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Quality issues in drug purchase

Dr. Chandra M. GulhatiEditor, MIMS

(Monthly Index of Medical Specialities)February 22, 2015

RFHHA MDP 21-22 FEB 2015

Causes of public concern• Till about 2000, there was hardly any media

outcry and consequent public concern on theavailability of spurious or fake or counterfeit andeven sub-standard drugs in India.

• On June 2, 2001, Lancet carried a news item thatwrongly said: “One widely quoted WHO statisticplaces India as the leader, with as much as 35% ofworld’s production of fake drugs.”

• In fact it was merely a news item – not a reviewarticle - with no survey, no reference. Howeverdue to Lancet’s reputation of being a credible,peer-reviewed medical journal quoting asupposedly WHO statistic, the scare started.

• Till about 2000, there was hardly any mediaoutcry and consequent public concern on theavailability of spurious or fake or counterfeit andeven sub-standard drugs in India.

• On June 2, 2001, Lancet carried a news item thatwrongly said: “One widely quoted WHO statisticplaces India as the leader, with as much as 35% ofworld’s production of fake drugs.”

• In fact it was merely a news item – not a reviewarticle - with no survey, no reference. Howeverdue to Lancet’s reputation of being a credible,peer-reviewed medical journal quoting asupposedly WHO statistic, the scare started.


As part of the “evidence” the case ofnarcotic analgesics being smuggled byUzbek carriers but seized at New Delhiairport was quoted. The fact: the narcotic analgesics wereillegally produced for smuggling but wereNot Fake. Despite subsequent denial by WHO,this misinformation continues to berepeated by the media even till date.

As part of the “evidence” the case ofnarcotic analgesics being smuggled byUzbek carriers but seized at New Delhiairport was quoted. The fact: the narcotic analgesics wereillegally produced for smuggling but wereNot Fake. Despite subsequent denial by WHO,this misinformation continues to berepeated by the media even till date.


Interested MNCs, “Solution Providers”see blood, jump into the fray

• Unable to compete with expanding number ofIndian drug exporters on price front, some MNCswith huge resources and offices around the globehelped to spread the fire to create panic.Example: Kenya that virtually moved to banimports of medicines from India.

• Solution providers (such as suppliers of anti-counterfeiting devices like bar codes) saw goldenopportunity to make quick money by confusingcounterfeit with fake drugs and offering to solvethe problem.

• Unable to compete with expanding number ofIndian drug exporters on price front, some MNCswith huge resources and offices around the globehelped to spread the fire to create panic.Example: Kenya that virtually moved to banimports of medicines from India.

• Solution providers (such as suppliers of anti-counterfeiting devices like bar codes) saw goldenopportunity to make quick money by confusingcounterfeit with fake drugs and offering to solvethe problem.


Fake, Spurious, Counterfeit• In India, in public perception of the terms fake,

spurious and counterfeit convey the same meaning.• However as per WHO definition counterfeit drugs are

those that have “been deliberately and fraudulentlymislabelled with respect to identity and/or source.”

• In America counterfeit drugs include genuine, foreignmedicines/brands not approved by the United StatesFood and Drug Administration (USFDA) or produced inviolation of American laws on patents.

• No wonder according to USFDA, “Up to 25% of alldrugs consumed in poor countries are thought to becounterfeit or substandard.”

• Note: “counterfeit” is clubbed with “sub-standard.”(Ref: The Lancet, Vol. 362, 22 November 2003).

• In India, in public perception of the terms fake,spurious and counterfeit convey the same meaning.

• However as per WHO definition counterfeit drugs arethose that have “been deliberately and fraudulentlymislabelled with respect to identity and/or source.”

• In America counterfeit drugs include genuine, foreignmedicines/brands not approved by the United StatesFood and Drug Administration (USFDA) or produced inviolation of American laws on patents.

• No wonder according to USFDA, “Up to 25% of alldrugs consumed in poor countries are thought to becounterfeit or substandard.”

• Note: “counterfeit” is clubbed with “sub-standard.”(Ref: The Lancet, Vol. 362, 22 November 2003).


USFDA action on Ranbaxy:Globalization of confusion

• In 2008 US banned import of just over 30 drugsproduced by Ranbaxy at one of its facilities.

