Are you worried about the safety of your medicines? You have every reason to be. Chances are the most frequently prescribed medicines such as painkillers, cough medicines, antibiotics or anti-inflammatory tablets that you pick up from the neighbourhood chemist are counterfeit. Medicines for treating cancer, HIV, malaria, diabetes, hypertension, cardiovascular disease, Alzheimer?s disease, erectile dysfunction, asthma and fungal infections might be fake too. Medications for weight and hair loss aren?t spared either.
While the extent of counterfeiting in the pharmaceuticals industry has reached alarming proportions globally, India is not immune to this malaise. The government has recently amended the Drugs and Cosmetics Act, providing for stricter penalties to those engaged in making of spurious, adulterated, misbranded and substandard medicines.
Put simply, custodial sentences now start from a minimum of three years to life imprisonment, while fines for those found guilty of selling fake medicines range from Rs 10 lakh or three times the value of confiscated goods whichever is more. Earlier, the law prescribed imprisonment for five years and a minimum fine of Rs 10,000. In addition, the offence was easily bailable. ?Penalties are now severe. This should prove to be a deterrent. Enforcement is now the key,? says Ramesh Adige, president, Ranbaxy Laboratories.
Yet, the menace seems to be deep-rooted. More recently, the Drug Controller General of India (DCGI) has launched a country-wide survey of counterfeit medicines and the results are expected soon. The recent incident of Nigeria?s National Agency for Food and Drug Administration and Control (NAFDAC) detecting a large consignment of anti-malarial drugs from China, which had been labeled ?Made in India?, has brought Indian drug companies under the radar. ?Counterfeiting is a low-risk high returns business, making it lucrative for unscrupulous people all over the world. The problem of counterfeit medicines has done serious harm to the image of the Indian pharmaceutical industry,? says Ranjit Shahani, vice-chairman and managing director, Novartis India.
World Health Organisation (WHO) estimates that the value ascribed to counterfeit medicines across the world will reach $75 billion by the end of 2010, up by 90% since 2005. It is estimated that fake drugs account for approximately 10% of the global pharmaceuticals industry and close to 40% of the counterfeit medicines contain no active ingredients.
Indian pharmaceuticals industry is waking up to this ugly reality. According to WHO estimates, counterfeits in India have been estimated at 20-25% of the market volume, which translates to a very large volume owing to the large size of the Indian pharmaceuticals market. Based on these estimates, the counterfeit drugs market in India is worth Rs 6,500 crore annually.
Interestingly, the pharmaceutical industry is at odds with divergent views on counterfeit medicines. Tapan Ray, director-general, Organisation of Pharmaceuticals Producers of India (OPPI), says, ?The innovator companies feel that the generic pharmaceutical industry and the drug regulators are not really very keen to effectively address and resolve this global public health issue. The generic companies and the drug regulators feel that the problem is not as acute as it is projected to be. And, other groups claim that an important public health sentiment is being used by the R&D based global pharmaceutical companies to extend intellectual property rights (IPR) to patients? safety issue.?
A European Union (EU) report last year pointed out that India was the largest source for the 2.7 million counterfeit medicines that were seized in Europe in 2006. The WHO claims that India is the source of 35% of all counterfeit drugs in the world, while the Organisation for Economic Cooperation and Development (OECD) pegs the figures at 75% and India?s ministry of health and family welfare pegs it at 5%. While the estimates may vary and the potential impact is difficult to quantify as yet, one thing is clear: the magnitude of the problem is very large and needs to be addressed immediately.
?The menace of counterfeits affects both branded and generics companies alike. Its incidence is higher for companies with large volume and extensive distribution,? says a Sun Pharmaceuticals official. Counterfeit medicines are seen to be more pronounced in therapeutic segments having high revenue streams such as anti-cancer, anti-infectives, anti-histamines and steroids. Some of them are even life-saving drugs, reveals Adige.
The production of counterfeit medicines does not occur in large infrastructures. The majority of the counterfeiters apprehended so far carried out their activities in ordinary households, small cottage industries, or in backyards. Their motivation: counterfeiting of medicines is a hugely lucrative business due to the continued high demand for medicines and low production costs.
Counterfeits have an enormous negative impact on manufacturers, retailers and patients and are considered to be a major public health hazard. For pharmaceutical companies, counterfeit medicines cause a revenue loss of 5-7% per annum, estimates WHO. More than that, the brand image of the company gets sullen and there is severe loss of credibility in the market place, not to mention the public health risk attached.
Counterfeit medicines are not equivalent in safety, efficacy and quality norms when compared to their genuine counterparts. Further, they are outside the control of the respective country?s drug regulatory authority (DRA). As a result, if needed, an effective product recall would not be possible, leading to disastrous consequences for the population that consumes those medicines, and for the reputation and thus the financial standing of the pharmaceutical company under whose name those medicines are selling. The dented reputation would ultimately result in low consumer loyalty.
