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Quality flaws in pharmaceutical products are a matter of serious concern: Dr Girish Pait pharma export & medical tourism: Dr RB Smarta
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Nandita Vijay, Bengaluru
July 07 , 2020
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Quality issues in a pharmaceutical product are a matter of serious concern. This is because it affects patients and its implications are dangerous and life-threatening, said Dr Girish Pai K, assistant professor, Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences.
The key aim of a pharmaceutical manufacturer is to achieve zero defect. But due to the complex processes, various challenges, market competition, regulatory hurdles and associated factors, defective products which escape stringent quality checks reach the consumer. This tarnishes the goodwill and reputation of the pharma company, he added.
India is referred to as the pharmacy of the world. It accounts for the highest number of US FDA approved production units surpassing that of the US. However, it has been receiving a slew of FDA observations that were severe in nature ranging from 483s to warning letters, penalties and import alerts.
Most of the product recalls were attributed to minor issues that could have been avoided, provided the personnel involved had a good sense of observation and commitment. The profession of pharmaceuticals is dependent on current Good Manufacturing Practices (cGMPs), safety and efficacy of the product. Quality is an important parameter that makes any consumer confident, Dr Pai told Pharmabiz.
At times, with a lack of awareness, the end-user unknowingly consumes these defective products, which may lead to serious complications. Poor sense of observation or casual approach by personnel across areas like manufacturing, pharmacy outlets, and hospital set-ups are mainly responsible for such errors, he said.
Looking at a series of events, the book ‘Pharmaceutical Consumer Complaints’ was authored to bring in a sense of quality consciousness. It was conceptualized in 2017 to capture real-life cases to educate the students. It took almost 4 years to encapsulate 50 defects which can be a reference guide for faculty in academia, technical staff in pharma industries as a training & development module besides being as a ready-reckoner for dispensing pharmacists, said Dr Pai.
The key objective of the book is to highlight the importance of GMP and ethics right from the academic curriculum so that the fundamentals are sound with regard to its commitment towards quality.
The book highlights live examples masking company and product information but point out to product defects with information like dosage form, description of defects/complaints, probable root causes, preventive measures, remediation and clinical significance. These complaints have been presented along with illustrations, he said.
The book is in the process of completion. It will be available in leading book houses and distributors across the country. The co-editors are Dr Muddukrishna BS, Faculty, Department of Pharmaceutical Quality Assurance, MCOPS, MAHE, Manipal and Dr Richa Dayaramani, Principal, Professor of Pharmaceutical Quality Assurance, Khyati College of Pharmacy, Palodiya, Ahmedabad.
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