• None of the drugs was found to be of poor qualityand hence did not pose any danger to patients.

• The ban was due to non-compliance with requiredstep by step documentation right from purchase ofraw material up to shipment of formulations.

• American laws are based on “Prevention” of entry ofdrugs not certified as per USFDA rules.

• However a global scare was created. News hungrymedia blamed Ranbaxy and by implication India forexporting drugs that can harm patients.

• In 2008 US banned import of just over 30 drugsproduced by Ranbaxy at one of its facilities.

• None of the drugs was found to be of poor qualityand hence did not pose any danger to patients.

• The ban was due to non-compliance with requiredstep by step documentation right from purchase ofraw material up to shipment of formulations.

• American laws are based on “Prevention” of entry ofdrugs not certified as per USFDA rules.

• However a global scare was created. News hungrymedia blamed Ranbaxy and by implication India forexporting drugs that can harm patients.


Misinformation continues unabated• “There has been no full international survey butestimates from WHO and the pharmaceuticalindustry suggest that at least 5% of medicines incirculation (worldwide) may be counterfeit” (Ref:The Lancet, 5 October 2002)

• “Counterfeiting in Peru is as high as 80% accordingto Merck, Sharp, and Dohme.” How come everyoneis still alive in Peru!

• “In 2002, India’s pharmaceutical companiessuggested that in India’s major cities, one in fivemedicines sold was a fake. They claimed a loss inrevenue of between 4% and 5% annually. Theindustry also estimated that illegal drugs had grownfrom 10% to 20% of the total market.” (Ref: WHOFact Sheet revised, 14 November 2006)

• “There has been no full international survey butestimates from WHO and the pharmaceuticalindustry suggest that at least 5% of medicines incirculation (worldwide) may be counterfeit” (Ref:The Lancet, 5 October 2002)

• “Counterfeiting in Peru is as high as 80% accordingto Merck, Sharp, and Dohme.” How come everyoneis still alive in Peru!

• “In 2002, India’s pharmaceutical companiessuggested that in India’s major cities, one in fivemedicines sold was a fake. They claimed a loss inrevenue of between 4% and 5% annually. Theindustry also estimated that illegal drugs had grownfrom 10% to 20% of the total market.” (Ref: WHOFact Sheet revised, 14 November 2006)


Impact of IMPACT by WHO• The WHO-funded International Medical Products Anti-

Counterfeiting Taskforce (IMPACT) proposed a new definitionof counterfeit drugs as medical products with a "falserepresentation about their identity, history or source.”

• Such a wide definition would have meant the end of drugindustry in India and other generic drugs exporting countries.

• There was a proposal to involve police, customs, postalauthorities, airlines, ships in the “fight against offendingdrugs.”

• India along with other BRICS nations opposed the move.• IMPACT was replaced with WHO Working Group on

Substandard/Spurious/Falsely-labelled/Falsified/Counterfeit(SSFFC) Medical Products.

• Depending on definitions any product could fall in the net.

• The WHO-funded International Medical Products Anti-Counterfeiting Taskforce (IMPACT) proposed a new definitionof counterfeit drugs as medical products with a "falserepresentation about their identity, history or source.”

• Such a wide definition would have meant the end of drugindustry in India and other generic drugs exporting countries.

• There was a proposal to involve police, customs, postalauthorities, airlines, ships in the “fight against offendingdrugs.”

• India along with other BRICS nations opposed the move.• IMPACT was replaced with WHO Working Group on

Substandard/Spurious/Falsely-labelled/Falsified/Counterfeit(SSFFC) Medical Products.

• Depending on definitions any product could fall in the net.


UN agrees with BRICS In January 2015, the UN agency for drug control

has assured India and the other BRICS nationsthat it will steer clear of intellectual propertyrights matters while drafting a model law tocombat fraudulent drugs.

India is leading peers in the BRICS group of bigworld economies— Brazil, Russia, China andSouth Africa—to oppose the United NationsOffice on Drugs and Crimes (UNODC) move tofloat a model law on fraudulent drugs withoutconsultations with member states.

In January 2015, the UN agency for drug controlhas assured India and the other BRICS nationsthat it will steer clear of intellectual propertyrights matters while drafting a model law tocombat fraudulent drugs.

