Fake drug industry operates openly

[Guest guest]

Instead of focusing or Ramdev, GM food, Govt Agriculture policy or

anti-vaccine, how about focusing on this type of issues?

Jay Shah

=============================================

Fake drug industry operates openly

Bill to punish offenders stuck in Parliament since May 2005; Delhi’s

Bhagirath Palace is the heaven for fake pills

Bhuma Shrivastava and K.P. Narayana Kumar

 

New Delhi: The first occupant of Bhagirath Palace, built in the 1820s

in what was then central Delhi, was Begum Sombre, a mercenary queen.

“Sumroo,†as her name got corrupted locally, lent her forces to the

last feeble Mughal emperors to help drive away invaders and quell

minor rebellions.

 

Nearly two centuries later, today’s crowded Bhagirath Palace in

Chandni Chowk, a bustling locality in Old Delhi, still has its

soldiers of fortune. Mercenaries who make and sell fake drugs, copies

of the most complex medicines, for any distributor and retailer who

wants to make a quick buck or exporters who sell them to unsuspecting

health administrators in Sub-Saharan Africa, who receive some of the

millions in aid money that is trying to fight HIV/AIDS, malaria or

tuberculosis.

Nobody is sure of the extent of India’s fake drugs industry, but what

is for sure is that the country neither has the enforcement resources

nor, as it increasingly appears, the political or corporate will to

stop such practices. India has only about 1,200 drug inspectors to

monitor drug manufacturing firms that, depending on who you ask,

number anywhere between 6,000 and 15,000.

 

Just miles from Bhagirath Palace, already watered-down federal

legislation that seeks to impose fines and prison terms for those who

make and sell counterfeit drugs is gathering dust in the Parliament

since 10 May 2005.

 

India’s drug giants†" often cited as global success story in making

cheap drugs†" as well as their foreign rivals don’t want to talk openly

about the fake drugs problem for the fear that their own brands get

bad publicity. They point the fingers at the government, which in

turn, points the fingers straight back at the drug industry.

 

Health minister A. Ramadoss and other ministry officials didn’t

respond to several attempts by Mint to discuss the fake drugs

situation or reasons why legislation isn’t moving forward. “The Drugs

and Cosmetics Act (the law that lays down punishment for such

offenders) is a social legislation where everyone has a

responsibility, from the manufacturers, suppliers, consumers to the

government, that counterfeit drugs don’t enter the market,†says M.

Venkateswarlu, the drug controller general.

 

But, at a licensed medical store in the narrow by-lanes of Bhagirath

Palace market, all a reporter had to do was ask for a cure for an

ebbing libido. “Have it after dinner, just before you start

you-know-what,†said the drugstore owner, pushing across a a packet of

four red, triangular tablets of “sildenafil citrate,†the chemical

name of Viagra, Pfizer Inc.’s blockbuster erectile dysfunction drug.

These tablets, sold as Vigora, in a graphic blue and black box that

doesn’t leave the affect of the drug to imagination, comes with a

clear warning that the Schedule H drug is “to be sold by retail on the

prescription of a Registered Medical Practitioner only.†A maximum

retail price of Rs106.33 is also clearly marked on the side.

 

“How much?†“

“Tees rupiya (Rs30),†the store manager said. The transaction is over

within minutes. No questions asked, no prescription needed, no receipt

provided. Vigora is actually a genuine generic version of Viagra and

marketed by German remedies division of Cadila Healthcare Ltd, an

Ahmedabad-based company that in turn gets the drug from HAB

Pharmaceuticals & amp; Research Ltd in Dehradun.

 

A spokesperson for Cadila said the genuine Vigora is usually sold for

about Rs110 and as a prescription drug. While the one obtained from

Bhagirath Palace does have a batch number as well as both a

manufacturing and expiry date, its cut-rate price suggests it is quite

unlikely to be the real Vigora but more likely to be a knock-off that

is extremely well packaged, down to the printed laundry list of

instructions to patients inside the box.

