Brands Name Vs Generic Products 3 Branded Drugs 5 IPR: Dug patenting in India 6 Case Study- Patents wars 9 Generic Drugs 12 Generic Drug Vs Branded Drug- A comparison 20 Indian Generic Market 21 India Healthcare Status 27 Jan Aushadi Pariyojana 30 Only Generics: Is India ready? 34

1. PME MAJOR PRESENTATION
Topic- BRANDED VS GENERIC
1

2. INDEX
Contents Slide Number
Brands Name Vs Generic Products 3
Branded Drugs 5
IPR: Dug patenting in India 6
Case Study- Patents wars 9
Generic Drugs 12
Generic Drug Vs Branded Drug- A comparison 20
Indian Generic Market 21
India Healthcare Status 27
Jan Aushadi Pariyojana 30
Only Generics: Is India ready? 34
2
Story of Generic and Brand Names- A journey from Products to Drugs, from
Global to India

3. vs
Brands Name Vs Generic Products
3
What will you prefer?

4. • People often stereotype generic brands as less tasty, of poor quality or less
effective than their brand-name counterparts.
• But given that trusted, brands demand more of your money, is there really a
difference between... brand-name and generic food or drugs?
• Fancier brand name packaging effect can be quite strong when it comes to
your taste preferences but when it comes to drugs, things are a little
different. A generic drugs have to be the same as the brand name.
4

5. BRANDED DRUGS
• Also called “innovator drugs”
• The process of drug development is costly and time consuming. It takes 17 to
20 years, and costs a pharmaceutical company millions to develop and win
approval for a new drug.
• When a company develops a new drug — often after years of research — it
applies for a patent, which prohibits anyone else from making the drug for a
fixed period.
5

6. A patent is a contract between an inventor and the government wherein the
government provides right of protection of the invention for a limited period of time
after the full disclosure of the invention by the inventor
Earlier, there was the system of “process patent” in the pharmaceutical industry.
Process patent means that only the process used to manufacture a particular drug
can be patented. The drug cannot be patented under this system. Other
manufacturers had to use some other method to manufacture the drug. But with the
introduction of the “product patent” regime, even the product (drug) could be
patented. Eg- Lemon Juice
Intellectual Property Rights In The Pharmaceutical
Sector
6

7. Patents Act, 1970
• Process patent
• Legalized "reverse engineering“
• Period of patents- 7 years
• Major boost to the Indian,
manufacturing medicines at a
cheaper rate
• Country break free from the curbs
imposed by monopoly
Reforms Post 2005
• Product patent
• Cannot manufacture patented
drugs
• Period of patents – 20 years
• To face challenges probing new
business models-
✔ Contract research (drug discovery
and clinical trials).
✔ Contract manufacturing.
Amendments were made to Patent Acts in 2005 to meet standards of
TRIPS Agreement. Not complying with it meant that the defaulting
country would no longer be a member of the WTO
7

8. Contract Research- This market is increasing at a rate of 20% per annum.
Offers services which include product development, formulation and
manufacturing, clinical trial management, toxicology and clinical, medical and
safety monitoring.
Contract Manufacturing- Many pharmaceutical multi nationals are looking
to outsource manufacturing to Indian companies, which have a cost advantage
in comparison to companies in the developed countries.
An on-patent period gives the companies the most
advantageous marketing edge. To recover the cost
of research and development, companies usually
price their brand- name drugs on the higher side 8

9. Case Study- Novartis Vs Union of India & others
• A landmark decision by a two-judge bench of
the Indian Supreme Court On the issue of
whether Novartis could patent Gleevec in
India.
Gleevec-invented chemical-Imatinib mesylate)
(Blood Cancer – Survival 95%)
Indian Generic Company sold them at USD 266 before patent expired
Novartis dragged them to SC
To broaden your perspective
Swiss MNC
USD 2666
per patient
per month
9

10. • FDA is the primary regulatory agency for pharmaceuticals. Marketing of a
new drug requires filing a “New Drug Application” (NDA) with the FDA,
along with clinical tests showing that the drug is both safe and effective for
the intended use.
• Approved drugs, and certain underlying patents, are listed in the “Orange
Book”. The publication Approved Drug Products with Therapeutic
Equivalence Evaluations identifies drug products approved on the basis of
safety and effectiveness and contains related patent and exclusivity
information.
10