India is leading peers in the BRICS group of bigworld economies— Brazil, Russia, China andSouth Africa—to oppose the United NationsOffice on Drugs and Crimes (UNODC) move tofloat a model law on fraudulent drugs withoutconsultations with member states.


Figures do not add up• If fake drugs are so much in abundance in

India, then why does the industry claim thattheir “loss of revenue” is between 4 and 5%?

• It should be more like 20% or even more.• It can be less ONLY if fake drugs fall

overwhelmingly in the cheaper range.• But why should cheap fake drugs be

manufactured and sold since the profits arenot be worth the trouble and risk?

• If fake drugs are so much in abundance inIndia, then why does the industry claim thattheir “loss of revenue” is between 4 and 5%?

• It should be more like 20% or even more.• It can be less ONLY if fake drugs fall

overwhelmingly in the cheaper range.• But why should cheap fake drugs be

manufactured and sold since the profits arenot be worth the trouble and risk?


Profits: Cheap vs. Expensive• Bulk paracetamol costs around Rs. 200 per kg (1000g).• Cost of active ingredient in one dose of 500mg comes

to just 10 paise or Re. 1 for a strip of 10 tablets.• The production cost of a strip of 10 tablets (without

active ingredient) comes to Rs. 1.50 . Thus productioncost is higher than cost of active ingredient.

• Sale price varies but is around Rs. 10 a strip of 10 tabs.• Bulk ceftriaxone costs over Rs. 11,000 per kg.• Cost of active ingredient in one dose (1g) vial comes to

Rs. 11.20.• The production cost without active ingredient is Rs.

4.40.• Sale price over Rs. 70• Will fake drug maker produce paracetamol or

ceftriaxone?• Profits lie in expensive products with large market.

• Bulk paracetamol costs around Rs. 200 per kg (1000g).• Cost of active ingredient in one dose of 500mg comes

to just 10 paise or Re. 1 for a strip of 10 tablets.• The production cost of a strip of 10 tablets (without

active ingredient) comes to Rs. 1.50 . Thus productioncost is higher than cost of active ingredient.

• Sale price varies but is around Rs. 10 a strip of 10 tabs.• Bulk ceftriaxone costs over Rs. 11,000 per kg.• Cost of active ingredient in one dose (1g) vial comes to

Rs. 11.20.• The production cost without active ingredient is Rs.

4.40.• Sale price over Rs. 70• Will fake drug maker produce paracetamol or

ceftriaxone?• Profits lie in expensive products with large market.


Fake drugs market growing, saysASSOCHAM

• NEW DELHI: With sale of fake and spurious drugscontinuing unabated in the country, industrybody ASSOCHAM said the market is growing at analarming rate of 20-25 per cent, which hasalready exceeded the Rs 15,000-crore per annummark nationally. "At all India levels, fake andcounterfeit drugs are so widely disbursed thattheir estimates as per latest figure exceed Rs15,000 crores per annum," ASSOCHAM GeneralSecretary D S Rawat said. (Ref: PTI, 8th February2008)

• NEW DELHI: With sale of fake and spurious drugscontinuing unabated in the country, industrybody ASSOCHAM said the market is growing at analarming rate of 20-25 per cent, which hasalready exceeded the Rs 15,000-crore per annummark nationally. "At all India levels, fake andcounterfeit drugs are so widely disbursed thattheir estimates as per latest figure exceed Rs15,000 crores per annum," ASSOCHAM GeneralSecretary D S Rawat said. (Ref: PTI, 8th February2008)


Estimates without Evidence

• Large drug industry associations (IDMA,OPPI) provide estimated percentage figuresof “fake” drugs.

• Methodology of arriving at estimates andconclusions are neither listed nor supportedwith evidence.

• Concrete examples are often not given.• Why should the drug companies shy away

from giving specific details?

• Large drug industry associations (IDMA,OPPI) provide estimated percentage figuresof “fake” drugs.

• Methodology of arriving at estimates andconclusions are neither listed nor supportedwith evidence.

• Concrete examples are often not given.• Why should the drug companies shy away

from giving specific details?


