인도의 의약특허산업

소개글

인도 의약품 시장의 가격결정과 특허정책 등에 알아보고 이를 둘러싼 이슈들의 해결이 어떻게 진행되고 있는지 분석해본 자료입니다. 고려대학교에서 A+받은 자료입니다.

목차

1. Market Overview
2. Controlling Drug Price
3. Controlling and Decontrolling
4. 4 Major issued in DPCO, 1995
5. Patent policy along with TRIPs
6. Conclusion & Discussion

본문내용

The Control of Formulation
Controlling Drug Price

Step 1. Technical Parameters

- Checking the quantity of bulk drug
used in formulation while comparing it
with formulation’s label claims
- The overage claim is only allowed
① if government fix the norms or
② in case of batch production

The Control of Formulation
Controlling Drug Price

Step 2. Prices of bulk drugs

- Indigenous formulation
① Made of controlled bulk drugs
: Notified price or existed actual price
being considered
② Made of non-controlled bulk drugs
: The available information on
non-scheduled bulk drug prices

The Control of Formulation
Controlling Drug Price

Step 2. Prices of bulk drugs

- Imported formulation
① Benchmark : The landed cost
: including customs duty and clearing charges
is the benchmark to fix prices
② Comparison with applicant- submitted price
: Weighted average import price is considered

The Control of Formulation
Controlling Drug Price

Step 3. Excipient claims
Excipient claims given in the application are examined and allowed after referring to information available in NPPA

The Control of Formulation
Controlling Drug Price

참고 자료

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