?The legitimate manufacturer may be held liable for injuries suffered by the consumer of the counterfeit medicine; especially if it is proven that the counterfeiting was foreseeable and could have been prevented by deploying cost-effective measures,? says Ajit Mahadevan, partner, health sciences advisory services, Ernst & Young. While it is difficult to verify the claimed losses, considering the magnitude of counterfeit volumes in the Indian pharmaceutical industry, revenue loss of 5-7% per annum do not seem unrealistic, he adds.
Indian pharmaceutical companies are alarmed as counterfeit medicines are rampant among anti-malaria, anti-tuberculosis, anti-HIV and antibiotics, specifically those for pneumonia and child-related illnesses. Medicines for these therapeutic segments fetch major revenue for Indian pharmaceutical companies.
Typically, counterfeiters are attracted to two types of medicines: those which are used in high volumes and those which have a high monetary value. Traditionally, generic drugs such as paracetamol and paediatric medicines have been frequently counterfeited. However, faking of drugs for life-threatening diseases is rapidly increasing in developing countries such as India.
In developed markets such as Europe, the products most commonly faked are ?lifestyle? medicines, such as those for erectile dysfunction, hair loss and weight management. These medicines are usually bought online. However, there have been instances wherein fake versions of lifesaving prescription medicines for cancer and serious cardiovascular diseases are also being sold to consumers online.
In the developing nations like parts of Asia, Latin America and Africa, more than 30% of the medicines are counterfeits. In South East Asia, estimated prevalence of counterfeit medicines for malaria is 33-53%, reveals Ray. ?It appears that in all those countries where access to modern medicines is poor, incidences of counterfeit medicines, ranging from anti-malarial, anti-hypertensive, anti-tubercular, anti-retroviral to cardiovascular and other life saving and life style drugs, are higher,? he adds.
According to an OECD study, the most frequently counterfeited healthcare products are medicines for treating cancer, HIV, malaria, osteoporosis, diabetes, hypertension, high cholesterol, cardiovascular disease, obesity, infectious diseases, Alzheimer?s disease, prostate disease, erectile dysfunction, asthma and fungal infections; antibiotics, anti-psychotic products, steroids, anti-inflammatory tablets, painkillers, cough medicines, hormones, and vitamins; and treatments for hair and weight loss.
To tackle counterfeiting, it becomes necessary for various government agencies, pharmaceutical companies and patients to work in tandem. While amendments to the Drugs and Cosmetics Act can probably serve to curb this menace to some extent, they need to be supported by improved enforcement of the laws. ?Legislation needs to be strengthened in order to make room for increased criminal penalties to act as a deterrent for counterfeiters and to punish those convicted,? informs Mahadevan.
Pharmaceutical industry feels there is need for a competent drug regulatory authority that is empowered with the necessary human and other resources to control the manufacturing, import, distribution and sale of medicines. Such an authority could work along with the government and the industry to create public awareness. Further, it could serve as an independent institution which would coordinate with the police, customs and the judiciary in order to effectively monitor and enforce drug regulations.
Further, a ?whistle blower? policy to reward informants of counterfeit medicines is also in consideration. ?The government has done well to bring in stricter legislation and to introduce a whistleblower policy which we hope will produce results,? feels Shahani.
On their part, Indian pharmaceutical companies, in line with their global counterparts, are increasingly looking at deploying anti-counterfeiting technologies to curb the menace of fake drugs. For instance, Ranbaxy has implemented RFID (Radio Frequency Identification) with a view to combat the challenge of counterfeiting. GSK India has been using dot matrix 2D holograms and 3D holograms, in addition to flip action, background text, kinetic movement, micro text and laser code.
Roche India has successfully implemented the mass-serialisation technology for most of its products being sold in India. Most Roche products now have a unique 16 digit alpha-numeric human readable, computer generated code on the packaging. Any consumer who now buys a Roche product will be able to confirm the authenticity of the product by emailing or
SMSing the 16 digit alpha-numeric security code to Roche?s database which will then either confirm or deny the authenticity of the product in question. Several other Indian pharmaceutical companies are upgrading their IT infrastructures to make their supply chains more robust.
The US Food and Drug Administration (USFDA) and other drug regulators are pushing for the adoption of RFID hardware and software throughout the pharmaceutical industry to combat sales of counterfeit drugs.
According to Mahadevan, implementing new, secure, cost-effective and user-friendly anti-counterfeiting technologies, such as RFID andnanotechnology is a good solution. However, it is imperative that technology be appropriately integrated into the pharmacy practice as well in order to ensure that technology facilitates the identification and reporting of suspect medicines at point-of-sale level.
Data from around the world indicates that brands protected by effective anti-counterfeit technologies have benefited from increased sales through a reduction in the number of counterfeits. Further, whenever counterfeiting has been attempted, the culprits have been easily identified and prosecuted, thereby leading to an increased consumer confidence in the brand.
Shahani feels that consumers should look for details such as batch number, manufacturing and expiry dates, manufacturer?s name and address on the pack when purchasing a medicine. They should also look for any abnormal appearance of the pack of medicines such as illegible label, improper sealing etc .
So the next time when you visit your chemist, make sure that you are vigilant. That in itself is a crucial step to combat the problem of counterfeit medicines. After all, the resolve to curb this menace has to be made stronger.