Since 2004, when the fraud at Ranbaxy first came to light, the Indian pharmaceutical industry and clinical research organizations have been rocked by a series of scandals after investigations by American and European drug regulators. More recently, contaminated Indian drugs have been implicated in the deaths of almost a hundred children in Africa and Uzbekistan. The Indian government has responded not with regulatory reform but conspiracy theories about “vested interests” working against India.

More worryingly, the Government of India has also turned a blind eye to an equally serious quality crisis within the country. At times, these quality issues manifest themselves in the deaths of Indian citizens, as happened in early 2020, when 11 children died in Jammu or when 5 patients died in Chandigarh due to contaminated drugs. Additionally, the dodgy drug approval process followed by the Indian regulator has led to the approval of questionable drugs, leading to Indian patients spending their hard-earned money on drugs that have little therapeutic effect.

These twin crises, in the domestic and export markets, is because India has either outdated regulations or no regulations. In a race for growth of the pharmaceutical industry, the Indian state has sacrificed scientific rigour and ignored the basic principles of public health. This timely, important and compelling book based on deep research, questions and analyzes the actions of the institutions that are responsible for the safety and efficacy of Indian drug supply in the context of the historical evolution of the Drugs Act 1940 from pre-Independence India to the present day.