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GMP is the hygiene code in pharma production: Dr H Basavanagowdappa
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Nandita Vijayasimha, Bengaluru
June 23 , 2025
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The JSS Academy of Higher Education & Research (JSSAHER) vice chancellor Dr H Basavanagowdappa has pointed out that Indian pharma industry should now think of GMP as the hygiene code for manufacturing. Referring to it as pharmaceutical ‘kitchens’, he insisted that production processes remain consistent, with every step documented, and each finished product proven to be efficacious every time. When such requirements are met, patients will never have to wonder whether their next dose will heal or harm.
India is the pharmacy of the world and for this to sustain the country should lead the world in pharmacy talent. Here JSS pledges to nurture the next generation of pharmacists of the world. They will be ready to uphold and advance good standards wherever they serve, Dr Basavanagowdappa said at the recently concluded National Conference by Indian Pharmaceutical Association (IPA), Mysuru on Enhancing Pharmaceutical Quality Assurance through GMP organised by the PHD Chamber of Commerce and Industry.
Noting that India now ranks third in global drug production by volume and supplies one-fifth of the world’s generic medicines, including 60 per cent of low-cost vaccines, he said the sector is expanding at roughly eight percent annually, with exports growing at nine percent in 2024 alone. Now while we take pride in these achievements, they also magnify our responsibility.
World Health Organization warns that one in ten medicines circulating in low- and middle-income countries are sub-standard or falsified, a statistic that translates into treatment failures, antimicrobial resistance, and avoidable fatalities. We witnessed this reality when contaminated cough syrups linked to tragedies in Gambia and Uzbekistan prompted a global outcry. Closer to home, risk-based inspections led CDSCO to shut over a third of the facilities it reviewed for quality lapses, he pointed out.
At the same time, objective measures show that excellence is well within reach. A recent industry analysis found that only 11 percent of US FDA inspections on Indian sites in 2024 resulted in ‘Official Action Indicated,’ down from 23 per cent a decade ago, which means almost nine out of ten facilities either needed only minor corrections or fully met global standards. Our challenge is to make that level of performance universal across every city, every batch, every shift, he said.
There are several efforts of the Union government to get us to this position. In June 2024 the Ministry of Health notified a modernised Schedule M aligned with WHO-GMP. Beginning July 2025, CDSCO launched nation-wide risk-based inspections. The Revamped Pharmaceutical Technology Up-gradation Assistance Scheme (RPTUAS) offers interest-subsidised loans of up to Rs. 10 crore and credit-linked grants up to Rs. 1 crore to install modern cleanrooms, continuous-manufacturing lines, and real-time analytics. This will show how compliance can become a growth catalyst, helping us aim for USD 55 billion in exports by 2030, stated Dr Basavanagowdappa.
With an outlay of Rs. 6,940 crore, the PLI scheme incentivises domestic production of 41 critical bulk drugs and targets a 75 per cent cut in API imports by 2027 reducing supply-chain vulnerabilities that can compromise quality. Further, there is digital transparency as the CDSCO’s new online portal for issuing and verifying WHO-GMP certificates will go live this year, ending the patchwork of state-level formats and allowing buyers anywhere globally to authenticate an Indian pharma plant’s GMP status with one click. Together, these initiatives form a quality ‘safety net’ that catches problems before they reach the patient and rewards plants that invest in excellence, said Dr Basavanagowdappa.
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