11. • But the expiry of patents on branded drugs will throw the gate open for
competition from relatively inexpensive generic drugs which will reduce
pricing of the branded drug by more than 80% in less than 12 to 18 months.
Now that is the power of Generic Drugs
• 1984 Hatch- Waxman Act – plethora of generic drugs entering into the
market by reducing the cost associated with the approval of a generic drug
and stating that pre-clinical and clinical testing does not have to be repeated
for generics.
11

12. Generic Drugs
• A drug product that is comparable to branded drug product in dosage
form, strength, route of administration, quality & performance
characteristics & intended use.
• WHEN GENERIC DRUG MARKETED?
✔ After patent and exclusivity protection ends
✔ Patent owner waives its rights
✔ FDA requirements are met
• An Abbreviated New Drug Application (ANDA) contains data which
when submitted to FDA's Centre for Drug Evaluation and Research, Office
of Generic Drugs, provides for the review and ultimate approval of a
generic drug product. Generic applicants must scientifically demonstrate
that their product is bioequivalent.
12

13. BRAND NAME DRUG
NDA REQUIREMENT
1. Labelling
2. Pharma
3. Chemistry
4. Manufacturing
5. Controls
6. Microbiology
7. Testing
8. Animal studies
9. Clinical studies
10. Bioavailability
1. Labelling
2. Pharma
3. Chemistry
4. Manufacturing
5. Controls
6. Microbiology
7. Testing
8. Bioequivalence
GENERIC NAME DRUG
ANDA REQIREMENT
13

14. • Since the manufacturer of these patent drugs do not involve a repeat of the
extensive clinical trials to prove their safety & efficiency, it costs less to
develop them. Generic drugs are, therefore cheaper.
• Only 5 in 5,000 drugs that enter preclinical testing progress to human testing.
One of these 5 drugs that are tested in people is approved. The chance for a
new drug to actually make it to market is thus only 1 in 5,000. Not very good
odds. Drug Approvals - From Invention to Market ... A 12- Year Trip.
• The true cost to bring a drug to market is estimated $2.56 billion.
14

15. Example
Ibuprofen is a drug that treats headaches fevers pains
it's also sold under brand names like Advil and Nurofen
but at the base of pills is the exact same thing-
✔ two hundred milligrams of ibuprofen
✔ the same dosage safety strength
✔ intended use.
The only way in which the pills meet difference between their filler ingredients,
flavoring or different colors
aren't exactly the same they are effectively the same.
15

16. Same
RODA
Same
Active
Ingredients
16

17. Company: Amaze-Bio Pharma
Research & Development
Invented molecule: *BAURAVOL* -Ebola virus
Brand Name: BOLA LOL
17

18. Exclusive right to sell for some time
No other company can sell for 20 years
YOUR novel molecule, it's your patented product
AND ONLY YOU HAVE THE SOLE RIGHTS
Bola-Lol patent expires
*BAURAVOL* is now off patent
18

19. Janarthan Pharma
Singh Pharma
Gupta Pharma
+
100 other companies
Singh Pharma can use is it's own brand name now.
Let's say
Company: Singh Pharma
Molecule: *BAURAVOL*
Brand name: S-Bauravol
S-Bauravol
Branded generics: It's a generic
molecule known by its brand name.
19

20. Branded
1. Expensive and less affordable
1. Take several years to be made &
come in market.
1. Charge you for their R&D cost
1. Have ‘name’ as their trademark
1. supplied by one drug company
(patents)
Generic
1) Cheaper and more affordable
1) No time required as don’t need
to do costly clinical
studies(Hatch Waxman)
1) Reduced cost, No R&D charges
involved
1) name of the drug > name of the
active ingredient (G- Bauravol)
1) supplied by more then one drug
company
20

