Fire-walling counterfeits

Fire-walling counterfeits

Counterfeit drugs not only affect a company’s reputation but they are also detrimental to patient safety, making this a magnanimous issue. Katya Naidu takes a look at the different strategies deployed by pharmacos to fight counterfeits.

For every blockbuster drug that is manufactured, there is an evil twin produced by an unscrupulous entity. This business of making counterfeits is a very profitable proposition to many fake drug makers and is thriving, thanks to the loopholes in the system that these counterfeiters manage to exploit. “Trade in counterfeit drugs is widespread and affects both developing and developed countries. All medicines are subject to counterfeiting, both branded and generic,” says Ranjit Shahani, President, OPPI.


Ranjit Shahani
President

OPPI

Counterfeit drugs might not have a catastrophic effect on a company’s profits or may not steal a product’s market share, but they do have a devastating effect in terms of patient safety. Pharma companies are affected most in the bargain as they are in the business of curing and a patient’s life is at stake every time a fake drug enters the healthcare system. Additionally, fake drugs also challenge the reputation of a company and its Intellectual Property Rights.

The effect

In developing countries, most of the drugs that are counterfeited, are those used to treat life-threatening conditions such as malaria, tuberculosis and HIV/AIDS. “Consequently, the problem of counterfeiting represents both a growing threat to global public health and a substantial danger to the pharmaceutical industry, and as such needs to be addressed on a war footing,” says Shahani.

The use of spurious medicines can have a very serious negative impact on patients. “Counterfeit medicines result in death or disability and could become a leading cause of therapeutic failure and disease resistance,” says Dr Bomi Gagrat, Executive Director-Technical, Pfizer India. Data analysis from different surveys reveal that, in majority of cases, counterfeit medicines contain no active ingredients and therefore, have no therapeutic benefits. This results in exacerbation of disease, development of resistance to medicines and sometimes death.

The risk of counterfeiting is most pronounced in malarial drugs. Artusenate is one of the best medicines to combat resistant malaria. According to The Lancet, 40 percent of Artusenate products available in developing countries contain no active ingredients. At the same time, one million deaths occur from malaria annually, of which as many as 2,00,000 would be avoidable if the medicines available were effective, of good quality and used correctly (WHO). It is believed that drug resistance resulting from the use of counterfeit medicines is among the key factors, which contribute to the upsurge of major infectious diseases in developing countries.

A counterfeit is a product or a pack that is not manufactured by the original manufacturer. A fake made by a counterfeiter with the deliberate intention of passing it off as the original. The product may or may not contain the active ingredient as printed on the label.

Counterfeit drugs can be found under different forms, including:

  • Products with the correct ingredients (but may contain incorrect quantities of active ingredients, or may contain expired drugs, the product may also have been relabelled, risking to trigger allergy reactions and cause harmful interactions with other drugs)
  • Products with the wrong ingredients (possibly toxic and therefore directly harmful to patients)
  • Products without active ingredients or fake packaging (will not give any therapeutic effect hence can endanger a patient’s life)

From where and how?

The complexity of the distribution network is the principal point from where fake drugs make their way into the pharmaceutical chain. Once a product leaves the company, a number of players like wholesalers and brokers get their hands on the goods. “From the time it is manufactured, to the time it reaches the patient, counterfeiting is one aspect that involves the w`hole supply chain integrity. I don’t think that distribution network affects counterfeiting but it certainly is the link that worries most people because that’s where the counterfeiters induce their products,” says Sujay Shetty, Associate Director of PricewaterhouseCoopers.

Yet another alarming medium through which counterfeit drugs are sold is through the Internet. Every now and then, people are bombarded by e-mails, which sell prescription drugs over the net. This is a global problem, which is very hard to address, considering the anonymous nature of the counterfeiter. Some of the most popular medicines that are sold on the Internet are drugs like Viagra and Cialis. “Anything to do with that kind of popular lifestyle drugs which people want and can’t get through prescription, through their own source; they log on to the Internet or any source, which promises to sell them at economical prices,” says Shetty.

Another way through which counterfeits slip in is by parallel trade which exists in Europe. Parallel trade is through which drugs can be legally imported into a country from another country by an intermediary without the authorisation of the company which has an IPR in that country. There are some people who worry that parallel trade may be an area through which counterfeited drugs can be inserted into a national health system because repackaging of goods is involved there.

Fighting counterfeits


Dr Homi Bhabha
Director

OPPI

Since the perils of counterfeiting are many, organisations like the OPPI have come up with a series of anti-counterfeiting guidelines for companies that are engaged in manufacturing, distributing or marketing of medicines. According to these guidelines, every company needs to protect its products and customers from the risks of counterfeiting. They need to protect the company by making it difficult for its products to be counterfeited and enabling the authentication of products and its source. Dr Homi Bhabha, Director, OPPI, suggests that pharma companies should be more vigilant. “You should keep on collecting samples of your products where you feel counterfeiting is done from the market and go on testing them. So you know if there is any counterfeit that is available, you can immediately take action,” he says.

