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Urgent need to build a culture of quality in pharma industry amid dramatic increase in US FDA inspections: Experts
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Shardul Nautiyal, Mumbai
April 15 , 2023
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Highlighting the decline in the number of Indian pharmaceutical companies receiving approvals from the US FDA, experts have recommended that there is an urgent need to build a culture of quality in pharma industry amid dramatic increase in US FDA inspections towards compliance and quality assurance.
These deliberations were a part of a workshop on “Hosting Unauthorised Audits and Response to 483” which concluded on April 13, 2023. The two-day event was organised by Bluetech Media with Sotax as Exhibit Partner, FDAlytics as Silver Partner and PharmaMantra as Knowledge Partner. Ashish Chauhan, director, BlueTech Media conducted the proceedings during the workshop.
“Considering the fact that the frequency of inspections have increased dramatically post pandemic because of the backlog mostly from the US FDA, stringent and punitive action is urgently required as per provisions of law including cancellation of licences to weed out non serious industry players. Offences related to spurious drugs should also be made cognizable and non-bailable,” said Dr Sanjt Singh Lamba, managing partner of Trillyum Consulting and Advisory and chief executive officer of Biocuris Pharmaceuticals Private Limited.
“Improvement in law enforcement activities and harmonisation of quality standards as per PICS (Pharmaceutical Inspection Cooperation Scheme) can salvage India’s reputation as the world’s pharmacy,” he said.
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“Modules during the workshop focused around US FDA and EU types of inspections, compliance focus, regulatory inspection management and consequences of non-compliance,” informed Udaykumar K Rakibe, course director and founder, PharmaMantra.
Besides quality assurance, lack of investment in research and development and disruptions caused by the Covid-19 pandemic has impacted India’s resilient supply chain of quality drugs.
“A robust quality culture therefore should be vigilant and proactive, patient-focused, science and risk-based, able to identify issues while they are still small, readily meets good manufacturing practices (GMPs), responsible for assuring any supplier or contract site is qualified to do the function and performed it satisfactorily. It should be supportive of business needs because assuring quality creates higher yield, dependability and sustainability, experts explained.
Madhubhashini Deshmukh, manager, quality assurance, Bharat Pharma (a unit of BEL), Lalitpur, Uttar Pradesh said, “In order to develop quality culture in pharma companies, a radical change in perception of quality and its interpretation need to be imbibed through continuous education of professionals in manufacturing department and quality department of the pharma company.
“The management needs to play a guiding role in daily decisions on myriad issues involving equipment, materials, maintenance, staff qualifications, supervision, process control, and investigations. This will ultimately determine the quality of the drugs that are shipped from a given facility,” Dr Lamba concluded.
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