Clinician View on Generic Medicine

1. Prescribing Generic MedicinePrescribing Generic Medicine
Clinician view pointClinician view point
Dr.Vinod SharmaDr.Vinod Sharma
MD; DM, FRCP (London)MD; DM, FRCP (London)
FACC, MBA (HCA)FACC, MBA (HCA)
11
National Heart Institute, New DelhiNational Heart Institute, New Delhi

2. 22
What Does an Ideal HealthcareWhat Does an Ideal Healthcare
System Look Like?System Look Like?

3. AccessibilityAccessibility
AvailabilityAvailability
AffordabilityAffordability
33
Quality of HealthcareQuality of Healthcare

4. Care that is safe & effective and producesCare that is safe & effective and produces
best outcome possible.best outcome possible.
Healthcare system that creates newHealthcare system that creates new
knowledge, so that we get better at caringknowledge, so that we get better at caring
sick people.sick people.
44

5. Metrics used determine performance ofMetrics used determine performance of
health systemhealth system
55
a
Data from the 2016 International Profiles of Healthcare Systems from the Commonwealth Fund. b
Data from OECD
Healthcare Quality Indicators. c
Data from OECD Main Science and Technology Indicators. d
Data from 2001-2010
from the Global Biomedical Industry: Preserving US Leadership, Milken Instt 2011

6. The Growing need forThe Growing need for
Healthcare SpendingHealthcare Spending
Out Of Pocket Expenditure (OOPE) constitutesOut Of Pocket Expenditure (OOPE) constitutes
more than 68% of all health expenses.more than 68% of all health expenses.
66
Approximately 63 million people fall into povertyApproximately 63 million people fall into poverty
each year due to lack of financial protection foreach year due to lack of financial protection for
their healthcare needs.their healthcare needs.
World Bank Data 2014World Bank Data 2014
National Health Policy Draft 2015National Health Policy Draft 2015
Medicine emerged as a principal component ofMedicine emerged as a principal component of
Total health expensesTotal health expenses
-- 72% in Rural area72% in Rural area
-- 68% in Urban area68% in Urban area

7. ``
77

8. 88
“Govt intended to
move a law to ensure
that doctors prescribe
medicines by their
generic names only”
Mr Narendra Modi,
Prime Minister of India
Surat
17 April 2017

9. MCI & Other official NotificationsMCI & Other official Notifications
Clause 1.6 of the Indian Medical CouncilClause 1.6 of the Indian Medical Council
(Professional Conduct, Etiquette, and Ethics)(Professional Conduct, Etiquette, and Ethics)
Regulations, 2002, stated as follows:Regulations, 2002, stated as follows:
““Use of generic names of drugs: every physicianUse of generic names of drugs: every physician
should, as far as possible, prescribe drugs withshould, as far as possible, prescribe drugs with
generic names and he / she shall ensure that there isgeneric names and he / she shall ensure that there is
a rational prescription and use of drugs”.a rational prescription and use of drugs”.
This clause encouraged the prescription of genericThis clause encouraged the prescription of generic
drugs but did not forbid the prescription of brands.drugs but did not forbid the prescription of brands.
99

10. MCI & Other official NotificationsMCI & Other official Notifications
The Clause was modified on Sept 21, 2016 (No. MCI-The Clause was modified on Sept 21, 2016 (No. MCI-
211 (2)/2016(Ethics) / 131118) and notified in the211 (2)/2016(Ethics) / 131118) and notified in the
Gazette of India on Oct 8, 2016; the modification readGazette of India on Oct 8, 2016; the modification read
as follows:as follows:
““Use of generic names of drugs: every physicianUse of generic names of drugs: every physician
should prescribe drugs with generic names legibly &should prescribe drugs with generic names legibly &
preferably in capital letters and he / she shall ensurepreferably in capital letters and he / she shall ensure
that there is a rational prescription and use ofthat there is a rational prescription and use of
drugs”.drugs”.
1010

