CSIR CRRI JSA (Paragraph 55)

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The Indian pharma industry is flourishing overseas, touching almost every part of the world. With low cost, speed and high quality advantage, India is gearing up to become the hub for contract research and manufacturing. Having a competitive edge is, one thing and maintaining it is another. Canada provides tax benefits up to 6 percent for research carried out within the country. Others like Korea and China without a large pool of scientists make up by facilitating foreign research in every conceivable way. India does not do any of this and faces many hurdles - diseases that it has been inflicted with since independence like Malaria and TB while Indian companies have only focused on reverse engineering blockbuster drugs from MNCs, overseas scientists have displayed little interest in researching sub-contiment specific diseases as there are more profits and public interest in lifestyle drugs such as obesity which in turn fund their research. In the interest of Indian research industry a decision must be taken quickly on the implementation of data protection laws. India is one of the few countries where data exclusivity provisions are not prevalent. Data protection is a contentious issue, wholly debated by the government and the industry. A pharma company wishing to market a drug is required to submit data to the drug controller to show that the drug is both effective and safe. The first (originator) company that makes the application for marketing approval has to submit its data relating to the clinical trials to the drug controller, who once satisfied that the drug is safe and effective will register it. Another drug company wishing to market the same drug only requires to show a bioequivalence company. Thus, as per the prevailing laws, the regulator in India can rely on an innovator's data to approve the competitor's product. While the system in general is responsible for maintaining the necessary secrecy, it is not accountable for the same-the competitor gets an unfair advantage over the innovator even when he is clandestinely abusing an innovator's intellectual property.