Podcast
Questions and Answers
What attracts global pharmaceutical companies to India?
What attracts global pharmaceutical companies to India?
- Limited medical colleges and hospitals
- Difficulty in conducting research and development activities
- Higher labour costs and raw material costs
- Lower cost of production due to various factors (correct)
What is an advantage of conducting clinical trials in India?
What is an advantage of conducting clinical trials in India?
- Limited access to medical colleges and hospitals
- Higher cost of production
- Longer and more expensive trials
- Speedier and less expensive trials with a vast patient pool (correct)
What is a significant feature of India's pharmaceutical industry?
What is a significant feature of India's pharmaceutical industry?
- Limited number of USFDA approved plants
- Maximum number of USFDA approved plants outside the US (correct)
- No existing manufacturing capability
- Higher labour costs and raw material costs
What was amended in March 2005?
What was amended in March 2005?
What is a concern that was alleviated post-TRIPS?
What is a concern that was alleviated post-TRIPS?
What is a characteristic of India's IPR framework post-TRIPS?
What is a characteristic of India's IPR framework post-TRIPS?
How many years of protection is a patented invention given in India?
How many years of protection is a patented invention given in India?
Which of the following international trademarks has been protected in India through judicial decisions?
Which of the following international trademarks has been protected in India through judicial decisions?
What type of programs can be patented in India?
What type of programs can be patented in India?
How are trade secrets and know-how protected in India?
How are trade secrets and know-how protected in India?
What type of patents are recognized for pharmaceutical products in India?
What type of patents are recognized for pharmaceutical products in India?
What is a disadvantage of a private company compared to a public company?
What is a disadvantage of a private company compared to a public company?
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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
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