Pressure blows the govt. off its feetUnder intense global media coverage, thegovernment sought to extinguish fire by hasty, ill-considered announcements such as:

• “We will change the law to give death penalty forproducers of fake drugs” Such a move would havebeen against Supreme Court orders and wasquickly dropped.

• The government settled for increase in prisonterms but so far no one has been jailed.

• “We will reward whistle-blowers.” In fact thisScheme still exists on CDSCO website.

Under intense global media coverage, thegovernment sought to extinguish fire by hasty, ill-considered announcements such as:

• “We will change the law to give death penalty forproducers of fake drugs” Such a move would havebeen against Supreme Court orders and wasquickly dropped.

• The government settled for increase in prisonterms but so far no one has been jailed.

• “We will reward whistle-blowers.” In fact thisScheme still exists on CDSCO website.


Counterfeit but not fake?• Not long ago counterfeit copies (not necessarily fake

or sub-standard) of a popular, widely used coughremedy flooded certain markets in eastern India.

• The company found that its product’s sale was eitherstable or going up all over the country except certainmarkets in eastern India where it was going down.

• The Company took action with local police help butdid not involve drug controller.

• The reason? Media coverage of the existence ofcounterfeit products would have led to boycott of thebrand by patients and doctors all over India!

• Besides the embarrassment of lodging complaintagainst standard, non-inferior, cheaper product.

• Not long ago counterfeit copies (not necessarily fakeor sub-standard) of a popular, widely used coughremedy flooded certain markets in eastern India.

• The company found that its product’s sale was eitherstable or going up all over the country except certainmarkets in eastern India where it was going down.

• The Company took action with local police help butdid not involve drug controller.

• The reason? Media coverage of the existence ofcounterfeit products would have led to boycott of thebrand by patients and doctors all over India!

• Besides the embarrassment of lodging complaintagainst standard, non-inferior, cheaper product.


Unregistered brand names• Unfortunately it is not mandatory to register brand

names with Trade Mark Registry.• Therefore a huge number of formulations are sold

under unprotected brand names.• Even large companies like Sun Pharma do not

necessarily register all brand names.• Thus doors are legally wide open for other

manufacturers to use identical or similar brand nameswithout violating any law.

• Some manufacturers do use similar, if not identical,brand names to take advantage of popularity.

• Unfortunately it is not mandatory to register brandnames with Trade Mark Registry.

• Therefore a huge number of formulations are soldunder unprotected brand names.

• Even large companies like Sun Pharma do notnecessarily register all brand names.

• Thus doors are legally wide open for othermanufacturers to use identical or similar brand nameswithout violating any law.

• Some manufacturers do use similar, if not identical,brand names to take advantage of popularity.


This Brand is registered. See ®


This brand is not registered.


Survey on counterfeits• SEARPharm (South East Asian FIP-WHO Forum of

Pharmaceutical Associations) conducted a studyon counterfeit medicines in India in 2007.

• A total of 10,743 samples were collected from234 retail outlets.

• In all 3.1% were found to be counterfeits.• The study acknowledged that “counterfeit drugs

may comply with quality standards whileimitating popular brands.”

• SEARPharm (South East Asian FIP-WHO Forum ofPharmaceutical Associations) conducted a studyon counterfeit medicines in India in 2007.

• A total of 10,743 samples were collected from234 retail outlets.

• In all 3.1% were found to be counterfeits.• The study acknowledged that “counterfeit drugs

may comply with quality standards whileimitating popular brands.”


Spurious: Different definition in IndiaThe term ‘Spurious Drug’ has been defined• if it is manufactured under a name which belongs to another drug;

or• if it is an imitation of, or is a substitute for, another drug or

resembles another drug in a manner likely to deceive or bears uponit or upon its label or container the name of another drug unless itis plainly and conspicuously marked so as to reveal its truecharacter and its lack of identity with such other drug ; or

• if the label or container bears the name of an individual or companypurporting to be the manufacturer of the drug , which individual orcompany is fictitious or does not exist; or

• if it has been substituted wholly or in part by another drug orsubstance; or

• if it purports to be the product of a manufacturer of whom it is nottruly a product.

