Re: Counterfeit Medicines- should image of India be tarnished alone?

[Guest guest]

Hi

Counterfeit problem exists in India and we are speaking, admitting.

But so do these in other countries.Only difference is that they can

not / do not talk about it.We are critical of counterfeits and do

not wish to have any counterfeit in the country. But the presence of

counterfeits should not not shame the country as a whole, because

not everyone is doing it.

In generic medicine production, competetive prices, supply to

economically poor countries and exports we are doing good and should

be proud of making affordable medicines available to suffering poor

populations.

Remember the hype of pharmaceutical giants for introduction of

patent regime? Same is the case in case of counterfeits. Pure

business motives are driving the criticism. All the sharks want is

human flesh!

Beware of negative reports and be proud of the country.

Vijay

>

> Dear friends,

>

> This one is the latest article in Economic Times.

>

> What does it means....Real problem....created problem through

competetion or what.....they are blaming us? or its

reality?....shamful to Indians....

>

> India hub of counterfeit drugs: EC

> 23 Jun, 2007, 0346 hrs IST,Khomba Singh & Gireesh Chandra Prasad,

TNN

> Print

> Save

> EMail

> Write to Editor

>

> NEW DELHI: Concerned over European

Commission's (EC) allegations about large scale supply

of `counterfeit' Indian drugs to the region, India has sought

clarifications from the EC on its claim and on its definition of

counterfeit drugs.

>

> A recent EC report claimed that India was the largest source of

the 2.7 million counterfeit drugs seized by its custom department in

2006.

>

> India, however, has decided to wait for the EC's response to its

queries before initiating any action. " We have no specific

information on the reason for the reported seizure. It could be even

intellectual property violations. We have asked for more

information. Counterfeiting need not be the only reason for seizure

of products, " Drug Controller General of India (DCGI) Venkateswarlu

told ET.

>

> The government is also keen to know the EU definition of

counterfeit as it varies from place to place, said the DCGI. Many

countries consider products not registered there as

counterfeits. " Some countries may have porous borders and medicines

may reach there from neighbouring countries where they are legally

sold, " he said.

>

> The regulator's intervention is significant as it comes in the

wake of the pharma industry's concern that reports like this could

harm India's reputation as the supplier of low cost but quality

drugs to the world.

>

> Terming the report as a " non-tariff barrier " , the Indian

pharmaceutical industry said such barriers will harm its global

expansion. India is the fourth largest producer of pharmaceuticals

by volume. According to latest reports, nearly half of its revenue

is coming from exports, mainly from the EU and the US.

>

> According to the EC report on counterfeit products, based on the

figures given by the customs departments of all EU members, India is

the number one source in counterfeit medicines, followed by the

United Arab Emirates and China. " Together, these three sources are

responsible for more than 80% of all counterfeit medicines, " the

report said.

>

> Counterfeits drugs seized in Europe had increased five-fold to 2.7

million in 2006 from 500,000 a year ago.

> " The emergence of India in this sector (pharma), reflects the

developing industrial capacity of this nation and highlights the

reality that counterfeiting is carried out on an industrial scale in

all sectors where a potential profit is perceived, " the EC report

added.

>

> Although, there are varying figures on the prevalence of

counterfeit drugs, it is estimated that it accounts for about 10% of

the global pharma market. US-based Centre for Medicines in the

Public Interest says counterfeit drug sales will reach $75 billion

globally in 2010, from the current estimate of $50 billion.

>

>

>

> Regards,

>

> Dr Kiran Chaudhari

>

> Lecturer (Pharmacology)

>

> GMC, Nagpur.

>

>

> ---------------------------------

> Bollywood, fun, friendship, sports and more. You name it, we

have it.

>

[Guest guest]

Certainly sir, we are very proud of our country. But

there are certain realities which we need to face and

think of remedial measures.

Following the serious case of intravenous (IV) fluid

contamination at JJ Hospital, Mumbai, in 1988-89 and a

few similar incidents the Indian government

constituted, an expert committee under the

chairmanship of R. A. Mashelkar, Director-General of

the Council for Scientific and Industrial Research

(CSIR).

The committee was required to evaluate the extent and

problem of counterfeit medicines in the country and

study the various aspects of the growing threat from

such medicines. Its mandate was to suggest a road map

for implementation of the recommended measures.

According to the report of the Mashelkar committee,

the figures quoted in the media and by different

sources on the extent of counterfeit medicines in

India have varied from 0.5 per cent and 35 per cent.

Obviously, given the variation, the data are

unreliable. The lower limit is based on the samples

tested by the State authorities for the period

1995-2003. The upper limit is from a report in the

medical journal Lancet in 2001 by an Indian

journalist, ostensibly based on WHO figures, which had

claimed that 35 per cent of world's counterfeit drugs

came from India, the fake drug market of which itself

was over Rs.4,000 crores (about 20 per cent of the

total turnover).

WHO, however, wrote to the committee - just a day

before the report was released - clarifying that there

was no study conducted by WHO that had said that 35

per cent of world's counterfeit drugs are produced in

India.

Interestingly, the WHO letter went on to add: " The

Indian pharmaceutical market, with annual sales

ranging between $7 billion and $8 billion, ranks third

in the world, and the majority of the Indian

pharmaceuticals are produced by large manufacturers

according to WHO Good Manufacturing Practices (GMP)! "

That’s a reason to cheer up!

But then there also is a matter of concern and that is

about counterfeit medicines produced in India being

seized in other countries.

Indian pharma industry officials are concerned that

the growing export of counterfeit medicines from the

country will malign the image of the Indian pharma

industry.

The fake drugs are mostly manufactured by small-time

companies and traders who want to make quick money.

But such instances, unfortunately, end up damaging the

reputation of the whole pharma industry.

The Mashelkar committee has suggested some measures to

tackle this problem. Can anybody throw light on

this?

Can our friends from other countries enlighten the

members about the situation in their country?

Smita Sontakke

--- Vijay <drvijaythawani@...> wrote:

> Hi

> Counterfeit problem exists in India and we are

> speaking, admitting.

> But so do these in other countries.Only difference

> is that they can

> not / do not talk about it.We are critical of

> counterfeits and do

> not wish to have any counterfeit in the country. But

> the presence of

> counterfeits should not not shame the country as a

> whole, because

> not everyone is doing it.

