do not have reliable data,” Suzanne Hill, BMed, PhD, director of the WHO Department of Essential Medicines and Health Products, said during the telebriefing. “One of the points we want to make in this report is that we need better data from countries on how much they spend on pharmaceuticals.” – by Gerard Gallagher

https://www.healio.com/infectious-disease/antimicrobials/news/online/%7b82afac1e-c5a9-4a75-99be-42c18eb26170%7d/who-10-of-medicine-in-developing-countries-fake-or-substandard?page=2

What’s the issue with melamine in milk?

  1. Melamine: An organic base chemical most commonly found in the form of white crystals rich in nitrogen
  2. Use: Widely in plastics, adhesives, countertops, dishware, whiteboards
  3. FSSAI: Melamine content of more than 1 ppm in infant formula and more than 2.5 ppm in other foods should be viewed with suspicion of adulteration
  4. Addition of melamine into food is not approved by the FAO/ WHO Codex Alimentarius (food standard commission), or by any national authorities
  5. Chinese milk scandal: In 2008, at least four babies in China died and around 100,000 became sick after consuming powdered milk baby food laced with melamine
  6. Due to the presence of nitrogen, the addition of melamine to milk makes it look protein-rich

How do I identify adulterated milk and milk products at a home level without using chemicals?

Milk is a common drink of our daily diet. But not every-time the milk we take is pure; it may have urea, formalin, vanaspati, starch and water as impurity. Packed milk from reputed brands as well as milk purchased from milk-vendors can be adulterated so its important to check for them before consuming.

Test for adulteration in milk can be done at home using following ways,

1. Reduction Test

Boil milk on slow heat for 2-3 hours till it solidifies and become hard (khoya). Rock solid, rough residue means the milk is adulterated while oily residue means its of good quality.

2. Checking for Synthetic Milk

Synthetic milk is made by mixing chemicals and things like soap in natural milk. Synthetic milk can be easily identified by bad taste. It feels soapy when rubbed and turns yellowish when heated.

3. Water in milk

Water in milk may not be bad for your health but definitely for your pocket. To check, put a drop of milk on your fist or any slanted surface and let it flow down. If the milk leaves a trail behind, it’s not pure else its good.

4. Vanaspati/Dalda in milk

Vanaspati is not good for health if consumed in big quantity. To check if milk is adulterated with vanaspati, add 2 tbps of hydrochloric acid and 1 tbsp of sugar to 1 tbsp of milk. If the mixture turns red, its impure.

5. Starch in milk

If your vendor has added starch to milk, you can detect it by adding 2 tablespoons to salt (iodine) to 5 ml of milk. Mixture will turn blue if milk is adulterated else it remains intact.

6. Formalin in milk

Formalin is used for preservation purposes. Since its transparent in color and can preserve milk for long time, packaged manufacturers use it for adulteration purposes. To test for formalin existence in milk, take 10 ml of milk in test tube and put 2-3 drops of sulphuric acid into it. If a blue ring appears at the top, milk is adulterated else not.

7. Test for urea in milk

One of the most common form of adulteration in milk is mixing of urea since it doesn’t changes the taste and is little difficult to detect. To check for urea in milk, mix half tablespoon of milk and soyabean (or arhar) powder together and shake well. After 5 minutes, dip litmus paper for 30 seconds and if there is a color change from red to blue it means the milk has urea in it.

https://www.quora.com/How-do-I-identify-adulterated-milk-and-milk-products-at-a-home-level-without-using-chemicals?ch=3&share=483769ad&srid=oyRV

Melamine test in milk, milk products and other foods

In the year 2008 there were several reports that high levels of melamine have been detected in food and feed from around the world which triggered large-scale melamine testing of food products. On investigation the adulteration of the food and feed melamine was traced back to China.

It was later established that certain unscrupulous individuals had carried out large-scale adulteration of food with melamine powder to falsely increase the protein content. When protein content was tested in the melamine contaminated foods the values were significantly higher value. This is due to the nitrogen content of melamine molecules. It was reported that more than 1 lakh children had become sick after consuming powdered milk and baby food which had been adulterated with melamine.

Based on these reports the Food Safety and Standards Authority of India had issued an advisory in 2008 highlighting the incidence of melamine adulteration. The harmful effect of melamine along with toxicological references as well as a list of methods for melamine testing of food products was publicized.

FSSAI also had directed the State food authorities to carry out extensive melamine contamination testing of food materials and to enforce withdrawal of Chinese dairy products from the market if they contain more than 2.5 ppm of melamine.

On 5 January 2016 the Gazette notification was published on amending the Food Safety and Standards (Contaminants, Toxins and Residues) Regulation 2011. These amendments have come into force on the date of their publication. Through this amendment limits have been prescribed for melamine in products like powdered infant formula, liquid infant formula as well as other foods. The limits are given in the table below –

https://testing-lab.com/melamine-test/