Book highlights burning issues on drug regulation in India

    New Delhi, Oct 6 (PTI) Amid the WHO saying cough syrups manufactured by an Indian firm could potentially be linked to the death of 66 children in Gambia, a soon-to-be released book highlights burning issues related to drug regulation in the country and raises crucial questions.
    "The Truth Pill: The Myth of Drug Regulation in India" by Ranbaxy whistle-blower Dinesh Singh Thakur and lawyer Prashant Reddy Thikkavarapu analyses the actions of the institutions that are responsible for the safety and efficacy of the Indian drug supply in the context of the historical evolution of the Drugs Act, 1940 from pre-Independence India to the present day.
    Adulterated medicines are a recurring problem with the Indian pharmaceutical industry due to its failure to follow basic good manufacturing practices (GMP).
    As the authors document in their book, published by Simon & Schuster India, the Indian pharmaceutical industry has had a DEG poisoning problem for a long time now, with the first event being reported in 1972 in Madras.
    That was followed by 4 other DEG poisoning events, the most recent one being in 2020 when 11 children from Jammu died in PGIMER, Chandigarh where they had been taken for treatment.
    The reason that such poisoning events take place is because many pharmaceutical companies in India do not test all excipients before they are used in manufacturing drugs, despite the GMP code expressly requiring such testing, the book says.
    When pharma companies procure propylene glycol to use in the manufacture of cough syrups, they should test it for contamination because DEG adulteration has been a known issue since 1937 when the first mass DEG poisoning event in the US killed over 100 adults and children.
    The US has managed to prevent any repeat incidents but why has India failed? The answer, as the authors have outlined in their book lies in systemic failures at every level of the drug regulatory framework in India.
    Yet the recently-drafted legislation to replace the colonial era Drugs & Cosmetics Act 1940 does little to remedy these systemic issues. This resistance to reform is largely because the regulatory apparatus in India has been "captured" by the pharmaceutical industry which has always put profits above patients.
    Since 2004, when the fraud at Ranbaxy pharmaceutical company first came to light, the Indian pharmaceutical industry and clinical research organisations have been rocked by a series of scandals after investigations by American and European drug regulators. PTI ZMN RB
RB

(This story has not been edited by THE WEEK and is auto-generated from PTI)