>

> In generic medicine production, competetive prices,

> supply to

> economically poor countries and exports we are doing

> good and should

> be proud of making affordable medicines available to

> suffering poor

> populations.

>

> Remember the hype of pharmaceutical giants for

> introduction of

> patent regime? Same is the case in case of

> counterfeits. Pure

> business motives are driving the criticism. All the

> sharks want is

> human flesh!

>

> Beware of negative reports and be proud of the

> country.

> Vijay

>

> >

> > Dear friends,

> >

> > This one is the latest article in Economic

> Times.

> >

> > What does it means....Real problem....created

> problem through

> competetion or what.....they are blaming us? or its

> reality?....shamful to Indians....

> >

> > India hub of counterfeit drugs: EC

> > 23 Jun, 2007, 0346 hrs IST,Khomba Singh & Gireesh

> Chandra Prasad,

> TNN

> > Print

> > Save

> > EMail

> > Write to Editor

> >

> > NEW DELHI: Concerned over

> European

> Commission's (EC) allegations about large scale

> supply

> of `counterfeit' Indian drugs to the region, India

> has sought

> clarifications from the EC on its claim and on its

> definition of

> counterfeit drugs.

> >

> > A recent EC report claimed that India was the

> largest source of

> the 2.7 million counterfeit drugs seized by its

> custom department in

> 2006.

> >

> > India, however, has decided to wait for the EC's

> response to its

> queries before initiating any action. " We have no

> specific

> information on the reason for the reported seizure.

> It could be even

> intellectual property violations. We have asked for

> more

> information. Counterfeiting need not be the only

> reason for seizure

> of products, " Drug Controller General of India

> (DCGI) Venkateswarlu

> told ET.

> >

> > The government is also keen to know the EU

> definition of

> counterfeit as it varies from place to place, said

> the DCGI. Many

> countries consider products not registered there as

> counterfeits. " Some countries may have porous

> borders and medicines

> may reach there from neighbouring countries where

> they are legally

> sold, " he said.

> >

> > The regulator's intervention is significant as it

> comes in the

> wake of the pharma industry's concern that reports

> like this could

> harm India's reputation as the supplier of low cost

> but quality

> drugs to the world.

> >

> > Terming the report as a " non-tariff barrier " , the

> Indian

> pharmaceutical industry said such barriers will harm

> its global

> expansion. India is the fourth largest producer of

> pharmaceuticals

> by volume. According to latest reports, nearly half

> of its revenue

> is coming from exports, mainly from the EU and the

> US.

> >

> > According to the EC report on counterfeit

> products, based on the

> figures given by the customs departments of all EU

> members, India is

> the number one source in counterfeit medicines,

> followed by the

> United Arab Emirates and China. " Together, these

> three sources are

> responsible for more than 80% of all counterfeit

> medicines, " the

> report said.

> >

> > Counterfeits drugs seized in Europe had increased

> five-fold to 2.7

> million in 2006 from 500,000 a year ago.

> > " The emergence of India in this sector (pharma),

> reflects the

> developing industrial capacity of this nation and

> highlights the

> reality that counterfeiting is carried out on an

> industrial scale in

> all sectors where a potential profit is perceived, "

> the EC report

> added.

> >

> > Although, there are varying figures on the

> prevalence of

> counterfeit drugs, it is estimated that it accounts

> for about 10% of

> the global pharma market. US-based Centre for

> Medicines in the

> Public Interest says counterfeit drug sales will

> reach $75 billion

> globally in 2010, from the current estimate of $50

> billion.

> >

> >

> >

> > Regards,

> >

> > Dr Kiran Chaudhari

> >

> > Lecturer (Pharmacology)

> >

> > GMC, Nagpur.

> >

> >

> > ---------------------------------

> > Bollywood, fun, friendship, sports and more. You

> name it, we

> have it.

> >

>

>

>

Now you can chat without downloading messenger. Go to

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[Guest guest]

Dear Madam, I would like to mention the measures adopted by the Mashelkar Committee. It has provided vast and detailed guidelines not only for the Government but for the Pharma industry and the consumer forums as well as human right organizations too. I am giving below the related details from the report, There was some problem in copy and paste functioninf from the site of report. Hence I am giving below the link for same. Click on the link you will get a pdf. its too big nearly 2.5 MB But just jump dirctly to POINT NUMBER 4 which is dealing with the issue of Counterfeit/spurious drugs. http://www.cdsco.nic.in/html/Final%20Report%20mashelkar.pdf. or go to the following html link. http://72.14.235.104/search?q=cache:AaBAwgQ_8RAJ:www.cdsco.nic.in/html/Final%2520Report%2520mashelkar.pdf+counterfeit+drugs+criteria+CDSCO+India & hl=en & ct=clnk & cd=1 & gl=in regards, smita sontakke <smitaavanti@...> wrote: Certainly sir, we are very proud of our country. Butthere are certain realities which we need to face andthink of remedial measures.Following the serious case of intravenous (IV) fluidcontamination at JJ Hospital, Mumbai, in 1988-89 and afew similar incidents the Indian governmentconstituted, an expert committee under thechairmanship of R. A. Mashelkar, Director-General ofthe Council for Scientific and Industrial Research(CSIR).The committee was required to evaluate the extent andproblem of counterfeit medicines in the country andstudy the various aspects of the growing threat fromsuch medicines. Its mandate was to

suggest a road mapfor implementation of the recommended measures.According to the report of the Mashelkar committee,the figures quoted in the media and by differentsources on the extent of counterfeit medicines inIndia have varied from 0.5 per cent and 35 per cent.Obviously, given the variation, the data areunreliable. The lower limit is based on the samplestested by the State authorities for the period1995-2003. The upper limit is from a report in themedical journal Lancet in 2001 by an Indianjournalist, ostensibly based on WHO figures, which hadclaimed that 35 per cent of world's counterfeit drugscame from India, the fake drug market of which itselfwas over Rs.4,000 crores (about 20 per cent of thetotal turnover). WHO, however, wrote to the committee - just a daybefore the report was released - clarifying that therewas no study conducted by WHO that had said that 35per cent of world's counterfeit