 

“There is a big menace of spurious drugs,†says a senior Cadila

executive who did not want his name used. “Discounts can make a drug

that costs Rs106 cheaper by around Rs20-Rs25, but if it is selling at

Rs30, then there must be something wrong with it.â€

 

Indeed, a 2004 survey by the Delhi Medical Association found just four

of 53 drugs they sampled from Bhagirath Palace, perhaps the biggest

medicines bazaar in the India, to be genuine. That is not to say

everything at this market is fake. Bhagirath Palace is actually home

to hundreds of wholesalers who sell medicines to retailers from most

of north India and some states in the northeast.

 

But allegations of counterfeit medicines being supplied through this

bazaar have been levelled by many a pharmaceuticals company for years

though action against suspected traders seems spotty. “The crime

branch has registered a few cases against some drugstore owners

associated with Bhagirath Palace,†says one senior Delhi Police

officer who didn’t want to be named because of pending cases.

 

It is not easy to get one’s arms around the extent of counterfeit

drugs in the country. One government study suggested counterfeit drugs

were just 0.5% of the industry while a study by Assocham, the body

that represents chambers of commerce in India, recently put it at a

high 30% of all drugs sold in India, or about Rs10,200 crore out of an

industry that sells Rs34,000 crore each year.

 

Harinder Sikka, whose public interest litigation against the

government that is partly about this same issue and was admitted by

the Delhi high court, puts the market for spurious drugs at Rs4,000

crore. Sikka filed the litigation in his personal capacity though he

is also a senior president withdrug giant Nicholas Piramal India Ltd.

 

Praful Sheth, vice-president of the International Pharmaceutical

Federation (FIP), a trade group, says there is no accurate or verified

data on how many people could have been affected or have died on

account of fake drugs. “No one knows the extent of damage and you get

figures all over the place,†says the industry veteran, likening it to

the Vietnam war.

 

While these numbers might be exaggerated, what is certain is that

almost every drug in the country is being duplicated and sold. All the

top medicines sold in India, as tracked by medicine sales tracking

agency ORG IMS, are prone to fakes as they sell in large volumes, or

are expensive or have a steady stream of users, say industry insiders.

These include insulin of Novo Nordisk India Pvt. Ltd, Wockhardt Ltd,

Eli Lilly and Co. (India) Pvt. Ltd; Novartis India Ltd’s pain relief

pill Voveran; Pfizer’s cough syrup Corex and vitamin tablet Becosules;

Cifran and Sporidex of Ranbaxy Laboratories Ltd; GlaxoSmithKline

Pharmaceuticals Ltd’s Augmentin and Zinetac; Combiflam of Aventis

Pharma Ltd; and Cipla Ltd’s Ciplox and Asthalin. Most of these firms

didn’t want to comment on specific brands and associated counterfeit

problems.

 

Global problem

With India’s growing reputation†" much of it genuinely attained†" of being

a low-cost drug manufacturer, India’s fakes are also having global

ripples. The Narcotics Control Bureau (NCB) here in Delhi is

concerneed that drugs sold online from India to the US customers, for

instance, may be spurious. “The market for cheap imported drugs in the

US is growing by the day and is now valued at around $50 billion.

There are bound to be more racketeers in India who would want to make

money,†says A.P. Siddiqui, deputy director, NCB. “We still do not

know if the racketeers sourced the medicines from dubious distributors.â€

Says FIP’s Sheth, who is currently doing a study on fake drugs for the

World Health Organization: “Tracking a counterfeit drug-maker is like

stalking a shadow. They work in small pockets of organized crime and

keep moving from one place to another.â€

 

But these small pockets have now grown large enough to cause

considerable embarrassment for India, often seen as a dependable

source for medicines to fight diseases in Africa and poor parts of the

world. According to Medecins Sans Frontiers, India ranks second, after

Belgium, on the list of countries from which Unicef purchases medical

supplies. While there is no evidence that any of these world bodies

are concerned about such drug supplies, there have been instances

where fake drugs from India have made their way to, as far as, Africa.

