By M H Ahssan & Samiya Anwar
Distinguishing a spurious drug from a genuine one is difficult. Only a proactive consumer and a vigilant Government imposing stiff penality to those indulging in the crime can strangle the industry.
The spurious drug industry is becoming well established in India. According to World Health Organisation's (WHO) 2001 statistics, 35 per cent of the world's spurious drugs are produced in India, followed by Nigeria at 23 per cent. By all accounts the magnitude of this problem would have only increased in the last two years.
North India already shows signs of this industry doing brisk business at the consumers' cost. And its tentacles are spreading far and wide. Unfortunately, consuming a spurious drug unlike buying a counterfeit designer shoes or apparel has mind-boggling ramifications. "There is no safe counterfeit. Spurious drugs are life threatening and not life saving drugs," said Mr. Sahane succinctly.
Even when spurious drugs do not endanger life, they can leave the patient seriously ill and those with inadequate potency do bigger harm to the society in general. Drug resistance develops when patients consume drugs with inadequate potency forcing them to look for costlier new generation drugs. And these patients could put the entire society at risk by spreading drug resistance.
Unlike other cases where the consumer knows his intent, the spurious drug industry thrives on consumers' ignorance, lack of stiff penalty for indulging in such activity and finally on lax regulatory system. Packaging is so nearly perfect that distinguishing a spurious drug from a genuine one is almost impossible. "They spend nearly 5-15 per cent of their investment in packaging. They even have the batch numbers right," Mr. Sahane noted.
Reusage of drugs past their expiry date is yet another menace. Or take the case of state governments settling for tenders quoting the lowest bid. "Nearly seven out of ten drugs have been found to be of less potency," recalled Harinder S. Sikka, Senior President, Corporate Affairs, Nicholas Piramal India Ltd. Is price or quality more important? It is time state Governments come to grips with reality.
Filling spurious drugs in used medicine bottles is another modus operandi. "We at Nicholas Pirmal face this peculiar problem with phensidyl cough syrup. People in north-eastern states get empty bottles from Bangladesh and refill them with a higher content of narcotics and sell them," said Mr. Sikka.
Cheaper substitutes for biotech drugs are another area of concern. "Neupogen for instance is available for nearly half the price. These spurious drugs are made available from across the border," pointed out Swati Piramal, Marketing Manager at Nicholas Piramal India Ltd. Nicholas Piramal is trying to beat these people using advanced technology and distribution system. Alu-alu packaging, patented sugar coating on certain medicines and having its own clearing and forwarding (C&F) in all states have made it difficult for the counterfeiters.
Incidentally, the consequences are not restricted to consumers alone. With a market share of nearly 20 per cent of the total drug market in India (it is worth nearly Rs. 4000 crores) the spurious drug industry's thirst for more is clear to see. It has already set its eye on the export market and succeeded in taking spurious drugs beyond our shores.
For instance, Africa and Latin America have taken cognizance of the increased export of spurious/sub-standard drugs from India and have started complaining about it. And worse, nearly 3-5 per cent of the drugs landing in the U.S. are spurious. The U.S. has already put India in the 301 watch list threat some months ago. If implemented it would totally ban export of drugs from India and sound the death knell for the Indian drug industry.
The low-risk, high-return spurious drug industry is bound to grow. Though belatedly, the Government is slowly waking up to reality. It plans to advocate death penalty for spurious drug racketing. Plans are afloat to reward anyone providing evidence of spurious drug manufacturing or selling, and finally to educate the public about the ills of spurious drugs through the electronic media.
In the meanwhile the consumers can become more proactive by buying medicines only from reputed and well-established chemists.
So the next time before you pop a pill or take a jab spare a moment. Do you want to consume chalk powder, sub-standard drugs or medicines past their expiry date? It's your health and the nation's future at stake. Chemists are a part of the chain and shunning the bad guys is one sure way to kill the spurious drug industry. Are the consumers game for it?
Beware of spurious drugs
According to the study by ASSOCHAM, the spurious drugs market is growing at 25% annually and has captivated 20-25% of the total market share. India has emerged as the leading distributor of spurious drugs and enjoys a share of 75% in the total fake drugs supplied all over the world. However, health ministry estimates that only 5% of the drugs in India are spurious.
The enormous growth of spurious drug industry and its disastrous impact has led the genuine drug manufacturers to take vital measures in order to ensure that their consumers get authentic drugs. Companies like GlaxoSmithKline Consumer Healthcare, Enosss and Piramal Healthcare have come out with 3D hologram as a symbol of authenticity so as to protect the health interest of the society.
