View attachment 33537 The World Health Organisation (WHO) has a humble disclosure to make: there is still no accurate estimate of the global scale of counterfeit medicines. Perhaps as compensation, the multilateral body has hung a new name on such products: substandard, spurious, falsely labelled, falsified and counterfeit (SSFFC) medicines.
Various reports by others suggest that the size of the global fake drugs industry could run into hundreds of billions of dollars. Deloitte's vice-president Terry Hisey says it could be in the range of $50 billion to $200 billion annually. Health economist Roger Bate, who is also the author of the book Phake, which is an outcome of years of research into counterfeit drugs, says countries such as India and China are at the forefront of such a menace, selling fake drugs locally and globally.
But he doesn't blame Indian companies entirely, and hastens to add that one must differentiate the substandard from the fake. That makes sense, says the father of an eight-yearold child in Bangalore who became "semi-blind" after using fake eye drops. The 40-year-old father didn't wish to be named. He also didn't name the company that sold the product. "A substandard drug wouldn't have harmed his vision, but a counterfeit or fake drug in which the components are chalk or dust or some other cheap powder has," says a Karnataka health ministry official who asked not to be named because he is not authorised to speak to the media.
Another health official, based in Delhi, is worried: will health regulations help? Can the private sector chip in to check the menace? He doesn't have an answer yet. He spoke on condition of anonymity.
Death By a Pill
Kolkata-based Shanth, 25, who doesn't want to disclose his surname, believes that his 65-yearold father died last year of a heart attack after using "a famous antitriglyceride drug" made by a foreign company for two years; he was told by doctors that the drug appeared ineffective. "We paid for the drugs and were sold fake drugs," he claims. Doctors that ET Magazine spoke to say a person with high triglycerides can die of multiple reasons, but don't rule out the possibility of "the villain": the fake drug. While several reports quoting the WHO say that up to 20% of the drugs sold in India are fake, the health body told ET Magazine that "we will not comment on individual countries. This is a worldwide problem".
It is a global menace indeed: according to a report by International Protection Network, fake tuberculosis and malaria drugs are estimated to kill 700,000 people a year; it adds that most fake drugs originate from India and China. A recent Lancet study says 7% of anti-malarial drugs in India — where 70% of the population faces the risk of contracting the killer disease — are counterfeit.
View attachment 33538 Victim of Perception?
Dr Jeffrey L Sturchio, senior partner at US-based health consultancy Rabin Martin and former president and CEO of the Global Health Council, says almost all the recent studies on counterfeit drugs indicate that India and China are two countries from which a large fraction of the global flow of SSFFC medicines come. But he feels that it not so much the big Indian companies which are responsible for counterfeits.
"After all, many of them have substantial export businesses to markets in North America and Western Europe and would not want to jeopardise their investments in products for those markets," notes Sturchio, adding that "although from time to time you might find an example like the Ranbaxy products for which test data were falsified, for the most part Indian pharma firms have a clear economic interest in producing medicines of international quality standards".
Ranbaxy, India's No. 1 drugmaker by sales, was recently fined $500 million in the US after it was found guilty of misrepresenting clinical generic drug data and selling adulterated drugs to the US. A Ranbaxy spokesperson insisted that it sold "only adulterated drugs, not fake drugs". Both Sturchio and Bate feel that the problem in both India and China — and in several African markets like Nigeria — is that there are thousands of pharmaceutical producers, many of which are small businesses beyond the reach of overworked regulators. "Without adequate surveillance and appropriate penalties for not playing by the rules, regulators don't have the tools to enforce quality standards and take SSFFC off the market," says Sturchio.
View attachment 33539 SSFFC What?
Sturchio has his reservations about the nomenclature. "Rather than speak only of counterfeit medicines [it would seem the definition of these is straightforward — medicines that are not what they purport to be], we have the complex locution of SSFFC. The challenges to global public health from unscrupulous producers are as clear as the solutions are elusive," he argues.
Prafull D Sheth, a former president of the Indian Pharmaceutical Association who has done a survey for the WHO on India's counterfeit medicines, says: "Unfortunately, media reports have a multiplier effect and the situation in India is clearly blown out of proportion." His logic is similar to Bate's and unlike Jeff's: differentiate between fake and substandard drugs. The former is far more dangerous than the latter, argues the health ministry official.
The study led by Sheth in 2007 arrived at the conclusion that the extent of counterfeit suspects was to the tune of 3.1% of total drugs sold in the country. He said the country faced a graver problem from substandard drugs that did not have all the ingredients that should be there in a drug. "Based on domestic sales of Rs 31,500 crore in 2006, the extent of suspected counterfeit medicines would be extrapolated to Rs 100 crore. The figure is considerably lower than Rs 4,000 crore in earlier reports," the report said. Sheth was executive vice-president of Ranbaxy.
For her part, Dr Mira Shiva, renowned public activist, sees a conspiracy against the flourishing Indian pharmaceutical sector which sells "cost-effective as well as highquality drugs". But the health ministry official begs to disagree: "Since we got freedom we have been fed on this foreign hand political diet. I think it is baseless to blame foreign companies for malpractices by our companies."
He concedes that various panels set up to look into manufacture and sales of counterfeit drugs following a rap by the Allahabad High Court three years ago have not yet produced much results. The court had noted that fly-bynight operators had set up base in several areas of Uttar Pradesh and Haryana, and that more than 60% of the drugs go to rural markets or to Africa.