drugs are produced inIndia.Interestingly, the WHO letter went on to add: "TheIndian pharmaceutical market, with annual salesranging between $7 billion and $8 billion, ranks thirdin the world, and the majority of the Indianpharmaceuticals are produced by large manufacturersaccording to WHO Good Manufacturing Practices (GMP)!"That’s a reason to cheer up!But then there also is a matter of concern and that isabout counterfeit medicines produced in India beingseized in other countries. Indian pharma industry officials are concerned thatthe growing export of counterfeit medicines from thecountry will malign the image of the Indian pharmaindustry.The fake drugs are mostly manufactured by small-timecompanies and traders who want to make quick money.But such instances, unfortunately, end up damaging thereputation of the whole pharma industry.The Mashelkar committee has suggested some

measures totackle this problem. Can anybody throw light onthis?Can our friends from other countries enlighten themembers about the situation in their country?Smita Sontakke--- Vijay <drvijaythawani (DOT) co.in> wrote:> Hi> Counterfeit problem exists in India and we are> speaking, admitting. > But so do these in other countries.Only difference> is that they can > not / do not talk about it.We are critical of> counterfeits and do > not wish to have any counterfeit in the country. But> the presence of > counterfeits should not not shame the country as a> whole, because > not everyone is doing it.> > In generic medicine production, competetive prices,> supply to > economically poor countries and exports we are doing> good and should > be proud of making

affordable medicines available to> suffering poor > populations. > > Remember the hype of pharmaceutical giants for> introduction of > patent regime? Same is the case in case of> counterfeits. Pure > business motives are driving the criticism. All the> sharks want is > human flesh!> > Beware of negative reports and be proud of the> country.> Vijay > > >> > Dear friends,> > > > This one is the latest article in Economic> Times.> > > > What does it means....Real problem....created> problem through > competetion or what.....they are blaming us? or its > reality?....shamful to Indians....> > > > India hub of

counterfeit drugs: EC> > 23 Jun, 2007, 0346 hrs IST,Khomba Singh & Gireesh> Chandra Prasad, > TNN> > Print> > Save> > EMail> > Write to Editor> > > > NEW DELHI: Concerned over> European > Commission's (EC) allegations about large scale> supply > of `counterfeit' Indian drugs to the region, India> has sought > clarifications from the EC on its claim and on its> definition of > counterfeit drugs. > > > > A recent EC report claimed that India was the> largest source of > the 2.7 million counterfeit drugs seized by its> custom department in > 2006. > > > > India, however, has decided to wait for the EC's> response to its > queries before initiating any action. "We have no> specific > information on the reason for the reported

seizure.> It could be even > intellectual property violations. We have asked for> more > information. Counterfeiting need not be the only> reason for seizure > of products," Drug Controller General of India> (DCGI) Venkateswarlu > told ET. > > > > The government is also keen to know the EU> definition of > counterfeit as it varies from place to place, said> the DCGI. Many > countries consider products not registered there as > counterfeits. "Some countries may have porous> borders and medicines > may reach there from neighbouring countries where> they are legally > sold," he said. > > > > The regulator's intervention is significant as it> comes in the > wake of the pharma industry's concern that reports> like this could > harm India's reputation as the supplier of low cost> but

quality > drugs to the world. > > > > Terming the report as a "non-tariff barrier", the> Indian > pharmaceutical industry said such barriers will harm> its global > expansion. India is the fourth largest producer of> pharmaceuticals > by volume. According to latest reports, nearly half> of its revenue > is coming from exports, mainly from the EU and the> US. > > > > According to the EC report on counterfeit> products, based on the > figures given by the customs departments of all EU> members, India is > the number one source in counterfeit medicines,> followed by the > United Arab Emirates and China. "Together, these> three sources are > responsible for more than 80% of all counterfeit> medicines," the > report said. > > > > Counterfeits drugs seized in Europe had

increased> five-fold to 2.7 > million in 2006 from 500,000 a year ago. > > "The emergence of India in this sector (pharma),> reflects the > developing industrial capacity of this nation and> highlights the > reality that counterfeiting is carried out on an> industrial scale in > all sectors where a potential profit is perceived,"> the EC report > added. > > > > Although, there are varying figures on the> prevalence of > counterfeit drugs, it is estimated that it accounts> for about 10% of > the global pharma market. US-based Centre for> Medicines in the > Public Interest says counterfeit drug sales will> reach $75 billion > globally in 2010, from the current estimate of $50> billion. > > > > > > > > Regards,> > > > Dr Kiran Chaudhari> >

> > Lecturer (Pharmacology)> > > > GMC, Nagpur.> > > > > > ---------------------------------> > Bollywood, fun, friendship, sports and more. You> name it, we > have it.> >> > > Now you can chat without downloading messenger. Go to http://in.messenger./webmessengerpromo.phpDr.Kiran ChaudhariMD Pharmacology(Lecturer, Govt.Medical College,Nagpur)66,Saraswati Society,Deendayal nagar,Nagpur.Maharashtra.India.440022

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[Guest guest]

Dear Dr Smita, I am enclosing the Mashelkar report: PROBLEM OF SPURIOUS AND SUBSTANDARD DRUGS 4. Evaluate the Extent of Spurious and Sub-Standard Drugs and Recommend Measures Required to Deal with the Problem 4.1 The Committee came to the

conclusion, after examining all the data and reports at hand, that there was an absence of a scientifically and statistically designed investigation, which could give a realistic estimate of the menace of spurious drugs. 4.2 The model for such an evaluation presented to the Committee by the Delhi Pharmaceutical Trust appears to be one, which had a rational approach to achieve this objective. The Committee recommends that the Central Government should provide assistance to undertake such scientific and statistically significant study in order to have a clear picture about the exact extent of spurious drugs in the country. 4.3 The gist of the recommendations to tackle the spurious drugs problem is as follows: Creation of effective interaction between the stakeholders i.e. industry and regulators, industry and consumers, trade

and regulators and medical professional and regulators. Creation of intelligence cum legal cells in State and Central offices. Discouragement of proliferation of drug distribution outlets. Making changes in law to provide enhanced penalties, making the offences cognisable and non-bailable in the light of similar provisions in Narcotic Drugs and Psychotropic Substances Act. Designation of special courts to try the cases of spurious drugs. Preparation of dossiers of suspected dealers and manufactures. Provision of secret funds and incentives to