Spurious drugs are so perfect in look that it is very hard to distinguish it from the genuine drugs through the naked eyes. Among the spurious drugs commonly found in the Indian market are fake insulin which may be taken by an unsuspecting diabetic, fake chemotherapy that may be administered to a final-stage cancer patient, the use of chalk instead of paracetemol in painkillers, or the use of coloured tap-water presented as cough syrups without any effect until it is too late. Sub-strength spurious drugs such as anti-malarial drugs not only fail to cure but over time, create resistance in the malarial parasite with disastrous consequences for the patient. Yet other spurious drugs are contaminated, containing substances injurious to health, such as contaminated intravenous drips and eye drops that are supposed to cure but instead cause blindness.
SPURIOUS DRUGS: NO SOLUTION YET
Manufacture and trading in spurious and substandard drugs continues to pose a major threat to public health in India with total failure on the part of the Central and state authorities to check this illegal activity. No doubt, this is a massive task requiring suitable legislative measures and coordination of various law enforcement agencies. Unfortunately, no concerted action has been initiated by the Central government so far in this regard. An attempt was made by Union ministry of health in July 2001 to frame a broad based legislative mechanism to counter fake drugs by appointing a 13-member committee headed by Director General of Health Services with DCGI, chiefs of some of the state drug control authorities and representatives from industry associations. The committee was given three months time to take stock of the situation and recommend measures to build an effective national vigilance system.
Nothing is known about this committee afterwards. Last year, Indian Pharmaceutical Alliance had undertaken a campaign to crack down spurious trade by organising search and seizure operations for its member companies. This initiative may have benefited the member companies of IPA to some extent. Last week, the drug control administration of Andhra Pradesh has appealed to retail chemists to get their stocks only from authorised distributors and asked the public to insist on bills when buying drugs. AP administration has also asked the print media not to accept ads that violate provisions of Drugs & Cosmetics Act. The move is in a bid to bring in some control to the trading in spurious and substandard drugs. These actions are certainly laudable but are isolated and cannot bring any major relief to this serious problem on a national scale.
According to an industry estimate, 15 percent of the drugs and pharmaceuticals sold in India are either spurious or substandard and the percentage is only growing with no effective check on this illegal activity. Increasing pressure of a powerful industry lobby on the government to allow certain drugs and cough preparations as OTC and the government's move to classify a set of ayurvedic preparations as food supplements may add a new dimension to the problem of spurious and substandard drugs in future. By permitting drugs for minor ailments as OTC and allowing them to be sold by stores other than medical shops, monitoring of their safety and efficacy will be almost impossible for state drug authorities just because of the huge number of such stores in each state.
Similarly by classifying ayurvedic preparations as food supplements, they will come out of the ambit of control of drug control authorities. Many of the manufacturers are, already promoting these products as medicines with highly exaggerated claims. There is currently no law to effectively control such products and their promotion. Such liberalization of regulatory control at this stage can only embolden the spurious manufacturers to expand their activities aggravating the current situation. The government should, therefore, first bring some control on the growth of spurious drugs trade before thinking of liberalizing regulatory controls in this sector.
The other side
Money, money, money, it is not just a medium of exchange. It is everything. It makes the world go around. Every person desires for money. They are having a liking for money. “Getting rich” is something on their “to-do list”. And why not from birth to death, for each thing one requires money. Though God born us we need money for survival, Right!
But money can bribe, manipulate, and play mischief to get the evil out of you. The act of crimes, destruction, duping is increasingly done just for one thing-money. As only few makes money in the right path, whereas others become slaves of their own crave. That is why very few people want to be teachers because teaching is not a lucrative profession. They want some degree or course which pays off in future in the form of “huge money”.
With the economic slowdown, now more and more students are likely to get into the medical field. There was a time, when every parent wants their son/daughter to be engineer or doctor. Now, it is no longer. They want the doctors and pharmacists because they are in huge demand. Doctors are said to be highly paid or over-paid for their work. My friend, Zainab is married to a doctor, a year ago. Her parents wanted their daughter to marry only someone who is MBBS.
They also said “doctors are money-making machines”. Also, if some body asks me, I would say, to some extent the business of doctors never falls. Moreover, every day in newspapers, TV, there is shown, some new disease coming into the light of “common people”, and the aam janta needs a physician, they are always to shine.