Many pharma companies too have woken up to the hazard and have come up with various initiatives to curb it like, hiring detective agencies. Plagued by massive fakes for its popular brand Viagra, Pfizer has taken to crackdown the online sales of the drug. It has initiated legal action against illegitimate online pharmacies and has co-perated with law enforcement agencies to block sales of counterfeit Pfizer products. It has also coordinated with law enforcement agencies to halt the import of pharmaceutical products and their seizure. The company has also implemented public education programmes to inform consumers about dangers of purchasing medicines over the Internet. They have also tried to compete with counterfeiters by promoting Internet purchases from Verified Internet Pharmacy Practice Sites (VIPPS), which are certified by the National Association of Boards of Pharmacy (NABP).

There are various calculations on the flow of counterfeit drugs. “It is felt that there are 20 percent to 30 percent counterfeited drugs that are floating around the market places. Syrups and generic drugs have been the easy target to counterfeiters. Target markets for the counterfeit drugs are those villages or states where illiteracy is predominant,” says Banerjee.

“There is no accurate and adequate information about the scale of counterfeiting. Estimates are that about seven percent of medicines are found to be counterfeit. The situation in India is quite alarming,” says Dr Bomi Gagrat, Executive Director, Technical, Pfizer India.

To get an estimate of the menace, the Indian Government appointed an expert committee in January 2003 to assess the scale of the challenge. Testing showed that nine percent of the samples evaluated by the State Government inspectors were poor quality drugs and 0.3 percent were fakes, but the level of counterfeiting is widely thought to be much higher than these figures imply.

Technology to the rescue

One of the most effective means to curb counterfeiting is the use of innovative packaging technology. “Sophisticated new generation packaging is the only way to keep the counterfeiter three steps behind, to catch up with the technology,” says M K Banerjee, Director-Creativity and Innovations, Essel Propack Global. Agrees Gagrat, “Effective and innovative packaging will make it difficult or impossible for counterfeiters to copy, and in this way, the healthcare system of the country and the market revenues can be improved.”

In general, unique shape, material, textures, colours with complex graphics and tamper evident closures or seals should be a part of composite packaging strategies. Depending upon the value of the drugs, multi-level security systems need to be built into the packaging design. “While designing an innovative packaging, a designer should encompass packaging raw material, process and drug delivery system and disposability mechanism,” says Banerjee.

Some of the commonly used technologies are RFID, colour shifting, chemical markers, holograms, laser coding, inkjet technology and invisible tags. There are two features to innovative packaging technologies—the overt measures and the covert measures. The overt measures are those, which are visible to customers and the covert measures are those which are known to manufacturer only. “Some overt measures that are used are inkjet printing, embossing on the strip and multi-colour printing,” says T Gautam Buddha, Head of Packaging Development, Dr Reddy’s Laboratories.

Not fool proof

But no technology is fool proof. “We cannot prevent anybody from copying but we have to make a distance between the counterfeiter and original by building anti-counterfeit measures which are more difficult to copy. By the time he catches up, we have to recharge our strategy and go to the next level,” says Buddha. The salient features of these technologies are to make it difficult to copy the packaging material, thereby curbing menace of counterfeits. Even if one thinks of copying this technology, it should mean huge investment in terms of equipment, and machinery and procurement of specialised packaging material available at very selective places. Hence, these methods may decrease the probability of counterfeiting, if not curb it totally.

The real drawback of technology comes in the form of cost. “However, the main concern that the industry faces is with respect to the increase in the product cost, due to innovative packaging like investment in equipment, machinery and costly packaging material. The increase in cost must be duly recognised and compensated for in pricing norms,” says Gagrat. Moreover, there are infrastructure issues where technology like RFID is not employable. The other end of the supply chain like retailers and distributors do not have the same technology rendering it useless.

Counterfeiters beware!

A lot of people feel that an effective way to tackle counterfeiting is by tightening the law and holding the responsible people in the supply chain liable for drug quality. “I think distributors need to be accountable to the government in what they are distributing. There should be some system where they report what they are selling and what they are distributing. These discussions are going on even in the West,” says Shetty.

The laws are also very lax against counterfeiters making the risk-to-reward ratio very high and counterfeiting, a profitable business. The Government has already got in a legislation, which increases the punishment for counterfeiting of drugs, and makes the offence non-bailable. But unfortunately, this legislation has not yet been passed. In addition to increasing the punishment, the convictions should change too. “The law enforcement agencies feel that this is a very small offence. But they don’t realise that counterfeit medicine actually kills. It is murder in disguise as, if a person uses a spurious medicine, chances are that the person might die,” says Bhabha. Looks like all the King’s army and all the King’s men need to crack the whip on counterfeiters.

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