Andhra University (AU) and US Food and Drug Administration (USFDA) will jointly organise a two-day workshop on ‘Current Good Manufacturing Practices (CGMP)‘ here on the university campus from February 23. The workshop will be held in Dr. YVS Murthy Auditorium and AU College of Pharmaceutical Sciences Auditorium, said Vice-Chancellor P.V.G.D. Prasad Reddy.
Speaking to reporters here on Tuesday, Prof. Prasad Reddy said a team from the prestigious U.S. drug regulatory body FDA, headed by Dr Carmelo Rosa, will deliver the keynote address on pharma regulatory issues, basic and advanced good manufacturing practices.
“This workshop is a first between USFDA and any other university out side the USA, and is expected to be attended by around 300 pharma industry top management personnel, academicians, Indian drug regulatory members, scholars and post graduate students of pharmacy institutions across the country,” he said.
Deva H Puranam, Head of Global Quality Investigations at Viatris, a global healthcare company, and also alumnus of the AU, said the USFDA regularly checks the quality of Indian pharma products before allowing them into the US. Post COVID-19, USFDA intensified its inspections and expressed dissatisfaction with the quality of products due to fall in standards, he added.
“Number of pharma companies in India are about 3,000. Of them, about 500 pharma companies export pharma products to the US. These companies are registered with the USFDA, which then checks their quality. The average growth rate is 18% every year, and sometimes it decreases. The annual export value of pharma products from India to the US is around $6.5 billion,” Mr. Puranam told The Hindu.
If a drug exported to the US appears to be adulterated, misbranded and unapproved, entry may be denied. The FDA inspects and analyses drug samples to ensure they meet applicable standards and label requirements. Prescription drugs, investigational new drugs, OTC drugs and active pharmaceutical ingredients are the type of drugs exported to the US, he added.
Regulatory issues
AU College of Pharmaceutical Sciences Principal Y. Rajendra Prasad said that the workshop will focus on regulatory issues of the pharma industry during manufacturing and testing for export of drugs to the US, and the inspection by the USFDA team. The topics to be covered in the workshop will be useful for students and faculty in enhancing their knowledge, he added.