Entirely all agree doctors and medicines save our lives. But not all doctors are life saviors. There are only few who do job selflessly. Others work for money. Like Shiva’s father who don’t trust doctors because for just a fever and cold, the doctors in clinics gives four-six pills and that to not for a day, for five days minimum. They are just making money out of their patients. If one goes to the doctor complaining of back ache and pain in abdomen or chest, they just ask you to go for X-rays, radio graphs, etc. the people who cannot spend money on various tests start self-medication.
They take pain-killers for pain reduction unknowingly. The blood and urine test seems to be nothing more than common for any patient these days. Also it is a mere observation, but no false that in OLD City of Hyderabad many doctors run more than three clinics at a time. The morning, evening and night shifts only to make money. They ask patients to come for regular check-ups every week. This is true and unfortunate reality.
And can you ever imagine, or spared a thought of taking fake medicines under any circumstances? The answer would be no to “some” and a shock to others who are in ignorance. Yes, agree or disagree, believe or believe not, many drug dealers in India sell the fake medicines without the knowledge of the masses. When buying medicines from any medicine store, beware! Your life may be at risk.
The spurious medicines are usually made by the people involved in recycling who has no license. They collect the used vials with intact labels, removing the closures, filling the containers with enough material and reseal it by using hand operated sealing machines which are easily available. This process is done by the ones who have knowledge of pharmacy. These operations are carried out in small places like villages or remote places in the town and the activity is rotated from place to place.
The fake medicine seizures have been reported in China, Zimbabwe and Saudi Arabia from years. And for us, the most worrying aspect is that India was the leading source of fake drugs exported to European Union in 2008. It was 2nd largest exporter of fake medicines. It is also apprehended that spurious and substandard drugs is an Rs 15,000-crore racket growing at 25% every year.
The investigations revealed that some corrupt medical practitioners and drug control authorities are “making money” out of the export of fake medicines from many parts of India. In 2002 and 2006 the racket of spurious medicines were largely found. Then it continued in 2008at higher level. The number of places in Bhubaneswar, Orrisa discovered with fake drug dealers. Again in Lucknow, an inter-state gang dealing in fake medicines was busted with the arrest of three people and recovery of spurious drugs worth Rs.4 million in Uttar Pradesh. The arrested dealers have confessed that they used to manufacture and supply spurious medicines to drug dealers of Bihar, Madhya Pradesh, Uttarakhand and other neighboring states.
It seems that the fake drug dealers have expanded their base to the rural belt of India, where people can hardly make the difference between genuine and fake medicines. They are uneducated and trust the doctors blindly. It's really sad. It’s unfortunate that such practice existed in the country for a long time and nobody even got a slight hint until the media intervened.
Poor Durga, who was in medication for epilepsy was consuming fake medicines without knowledge and died suddenly. All blamed the disease she was suffering from until the fact discloses of spurious medicines. In other cases the people of High BP, diabetes and regular patients of doctors fail to identify the number of tablets given to them.
Now the concern is, how would one knows that he/she is purchasing the non-fake medicines, and what do they look at, because even the experts find it difficult to differentiate the fake medicine and artificial. It is like having a fake medicine and inviting allergies and diseases ill literally. The drug dealers use modern technology to apply the same labels and packaging on the fake medicines. If the government and administration fails to prevent the sale of fake medicines, then how the general public will understand, it is a serious issue.
In fact a global issue, as fake medicine rackets exists in many parts of the world. Also, it’s particularly irksome to know that Internet being a boon is a bane. Probably the biggest market place for counterfeit medicine is internet in present day the trade has waved with the advancement of technology. More frequently, the drugs these days are sent in E-mails as Spam messages. And the people who do self-medication fall in as victims to such spurious drugs. But this business has assumed a greater significance for health care professionals as well as drug firms as it affects their profits.
It is truly disheartening and depressing as doctors are in the business of saving our lives are getting rich on cost of sick. It is really sick that physicians, who have an immensely responsibility are players of our life, maker of money. Better they recall and comprehend that it is good to make money for need and betterment to the extent that leaves you happy, contented and peaceful. If the live saviors becomes greedy, who to trust on?
Ultimately, we need to crush out the illicit medicines trade and punish the doctors and pharmacists engaged in the illegal and deadly menace. The tough governmental legislations with strict enforcement can bring in a positive change in controlling this trade. However, the fake medicines are usually priced lower than the authentic price, so be cautioned while purchasing medicines. And “STOP SELF-MEDICATION”. Buying medicines only from reputed, well-established chemists is one way to strangle the spurious drug industry. It is your life and you have to be careful because “the doctors are to be feared more than the disease” these days.
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