informers. Creating effective networking system between States Checking on drug supplies to practitioners who buy and supply drugs to their patients. Creation by the industry of its counterfeit drug strategies, better surveillance and efficient complaint handling system. Creation of better surveillance system by the Trade Association on defaulting members and to take strict action against

them. Creation of better awareness amongst consumers. 4.4 The Committee noted that there is non-uniformity in the action taken on substandard drugs, especially when the manufacturer of substandard drugs is located in a different state. The Committee recommends

that: a) The DCC should deliberate on the issue of action to be taken on substandard drugs and review the existing guidelines. It should analyse the nature of substandard reports and status of concerned manufacturing units as well as the system of distribution; and The existing classification by DCC of defects found in substandard drugs into category A and category B and the action to be taken on each category of defects needs to be reviewed and updated. 4.5 The Committee noted that majority of the States are not either adequately staffed or technically equipped to monitor the quality of drugs manufactured and sold in their State. There is a strong need to strengthen the organizations with competent and trained manpower and with adequate budgets. This will

enable them to detect, investigate and take quick action in spurious/counterfeit drug cases. 4.6. The officers needed to be specially trained for the purpose. The Committee recommends that: a. The drug control organizations in States should be adequately strengthened. Additional manpower, infrastructure, technical capabilities and financial resources should be made available to the organization. They should have continuous vigilance facilities and strategies to implement an effective system to monitor and control the manufacture and distribution of spurious

drugs. b. States should set up Intelligence cum legal cells under thesupervision of trained senior officer. State Governments should put in place efficient mechanism for timely police help to these officers. c. States should establish a proper surveillance system for keeping a watch over suspected individuals. Watchers should be employed to purchase samples from suspected persons without disclosing their identity. Secret funds should be made available for intelligence activities. d. States, which have a large number of drug

distribution outlets, should set-up a well-equipped testing laboratory to enable them to test all categories of drugs in shortest possible time. All States should plan to take more samples to check the quality of drugs manufactured and sold in the market. Those States, where it was not technically and economically viable to support their own drug testing facilities, needed to make use of facilities of other States and Central laboratories or even the private approved laboratories for testing of suspected samples. e. States should set up an efficient

communication network system between the Center and other States in order to facilitate exchange of information and rapid investigation in cases involving inter-state movement. f. States should also monitor the source of purchase and quality of drugs stocked by dispensing registered medical practitioners through their drugs inspectors. 4.7 As regards the improvement of the drug testing laboratories, the committee recommends the following: a) Drugs and Cosmetics Rules should be amended to include GLP norms as statutory requirement for approved testing labs and also the in house testing labs of manufacturers. Accreditation with NABL should be made mandatory for all testing laboratories including the Government laboratories. c) The Central Government

should initiate a programme to have coded samples of the same product tested at different central and state labs from time to time and have the results assessed by experts for their proficiency testing. D) The state testing labs should be frequently audited by a team of experts to ensure their proper functioning. e) A separate Division needs to be established under CDA to oversee the overall working of drug testing laboratories in the country. 4.8 The Committee noted that specific penalties in Drugs and Cosmetic Act were provided in 1982 for offences concerning manufacture and sale of spurious drugs. However, the penal provisions have not acted as adequate deterrents and have not instilled the desired extent of fear among the offenders. It was, therefore, felt that the penalties for all offences related to spurious/counterfeit drugs should be further enhanced. 4.9 The Committee, more specifically, recommends that: a. The penalty for sale and manufacture of spurious drug that causes grievous hurt or death should be enhanced from life imprisonment to death. Even the penalty for manufacture and sale of spurious drugs that do not cause grievous hurt or death should also be made more severe (Annexure 13, 27a and 27aa). b. The offences related to spurious drugs should be madecognisable and non-bailable. The bail, if

considered by the court should be granted only after a period of three months (Annexure 13, 32b). c. The penalty for not disclosing the source of purchase of drugs by a dealer should be made stringent (Annexure 13, 28a). d. A provision should be included in the Drugs and Cosmetics Act to enable the Central and State Governments to designate special courts for speedy trial of spurious drugs cases (Annexure 13, 32(2)) e. A provision for compounding of offences should be included in the Drugs and Cosmetics Act (Annexure 13, 32©). f. Under Drugs and Cosmetics Act, besides the Drug Inspectors, Police should also be authorized to file prosecution for offences related to spurious drugs (Annexure 13, 32(1(a)) prosecution for offences related to spurious drugs Recommended steps to be taken by the Pharmaceutical Industry and Pharmacy Association to tackle the Problem of Spurious Drugs. 4.10 Recommended Action for Pharma industry a. Use their well-developed marketing network to identify distribution channel and persons involved in spurious drug trade. b. Assist, through its associations in detection and unearthing of spurious/counterfeit drugs by cooperating with the regulatory and/or police authorities. c. Prepare, through its associations, a checklist for the guidance of manufacturers, wholesalers and retail sellers to identify and distinguish between

the spurious and genuine products. d. Formulate its own spurious/counterfeit drugs policy and a surveillance strategy to tackle the problem of spurious drugs. e. Establish a close interaction with regulatory

authorities and extend full cooperation to eliminate the menace of spuriousdrugs. f. Streamline their supply chain and distribution network. g. Ensure proper storage of products during transit as well as at places of distribution. 4.11 Recommended Action for the Pharma Trade Association a. Play a proactive and visible role to contain the menace of spurious/counterfeit drugs b. Develop its mechanism in identifying the persons directly or indirectly involved in abetting the distribution of spurious, counterfeit or questionable quality drugs c. Prepare a checklist for the guidance of members and widely publicize it for information of all members d. Sub Rule 3 of Rule 65 (4) of Drugs & Cosmetics Rules requires that the supply by retail

of any drug shall be made against a cash/credit memo. This condition of license should be strictly adhered to by all retail licensees. e. Every chemist/pharmacist to act as a watchdog to prevent entry of any spurious/doubtful quality drugs or those purchased from unauthorized sources or without proper bills in the supply chain. 21 4.12 Recommended Action by the Consumer and other Professional Associations There is an urgent need for an awareness campaign to educate the consumers and the medical and paramedical professionals. The Committee, in particular, recommends that the Consumers and health professional/associates should play an active and visible role to create awareness about the hazards