The term ‘Spurious Drug’ has been defined• if it is manufactured under a name which belongs to another drug;

or• if it is an imitation of, or is a substitute for, another drug or

resembles another drug in a manner likely to deceive or bears uponit or upon its label or container the name of another drug unless itis plainly and conspicuously marked so as to reveal its truecharacter and its lack of identity with such other drug ; or

• if the label or container bears the name of an individual or companypurporting to be the manufacturer of the drug , which individual orcompany is fictitious or does not exist; or

• if it has been substituted wholly or in part by another drug orsubstance; or

• if it purports to be the product of a manufacturer of whom it is nottruly a product.


CDSCO Survey on spurious drugs: 2009

• Samples collected: 24,136• Samples accepted by manufacturers as

genuine: 24,125• Thus only 11 samples were found to be

counterfeits.• This translates to 0.045% brands being

counterfeits.

• Samples collected: 24,136• Samples accepted by manufacturers as

genuine: 24,125• Thus only 11 samples were found to be

counterfeits.• This translates to 0.045% brands being

counterfeits.


Laws on defective drugs

• Not of Standard Quality: Second Schedule tothe Drugs & Cosmetics Act.

• Adulterated drugs: Section 17A of the Drugs &Cosmetics Act

• Spurious drugs: Section 17B of the Drugs &Cosmetics Act

• Penalty: Section 27 of the Drugs & CosmeticsAct ranges from one year to lifeimprisonment.

• Not of Standard Quality: Second Schedule tothe Drugs & Cosmetics Act.

• Adulterated drugs: Section 17A of the Drugs &Cosmetics Act

• Spurious drugs: Section 17B of the Drugs &Cosmetics Act

• Penalty: Section 27 of the Drugs & CosmeticsAct ranges from one year to lifeimprisonment.


Quality standards of drugsRule 124 of Drugs & Cosmetics Rules

(a) The standards for identity, purity and strength shallbe those as may be specified in the edition of theIndian Pharmacopoeia for the time being in force.

(b) In case the standards for identity, purity andstrength for drugs are not specified in the edition ofthe Indian Pharmacopoeia for the time being inforce but are specified in the edition of the IndianPharmacopoeia immediately preceding, thestandards for identity, purity and strength shall bethose occurring in such immediately precedingedition of the Indian Pharmacopoeia.

Rule 124 of Drugs & Cosmetics Rules

(a) The standards for identity, purity and strength shallbe those as may be specified in the edition of theIndian Pharmacopoeia for the time being in force.

(b) In case the standards for identity, purity andstrength for drugs are not specified in the edition ofthe Indian Pharmacopoeia for the time being inforce but are specified in the edition of the IndianPharmacopoeia immediately preceding, thestandards for identity, purity and strength shall bethose occurring in such immediately precedingedition of the Indian Pharmacopoeia.


Drugs not listed in IPThe standards for identity, purity and strength shall bethose as may be specified in the edition of the officialpharmacopoeia, for the time being in force, of any countryto which the drug claims to comply with.

(b) In case the standards for identity, purity and strength fordrugs are not specified in the edition of such officialpharmacopoeia for the time being in force, but arespecified in the edition immediately preceding, thestandards for identity, purity and strength shall be thoseoccurring in such immediately preceding edition of suchofficial pharmacopoeia to which the drug claims tocomply with.

(c) For drugs for which standards are not included in theedition of the official pharmacopoeia, for the time beingin force, of any country or in edition immediatelypreceding, but included in the official compendia of drugstandards, namely, the British Pharmaceutical Codex orthe National Formulary of the United States, for the timebeing in force, to which the drug claims to comply with.

The standards for identity, purity and strength shall bethose as may be specified in the edition of the officialpharmacopoeia, for the time being in force, of any countryto which the drug claims to comply with.

(b) In case the standards for identity, purity and strength fordrugs are not specified in the edition of such officialpharmacopoeia for the time being in force, but arespecified in the edition immediately preceding, thestandards for identity, purity and strength shall be thoseoccurring in such immediately preceding edition of suchofficial pharmacopoeia to which the drug claims tocomply with.

(c) For drugs for which standards are not included in theedition of the official pharmacopoeia, for the time beingin force, of any country or in edition immediatelypreceding, but included in the official compendia of drugstandards, namely, the British Pharmaceutical Codex orthe National Formulary of the United States, for the timebeing in force, to which the drug claims to comply with.


