There is a web of regulations in the research – intensive, highly dynamic pharmaceutical sector Industry regulates the entire drug life cycle, including the patent application competitions with generics, marketing approval, and patent expiration. Regulation also controls all prescribing physicians, Wholesalers, Retailers, and Manufacturers in the pharm industry. The political factors that impact the profitability or chances of survival of the company are quite diverse.

1. IMPACT OF
POLITICAL ENVIRONMENT
ON
PHARMACEUTICAL COMPANY

2.  IMPACT
1) Regulates the import
2) Manufacture
3) Distribution
4) Sale of drugs in India

3.  International Conference on Harmonization of Technical Requirements
 IMPACT
1) Guidelines defining quality, safety, efficacy & related aspects
for developing Nations
2) Registering new medicinal products in Europe, Japan and
U.S.A.

4.  National Pharmaceutical Pricing Authority (NPPA)
 IMPACT
1) Control price
2) Describe 76 medicine’s price – how to be calculated
3) Various rules and guideline for setting up price

5.  Agency of U.S.A. that is concerned with international public health
 IMPACT
1) Directing and coordinating authority on international health
work
2) Work as technical assistance, help in emergencies,
necessary aid upon the request or acceptance of
Governments
3) Co-ordinated with various government to form health policies

6.  Objectionable Advertisement Act
 IMPACT
1) Provides to control the advertisements regarding drugs
2) Prohibits the advertising of remedies alleged to possess
magic qualities