11. MCI & Other official NotificationsMCI & Other official Notifications
MCI circular No: MCI-211(2)(Gen)/2012 – Ethics/ 145183 dated
Nov 22, 212 and Jan 18, 2013 had called upon doctors
practicing medicine to prescribe drugs with generic names, as
far as possible. After the modification of Clause 1.5, the MCI
circular No: MCI-211(2_(Gen)/2017-Ethics /104728 dated April
21, 2017 threatened doctors found violating clause 1.5 of the
Ethics Regulations with suitable disciplinary action by the
concerned state medical council or by the MCI.
1111

12. Branded DrugBranded Drug
A drug is a brand, when it is marketed under aA drug is a brand, when it is marketed under a
trade name by the Company that holds thetrade name by the Company that holds the
patent on the drug. This is applicable even if thepatent on the drug. This is applicable even if the
patent on drug has expired.patent on drug has expired.
1212

13. Global Standard on GenericsGlobal Standard on Generics
“A generic drug is approved only after it has met rigorous
standards established by the FDA with respect to
identity, strength, quality, purity, and potency. All
generic manufacturing, packaging and testing sites must
pass the same quality standard as those of brand name
drugs. The generic drug manufacturer must prove its
drug is the same as (bioequivalent) to the brand name
drug”.
USFDA
1313

14. Unbranded generics are referred to and soldUnbranded generics are referred to and sold
under their international non-proprietary names.under their international non-proprietary names.
A drug is generic, when it is supplied in bulk & toA drug is generic, when it is supplied in bulk & to
the hospital under a pharmacologicial namethe hospital under a pharmacologicial name
rather than trade name.rather than trade name.
Doctors are expected to use this name whenDoctors are expected to use this name when
writing prescriptions.writing prescriptions.
1414

15. ControversyControversy
What to call a drug that is supplied underWhat to call a drug that is supplied under
a trade name by a Company that is nota trade name by a Company that is not
the original inventor, after the patent onthe original inventor, after the patent on
drug has expired.drug has expired.
1515

16. ““Branded Generics”Branded Generics”
An Indian Creation, OxymoronAn Indian Creation, Oxymoron
AA ‘Jugaad’‘Jugaad’ for Indian Pharma’s effort tofor Indian Pharma’s effort to
distinguished its generic from the genericsdistinguished its generic from the generics
of other company.of other company.
1616

17. Scenario in Developed CountriesScenario in Developed Countries
Drug marketed by patent holder is defacto the brand &
all other version of the same drug, marketed by one or
more companies (once the patent of drug expires), are
generics.
Multinational Pharmaceutical companies generally do
not venture into generic market space.
Indian pharmaceutical companies have few or no original
drug in market, means all or almost all drug market in
India by MNC are brands & ALL OR ALMOST ALL
DRUGS MARKETED IN INDIA BY INDIAN COMPANIES
ARE GENERICS (> 90% of medicine market).
1717

18. Big ControversyBig Controversy
““Social activists in India refers to all drugsSocial activists in India refers to all drugs
as brands unless they are marketed underas brands unless they are marketed under
pharmacological names”.pharmacological names”.
----------------------------------------------------------------------------------------------------------------------
MCI – Does not have a definition for whatMCI – Does not have a definition for what
a generic drug is?a generic drug is?
1818

19. Defeat of Basic Intention of makingDefeat of Basic Intention of making
medicine affordablemedicine affordable
Brand Vs Generic – DefinitionsBrand Vs Generic – Definitions
MCI (Ref No. MCI-7(10)/2014-RTI/161673 dated Dec 24, 2015;
handwritten numerals presented as deciphered) to a Right to
Information (RTI) application which indicates that the MCI does
not have a definition for what constitutes a generic drug.
In the RTI response, the MCI instead provides a web reference
for the term in a World Health Organization glossary that no
longer exists.
C Andrade et al; Indian J Psychiatry 2017 Apr – Jun 59(2); 133-137
1919

