Comprehension Set – 23

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 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 sub-continent-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 provisions 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 show a 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 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 home 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 date 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, the 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?

1. Which of the following is a reason for India’s continuing battle with commonplace diseases?

(a) Rigid patent laws mean essential foreign drugs are not easily available in India.

(b) Newer more effective treatments and drugs are unaffordable.

(c) Government does not adequately subsidise drugs required for treatment of these diseases.

(d) Research and development of drugs for such diseases is taken up only by advanced countries.

(e) None of these

2. Which of the following is/are TRUE in the context of the passage?

(A) Countries like China prefer to outsource research at home.

(B) Multinational pharma companies are pressuring India to have product patent

(C) The Indian pharmaceutical industry is booming.

(a) Only A

(b) Only C

(c) Both B and C

(d) Both A and B

(e) None of these

3. According to the passage, what is the main purpose of data protection laws?

(a) To ensure that foreign countries invest in research for drugs to treat diseases like TB

(b) To attract Indian scientists back to the country

(c) To prevent misuse of research to make profit by competing companies

(d) To make clinical trials more acceptable to the public

(e) None of these

4. Which of the following measures has Korea taken to be competitive in the pharma industry?

(a) It offers blockbuster drugs at highly subsidized rates.

(b) It collaborates with foreign research firms.

(c) It provides regulatory approvals.

(d) It enacts relaxed tax laws.

(e) None of these

5. Which of the following is/are India’s strengths in drug discovery and research?

(A) Relaxed patent laws

(B) Reverse engineering of foreign blockbuster drugs

(C) Incentives to foreign companies researching subcontinent diseases

(a) Only C

(b) Both A and C

(c) Only A

(d) All of these

(e) None of these

6. According to the author, what is the disadvantage of holding clinical trials abroad?

(a) Research facilities in India are far more sophisticated.

(b) Authenticity of research methodology cannot be monitored.

(c) Delayed processing of test data

(d) Higher cost resulting in the drain of financial resources

(e) The laws abroad are more stringent.

7. The argument against making data exclusivity a law is:

(A) specialized knowledge will be shared.

(B) it will unfairly favour large western pharma companies.

(C) it is not in the interest of the general public.

(a) Only A

(b) Both A and C

(c) Only C

(d) Both B and C

(e) None of these

8. What is the objective of the TRIS agreement?

(a) To allow the government to determine the focus of drug research conducted

(b) To ensure India meets international legal requirements

(c) To give developed countries an edge in pharma manufacturing

(d) To ensure that competing companies do not benefit commercially from using each other’s clinical data

(e) None of these

9. Which of the following is NOT TRUE in the context of the passage?

(a) Costs of clinical trials and research are relatively lower in India.

(b) India has laws to ensure patent protection but data exclusively provisions are not prevalent.

(c) China has a large number of well-qualified clinical research personnel which has made it attractive to MNCs.

(d) Indian pharma companies can no longer duplicate patent-protected foreign drugs.

(e) None of these

10. The Indian pharma industry

(a) is hampered by severe intellectual property rights laws

(b) trails in research on health threats like obesity

(c) is the largest growing one in the world

(d) only has the expertise to reverse-engineer drugs

(e) provides quality research at low cost

Directions (Q.11-13): Choose the word/phrase which is most nearly SAME in meaning as the word printed in bold as used in the passage.

11. PREVAILING

(a) popular

(b) implemented

(c) existing

(d) persuading

(e) winning

12. HURDLES

(a) bars

(b) defects

(c) rejections

(d) protests

(e) obstacles

13. INCURRED

(a) collected

(b) included

(c) spent

(d) experienced

(e) adjusted

Directions (Q.14-15): Choose the word/phrase which is most OPPOSITE in meaning of the word printed in bold as used in the passage.

14. FLOURISHING

(a) drooping

(b) declining

(c) fluctuating

(d) opposing

(e) lacking

15. VITAL

(a) practical

(b) voluntary

(c) negative

(d) worthless

(e) minimum

Answer key:

1. (d) 2. (c) 3. (c) 4. (d) 5. (e) 6. (d) 7. (d) 8. (d) 9. (c) 10. (d) 11. (c) 12. (e) 13. (d) 14. (b) 15. (d)

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