21. Indian Generics Market
• India supplies 20% of global generic medicines, in terms of volume, making
the country the largest provider of generic medicines globally and expected
to expand even further in coming years.
• India became the third largest global generic API merchant market in 2016,
with a 7.2 per cent market share. India a major destination for generic drug
manufacturing
• The Indian pharmaceutical industry accounts for the 2nd largest number of
Abbreviated New Drug Applications (ANDAs), is the world’s leader in Drug
Master Files (DMFs) applications with the US.
• Indian pharmaceutical companies received 300 generic drug approvals in
USA during 2017.
21

22. 70%
21%
9%
Generic drugs
OTC Medicines
Patented drugs
• With 70 per cent of market share (in terms of revenues), generic
drugs form the largest segment of the Indian pharmaceutical sector.
• The share of generic drugs is expected to continue increasing;
domestic generic drug market is expected to reach US$ 27.9 billion
in 2020. It has reached US$ 26.1 billion in 2016
• India has over 60,000 generic brands across 60 therapeutic
categories. Most common includes Anti-infectives, Respiratory,
Pain, Gynaecology.
Revenue share of Indian pharmaceutical sub-segments in 2015
22

23. Generic drug market is expected to grow in the next few years,
with many drugs going off-patent in the US and other
countries.
0
5
10
15
20
25
2008 2009 2010 2011 2012 2013 2014 2015
Patented drugs Generic drugs
Share of patented and generic drugs in prescribed drug market
(US$ billion)
23

24. The Indian Pharmaceuticals Industry generates around 50 per cent of its revenues from
generics exports.
In FY17, India exported pharmaceutical products worth US$ 16.8
billion, with the number expected to reach US$ 40 billion by 2020.
Indian drugs are exported to more than 200 countries in the world,
with the US as the key market.
0
2
4
6
8
10
12
14
16
18
FY12 FY13 FY13 FY14 FY15 FY16 FY17
Export Import
Trade data of Indian Pharma Sector (US$ billion)
24

25. India remains one of the cheapest places in the world for medicines.
We have a ruthlessly competitive industry that has delivered an amazing
range of molecules across therapy areas.
25

26. India - Analysis of leading generic drug firms
The top brands in generic medicine in the country.
Anti-diabetic drugs rule the top 20 list.
• Sun Pharmaceutical Industries
• Dr. Reddy's Laboratories
• Lupin
• Ranbaxy (Volini BG Top 15 generic- turnover)
• Aurobindo
• Glenmark
• Wockhardt
26

27. • Generic drugs aren’t popular in India
✔ Private doctors never hand out generic drugs because there are no
incentives involved from pharma companies.
✔ The government’s Department of Pharmaceuticals is also to blame for the
lack of awareness. (Myth)
Total GDP of India $2.26 Trillion is
comparable to US spending alone on
healthcare was $3.3 trillion. (2016)
Medical Representatives
27

28. • As per World Bank, India falls among low-middle income countries.
22% of its population is below official poverty limit.
• National Sample Survey Office survey on healthcare, in 2014,
medicines emerged as a principal component of total health
expenses—72% in rural areas and 68% in urban areas.
• For a country with one of the highest per capita out-of-pocket
expenditures on health, even a modest drop in drug prices will free
hundreds of households from the widespread phenomenon of a
medical poverty trap.
They cannot even afford generics
28

29. • That’s why recently Indian Government and The Medical Council of India
(MCI) has mandated that generic names of drugs would have to be
mentioned along with the brands in prescriptions to patients because there
are so many medicines which are available in generics and people cannot
afford it.
• Indian government is also encouraging the use of generic medicines by
establishing some Jan Aushadhi Medical Stores in India and nowadays
large number of retail generic outlets are appearing in the market.
Pharmacies may soon have separate shelf for
generics
The government is also said to be considering a
plan to allow medicine stores to sell a generic
version of a drug if a doctor prescribes the
branded one
Wed, Mar 14 2018
29

30. PRADHAN MANTRI
BHARTIYA JAN AUSHADHI PARIYOJANA
(PMBJP)
“In the coming days, the government will bring a legal framework under
which doctors will have to prescribe generic medicines which are cheaper
than equivalent branded drugs, to the patients” the Prime minister said.
Objective- 'ensuring availability of quality medicines at affordable prices to all’
A total 861 PMBJP Kendras are functional in 28 states – at which 99 private
manufacturing companies, certified by the WHO, supply generic drugs,
specially manufactured & packed for the PMBJP.
30