20. Prescribing by a Pharmacological name:Prescribing by a Pharmacological name:
ConcernsConcerns
If it is illegalIf it is illegal for a brand to be prescribedfor a brand to be prescribed. How. How
can multinational drug companies be permittedcan multinational drug companies be permitted
to market their brands in India if doctors in Indiato market their brands in India if doctors in India
not allowed to prescribe these brands.not allowed to prescribe these brands.
PARADOXICAL SITUATION & BAD IN LAWPARADOXICAL SITUATION & BAD IN LAW
2020

21. Clear Conflict of InterestClear Conflict of Interest
Generic medicines are as good as branded medicinesGeneric medicines are as good as branded medicines
with regards to bioequivalence and therapeuticwith regards to bioequivalence and therapeutic
equivalence.equivalence.
-- Only to the generic products that have passedOnly to the generic products that have passed
throughthrough quality assurance programme,quality assurance programme, includingincluding
thosethose manufactured in plants thatmanufactured in plants that have ahave a
GMP certification.GMP certification.
-- Many branded generics in India are marketed byMany branded generics in India are marketed by
companies that have a USFDA approval. There iscompanies that have a USFDA approval. There is
an assurance of quality control.an assurance of quality control.
-- Pharmacological generics are suspects on counts ofPharmacological generics are suspects on counts of
inadequate / excess content of active ingredients,inadequate / excess content of active ingredients,
presence of impurities or both.presence of impurities or both.
2121

22. 2222

23. 2323

24. Clear Conflict of InterestClear Conflict of Interest
Pharmacist would have liberty to dispense drugsPharmacist would have liberty to dispense drugs
according to their preferences (which doctorsaccording to their preferences (which doctors
are presently being accused off) and aare presently being accused off) and a
Pharmacist – Pharma nexus may replace soPharmacist – Pharma nexus may replace so
called the Doctor – Pharma nexuscalled the Doctor – Pharma nexus..
Pharmacist may dispense a brand, a brandedPharmacist may dispense a brand, a branded
generic, a nominally branded generic or ageneric, a nominally branded generic or a
pharmacologic generic depending on his / herpharmacologic generic depending on his / her
ethical standard and perhaps depending onethical standard and perhaps depending on
which version offers the highest margin of profit.which version offers the highest margin of profit.
2424

25. Clear Conflict of InterestClear Conflict of Interest
If patient fail to respond or suffers anIf patient fail to respond or suffers an
unexpected adverse effectunexpected adverse effect with a version of drugwith a version of drug
chosen by a pharmacist, especially when thechosen by a pharmacist, especially when the
choice is pharmacological generic. It would notchoice is pharmacological generic. It would not
be clear whether it is treatment failure orbe clear whether it is treatment failure or
adverse effect due to drug itself or to theadverse effect due to drug itself or to the
dispensed version.dispensed version.
In case of an adverse event, particularly aIn case of an adverse event, particularly a
serious adverse event,serious adverse event, who would takewho would take
responsibility for legal liabilityresponsibility for legal liability, the Doctor or, the Doctor or
Pharmacist?Pharmacist? 2525

26. Clear Conflict of InterestClear Conflict of Interest
At least 90% of Indian domestic Pharmaceutical market ofAt least 90% of Indian domestic Pharmaceutical market of
100000 crore and max, comprises drugs sold under brand100000 crore and max, comprises drugs sold under brand
names. They simply are not enough generic name equivalentnames. They simply are not enough generic name equivalent
of branded medicines sold.of branded medicines sold.
About half the market – 50000 crore & more – is for Fixed DoseAbout half the market – 50000 crore & more – is for Fixed Dose
Combination (FDC) of drugs, a further half of them irrational.Combination (FDC) of drugs, a further half of them irrational.
Many FDC drugs contain even eight or nine medicines. ToMany FDC drugs contain even eight or nine medicines. To
write & remember each constituents impractical.write & remember each constituents impractical.
2626

27. FDCFDC
Pharmacodynamic mismatch between twoPharmacodynamic mismatch between two
components.components.
Pharmacokinetic mismatch & having peak efficacy atPharmacokinetic mismatch & having peak efficacy at
different time.different time.
Chemical incompatibility leading to decreased shelfChemical incompatibility leading to decreased shelf
life.life.
Drug interaction because common metabolizingDrug interaction because common metabolizing
pathways.pathways.
Limitation of finer dosing titration of individualLimitation of finer dosing titration of individual
ingredients.ingredients. 2727

