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Export-Import Policy: While ensuring the highest quality standards of drugs produced in India, it is also important that the norms that govern imports into the country are strengthened and internationally comparable so that the domestic industry is not harmed in the post -product patent era. A set of such norms are under active consideration by the government. These include a fee structure and a new registration system for exports in to India. The major highlights of the proposed norms are: 

The exporting firms have to pay Rs. 75000 as fees for registration with Indian licensing authority and an additional Rs. 5000 for each product. The maximum registration fee for a single firm is Rs. 100000. The registration certificate is valid for five years.

• The foreign manufacturers are required to bear the expenses for the licensing authority's inspection of manufacturing facilities as well as the testing fee to be paid to Indian laboratories. 

• Drugs prohibited in the country of origin would not be allowed to be imported into India. The regulating firm has to furnish manufacturing license, lists of drugs and formulations approved for marketing in the country of origin, GMP certificate conforming to and a warranty certificate stating that the manufacturer would adhere to Indian regulatory norms. 

• Another important step will be the establishment of an export promotion Council of pharmaceuticals.

Recommendations to Policy makers:
Government has to restructure its role from that of protector to that of a promoter and facilitator for long-term development of Pharmaceutical industry. Hence, besides providing basic infrastructure including low cost Power, Fuel, Raw material and low cost finance the measures such as setting up the tech incubators to assist the growth of this industry, are very much required.

Large size Pharmaceutical companies should be encouraged to take advantage of the provision of 24% equity share in small and medium size industry. This will go a long way in supporting SSI tech upgradation and modernization.

There is a need to create and strengthen special cells with legal backup to deal with the WTO related problems of some of the pharma industry in concerned departments.

There is an urgent need to create a single regulatory agency for Bio-Pharmaceutical products. Today, biotechnology products need to seek approvals from four regulatory authorities. This will enable the streamlining and simplifying of the procedures for Regulatory approval. It is also expected to help companies achieve regulatory compliance with high levels of clarity and accountability. 

Subsidies for R&D and weighted income tax deduction status for R&D spend of Pharmaceutical industry beyond March 2005 should be actively considered as Indian Pharmaceutical companies are at a crucial point of evolution, and the continuation of this incentive will assist them to allocate higher funds for research and technological upgradation.

Government must strengthen the antidumping measures and decrease excise duties on the raw material.