Nigeria’s drugs regulator, the National Agency for Food and Drug

Control, in one of its presentations before the World Bank in 2003

said a large consignment of a controlled narcotic analgesic was

concealed in T-shirts and imported from India via Lagos airport. In

2004, the agency said, 32 containers of various pharmaceuticals were

smuggled in as motor vehicle spare parts. A year later, Nigeria

blacklisted purchases from 14 Indian drug companies, including Kamala

Overseas Bombay, Welcure Drugs and Pharmaceuticals, Wardex

Pharmaceuticals, Unibios Lab, Shreechem Pharmaceuticals and Merit

Organics, on charges of counterfeit and substandard supply of

medicines. “No country is immune to counterfeiting of drugs due to

inter-country commerce and porous borders,†maintains Sheth. “Though

associated with India and China, there are manufacturing hubs in

eastern Europe, Latin America and South Asian countries, too.†The New

York-based Centre for Medicines in the Public Interest estimates that

global counterfeit drug sales will reach $75 billion by 2010, nearly

double from 2005.

 

Regulatory issues

The regulatory agency, Office of Drug Controller General of India,

admits it is ill-equipped to handle the extent of vigilance required

to comb a vast country with just 35 drug inspectors at the central

level and 1,100 in the states. The All India Drugs Control Officers’

Confederation (AIDCOC), a representative body of drug inspectors,

estimates that India needs at least 4,500 additional drug inspectors

to monitor 15,000 drug manufacturing units and more than half a

million retail outlets. The drug control regime is “crippled,†says

Ravi Uday Bhaskar, AIDCOC secretary general. “There is inadequate

manpower, infrastructure and auxiliary staff. This issue of

upgradation has been in a limbo for 25 years now,†he says, but

bristles at the notion that drug inspectors, sometimes suspected of

being part of the problem, are also to blame for the spread of

counterfeit drugs.

 

Meanwhile, a multiplicity of regulatory agencies leave loopholes that

rogue drug makers exploit. A manufacturing licence for a drug unit is

given by state drug authorities, licences for different drugs by the

Central government, and checks for quality compliance is done jointly

by the two. The law mandates one annual inspection at each unit, but

for effective monitoring, up to 20-30 checks may be required, admits

AIDCOC’s Bhaskar.

 

The fake drugs cell of the Indian Pharmaceutical Alliance, a lobby

group representing large Indian drug makers, has been tracking and

investigating spurious drugs since 2001 but its effort has been too

small to make a dent. The cell is part of raids conducted almost every

other month and has participated in over 70 raids that seized goods

worth Rs17 crore. There have been 106 arrests through such raids, but

most of those arrested typically manage to promptly secure bail.

“We face resistance from distributors and can only flag these cases to

the police who then have to take action. Even if we catch them

red-handed, they slip out on bail,†says P.N. Bhargava, a retired

intelligence officer who now works with the cell.

In February 2006, for instance, the Alliance’s anti-piracy team helped

raid a Sonepat, Haryana-based medicine company and found two large

rooms filled with cartons of fake drugs. Cifran, Voveran, Crocin,

drugs of many big brands, worth about Rs3 crore, were seized. The drug

maker, which operated with a licence to manufacturer ayurvedic

medicines, was actually a repeat offender: It had been busted in 2001

for making spurious drugs.

 

Bhargava recalls instances where they raided unlicensed drug godowns

in Agra only to see entire warehouses cleared overnight before the

police could act. Recently, the Karnataka state drug controller found

fakes of Nicholas Piramal’s Stemetil and is initiating legal proceedings.

Novartis India chairman Ranjit Shahani dubs counterfeit drugs the

perfect murder weapon “as the evidence disappears once you take the

pill and you die of the disease, not the pillâ€. He says that just one

counterfeit drug maker, making thousands of strips of drugs for

malaria that is consumed by hundreds of unsuspecting children, can

cause deaths within 48 hours because the medicine doesn’t work. “Now

multiply this toll for as many life-threatening diseases across

patients: it is like three jumbo jets crashing every day,†he says.

 

Novartis, like most drug companies, conducts checks and is part of

raids, sometimes two a month, in search of fake Novartis drugs.

Ranbaxy says it is making counterfeiting harder by using sophisticated

packaging technologies that are hard to mimic. These include the use

of holograms, innovative printing inks, optical character recognition

and smart card technologies.

 

Kewal Handa, Pfizer’s managing director in India, says his company

retains samples from each batch of medicine sent to distributors. This

helps differentiate between the original and the counterfeit product.

Most of the counterfeit drugs allegedly peddled in wholesale drug

markets such as Bhagirath Palace and the Dawa Mandis in Agra and

Kanpur are sourced from small units situated in industrial clusters in

Haryana and the national capital region in areas such as Okhla,

Mayapuri and Ghaziabad, all the way up to Meerut in western Uttar

Pradesh, say observers.