28. Fixed Dose Combination:-Fixed Dose Combination:-
Problem of PlentyProblem of Plenty
FDC withFDC with questionable justificationquestionable justification in India.in India.
-- Violation of scientific merit in many FDC withoutViolation of scientific merit in many FDC without
adequateadequate justification.justification.
FDC are new drugs but permitted by licensing authorityFDC are new drugs but permitted by licensing authority
-- Example of disconnect State Licensing AuthorityExample of disconnect State Licensing Authority
issued license to manufacture combination butissued license to manufacture combination but
without NOC from Central Drugs Standardwithout NOC from Central Drugs Standard ControlControl
Organization (CDSCO).Organization (CDSCO).
2828

29. Fixed Dose Combination:-Fixed Dose Combination:-
Problem of PlentyProblem of Plenty
The Good, The Bad and The Ugly of FDC in IndiaThe Good, The Bad and The Ugly of FDC in India
Good FDC’s – Carbidopa + LevodopaGood FDC’s – Carbidopa + Levodopa
- Gulfornamide + Trimethoprim- Gulfornamide + Trimethoprim
- Antihypertensive- Antihypertensive
- Anti-diabetes- Anti-diabetes
Bad FDC’sBad FDC’s – Majority fall in this category– Majority fall in this category
-- Dual NSAIDsDual NSAIDs
-- NSAIDs with muscle relaxantNSAIDs with muscle relaxant
-- NSAIDs with H2 receptor blockerNSAIDs with H2 receptor blocker
Ugly FDC’sUgly FDC’s – Neither evidence nor justification– Neither evidence nor justification
-- Anti-histaminics + decongestant + bronchodilator + coughAnti-histaminics + decongestant + bronchodilator + cough
suppressantsuppressant
-- Antifungal + antibiotic + steroid + topical local anaestheticAntifungal + antibiotic + steroid + topical local anaesthetic
YK Gupta: Indian Journal of Pharmacology (48) 2016YK Gupta: Indian Journal of Pharmacology (48) 2016
2929

30. Defeat of Basic Intention of makingDefeat of Basic Intention of making
medicine affordablemedicine affordable
Even if doctor manages to write a prescription inEven if doctor manages to write a prescription in
generic name, Pharmacist will sell the brand thatgeneric name, Pharmacist will sell the brand that
maximizes their profit and will not stock the lessmaximizes their profit and will not stock the less
costlier but equivalent brand or generic medicinecostlier but equivalent brand or generic medicine
that is as good.that is as good.
3030

31. It’s impossible to transfer legal authority ofIt’s impossible to transfer legal authority of
a doctor to a chemist or pharmacist, whoa doctor to a chemist or pharmacist, who
need not even have to see the patientneed not even have to see the patient
before handing over the medicine. Whobefore handing over the medicine. Who
would be responsible if a doctorwould be responsible if a doctor
prescribes a particular brand of genericprescribes a particular brand of generic
medicine and the pharmacist gives a poormedicine and the pharmacist gives a poor
quality one, leading to clinicalquality one, leading to clinical
complications –complications – C M Gulhati, FormerC M Gulhati, Former
Consultant to WHOConsultant to WHO 3131

32. Government InitiativeGovernment Initiative
Jan Aushadhis – (Pharmacy Selling only genericJan Aushadhis – (Pharmacy Selling only generic
medicines), giving preference to pharmaceuticalsmedicines), giving preference to pharmaceuticals
PSU’s.PSU’s.
Less than 3000 JA, against max than 8 lac retailLess than 3000 JA, against max than 8 lac retail
pharmacies in existence.pharmacies in existence.
3232

