safety arising under the law, and regulators can seek civil compensation for victims in that forum in addition to fines and penalties.71 The officers have exclusive jurisdiction of cases arising under the Act, placing it outside the authority of the regular civil courts.72

Although the substantive rules for liability do not appear as friendly as under U.S. law, India has taken significant recent steps toward increasing the access of plaintiffs to legal remedies under the product liability system through its consumer legislation. However, institutional problems caused by docket congestion and corruption plague the effectiveness of the civil justice system, and place in question its ability to serve as a backstop for product safety.

China

China’s legal and regulatory system is a product of civil law, Soviet law, and common law influences. China’s approach to FDA-product regulation is primarily state-centered. It relies heavily upon government agencies to conduct inspections and to penalize violations, either through fines or criminal prosecution. Usually, these are organized as periodic crackdowns, and in recent years, such campaigns have been waged on identified products of public concern, such as dairy and cooking oil.73

With respect to the substantive law, China formally adopted a tort law in 2009 that re-codified and provided greater detail on the scope of tort liability in various specific areas. It provides for strict liability for defective products.74 A defect is an “unreasonable danger existing in a product” that “endangers the safety of human life” or is not compliant with relevant safety standards.75 It appears that Chinese law also includes a development risk clause similar to the European one.76 In its new Food Safety law, China also provided for damages equivalent to 10 times the cost of the product if

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71 Food Safety and Standards Act, 2006, No. 34, secs. 65, 68, 70 (compensation provisions and powers of Adjudicating Officer and Appellate Tribunal).

72 Food Safety and Standards Act, 2006, No. 34, sec. 72.

73 See, e.g., Zhang Yan and Cao Yin, 32 held in ‘gutter oil’ crackdown, China Daily, Sept. 14, 2011, at http://europe.chinadaily.com.cn/china/2011-09/14/content_13682763.htm (last visited Nov. 7, 2011).

74 Tort Law (promulgated by Standing Committee of the National People’s Congress, Dec. 26, 2009, effective July 1, 2010), art. 41, translated in World Intellectual Property Organization, at http://www.wipo.int/wipolex/en/text.jsp?file_id=182630 (last visited Nov. 7, 2011) (P.R.C.).

75 Product Quality Law (promulgated by Standing Committee of the National People’s Congress, Feb. 22, 1993, amended and effective July 8, 2000), art. 46, translation at the Ministry of Science and Technology of China, http://www.most.gov.cn/eng/policies/regulations/200501/t20050105_18422.htm (last visited Nov. 7, 2011) (P.R.C.).

76 Product Quality Law, art. 41(3).



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