 

A counterfeit drug travels across several states, moving from a

manufacturer to another city in North India for packing, complete with

fake holograms, and is then sold in a dawa mandi in a third city. The

content of such drugs could involve the actual chemical that goes in

the drug, but in smaller potencies or raw lime and even just water

(for, say, insulin).

 

According to one veteran trucking company owner in Delhi, most of the

shops that sell fake drugs have an “arrangement†with a transporter.

“In every consignment, they carry a percentage of genuine drugs, which

are backed with proper documentation such as tax receipts and

invoices, while the fake medicines would be backed by fake papers. If

they are hauled up, they would show the genuine goods and papers to

‘convince’ authorities that the goods were all “pucca (in order),†he

says, preferring to remain anonymous. Transporters charge a premium

for carrying counterfeit drugs and earn even more if they actually

prepare and forge documents.

 

Industry insiders note that some 750 small drug units have gone out of

business over the mandatory implementation of “good manufacturing

practices†two years ago or because key customers switched to drug

units operating in benign tax regimes of Uttarakhand and Himachal

Pradesh. As a result, many of these firms, which have the necessary

equipment, could be susceptible to fake drug manufacturing, these

people say.

 

Some doctors say they have begun prescribing medicines that are not

available very easily to avoid fakes. Arjun Rastogi, of south Delhi’s

Geetanjali Hospital, say doctors can never be sure if a drug is

spurious. “The drug could be fake or the patient could be resistant to

the drug,†says Dr Rastogi.

 

Organized pharmacy chains, such as Apollo Pharmacy and Fortis

HealthWorld, have centralized procurement directly from the companies

to counter this threat. “We deal with large established distributors

representing big companies only, physically check every strip and bar

code them so that no unwanted supplies can trickle in,†says Ashish

Pandit, chief executive, Fortis HealthWorld.

 

Sikka, whose public interest litigation is also based on the premise

that spurious drugs violate the fundamental right to life under

Article 21 of the Indian Constitution, says that a lot of fakes make

their way into the government medicine programmes becacuse it buys on

the basis of lowest cost rather than quality.

 

Legislation on fake drugs meanwhile appears stuck in Parliament for

nearly two years. An amendment bill was drafted after a 2003 committee

report suggested the death penalty as punishment for offenders. That

report also noted that just seven among 17 government laboratories for

drug testing in 31 states and union territories were reasonably equipped.

 

Sushma Swaraj, the former health minister who helped draft the

counterfeit amendment to the Drugs & amp; Cosmetics Act, is furious

that the current government has watered down the death punishment to

life imprisonment and a fine of Rs10 lakh or three times of the value

of goods confiscated, whichever is greater. “This is mass murder and

done for the most guileful reason (of profit). I had wanted the

extreme punishment of a death sentence for the offender. The new

minister (Ramadoss) is still sitting on the bill,†she says. While

Ramadoss didn’t respond, Gurdial Singh Sandhu, joint secretary

(pharmaceuticals) in department of chemicals and petrochemicals, said

Parliament may take up the amendment bill in “the coming sessions.â€

(bhuma.s)

(Y.V. Phani Raj in Hyderabad contributed to this story.)

[Guest guest]

You know, It really floors me why safer, cost effective alternative methods of cure aren't utilized PERIOD!

 

Energy medicine, Homeopathy and Micro electricity such as Beck Rife protocol for HIV/AIDS. Billions of dollars are funneled into medical treatments and pharmaceuticals that NEVER address the real root cause of dis-ease. They are just developed to create a cycle of continuous need to increase wealth at the expense of middle and lower class. It wont be long before middle class doesn't even exist, just the two extremes of social status. We have got to be close to end time period. Maybe not in my life time but not far off human kind is sure to end itself.

