Read the passage and answer the following questions:
The Indian pharmaceutical 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 46 per cent 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 subcontinent 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 exclusively provision are not prevalent. Data protection is a contentious issue, hotly 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 shows bioequivalence to the drug of the originator 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.
Consequently, research-based pharma companies are being forced to undertake vital clinical trials abroad. Huge expenditures are incurred overseas, draining precious foreign exchange when this could be done at a fraction of the cost. The product patent law protections required by the TRIPS agreement and brought about by the 2005 amendment to the Patent Act require India to protect undisclosed test data from disclosure and unfair commercial use by competitors. Effective 2005 Indian Companies can no longer copy patent protected foreign drugs. Some negate the necessity to make data exclusivity a law. They argue that the advocates of making it a law, MNCs want the data to be protected absolutely for a period of 5 years. However, in case certain drugs are not available or unaffordable should the government for the common good not be able to exercise powers to get another company to make such drugs?