View attachment 33540 Early this year, India denied exporting large quantities of counterfeit drugs to Africa following an expose by the Guardian. "No fake medicines have been sent from India to the continent of Africa," a spokesman for the ministry of external affairs had said.
However, much to the anguish of all those who refer to "a foreign hand", the parliamentary standing committee on health and family welfare had last year issued a damning report accusing drug regulatory agency — Central Drugs Standard Control Organisation (CDSCO) — of "colluding" with pharmaceutical companies and medical experts.
The 78-page report pointed out a series of procedural failures and sought explanations on how some drugs banned for sale in the US were allowed to be sold in India. The local pharmaceutical market is the fourth largest in the world in terms of volume and generates $12 billion in sales.
Bate, who has studied the issue closely, says that following this "extensive corruption and misrepresentation of pharmaceutical drug data, the health ministry set up a committee to investigate the findings, but nothing has come of it".
The 13 drugs studied by the panel can't be sold in Canada, Britain, European Union and Australia as well. Shiva, who is a member of the Indian government's sub-group on "spurious and adulterated drugs" constituted by a "task force" headed by Dr VM Katoch, has not heard anything about its 2011 recommendations to "strengthen the drug sector" in the country.
The Chinese Hand
A foreign ministry official ET Magazine spoke to alleges that several Chinese companies are zealously manufacturing "Made in India" drugs for sale in Africa, especially in Nigeria where many "Indian counterfeit" drugs have been confiscated over the past few years.
ET Magazine couldn't independently verify this claim. Sheth also backed the official version, adding that the Indian government has very often taken up the matter with the Chinese government. According to official estimates, of the Rs 1,00,000 crore worth drugs made by the Indian manufacturing industry, medicines worth Rs 42,000 crore are exported.
Whatever the claims and counter-claims are, says Sturchio, the impact of counterfeit medicines and substandard medicines around the world is appalling. Explains he: "When life-saving medicines are counterfeited and don't contain the active ingredient, they can kill the patients. Other counterfeit medicines might have deleterious products in them that cause harm. The global trade in these SSFFC medicines is now measured in tens of billions of dollars, and governments, industry and civil society are beginning to take up seriously the need to develop the necessary partnerships to curb these practices."
Problem at Hand
Ranjit Shahani, managing director of Novartis India, is highly pessimistic about implementation of local rules. "The regulations against counterfeiters exist. The serious gap is in their implementation. Most major pharmaceutical companies together with the regulatory authorities carry out raids against counterfeit medicines but it seems to be an uphill task notwithstanding the stringent penalties for counterfeits.
A whistle-blower policy was announced by the health minister with a reward of Rs 25 lakh two years ago. No one has received it so far — that speaks for itself," he points out, emphasising that the situation is very grave at home. In a country that is home to more than 6,000-8,000 small units manufacturing medicines, he says, the government must first ensure that they adhere to basic good manufacturing practices. He can't hide his scorn for the talk of lack of resources when it comes to health care.
"What can be more important than health and yet you always hear 'lack of resources' — we have heard this long before, we hear it today and I can assure you we will hear it tomorrow as well," he declares. Shahani shares the views of several other health experts that lack of "proper data" is a big curse. "India, of course, is not a data rich country and there is no reliable data available [on fake drugs]. Estimates available vary widely," he says, adding, "It is important, however to note that the quality of medicines available in the country is highly variable. At one end, you have plants with global standards and at the other end you have plants that are literally hole-in-thewall operations."
Bate feels that the most important thing for the Indian government is to acknowledge the problem of fake and substandard drugs. The government must stop pretending that anyone raising concerns is just trying to destroy Indian exports or is working for a competitor. He, however, adds: "There are folks out there who want to run down Indian generics, and the government is right to oppose them."
He also says that India should take the lead at international SSFFC fora and push for better global law against fakes and substandards. "As I explain in my book (Phake), this [move] would directly help patients and the Indian industry.
Right now the government of India is seen as obstructionist. As to taking Indian medicines...the last time I was in Chennai I was very sick, and knowing what I knew then about Ranbaxy I still took Ranbaxy drugs (ciprofloxacin in that case).... In other words Indian drugs are generally good, but Indian companies need to do more to ensure they improve," he adds.
Rays of Hope
A Lupin spokesperson says: "If there is no barcode [or a unique number] and a phone number to SMS that number [on our medicines], they are not our drugs." He is referring to the serial number generated by global firm PharmaSecure, which is now actively present in India. There are many companies that provide "solutions" to check the threat of counterfeit drugs (see The Cure).
Kishore Kar, who heads PharmaSecure's business in India and South Asia as its senior vice-president, says the company offers compliance solutions to six of the top 10 pharma firms in India. Its solutions are simple: a serial number and a phone number on the drug package. If you type the number and text it to the phone number — which is not yet toll-free — you get a reply similar to this one: "Lupin Limited authenticates genuine pack of lovax 150, Batch No PP20004. Thanks for your patronage."
In a country where people have more access to mobile telephony than toilets, this solution connects directly with the end user. Kar, a former IAF officer who later sold satellite-based technology solutions across Asia, says the response is huge. PharmaSecure has also launched value-added services such as drug refill reminders and calls to alert a patient to take his or her medications. Kar explains that the new launches have shown to increase patient retention for companies by up to 5%.
That is good news indeed in a market where everything from relatively less hazardous Viagra knockoffs to fake HIV/AIDS and cancer drugs are aplenty.
By Ullekh NP, ET Bureau | 16 Jun, 2013
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