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Strengthening Pharmaceutical Manufacturing Standards

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22 Aug, 23 05:55
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Strengthening Pharmaceutical Manufacturing Standards

The recent directive from the Union Government mandatingpharmaceuticalcompaniestoadoptGoodManufacturing Practices (GMP) in line with WHO regulations is a crucial step towards ensuring drug safety and quality in India. With an emphasis on companies with an annual turnover exceeding Rs 250 crore, the government has set stringent timelines for compliance – six months for larger firms and 12 months for others. Penalties will be imposed on those failing to adhere to the deadlines. This move comes amidst troubling reports, such as the case of a Madhya Pradesh-based pharma firm being asked to halt the manufacturing of acoughsyruplinkedtochild deathsinCameroon.Similar incidents involving pharma companies from Haryana and Uttar Pradesh were connected to child fatalities in the Gambia and Uzbekistan, respectively. These unfortunate events have not only impactedthecredibilityofIndianpharmaceuticalfirmsbutalsodiminished India's standing as the 'pharmacy of the world', particularly in the Global South. What adds to the concern is that only a small fraction of India'spharmamanufacturingunits–predominantly theMicro, Small, and Medium Enterprises (MSMEs) – possess WHO GMPcertification.Recentinspectionsbydrugregulatorshave revealed numerous irregularities, including poor documentation, lack of analytical validation, failure to investigate quality issues, and absence of internal product quality reviews. The government's attempts at encouraging self-regulation amongpharmacompanieshavenotyieldedthedesiredresults, making it evident that a mandatory compliance approach is necessary. However, implementing mandatoryGMPcompliance may not be a smooth journey unless immediate action is taken to address the gaps in the regulatory system. There can be no compromise on the quality and safety of drugs manufactured in the country, whether for domestic consumption or export purposes. To safeguard public health and maintain India's reputation as a reliable pharmaceutical exporter, exemplary action must be taken against companies found to be at fault. It is imperative that the government, regulatory bodies, and pharmaceutical industry work togetherto ensure a robust andeffectiveGMPframework.This includesaddressingissues related to documentation, analytical validation, quality investigation, and internal product reviews. Furthermore, support should be extended to MSMEs to enable them to attain GMP certification and adhere to the highest standards. ByadoptingacollaborativeandrigorousapproachtoGMP compliance, India can bolster the quality and safety of its pharmaceutical products, not only benefitting its citizens but also reinforcing its position as a trusted supplier of medicines worldwide.


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यह खबर निम्न श्रेणियों पर भी है: Editorial
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