of spurious drugs. They should undertake campaigns at the national level to educate the public on the ways and means of detecting spurious drugs and the advantages of purchasing from licensed sources with valid cash memos. Anupama (Jamnagar) smita sontakke <smitaavanti@...> wrote: Certainly sir, we are very proud of our country. Butthere are certain realities which we need to face andthink of remedial measures.Following the serious case of intravenous (IV) fluidcontamination at JJ Hospital, Mumbai, in 1988-89 and afew similar incidents the Indian governmentconstituted, an expert committee under thechairmanship of R. A. Mashelkar, Director-General ofthe Council for Scientific and Industrial Research(CSIR).The committee was required to evaluate the extent andproblem of counterfeit medicines in the country andstudy the various aspects of the growing threat fromsuch medicines. Its mandate was to suggest a road mapfor implementation of the recommended measures.According to the report of the Mashelkar committee,the figures quoted in the media and by differentsources

on the extent of counterfeit medicines inIndia have varied from 0.5 per cent and 35 per cent.Obviously, given the variation, the data areunreliable. The lower limit is based on the samplestested by the State authorities for the period1995-2003. The upper limit is from a report in themedical journal Lancet in 2001 by an Indianjournalist, ostensibly based on WHO figures, which hadclaimed that 35 per cent of world's counterfeit drugscame from India, the fake drug market of which itselfwas over Rs.4,000 crores (about 20 per cent of thetotal turnover). WHO, however, wrote to the committee - just a daybefore the report was released - clarifying that therewas no study conducted by WHO that had said that 35per cent of world's counterfeit drugs are produced inIndia.Interestingly, the WHO letter went on to add: "TheIndian pharmaceutical market, with annual salesranging between $7 billion and $8 billion,

ranks thirdin the world, and the majority of the Indianpharmaceuticals are produced by large manufacturersaccording to WHO Good Manufacturing Practices (GMP)!"That’s a reason to cheer up!But then there also is a matter of concern and that isabout counterfeit medicines produced in India beingseized in other countries. Indian pharma industry officials are concerned thatthe growing export of counterfeit medicines from thecountry will malign the image of the Indian pharmaindustry.The fake drugs are mostly manufactured by small-timecompanies and traders who want to make quick money.But such instances, unfortunately, end up damaging thereputation of the whole pharma industry.The Mashelkar committee has suggested some measures totackle this problem. Can anybody throw light onthis?Can our friends from other countries enlighten themembers about the situation in their

country?Smita Sontakke--- Vijay <drvijaythawani (DOT) co.in> wrote:> Hi> Counterfeit problem exists in India and we are> speaking, admitting. > But so do these in other countries.Only difference> is that they can > not / do not talk about it.We are critical of> counterfeits and do > not wish to have any counterfeit in the country. But> the presence of > counterfeits should not not shame the country as a> whole, because > not everyone is doing it.> > In generic medicine production, competetive prices,> supply to > economically poor countries and exports we are doing> good and should > be proud of making affordable medicines available to> suffering poor > populations. > > Remember the hype of pharmaceutical giants for> introduction

of > patent regime? Same is the case in case of> counterfeits. Pure > business motives are driving the criticism. All the> sharks want is > human flesh!> > Beware of negative reports and be proud of the> country.> Vijay > > >> > Dear friends,> > > > This one is the latest article in Economic> Times.> > > > What does it means....Real problem....created> problem through > competetion or what.....they are blaming us? or its > reality?....shamful to Indians....> > > > India hub of counterfeit drugs: EC> > 23 Jun, 2007, 0346 hrs IST,Khomba Singh & Gireesh> Chandra Prasad, > TNN> > Print> >

Save> > EMail> > Write to Editor> > > > NEW DELHI: Concerned over> European > Commission's (EC) allegations about large scale> supply > of `counterfeit' Indian drugs to the region, India> has sought > clarifications from the EC on its claim and on its> definition of > counterfeit drugs. > > > > A recent EC report claimed that India was the> largest source of > the 2.7 million counterfeit drugs seized by its> custom department in > 2006. > > > > India, however, has decided to wait for the EC's> response to its > queries before initiating any action. "We have no> specific > information on the reason for the reported seizure.> It could be even > intellectual property violations. We have asked for> more > information. Counterfeiting need not be the only>

reason for seizure > of products," Drug Controller General of India> (DCGI) Venkateswarlu > told ET. > > > > The government is also keen to know the EU> definition of > counterfeit as it varies from place to place, said> the DCGI. Many > countries consider products not registered there as > counterfeits. "Some countries may have porous> borders and medicines > may reach there from neighbouring countries where> they are legally > sold," he said. > > > > The regulator's intervention is significant as it> comes in the > wake of the pharma industry's concern that reports> like this could > harm India's reputation as the supplier of low cost> but quality > drugs to the world. > > > > Terming the report as a "non-tariff barrier", the> Indian > pharmaceutical industry said such

barriers will harm> its global > expansion. India is the fourth largest producer of> pharmaceuticals > by volume. According to latest reports, nearly half> of its revenue > is coming from exports, mainly from the EU and the> US. > > > > According to the EC report on counterfeit> products, based on the > figures given by the customs departments of all EU> members, India is > the number one source in counterfeit medicines,> followed by the > United Arab Emirates and China. "Together, these> three sources are > responsible for more than 80% of all counterfeit> medicines," the > report said. > > > > Counterfeits drugs seized in Europe had increased> five-fold to 2.7 > million in 2006 from 500,000 a year ago. > > "The emergence of India in this sector (pharma),> reflects the >

developing industrial capacity of this nation and> highlights the > reality that counterfeiting is carried out on an> industrial scale in > all sectors where a potential profit is perceived,"> the EC report > added. > > > > Although, there are varying figures on the> prevalence of > counterfeit drugs, it is estimated that it accounts> for about 10% of > the global pharma market. US-based Centre for> Medicines in the > Public Interest says counterfeit drug sales will> reach $75 billion > globally in 2010, from the current estimate of $50> billion. > > > > > > > > Regards,> > > > Dr Kiran Chaudhari> > > > Lecturer (Pharmacology)> > > > GMC, Nagpur.> > > > > > ---------------------------------> >

Bollywood, fun, friendship, sports and more. You> name it, we > have it.> >> > > Now you can chat without downloading messenger. Go to http://in.messenger./webmessengerpromo.php

Bollywood, fun, friendship, sports and more. You name it, we have it.

