INDIAN PHARMA : RAISING BAROMETER OF SUCCESS BEYOND GENERICS

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Sr. No.

Name of the drug

Category

Patent Holder

Expiry Year

1.

Zafirlukast

Respiratory

Glaxo

Sept. 2010

2.

Zelienton

Respiratory

Abbott

Dec., 2010

3.

Atrovastatin Cal.

C.V.

Wartner

Dec., 2010

4.

Irbesartan

C.V.

Sanofi

March, 2011

5.

Olanzapine

C.N.C.

Eli Lilly

April, 2011

6.

Tirofiban

C.V.

Merck

March, 2011

7.

Rosuvastatin

C.V.

A.Z.

June, 2012

8.

Zolmitriptan

Migraine

A.Z.

Nov., 2012

9.

Frovatriptan

C.N.C.

GSK

Nov., 2012

10.

Valsortan

C.V.

Novartis

March, 2012

11.

Ertapenem

Antibiotic

Merck

Feb, 2013

12.

Caspofungi

Antibiotic

Merck

March, 2013

13.

Voriconazole

Antibiotic

Pfizer

Oct, 2013

14.

Rizatriptan

Migraine

Merck

Jan., 2013

15.

Eletriptan

Migraine

Merck

Aug. 2013

16.

Almotriptan

Migraine

Pharmacia

Oct, 2013

17.

Teriparatide

Hormone

Eli Lilly

July, 2013

18.

Risedronate Sodium

Hormone

P & G

Dec, 2013

19.

Imatinib Mesylate

Oncology

Novartis

May, 2013

20.

Insulin Lispro

Diabetes

Eli Lilly

May, 2013

21.

Insulin Aspart

Diabetes  

Novo

Sept, 1013

22.

Rituximab

Biopharm

Gentech

March, 2013

23.

Decliximab

Biopharm

Protein Design

June, 2013

24.

Erytropoietin

Biopharm

Amgen

Aug, 2013

25.

Palvizumab

Biopharm

Medi Immune

Dec., 2013

26.

Tegaserod

Gastro

Novartis

April, 2013

27.

Montelukast

Respiratory

Merck

Oct, 2013

28.

Grepafloxacin

Antibiotic

Glaxo

Dec, 2013

29.

Colesevelam

C.V.

Geltek

Dec, 2014

30.

Linezolid

Antibiotic

Pharmacia

Nov, 2014

31.

Posaconazole

Antibiotic

Shering

Aug, 2014

32.

Idiotypic CEA

Oncology

Titan

Dec, 2014

33.

Insulin Glargin

Diabetes

Aventis

April, 2014

34.

Transtuzumab

Biopharm

Gentech

Oct, 2014

35.

Esomeprazole

Gastro

A.Z.

May, 2014

36.

Telmistran

C.V.

 

Jan, 2014

37.

Omaptrilar 

C.V.

B.M.

June, 2015

38.

Telethromycin

Antibiotic

Aventis

April, 2015

39.

Gemifloxacin

Antibiotic

GSK

June, 2015

42.

Omalizumb

Respiratory

Roche

Feb, 2015

TABLE 1 List of the drugs going off patent in near future

3. Continue its expansion in the low-priced segment
Based on the present infrastructure of generic pharmaceutical firms, exports to unregulated markets can continue so that it can provide funds required for transition of some larger generic companies to research based companies.

4. Develop bio-generic drugs.
Indian bio-generics have to move beyond its domestic boundaries. The Indian government should lobby on the bilateral level to remove regulatory barriers in exporting the bio-generic products to regulated markets. A procedure for approval of drugs filed through Biologics Licensing Application needs to be established. And as soon as the FDA and the European Medicines Agency introduce an approval mechanism for bio-generics, India should move ahead in this field.

5 Comparative advantage in conducting clinical trials
The generic pharmaceutical companies can undertake clinical trials since India has a large population of treatment-naïve patients and plethora of diseases. But proper measures to control any abuse of recruitment of patients need to be taken care of.

(c)The third tier is for approaching new emerging markets.

(a) Generic generics
Currently, the market share of generic generics is very low. We see two main hurdles to pure genericisation of the Indian market:
1. Lack of generic generics regulations and guidelines for the establishment of bio-equivalence, for example the Abbreviated New Drug Application (ANDA) guidelines that exist in the U.S.
2. Doctor comfort derived from prescribing medications on the basis of brand name.

