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CHALLENGES IN INDIAN
PHARMACEUTICAL INDUSTRY DUE
TO GLOBALIZATION OF IPR
Vishnu GM
Indian pharmaceutical industry
• One of the most successful industries in India.
• Ranks 3rd in the volume of production.
• Ranks 10th in value.
• Produces about 20 %of the world’s drugs.
• India has become a prime destination for
manufacture of branded and generic drugs
with a strong export element.
• It is estimated that around 40 % of the generic
drugs in the US come from India.
• India to be recognized as ‘ Pharmacy of the
World’.
• Total turn over between 2008-09 :$21 billion
• Grown from $0.3 billion in 1980
Challenges faced by IPI
• Control of the drug price
• Regulatory aspects
• Research and drug discovery
• Patents and intellectual property rights
• Health Insurance and Out of Pocket
Expenditure
• Ethics
• Human Resources Requirement
• Patented drugs make up approx 8% of total
market sales in India.
• 92% of Indian drug market is out of patent.
• Prior to 2005, only processes were patentable
and not the end product.
• So, if a company chose to manufacture the
same product but used a different process, it
could do so without violating Indian patent
laws.
• With the 2005 ammendment , product
patents and process patents have permitted
for 20 years .
• IPR in the pharma sector has been a
contentious issue globally.
• Over a period of time , the Indian authorities
have become more sensitized to the need and
importance of IPR protection for the long term
good of industry.
Alternatives to reduce price
• patent opposition
• compulsory licensing
2. Pitfalls to R&D
1. Commitment of huge investment without
any returns for 8-10 years
2. Drug discovery hindered by lack of quqlified
scientists
Challenges in indian pharmaceutical industry due to globalization
Challenges in indian pharmaceutical industry due to globalization
Challenges in indian pharmaceutical industry due to globalization

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Challenges in indian pharmaceutical industry due to globalization

  • 1. CHALLENGES IN INDIAN PHARMACEUTICAL INDUSTRY DUE TO GLOBALIZATION OF IPR Vishnu GM
  • 2. Indian pharmaceutical industry • One of the most successful industries in India. • Ranks 3rd in the volume of production. • Ranks 10th in value. • Produces about 20 %of the world’s drugs. • India has become a prime destination for manufacture of branded and generic drugs with a strong export element.
  • 3. • It is estimated that around 40 % of the generic drugs in the US come from India. • India to be recognized as ‘ Pharmacy of the World’. • Total turn over between 2008-09 :$21 billion • Grown from $0.3 billion in 1980
  • 4. Challenges faced by IPI • Control of the drug price • Regulatory aspects • Research and drug discovery • Patents and intellectual property rights • Health Insurance and Out of Pocket Expenditure • Ethics • Human Resources Requirement
  • 5.
  • 6. • Patented drugs make up approx 8% of total market sales in India. • 92% of Indian drug market is out of patent. • Prior to 2005, only processes were patentable and not the end product. • So, if a company chose to manufacture the same product but used a different process, it could do so without violating Indian patent laws.
  • 7. • With the 2005 ammendment , product patents and process patents have permitted for 20 years . • IPR in the pharma sector has been a contentious issue globally. • Over a period of time , the Indian authorities have become more sensitized to the need and importance of IPR protection for the long term good of industry.
  • 8.
  • 9. Alternatives to reduce price • patent opposition • compulsory licensing
  • 10.
  • 11.
  • 12.
  • 13.
  • 14. 2. Pitfalls to R&D 1. Commitment of huge investment without any returns for 8-10 years 2. Drug discovery hindered by lack of quqlified scientists