 

Mary

On 5/12/07, anuchoksey <jayanu wrote:

 

 

 

 

 

Instead of focusing or Ramdev, GM food, Govt Agriculture policy oranti-vaccine, how about focusing on this type of issues?Jay Shah=============================================Fake drug industry operates openly

Bill to punish offenders stuck in Parliament since May 2005; Delhi’sBhagirath Palace is the heaven for fake pillsBhuma Shrivastava and K.P. Narayana KumarNew Delhi: The first occupant of Bhagirath Palace, built in the 1820s

in what was then central Delhi, was Begum Sombre, a mercenary queen.“Sumroo,†as her name got corrupted locally, lent her forces to thelast feeble Mughal emperors to help drive away invaders and quellminor rebellions.

Nearly two centuries later, today’s crowded Bhagirath Palace inChandni Chowk, a bustling locality in Old Delhi, still has itssoldiers of fortune. Mercenaries who make and sell fake drugs, copiesof the most complex medicines, for any distributor and retailer who

wants to make a quick buck or exporters who sell them to unsuspectinghealth administrators in Sub-Saharan Africa, who receive some of themillions in aid money that is trying to fight HIV/AIDS, malaria ortuberculosis.

Nobody is sure of the extent of India’s fake drugs industry, but whatis for sure is that the country neither has the enforcement resourcesnor, as it increasingly appears, the political or corporate will to

stop such practices. India has only about 1,200 drug inspectors tomonitor drug manufacturing firms that, depending on who you ask,number anywhere between 6,000 and 15,000.Just miles from Bhagirath Palace, already watered-down federal

legislation that seeks to impose fines and prison terms for those whomake and sell counterfeit drugs is gathering dust in the Parliamentsince 10 May 2005.

.. -- In Love, Light and Honor.............. May You and Yours be Blessed with Health, Happiness, Wisdom and Prosperity.

[Guest guest]

Fake drug industry is thriving under political patronage hence no government will ever take any serious step to curb or eliminate the menace. However, as a cosmetic measure, at times few will be caught and still fewer would be prosecuted to show its concern etc.The real big fish will be left untouched. On 5/13/07, kayedoe <kayedoe wrote:

 

 

 

 

You know, It really floors me why safer, cost effective alternative methods of cure aren't utilized PERIOD!

 

Energy medicine, Homeopathy and Micro electricity such as Beck Rife protocol for HIV/AIDS. Billions of dollars are funneled into medical treatments and pharmaceuticals that NEVER address the real root cause of dis-ease. They are just developed to create a cycle of continuous need to increase wealth at the expense of middle and lower class. It wont be long before middle class doesn't even exist, just the two extremes of social status. We have got to be close to end time period. Maybe not in my life time but not far off human kind is sure to end itself.

 

Mary

On 5/12/07, anuchoksey <jayanu wrote:

 

 

 

 

 

 

Instead of focusing or Ramdev, GM food, Govt Agriculture policy oranti-vaccine, how about focusing on this type of issues?Jay Shah=============================================Fake drug industry operates openly

Bill to punish offenders stuck in Parliament since May 2005; Delhi’sBhagirath Palace is the heaven for fake pillsBhuma Shrivastava and K.P. Narayana KumarNew Delhi: The first occupant of Bhagirath Palace, built in the 1820s

in what was then central Delhi, was Begum Sombre, a mercenary queen.“Sumroo,†as her name got corrupted locally, lent her forces to thelast feeble Mughal emperors to help drive away invaders and quellminor rebellions.

Nearly two centuries later, today’s crowded Bhagirath Palace inChandni Chowk, a bustling locality in Old Delhi, still has itssoldiers of fortune. Mercenaries who make and sell fake drugs, copiesof the most complex medicines, for any distributor and retailer who

wants to make a quick buck or exporters who sell them to unsuspectinghealth administrators in Sub-Saharan Africa, who receive some of themillions in aid money that is trying to fight HIV/AIDS, malaria ortuberculosis.

Nobody is sure of the extent of India’s fake drugs industry, but whatis for sure is that the country neither has the enforcement resourcesnor, as it increasingly appears, the political or corporate will to

stop such practices. India has only about 1,200 drug inspectors tomonitor drug manufacturing firms that, depending on who you ask,number anywhere between 6,000 and 15,000.Just miles from Bhagirath Palace, already watered-down federal

legislation that seeks to impose fines and prison terms for those whomake and sell counterfeit drugs is gathering dust in the Parliamentsince 10 May 2005.

.. -- In Love, Light and Honor.............. May You and Yours be Blessed with Health, Happiness, Wisdom and Prosperity.