Masterarbeit

The Regulatory Framework concerning the Import of Medicinal Products in India and in the European Union (e.g. Germany)

Dr. Sanjiv Verma (2008)

Language: English

Due to the policy of each pharmaceutical company and due to different price control methods and the different Gross Domestic Product (GDP) of each country the price of the same or similar medicinal product is different in most countries. These price differences e.g. for generics or patented products together with the globalisation trend and continuously rising pharmaceutical expenditure leads to a considerable increase of global import and export activities.

Germany and India are very interesting countries with respect to import and export of medicinal products. Germany is the largest pharmaceutical market in Europe whereas the healthcare industry in India is one of the fastest growing industries worldwide. The growing demand on quality pharmaceuticals and the new patent regulations since 2005 could increase market attractiveness of the Indian market for international companies.

The main objective of the thesis is to give both an overview on the regulatory requirements for the import of a common western medicinal product into India and into Germany and also the parallel import. The import activities and the required regulatory documents depend on the drug as well as on the drug quantity to be imported towards India and Germany respectively. Different regulatory situations are identified and a supportive tool in respect of the identification of each regulatory situation is given. For planning an import of a common medicinal product time duration, costs and other basic elements for different regulatory activities are outlined. Finally the actual import situation in Germany and in India from the regulatory point of view is compared. To sum up also the actual European and global situation with regard to import of medicinal products some global scenarios are illustrated and potential prospects are presented.

Pages: 83