Active ingredients with no standards• In India, there are some formulations that contain

ingredients that do not fall in in any of the rulesthat specify standards [Ref: 124 (1) and 124 (2) orThe Second Schedule.]

• Such ingredients can not be tested since noofficial standards are available (except those ofmanufacturers themselves).

• Example Melitracen (one ingredient of Deanxit)could not be tested despite the other ingredient(Flupenthixole) being found inadequate: justover 52%.

• How to legally deal with such cases?

• In India, there are some formulations that containingredients that do not fall in in any of the rulesthat specify standards [Ref: 124 (1) and 124 (2) orThe Second Schedule.]

• Such ingredients can not be tested since noofficial standards are available (except those ofmanufacturers themselves).

• Example Melitracen (one ingredient of Deanxit)could not be tested despite the other ingredient(Flupenthixole) being found inadequate: justover 52%.

• How to legally deal with such cases?


Some standards lower than West

• In certain formulations, the Indian standards, aslisted in IP, are lower than western countries.

• This creates doubts in overseas markets and isused by MNCs competitors to defame Indianmedicines.

• For example: Potency of rDNA insulin in India isacceptable up to 90% while in Western countriesit is not permitted to be under 95%.

• Thus sub-standard products not marketable inWest can be sold in India.

• In certain formulations, the Indian standards, aslisted in IP, are lower than western countries.

• This creates doubts in overseas markets and isused by MNCs competitors to defame Indianmedicines.

• For example: Potency of rDNA insulin in India isacceptable up to 90% while in Western countriesit is not permitted to be under 95%.

• Thus sub-standard products not marketable inWest can be sold in India.


Shelf life: Is it not too long?• India generally follows shelf-life of

formulations as stipulated in the Westwith cold climates.

• Due to hot, humid weather and storageproblems, shelf life needs to be re-worked.

• Technical trials should be undertaken todetermine safe shelf life for differentproducts.

• India generally follows shelf-life offormulations as stipulated in the Westwith cold climates.

• Due to hot, humid weather and storageproblems, shelf life needs to be re-worked.

• Technical trials should be undertaken todetermine safe shelf life for differentproducts.


Sub-standard drugs• In the Drugs and Cosmetics Act and Rules the

terminology is defined as “Not of standardquality.”

• Production of substandard drugs can bedeliberate or due to negligence.

• Fault may also lie with transporters, distributorsand retailers with regard to storage oftemperature sensitive items that can renderstandard into substandard products e.g. insulin,vaccines etc.

• During transportation, breakage of bottlescontaining sugary syrups can lead to invasion byants etc. into the Box and other bottles.

• In the Drugs and Cosmetics Act and Rules theterminology is defined as “Not of standardquality.”

• Production of substandard drugs can bedeliberate or due to negligence.

• Fault may also lie with transporters, distributorsand retailers with regard to storage oftemperature sensitive items that can renderstandard into substandard products e.g. insulin,vaccines etc.

• During transportation, breakage of bottlescontaining sugary syrups can lead to invasion byants etc. into the Box and other bottles.


Parliamentary Committee on Sub-standard drugs: May, 2012

“It is known that retail chemists also stock and sellitems other than drugs including chocolates, colddrinks etc. During summer these items are stored inthe refrigerator while due to paucity of spacetemperature-sensitive medicines may be lyingoutside. When samples are picked up, tested andfound to be sub-standard, the State Drug Authoritiesblame and prosecute manufacturers. Therefore theCommittee recommends that specifically in the caseof temperature sensitive products such as insulins,due consideration should be given to the referencesamples of the same batch preserved by themanufacturers. (Para 15.7)

“It is known that retail chemists also stock and sellitems other than drugs including chocolates, colddrinks etc. During summer these items are stored inthe refrigerator while due to paucity of spacetemperature-sensitive medicines may be lyingoutside. When samples are picked up, tested andfound to be sub-standard, the State Drug Authoritiesblame and prosecute manufacturers. Therefore theCommittee recommends that specifically in the caseof temperature sensitive products such as insulins,due consideration should be given to the referencesamples of the same batch preserved by themanufacturers. (Para 15.7)


NSQ: A real problem• During 5 years, out of 2,07,142 samples

randomly picked up by drug inspectors, asmany as 14,581 were found to be sub-standard.

