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, the Indian pharmaceutical industry has been implicated in close to a hundred deaths in Africa and Uzbekistan due to the supply of contaminated cough syrup. While the West has responded to concerns about quality of “Made in India” medicine by blocking exports from many Indian pharmaceutical companies, the Indian government responded not with regulatory reform but conspiracy theories about “vested interests” working against India.More worryingly, the Indian state has also turned a blind eye to a far more serious quality crisis in its domestic pharmaceutical market. At times, these quality issues manifest themselves in the deaths of Indian citizens as happened in early 2020 when 11 children died in Jammu because of adulterated cough syrup or when 5 patients died in Chandigarh due to contaminated drugs. Additionally, the dodgy drug approval process has led to the Indian regulator approving sales of drugs that have never been approved by regulators in the developed markets, leading to Indian patients spending their hard-earned money on questionable drugs.These twin crises, in both the domestic and export markets, is because India has either outdated regulations or no regulations in some areas. In a race for growth of the pharmaceutical industry, the Indian state has sacrificed scientific rigour and ignored the basic principles... See more
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, the Indian pharmaceutical industry has been implicated in close to a hundred deaths in Africa and Uzbekistan due to the supply of contaminated cough syrup. While the West has responded to concerns about quality of “Made in India” medicine by blocking exports from many Indian pharmaceutical companies, the Indian government responded not with regulatory reform but conspiracy theories about “vested interests” working against India.More worryingly, the Indian state has also turned a blind eye to a far more serious quality crisis in its domestic pharmaceutical market. At times, these quality issues manifest themselves in the deaths of Indian citizens as happened in early 2020 when 11 children died in Jammu because of adulterated cough syrup or when 5 patients died in Chandigarh due to contaminated drugs. Additionally, the dodgy drug approval process has led to the Indian regulator approving sales of drugs that have never been approved by regulators in the developed markets, leading to Indian patients spending their hard-earned money on questionable drugs.These twin crises, in both the domestic and export markets, is because India has either outdated regulations or no regulations in some areas. 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.