[Guest guest]

Hi

Even though I am critique of irrationality, I do not apporove of

discussion of figures unless the same are the result of the factual

research, WHO included.

Your quote - " WHO figures, which had claimed that 35 per cent of

world's counterfeit drugs came from India, the fake drug market of

which itself was over Rs.4,000 crores (about 20 per cent of the

total turnover). WHO, however, wrote to the committee - just a day

before the report was released - clarifying that there was no study

conducted by WHO that had said that 35 per cent of world's

counterfeit drugs are produced in India. " supports my contention.

None is above the truth!

Vijay

> > >

> > > Dear friends,

> > >

> > > This one is the latest article in Economic

> > Times.

> > >

> > > What does it means....Real problem....created

> > problem through

> > competetion or what.....they are blaming us? or its

> > reality?....shamful to Indians....

> > >

> > > India hub of counterfeit drugs: EC

> > > 23 Jun, 2007, 0346 hrs IST,Khomba Singh & Gireesh

> > Chandra Prasad,

> > TNN

> > > Print

> > > Save

> > > EMail

> > > Write to Editor

> > >

> > > NEW DELHI: Concerned over

> > European

> > Commission's (EC) allegations about large scale

> > supply

> > of `counterfeit' Indian drugs to the region, India

> > has sought

> > clarifications from the EC on its claim and on its

> > definition of

> > counterfeit drugs.

> > >

> > > A recent EC report claimed that India was the

> > largest source of

> > the 2.7 million counterfeit drugs seized by its

> > custom department in

> > 2006.

> > >

> > > India, however, has decided to wait for the EC's

> > response to its

> > queries before initiating any action. " We have no

> > specific

> > information on the reason for the reported seizure.

> > It could be even

> > intellectual property violations. We have asked for

> > more

> > information. Counterfeiting need not be the only

> > reason for seizure

> > of products, " Drug Controller General of India

> > (DCGI) Venkateswarlu

> > told ET.

> > >

> > > The government is also keen to know the EU

> > definition of

> > counterfeit as it varies from place to place, said

> > the DCGI. Many

> > countries consider products not registered there as

> > counterfeits. " Some countries may have porous

> > borders and medicines

> > may reach there from neighbouring countries where

> > they are legally

> > sold, " he said.

> > >

> > > The regulator's intervention is significant as it

> > comes in the

> > wake of the pharma industry's concern that reports

> > like this could

> > harm India's reputation as the supplier of low cost

> > but quality

> > drugs to the world.

> > >

> > > Terming the report as a " non-tariff barrier " , the

> > Indian

> > pharmaceutical industry said such barriers will harm

> > its global

> > expansion. India is the fourth largest producer of

> > pharmaceuticals

> > by volume. According to latest reports, nearly half

> > of its revenue

> > is coming from exports, mainly from the EU and the

> > US.

> > >

> > > According to the EC report on counterfeit

> > products, based on the

> > figures given by the customs departments of all EU

> > members, India is

> > the number one source in counterfeit medicines,

> > followed by the

> > United Arab Emirates and China. " Together, these

> > three sources are

> > responsible for more than 80% of all counterfeit

> > medicines, " the

> > report said.

> > >

> > > Counterfeits drugs seized in Europe had increased

> > five-fold to 2.7

> > million in 2006 from 500,000 a year ago.

> > > " The emergence of India in this sector (pharma),

> > reflects the

> > developing industrial capacity of this nation and

> > highlights the

> > reality that counterfeiting is carried out on an

> > industrial scale in

> > all sectors where a potential profit is perceived, "

> > the EC report

> > added.

> > >

> > > Although, there are varying figures on the

> > prevalence of

> > counterfeit drugs, it is estimated that it accounts

> > for about 10% of

> > the global pharma market. US-based Centre for

> > Medicines in the

> > Public Interest says counterfeit drug sales will

> > reach $75 billion

> > globally in 2010, from the current estimate of $50

> > billion.

> > >

> > >

> > >

> > > Regards,

> > >

> > > Dr Kiran Chaudhari

> > >

> > > Lecturer (Pharmacology)

> > >

> > > GMC, Nagpur.

> > >

> > >

> > > ---------------------------------

> > > Bollywood, fun, friendship, sports and more. You

> > name it, we

> > have it.

> > >

> >

> >

> >

>

>

>

> Now you can chat without downloading messenger. Go to

http://in.messenger./webmessengerpromo.php

>

[Guest guest]

Hi

None from any other country except India has dared to speak on the

subject. Why?

" The upper limit is from a report in the medical journal Lancet in

2001 by an Indian journalist, ostensibly based on WHO figures " has a

bias and conflict of interest.

We may be bad but then that does not mean others are good.

Vijay

> > >

> > > Dear friends,

> > >

> > > This one is the latest article in Economic

> > Times.

> > >

> > > What does it means....Real problem....created

> > problem through

> > competetion or what.....they are blaming us? or its

> > reality?....shamful to Indians....

> > >

> > > India hub of counterfeit drugs: EC

> > > 23 Jun, 2007, 0346 hrs IST,Khomba Singh & Gireesh

> > Chandra Prasad,

> > TNN

> > > Print

> > > Save

> > > EMail

> > > Write to Editor

> > >

> > > NEW DELHI: Concerned over

> > European

> > Commission's (EC) allegations about large scale

> > supply

> > of `counterfeit' Indian drugs to the region, India

> > has sought

> > clarifications from the EC on its claim and on its

> > definition of

> > counterfeit drugs.

> > >

> > > A recent EC report claimed that India was the

> > largest source of

> > the 2.7 million counterfeit drugs seized by its

> > custom department in

> > 2006.

> > >

> > > India, however, has decided to wait for the EC's

> > response to its

> > queries before initiating any action. " We have no

> > specific

> > information on the reason for the reported seizure.

> > It could be even

> > intellectual property violations. We have asked for

> > more

> > information. Counterfeiting need not be the only

> > reason for seizure

> > of products, " Drug Controller General of India

> > (DCGI) Venkateswarlu

> > told ET.