33. Drugs Technical Advisory BoardDrugs Technical Advisory Board
(DTAB)(DTAB)
Govt Considered amending Rule 65 (11A) of the drugs &Govt Considered amending Rule 65 (11A) of the drugs &
cosmetic Act 1940, so that Pharmacist can dispense genericcosmetic Act 1940, so that Pharmacist can dispense generic
name medicines & / or equivalent brand against prescribedname medicines & / or equivalent brand against prescribed
brand names.brand names.
DTAB rejected the proposal citing that the bioavailability of aDTAB rejected the proposal citing that the bioavailability of a
generic drug may not be as good as that of prescribed brand.generic drug may not be as good as that of prescribed brand.
Govt does not have confidence in product manufactured by theGovt does not have confidence in product manufactured by the
Govt own PSU’sGovt own PSU’s
3333

34. Making Medicines Affordable: SolutionsMaking Medicines Affordable: Solutions
Suggested shifting to the prescription of pharmacological
generics is a flawed idea.
An optional step, through appropriate notifications,
prescriptions can be mandated to include, in parentheses,
pharmacological name of the drug.
Govt can run pharmacies that stock pharmacological
generics that meet defined quality assurance criteria;
existing and new Jan Aushadi stores.
3434

35. Making Medicines Affordable: SolutionsMaking Medicines Affordable: Solutions
Legislation may be required here because, at present, pharmacists do
not have the discretionary powers to make substitutions.
Govt to ensure quality control not only at the time of initial approvals of
the pharmacological generics but also as part of an ongoing exercise,
much as is routinely conducted by the US FDA companies that default
should be heavily penalized, again as is done by US FDA.
If this solution is implemented, the Govt will take the responsibility of
quality assurance & patient will take the responsibility of opting for
Govt guaranteed quality.
Doctors and Pharmacists both move out of the picture and neither can
be indicted for either patient exploitation or dispensing of substandard
drugs.
3535

36. Need of HourNeed of Hour
Clear directive from Govt & Regulatory Authority
regarding prescription of Branded Vs Generic Vs
Branded Generics.
The Govt should bring a legal framework to ensure
“quality” in generic drug testing.
No more than 1% of generic drugs sold in India undergo
quality tests. Generic drugs should work
“therapeutically” and the government should ensure
“uniform quality”.
Govt must put in place reforms that will make it
mandatory for drug manufactures in India to adhere to
globally accepted standards. 3636

37. Brand Vs GenericBrand Vs Generic
Has the brouhaha ended?Has the brouhaha ended?
For time being, the subject is no
longer in the news.
Matter may surface again in future,
when the opportunity for political
gains present itself.
3737

38. Prescription can have brand name of drugsPrescription can have brand name of drugs
Kalyan Ray, DH News Service, May 13, 2017Kalyan Ray, DH News Service, May 13, 2017
Margins for branded generic drugs are in the range of 201 – 1016%,Margins for branded generic drugs are in the range of 201 – 1016%,
according to a study conducted by the Delhi University in 2010according to a study conducted by the Delhi University in 2010 3838

39. Notwithstanding the brouhaha over generic medicines,
doctors will not be prohibited from writing popular brand
names of medicines in prescriptions, government
officials have clarified.
The government is in no position to make it mandatory
for the doctors to write only generic names, as there are
multiple legal and technical challenges, officials in the
pharmaceuticals department said.
3939
Prescription can have brand name of drugsPrescription can have brand name of drugs

40. Govt is now aiming to encourage doctors to write
both. “We are promoting generic medicines. But
we are not banning the writing of brand name of a
medicine” – Union Minister for Chemicals &
Fertilizers Ananth Kumar
4040
Prescription can have brand name of drugsPrescription can have brand name of drugs

41. Capitalism has its limitations but is superior to socialism as a
philosophy of state if only because capitalism provides the incentives
for innovation, development, and hence a better quality of life.
Preventing exploitation through arbitrary pricing has a role (Govt
action resulted in a dramatic lowering in the prices of coronary
stents).
Such regulatory action can also do harm, as is already evident in India
because high quality stents, which were more expensive, may be
withdrawn from the market.
Because newer, high-quality Drugs / Devices may not be introduced in
the country for reasons of economic un-viability.
Eligible patients cannot exercise their right to pay for quality.
4141