• It means that at least 7% of drugs sold in thecountry lack efficacy or safety or both.

• These sub-standard drugs are worth Rs. 6,000crores.

• Since suspect, sensitive formulations were notspecifically targeted, this figure is on the lowerside for many medicines.

• During 5 years, out of 2,07,142 samplesrandomly picked up by drug inspectors, asmany as 14,581 were found to be sub-standard.

• It means that at least 7% of drugs sold in thecountry lack efficacy or safety or both.

• These sub-standard drugs are worth Rs. 6,000crores.

• Since suspect, sensitive formulations were notspecifically targeted, this figure is on the lowerside for many medicines.


Suspect, sensitive medicinesSome products are more likely to be sub-standard thanothers such as:

• Scored tablets due to problem of mixing activeingredients with exipients.

• Slow release, controlled release products due todifferent formulation methods employed.

• Suspensions and syrups due to problem of inadequatemixing ingredients with liquid used, micro bacterialcontamination, poor quality water, defective caps etc.

• Degradable: Enzymes (such as serratiopeptidase),vitamin D-3 that are easily

• Certain antibiotics such as amoxycillin with cloxacillin,clavulanic acid, dry powder injectable antibiotics,vancomycin.

• Hygroscopic: Protein powders, ranitidine,pseudoephedrine etc.

• Temperature sensitive products such as insulin, vaccines,sera etc.

• Near expiry formulations.

Some products are more likely to be sub-standard thanothers such as:

• Scored tablets due to problem of mixing activeingredients with exipients.

• Slow release, controlled release products due todifferent formulation methods employed.

• Suspensions and syrups due to problem of inadequatemixing ingredients with liquid used, micro bacterialcontamination, poor quality water, defective caps etc.

• Degradable: Enzymes (such as serratiopeptidase),vitamin D-3 that are easily

• Certain antibiotics such as amoxycillin with cloxacillin,clavulanic acid, dry powder injectable antibiotics,vancomycin.

• Hygroscopic: Protein powders, ranitidine,pseudoephedrine etc.

• Temperature sensitive products such as insulin, vaccines,sera etc.

• Near expiry formulations.RFHHA MDP 21-22 FEB 2015

Determination of harm by NSQ drugs• In public perception sub-standard means that the

active ingredient is inadequate.• However drugs can be categorized as NSQ for a

variety of reasons:(a) Inadequate active ingredients(b) Disintegration not conforming to standards(c) Dissolution not conforming to standards(d) Excipients problems (gluten, colouring

agents, preservatives).(e) Particulate matters being too high in injections.(f) Sustained or controlled release drugs not meetingstandards etc.

• In public perception sub-standard means that theactive ingredient is inadequate.

• However drugs can be categorized as NSQ for avariety of reasons:(a) Inadequate active ingredients(b) Disintegration not conforming to standards(c) Dissolution not conforming to standards(d) Excipients problems (gluten, colouring

agents, preservatives).(e) Particulate matters being too high in injections.(f) Sustained or controlled release drugs not meetingstandards etc. RFHHA MDP 21-22 FEB 2015

Reasons for sub-standard products• Quality of raw materials, particularly those imported from

countries with poor drug regulation. Examples: Korea,China, Argentina, Indonesia, Egypt etc. Unlike USFDA,MHRA etc. no inspection of source of such material ispossible.

• Raw material is supposed to be tested (potency 97 to 103%mandatory) before use but hardly any monitoring.

• Emphasis on end product but not continuous process ofquality control during manufacturing.

• Inadequate monitoring of GMP facilities. How many drugunits have HPLC?

• Poor in-house quality control and documentation. ExampleUSFDA action against Ranbaxy’s facilities.

• Inadequate monitoring due to insufficient technical staff byregulators with such a large number (10,584) of drugmanufacturers.

• Lack of monitoring in the transport chain and storage –from factory to distributor to retailers.

• Quality of raw materials, particularly those imported fromcountries with poor drug regulation. Examples: Korea,China, Argentina, Indonesia, Egypt etc. Unlike USFDA,MHRA etc. no inspection of source of such material ispossible.

