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Target the International market :
In the U.S. market alone, drugs with annual sales of more than $60 billion face patent expiration over the next decade; 13 of the leading 35 molecules will lose protection over the next five years. The main impetus is the promise of 180 days of generic exclusivity for the first ANDA with Paragraph IV certification; that is, claiming that it does not infringe the brand manufacturer's patents.
The US & European market is the largest and accounts for nearly 75% of the total pharmaceutical sales worldwide. Market is growing because of inclusion of Latam market (Brazil, Chile, Colombia, Mexico, Venezuela and Curacao) & East European countries (Malta, Poland, Czech, Estonia, Greece, Cyprus and Turkey). Roche -Bolar is a provision in the US "Hatch Waxman Act" which created favorable situation for a sizable number of pharma industry in India as they have capability in reverse engineering at lowest cost.
The Indian companies will have to get ANDAs for each dosage form for selling generic formulations in the international market. The critical part then is the marketing tie-up with international pharma majors. Other pharma industries will have to source bulk actives from suppliers with US FDA approval or with a manufacturing facility with USFDA approval.
POLICY ASPECTS: An enabling policy framework is a necessary prerequisite for the growth of any industry. The policy regime significantly impacts areas like pricing and taxation, quality exports and imports, research and development etc.
Taxation and Pricing: The total indirect tax burden on the consumer by way of customs and excise duty, sales tax, octroi etc. works out to be 37 per cent. The industry feels that increase in these or other taxes (like those on export earnings) will restrict subsidization of the domestic market. Associations of pharmaceutical manufacturers like OPPI and IDMA have been demanding a reduction in indirect taxes on medicines. Some of the specific demands are:
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Reduction in duty on vaccines to the lowest possible level;
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Same treatment to products that are subjected to state and central excise duties;
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Exemption of up to 50 per cent of income tax on foreign remittances received
for clinical trials on behalf of foreign or parent company.
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Full exemption on royalties received from certain foreign enterprises on account of R&D.
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