A good example of a generic generics programme in India is the government run ‘Jan Aushadi’. This programme provides no-name generic drugs at subsidized prices in 24-hour pharmacies that are located all over the country.

The free generics scheme, which mirrors policies in the states of Tamil Nadu and Rajasthan, is expected to be fully operational by the time voters go to the polls for the 2014 general election, when the populist Congress party will seek a third straight victory.Indian makers of generics such as Dr Reddy's and Cipla are best placed to benefit."The move will please the generics manufacturers who stand to gain substantially in competing for contracts,"

(b) Over-the-counter products
The OTC segment has been identified as one of the potential growth drivers for the Indian Pharma industry, as the sale of OTC drugs in India has been increasing over the years. The OTC market was worth about US$1.8 billion in 2009 estimates that by 2020, it will grow to US$11 billion. ‘OTC Drugs’ means drugs legally allowed to be sold ‘Over The Counter’ by pharmacists, without the prescription of a Registered Medical Practitioner. Although the phrase ‘OTC’ has no legal recognition in India, all the drugs not included in the list of ‘prescription-only drugs’ are considered to be non-prescription drugs (or OTC drugs).

Figure 8:  Key driver growth behind the OTC segment

3.  Retail vs. Institutional sales
Currently, majority (91%) of drug sales is through the retail markets, while institutional sales are very low (9%). it believes that the increase in institutional sales will be marginal in the next 5 years, and will be significant impact between 2015 and 2020. Increased institutional sales will be driven by the increase in the penetration of insurance, and the growing number of government and private hospitals.

Figure 8: percentage ratio of sales

4.  Rural Markets the next frontier
Majority of the Pharma market’s growth is driven by the urban markets. Accessibility ofmedication in rural areas is very poor,with less than 20% of the population having access.This gap represents a huge opportunity for pharmaceuticalcompanies to expand, and we believe that these markets will be the future volume drivers of the industry.

Figure 9: Multinational Pharmaceutical companies are looking to enter rural markets

5. Conclusion and remarks
The global pharmaceutical market is undergoing rapid transformation. As blockbuster drugs come off patent, there are fewer new products in the pipeline to replace them. Government must continue to invest in healthcare and medical infrastructure in rural markets, raise healthcare spending, encourage innovation, contain healthcare costs and work with private players to take the market to the next level. Amid slower growth in the generics space, large Indian players will look to enhance their focus in this area — it's never too early or too late to think about this critical challenge.Indian pharma companies can effectively leverage on the opportunities available and continue to be one of the leading pharma industries in the world.

6. References
1.    Journal of Intellectual Property Rights Vol 17, July 2012, pp 273-283 Post-TRIPS Thrust Triggers for Indian Pharmaceuticals in the IP Context[Online] Accessed from: nopr.niscair.res.in/bitstream/.../JIPR%2013(4)%20273-238.pdf [Accessed on 24 Aug, 2012]
2.    Journal of Intellectual Property Rights Vol 13, July 2008, pp 301-317 Battling with TRIPS: Emerging Firm Strategies of Indian Pharmaceutical Industry Post-TRIPS [Online] Accessed from: nopr.niscair.res.in/bitstream/.../JIPR%2013(4)%20301-317.pdf[Accessed on 28 Aug, 2012]
3.    An unhealthy future for the Indian pharmaceutical industry? [Online] Accessed from: twnside.org.sg/title2/resurgence/2012/259/cover03.htm [Accessed on 28 july, 2012]
4.    Pharma's Future Depends on These Three Trends by Sunil Gupta | April 26, 2010 ? [Online] Accessed from: lorandoslaw.com/Publications/Changes-in-Indias-Patent-Law.shtml [Accessed on 22 Aug, 2012]
5. finnegan.com/resources/articles/articlesdetail.aspx?news=24cedda7-28a3-4ac0-b100-ed9974123e67[Accessed on 24 Aug, 2012]
6.    twnside.org.sg/title2/resurgence/2012/259/cover01.htm[Accessed on 10 july, 2012]
7.    ispub.com/journal/the-internet-journal-of-third-world-medicine/volume-7-number-1/patents-regime-in-india-issues-challenges-and-opportunities-in-pharmaceutical-sector.html[Accessed on 6 July, 2012]
8.    pharmainfo.net/og/pharmindia/indian-pharma-a


 

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