• Raw material is supposed to be tested (potency 97 to 103%mandatory) before use but hardly any monitoring.

• Emphasis on end product but not continuous process ofquality control during manufacturing.

• Inadequate monitoring of GMP facilities. How many drugunits have HPLC?

• Poor in-house quality control and documentation. ExampleUSFDA action against Ranbaxy’s facilities.

• Inadequate monitoring due to insufficient technical staff byregulators with such a large number (10,584) of drugmanufacturers.

• Lack of monitoring in the transport chain and storage –from factory to distributor to retailers.


No prohibition in selling non-medicines


Retailers’ End: Poor infrastructure• Many areas in the country get power just for 8 hours or

less a day. Hence refrigerators do not function. It ismore profitable to store chocolates in refrigeratorsbecause visibly molten pieces can not be sold.

• During summer, temperatures zoom to 50 degree c incertain areas in Rajasthan.

• All medicines carry the instructions: “Store attemperature not exceeding 30 degree C” (Ref: Cobadexby GSK) or 25 degree C (Ref: Synasma by Ranbaxy) .Impossible with very high ambient temperature.

• Such warnings only protect the manufacturers fromlitigation.

• Blame is tossed on to transporters, distributors andretailers.

• Retailers blame the consumers.• Ultimately patients suffer.

• Many areas in the country get power just for 8 hours orless a day. Hence refrigerators do not function. It ismore profitable to store chocolates in refrigeratorsbecause visibly molten pieces can not be sold.

• During summer, temperatures zoom to 50 degree c incertain areas in Rajasthan.

• All medicines carry the instructions: “Store attemperature not exceeding 30 degree C” (Ref: Cobadexby GSK) or 25 degree C (Ref: Synasma by Ranbaxy) .Impossible with very high ambient temperature.

• Such warnings only protect the manufacturers fromlitigation.

• Blame is tossed on to transporters, distributors andretailers.

• Retailers blame the consumers.• Ultimately patients suffer.


Store below 30 degrees C


Store below 25 degree C. Where?


Poor quality drugs: Nothing to choosebetween MNCs, large & SS sectors

• Large manufacturers often blame the mediumand small scale sectors for producing sub-standard drugs.

• There is no evidence in support of such claims.• In MIMS, we have been following the instances of

sub-standard drugs for over a decade.• There is no difference in the percentages of subs-

standard drugs produced by large manufacturerscompared to medium and small scale sector.

• In fact large manufacturers get 40% or more oftheir brands produced by medium and SS units.

• Large manufacturers often blame the mediumand small scale sectors for producing sub-standard drugs.

• There is no evidence in support of such claims.• In MIMS, we have been following the instances of

sub-standard drugs for over a decade.• There is no difference in the percentages of subs-

standard drugs produced by large manufacturerscompared to medium and small scale sector.

• In fact large manufacturers get 40% or more oftheir brands produced by medium and SS units.


Sub-standard brands of Abbott, AFD, Albert David,Alembic, Alkem, Aristo, Bayer, Biochem, Intas, Ipca,J.B.Chemicals, Lupin, Macleods, Mandkind, Medley etc.


Subs-Standard Brands of Cadila Pharma, Cipla,Concept, Elder, Medley, Merck, Micro, Morepen,Panacea, Rallis, Reckitt.


Sub-standard brands of Endolabs, FDC, GalphaLabs, Franco- Indian, Ind-Swift, Indocco, RPG,Serdia, Sun Pharma, Torrent, UCB, Unichem, USV,Wallace, Wockhardt, Zydus.


Conclusions• Fake drugs confused and interchanged,

intermingled with “spurious”, “counterfeits” withdifferent definitions in different countries.

• Indian definition is too wide.• Highly inflated figures in media without any

evidence.• Sub-standard drugs: many shades from minor to

major.• Solution of sub-standard drugs is a national

problem, not restricted to MoHFW.

• Fake drugs confused and interchanged,intermingled with “spurious”, “counterfeits” withdifferent definitions in different countries.

• Indian definition is too wide.• Highly inflated figures in media without any

evidence.• Sub-standard drugs: many shades from minor to

major.• Solution of sub-standard drugs is a national

problem, not restricted to MoHFW.


Thank you for yourpatience.

Thank you for yourpatience.


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