> > >

> > > The government is also keen to know the EU

> > definition of

> > counterfeit as it varies from place to place, said

> > the DCGI. Many

> > countries consider products not registered there as

> > counterfeits. " Some countries may have porous

> > borders and medicines

> > may reach there from neighbouring countries where

> > they are legally

> > sold, " he said.

> > >

> > > The regulator's intervention is significant as it

> > comes in the

> > wake of the pharma industry's concern that reports

> > like this could

> > harm India's reputation as the supplier of low cost

> > but quality

> > drugs to the world.

> > >

> > > Terming the report as a " non-tariff barrier " , the

> > Indian

> > pharmaceutical industry said such barriers will harm

> > its global

> > expansion. India is the fourth largest producer of

> > pharmaceuticals

> > by volume. According to latest reports, nearly half

> > of its revenue

> > is coming from exports, mainly from the EU and the

> > US.

> > >

> > > According to the EC report on counterfeit

> > products, based on the

> > figures given by the customs departments of all EU

> > members, India is

> > the number one source in counterfeit medicines,

> > followed by the

> > United Arab Emirates and China. " Together, these

> > three sources are

> > responsible for more than 80% of all counterfeit

> > medicines, " the

> > report said.

> > >

> > > Counterfeits drugs seized in Europe had increased

> > five-fold to 2.7

> > million in 2006 from 500,000 a year ago.

> > > " The emergence of India in this sector (pharma),

> > reflects the

> > developing industrial capacity of this nation and

> > highlights the

> > reality that counterfeiting is carried out on an

> > industrial scale in

> > all sectors where a potential profit is perceived, "

> > the EC report

> > added.

> > >

> > > Although, there are varying figures on the

> > prevalence of

> > counterfeit drugs, it is estimated that it accounts

> > for about 10% of

> > the global pharma market. US-based Centre for

> > Medicines in the

> > Public Interest says counterfeit drug sales will

> > reach $75 billion

> > globally in 2010, from the current estimate of $50

> > billion.

> > >

> > >

> > >

> > > Regards,

> > >

> > > Dr Kiran Chaudhari

> > >

> > > Lecturer (Pharmacology)

> > >

> > > GMC, Nagpur.

> > >

> > >

> > > ---------------------------------

> > > Bollywood, fun, friendship, sports and more. You

> > name it, we

> > have it.

> > >

> >

> >

> >

>

>

>

> Now you can chat without downloading messenger. Go to

http://in.messenger./webmessengerpromo.php

>

[Guest guest]

Hi

With due respects to Dr Mashelkar, without undermining his claibre,

dedication and contribution:

The epitaph : Mashelkar resigned!

Vijay

> > >

> > > Dear friends,

> > >

> > > This one is the latest article in Economic

> > Times.

> > >

> > > What does it means....Real problem....created

> > problem through

> > competetion or what.....they are blaming us? or its

> > reality?....shamful to Indians....

> > >

> > > India hub of counterfeit drugs: EC

> > > 23 Jun, 2007, 0346 hrs IST,Khomba Singh & Gireesh

> > Chandra Prasad,

> > TNN

> > > Print

> > > Save

> > > EMail

> > > Write to Editor

> > >

> > > NEW DELHI: Concerned over

> > European

> > Commission's (EC) allegations about large scale

> > supply

> > of `counterfeit' Indian drugs to the region, India

> > has sought

> > clarifications from the EC on its claim and on its

> > definition of

> > counterfeit drugs.

> > >

> > > A recent EC report claimed that India was the

> > largest source of

> > the 2.7 million counterfeit drugs seized by its

> > custom department in

> > 2006.

> > >

> > > India, however, has decided to wait for the EC's

> > response to its

> > queries before initiating any action. " We have no

> > specific

> > information on the reason for the reported seizure.

> > It could be even

> > intellectual property violations. We have asked for

> > more

> > information. Counterfeiting need not be the only

> > reason for seizure

> > of products, " Drug Controller General of India

> > (DCGI) Venkateswarlu

> > told ET.

> > >

> > > The government is also keen to know the EU

> > definition of

> > counterfeit as it varies from place to place, said

> > the DCGI. Many

> > countries consider products not registered there as

> > counterfeits. " Some countries may have porous

> > borders and medicines

> > may reach there from neighbouring countries where

> > they are legally

> > sold, " he said.

> > >

> > > The regulator's intervention is significant as it

> > comes in the

> > wake of the pharma industry's concern that reports

> > like this could

> > harm India's reputation as the supplier of low cost

> > but quality

> > drugs to the world.

> > >

> > > Terming the report as a " non-tariff barrier " , the

> > Indian

> > pharmaceutical industry said such barriers will harm

> > its global

> > expansion. India is the fourth largest producer of

> > pharmaceuticals

> > by volume. According to latest reports, nearly half

> > of its revenue

> > is coming from exports, mainly from the EU and the

> > US.

> > >

> > > According to the EC report on counterfeit

> > products, based on the

> > figures given by the customs departments of all EU

> > members, India is

> > the number one source in counterfeit medicines,

> > followed by the

> > United Arab Emirates and China. " Together, these

> > three sources are

> > responsible for more than 80% of all counterfeit

> > medicines, " the

> > report said.

> > >

> > > Counterfeits drugs seized in Europe had increased

> > five-fold to 2.7

> > million in 2006 from 500,000 a year ago.

> > > " The emergence of India in this sector (pharma),

> > reflects the

> > developing industrial capacity of this nation and

> > highlights the

> > reality that counterfeiting is carried out on an

> > industrial scale in

> > all sectors where a potential profit is perceived, "

> > the EC report

> > added.

> > >

> > > Although, there are varying figures on the

> > prevalence of

> > counterfeit drugs, it is estimated that it accounts

> > for about 10% of

> > the global pharma market. US-based Centre for

> > Medicines in the

> > Public Interest says counterfeit drug sales will

> > reach $75 billion

> > globally in 2010, from the current estimate of $50

> > billion.

> > >

> > >

> > >

> > > Regards,

> > >

> > > Dr Kiran Chaudhari

> > >

> > > Lecturer (Pharmacology)

> > >

> > > GMC, Nagpur.

