12 Questions
What attracts global pharmaceutical companies to India?
Lower cost of production due to various factors
What is an advantage of conducting clinical trials in India?
Speedier and less expensive trials with a vast patient pool
What is a significant feature of India's pharmaceutical industry?
Maximum number of USFDA approved plants outside the US
What was amended in March 2005?
India's patent law
What is a concern that was alleviated post-TRIPS?
Protection of intellectual property rights
What is a characteristic of India's IPR framework post-TRIPS?
Well-established statutory, administrative, and judicial frameworks
How many years of protection is a patented invention given in India?
20 years
Which of the following international trademarks has been protected in India through judicial decisions?
Volvo
What type of programs can be patented in India?
Computer programs having technical applications to industry and in combination with hardware
How are trade secrets and know-how protected in India?
Through contractual obligations and the common law
What type of patents are recognized for pharmaceutical products in India?
Both product and process patents
What is a disadvantage of a private company compared to a public company?
Restrictions on invitation to the public to subscribe to securities
Study Notes
India's Pharmaceutical Market
- India offers a big market for both life-saving and lifestyle drugs
- The country has a large number of medical colleges (>300) and hospitals (>20,000)
- India has a potential for conducting research and development activities
Advantages of India for Pharmaceutical Companies
- Low cost of production due to lower labor costs and raw material costs
- Existing manufacturing capability to produce active pharmaceutical ingredients (APIs) and intermediates at lower cost while maintaining quality
- India has a maximum number of USFDA approved plants outside the US
- Ease of conducting clinical trials and bioavailability and bioequivalence studies due to a vast patient pool and speedier trials
Intellectual Property Rights (IPRs) in India
- Prior to TRIPS, IPR protection was a concern for global pharmaceutical companies
- Post-TRIPS, India has established statutory, administrative, and judicial frameworks to safeguard IPRs
- Patented inventions (including products) are now given 20 years of protection in India
- International trademarks, computer software, and databases are protected through judicial decisions and court orders
- Trade secrets and know-how are protected under common law and through contractual obligations
- India's patent law recognizes both product and process patents for pharmaceutical products
Private Companies in India
Advantages
- Less stringent regulation compared to public companies
- More flexibility in conducting operations, including management, securities issuance, and managerial remuneration
- Faster incorporation process
Disadvantages
- Restrictions on inviting the public to subscribe to securities
- Limited exit options
Learn about the opportunities and potential for global pharmaceutical companies entering the Indian market, including factors such as low production costs and a large market for various types of drugs.
Make Your Own Quizzes and Flashcards
Convert your notes into interactive study material.
Get started for free
