Ropes & Gray LLP (JD Supra India)
India Finalizes Rules Regarding Compensation for Subjects Injured in Clinical Trials and Post-Trial Access to Study Drugs
Since 2013, India’s clinical trials regulatory framework has undergone continuous, significant changes to bolster protections for clinical trial participants. In an effort to clarify these evolving requirements relating to clinical trials, on February 1, 2018, India’s Ministry of Health and Family Welfare (the “MoHFW”), in supersession of India’s Drugs and Cosmetics Rules, 1945, issued new draft...
Key Amendment to India’s Anti-Corruption Legislation Has Significant Implications for Multinationals Doing Business in India
In late July 2018, India’s parliament passed an amendment to the Prevention of Corruption Act 1988 (the "PCA"), India’s principal legislation for combating bribery and corruption involving public officials. The Prevention of Corruption (Amendment) Act, 2018 (the "Amendment") introduces changes that have considerable significance for multinational corporations (“MNCs”) doing business in India. In...
India Supreme Court Clarifies Standard for Enforcement of Indian Prevention of Corruption Act
Earlier this year, the Supreme Court of India clarified the standard necessary to prove violations of India’s Prevention of Corruption Act, 1988 (“PCA”), in a ruling that may limit enforcement of the PCA and that has potential ramifications for multinational companies operating in the country. The PCA is India’s major anti-corruption law, and is designed to combat corruption in government...
India Supreme Court Rules that Private Bankers Operating in India Are “Public Servants,” Significantly Expanding Anti-Corruption Risks
The Supreme Court of India recently issued a landmark ruling that may significantly expand the risk companies face under the U.S. Foreign Corrupt Practices Act (“FCPA”) and similar anti-bribery statutes across the world. On February 23, 2016, the Supreme Court held that employees of all banking companies, foreign and domestic, are “public servants” under India’s Prevention of Corruption Act, 1988