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Actions of a few non-compliant entities should not tarnish the reputation of entire industry: Dr Shenoy
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Nandita Vijayasimha, Bengaluru
October 14 , 2025
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The actions of a few non-compliant pharma companies such as the one allegedly linked to the recent cough syrup deaths of several children in Madhya Pradesh and Rajasthan must not be allowed to tarnish the reputation of the entire industry, said Dr Premnath Shenoy, former director QA RA and patient safety, AstraZeneca and immediate past president, Indian Pharmaceutical Association, Karnataka state branch.
Regulatory authorities play a critical role in upholding standards and protecting patient safety. It is a shame that even after about 5 decades of similar incidents happening in Maharashtra, regulators have failed to address the issue, he added.
On this occasion of World Standards Day, 2025 observed annually on October 14, companies observe the pivotal role of standards in safeguarding public health and ensuring quality. This year’s theme is ‘Shared vision for a better world: Spotlight on SDG 17 – Partnerships for the Goals’. Members of the ISO (International Organization for Standardization) among others who develop the voluntary technical agreements that are published as international standards pay tribute to the collaborative efforts of thousands of experts worldwide.
According to Dr Shenoy, Indian pharmaceutical sector has been instrumental in improving health outcomes, extending life expectancy, and alleviating suffering for millions both within India and across the globe through the provision of affordable medicines. India rightly holds the title of Pharmacy of the World, and with continued commitment to quality and ethics, it will retain this distinction for decades to come.
Calling for the need to reinforce trust and accountability, Dr Shenoy listed seven action plans for regulators. First is to ensure transparency of the publicly uploaded inspection reports of all pharmaceutical units on the websites of respective state drug control organizations.
Second is to uphold integrity and take a solemn pledge to never overlook non-compliance in exchange for minor inducements. Patient safety must never be compromised. Third is to enforce the law with no leniency on companies that violate regulatory norms.
Fourth is to prioritize quality over lobbying without delaying the implementation of the revised Schedule M under pressure from vested interests. Even if closures or job losses occur, Dr Shenoy urged the industry that quality is non-negotiable and patient lives are invaluable.
Fifthly, there is a need to mandate biannual inspections and conduct checks twice a year and make the reports publicly accessible. Sixth, address staffing gaps. Here the regulatory heads and health secretaries must urgently fill vacant positions. Many systemic issues stem from understaffed drug control departments. Seventh, there is a need to invest in training by engaging qualified experts to train inspectors on the updated requirements of Schedule M, said Dr Shenoy.
On a concluding note, Dr Shenoy urged Indian pharma industry to reaffirm its collective commitment to high standards, ethical governance, and the protection of public health.
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