31. Price Difference Between Generic and Branded
Medicines
31

32. Recent
Initiative for
personal
hygiene of
women
32

33. Also there are some players who are selling generic medicines
online like genericwala.
33

34. Medical Council Of India (to doctors)
“Prescribe generic drugs or face action”
34

35. What is the controversy?
Should doctor prescribe
Generic Drug (Salt/molecule)
Or
Branded Drug.
35

36. On government’s push for generic drugs, Kiran
Mazumdar Shaw, CMD of Biocon said,
"Implementation is going to be very challenging
because we are not ready yet".
We all lnow…“Chaos in the implementation of GST”
MCI move towards Generics
Intention is good but Execution remains a challenge!
36

37. Barriers
• Gujarat, for its 65 million population , has around 36500 medical stores
across 33 districts but has only around 90 drug inspectors. It has around
4000 total drug manufacturers but only around 50 drug inspectors for these.
(Manufacturers)80:1 / 405:1(Medical stores)
• For every 50 manufacturers, we will need one drug inspector & every 200
medical stores, a single drug inspector. According to International
Standards
(Manufacturers)50:1 / 200:1(Medical stores)
The number of drug inspectors are approximately 1500 now
– this should be increased.
37

38. No more 1% of generic drugs sold in
India undergo quality tests.
• In a country like India controls are very poor .
• So there is no guarantee that medicine you’ll be taking will be effective .
• Because a lot of generic sellers have no brand to protect .
• A generic seller is selling a product for low price for maximum profit.
38

39. So what is the solution?-
Price cap
Rate-of-return regulation is a system for setting
the prices charged by government-regulated
monopolies.
39

40. Case of stents
The National Pharmaceutical Authority of India
finally set the selling price of coronary stents at
Rs.29600 for drug eluting stents & Rs.7260 for
bare metal stents.
A stent placed temporarily inside a blood vessel to relieve an obstruction.
Eg- If you fix the price for car manufacturers as 2.5 lac, then everyone will
start manufacturing Maruti 800. The quality will slowly decrease.
40

41. The choice of which generic to give goes to
chemist
(Usually untrained in India)
Now number of companies will be making the
generic drug
So he will sell the one with maximum margin.
41

42. Another major issue.
Combination?
What to do in that case?
About 40% of the estimated 60,000 drug
formulations sold in India are fixed dose
combinations, or FDCs
One of the most common reason of this not being practical is that most
drugs come in combinations when they are non-generic, so it reduces the
number of pills the patient takes, & the non-generic drugs are easier to find
in pharmacies.
A combination drug is a fixed-dose
combination (FDC) that includes two or more
active pharmaceutical ingredients (APIs)
combined in a single dosage form, which is
manufactured and distributed in fixed doses. 42

43. Brand Recall For Doctors
Heavy Crowd In OPD
Doctors might not remember all the
formulations/generic salts.
Impossible in case of FDC
43

44. Merits
• To bring down drug prices and
expand access to affordable health
solutions
• The generics-only policy also
makes economic sense, promoting
- generic drug manufacturing
industry.
• Has far-reaching implications on
public health and international
human rights. (medical poverty
trap)
Demerits
• Inspection and verification of
generic drug -substandard quality
in many cases
• Concerns of efficacy
• The hygiene standards of the
manufacturing plants
• Lot of power into the hands of
medicine shops and thus
compromises patients safety
Generic- Only Policy
44

45. Our Analysis
• While the push for a generics-only policy is a step in the right direction, it
is important to assess and ensure that Indian generic companies are
competent enough to take on the task before institutionalizing such a
policy.
• For in a sector such as health, faulty policy design will directly affect the
country’s mortality statistics. Though the policy perspective should be
welcomed, the loopholes need to be plugged as soon as possible.
✔ Ensuring the correctness of pharmacist
✔ Making the patients literate
✔ Increasing the number of drug inspectors
✔ Ensuring the efficacy of Medical Council of India
Affordable
Healthcare
45

46. Thank you!
46