> > >

> > >

> > > ---------------------------------

> > > Bollywood, fun, friendship, sports and more. You

> > name it, we

> > have it.

> > >

> >

> >

> >

>

> Now you can chat without downloading messenger. Go to

http://in.messenger./webmessengerpromo.php

>

>

>

>

>

>

> ---------------------------------

> Bollywood, fun, friendship, sports and more. You name it, we

have it.

>

[Guest guest]

Hi Anupama

It was nice of you to attach the Mashelkar committee’s

report for the members to go through. I had gone

through it earlier.

Hope the others find it useful.

Smita Sontakke

--- anupama sukhlecha <anupama_acad@...>

wrote:

> Dear Dr Smita,

> I am enclosing the Mashelkar report:

>

> PROBLEM OF SPURIOUS AND SUBSTANDARD DRUGS

> 4. Evaluate the Extent of Spurious and

> Sub-Standard Drugs and

> Recommend Measures Required to Deal with the

> Problem

> 4.1 The Committee came to the conclusion, after

> examining all the data and

> reports at hand, that there was an absence of a

> scientifically and

> statistically designed investigation, which could

> give a realistic estimate

> of the menace of spurious drugs.

> 4.2 The model for such an evaluation presented to

> the Committee by the

> Delhi Pharmaceutical Trust appears to be one,

> which had a rational

> approach to achieve this objective. The Committee

> recommends that

> the Central Government should provide assistance

> to undertake such

> scientific and statistically significant study in

> order to have a clear picture

> about the exact extent of spurious drugs in the

> country.

> 4.3 The gist of the recommendations to tackle the

> spurious drugs problem is

> as follows:

> • Creation of effective interaction between

> the stakeholders i.e.

> industry and regulators, industry and consumers,

> trade and

> regulators and medical professional and

> regulators.

> • Creation of intelligence cum legal cells in

> State and Central

> offices.

> Discouragement of proliferation of drug

> distribution outlets.

> • Making changes in law to provide enhanced

> penalties,

> making the offences cognisable and non-bailable in

> the

> light of similar provisions in Narcotic Drugs and

> Psychotropic Substances Act.

> • Designation of special courts to try the

> cases of spurious

> drugs.

> • Preparation of dossiers of suspected

> dealers and

> manufactures.

> • Provision of secret funds and incentives to

> informers.

> • Creating effective networking system

> between States

> • Checking on drug supplies to practitioners

> who buy and

> supply drugs to their patients.

> • Creation by the industry of its counterfeit

> drug strategies,

> better surveillance and efficient complaint

> handling system.

> • Creation of better surveillance system by

> the Trade

> Association on defaulting members and to take

> strict action

> against them.

> • Creation of better awareness amongst

> consumers.

> 4.4 The Committee noted that there is

> non-uniformity in the action taken on

> substandard drugs, especially when the

> manufacturer of substandard

> drugs is located in a different state. The

> Committee recommends that:

> a) The DCC should deliberate on the issue of

> action to be

> taken on substandard drugs and review the existing

> guidelines. It should analyse the nature of

> substandard

> reports and status of concerned manufacturing

> units as

> well as the system of distribution; and

> The existing classification by DCC of defects

> found in

> substandard drugs into category A and category B

> and the

> action to be taken on each category of defects

> needs to be

> reviewed and updated.

> 4.5 The Committee noted that majority of the

> States are not either

> adequately staffed or technically equipped to

> monitor the quality of drugs

> manufactured and sold in their State. There is a

> strong need to

> strengthen the organizations with competent and

> trained manpower and

> with adequate budgets. This will enable them to

> detect, investigate and

> take quick action in spurious/counterfeit drug

> cases.

> 4.6. The officers needed to be specially trained

> for the purpose. The

> Committee recommends that:

> a. The drug control organizations in States should

> be

> adequately strengthened. Additional manpower,

> infrastructure, technical capabilities and

> financial resources

> should be made available to the organization. They

> should have continuous vigilance facilities and

> strategies to

> implement an effective system to monitor and

> control the

> manufacture and distribution of spurious drugs.

> b. States should set up Intelligence cum legal

> cells under thesupervision of trained senior

> officer. State Governments

> should put in place efficient mechanism for timely

> police

> help to these officers.

> c. States should establish a proper surveillance

> system for

> keeping a watch over suspected individuals.

> Watchers

> should be employed to purchase samples from

> suspected

> persons without disclosing their identity. Secret

> funds

> should be made available for intelligence

> activities.

> d. States, which have a large number of drug

> distribution

> outlets, should set-up a well-equipped testing

> laboratory to

> enable them to test all categories of drugs in

> shortest

> possible time. All States should plan to take more

> samples

> to check the quality of drugs manufactured and

> sold in the market. Those States, where it was not

> technically and

> economically viable to support their own drug

> testing

> facilities, needed to make use of facilities of

> other States

> and Central laboratories or even the private

> approved

> laboratories for testing of suspected samples.

> e. States should set up an efficient communication

> network

> system between the Center and other States in

> order to

> facilitate exchange of information and rapid

> investigation in

> cases involving inter-state movement.

> f. States should also monitor the source of

> purchase and

> quality of drugs stocked by dispensing registered

> medical

> practitioners through their drugs inspectors.

> 4.7 As regards the improvement of the drug testing

> laboratories, the

> committee recommends the following:

> a) Drugs and Cosmetics Rules should be amended to

> include

> GLP norms as statutory requirement for approved

> testing

> labs and also the in house testing labs of

> manufacturers.

> Accreditation with NABL should be made

> mandatory for all

> testing laboratories including the Government

> laboratories.

> c) The Central Government should initiate a

> programme to

> have coded samples of the same product tested at

> different central and state labs from time to time

> and have

> the results assessed by experts for their

> proficiency testing.

> D) The state testing labs should be frequently

> audited by a

> team of experts to ensure their proper

> functioning.

> e) A separate Division needs to be established

> under CDA to

> oversee the overall working of drug testing

> laboratories in

> the country.

> 4.8 The Committee noted that specific penalties in

> Drugs and Cosmetic Act

> were provided in 1982 for offences concerning

> manufacture and sale of

> spurious drugs. However, the penal provisions have

> not acted as

> adequate deterrents and have not instilled the

> desired extent of fear

>

=== message truncated ===

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