Failure of the new patent system: Prerequisites associated with Sec 3(d) of the Patent (Amendment) Act 2005 restrict the copyright of an existing drug. Moreover, mandatory licensing permits Indian companies to keep producing generics of copyright products for overseas selling to underdeveloped nations.
Lack of proper infrastructure: Issues associated with regular power cuts and lack of suitable transport infrastructure will decelerate the expansion of the sector.
Inadequate funds: Restricted funding from FIs, venture capitalists and the government may decelerate the expansion of biotechnology sector in India.
Regulatory impediments: Rising of due meticulousness and conformity with product standards leads to high costs and interruption in the launch of new products.
Severe competition: Low margins and restricted capital to assist R&D is the result of intense pricing competition among local producers. This rivalry will further deepen from the joining in of the big drug companies in the Indian market to control the cost benefit and large reserve sources.