In 2019, the US Food Drug Administration (FDA) issued warning letters to 19 Indian pharma giants. The number has drastically increased from 10 companies in 2018. The USFDA issues warning letters to pharma companies if the products do not meet specific regulatory requirements. The warning letter makes clear that the company must correct the problem and plan in a timeframe to inform FDA for its correction, according to USFDA.
Some of the key reasons for receiving warning letters include data integrity, insufficient documentation, misleading claims about the efficacy and risks associated with the use of a drug product, significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals and Active Pharmaceutical Ingredient (APIs), commercialization of unapproved or misbranded drugs.
Indian companies are at paramount of receiving warning letters owing to the rise in an inspection by the USFDA. Sharing his views on this Sudarshan Jain, Secretary-General, Indian Pharmaceutical Alliance (IPA), Mumbai says “There is an increase in FDA inspections in India from earlier 13 percent in 2018 to 17 percent YTD 2019 of global inspections this year. This is obvious given India’s contribution to the US healthcare system as every third tablet sold in the US is from India.” The USFDA which has established its office in India in 2008 has increased its inspections. In 2017, USFDA has 147 inspections which have gone up to 192 in 2018. In 2016 the number inspections done by USFDA were 176.
“India is crucial for the US market as India has got the highest number of FDA approved manufacturing facilities. Hence, vigilance on India would always be high and any issues related to quality in the US due to Indian players will bring FDA vigilance under criticism as well”, says Prashant Khadayate – Practice Head, Healthcare, GlobalData.
This story is from the February 2020 edition of Bio Spectrum.
Start your 7-day Magzter GOLD free trial to access thousands of curated premium stories, and 9,000+ magazines and newspapers.
Already a subscriber ? Sign In
This story is from the February 2020 edition of Bio Spectrum.
Start your 7-day Magzter GOLD free trial to access thousands of curated premium stories, and 9,000+ magazines and newspapers.
Already a subscriber? Sign In
Early Diabetic Retinopathy Detection Remains a Challenge
The Vitreo Retinal Society of India (VRSI) and the Research Society for the Study of Diabetes in India (RSSDI) have formulated a first-of-its kind diabetic retinopathy (DR) screening guideline to help physicians and diabetologists in India educate their patients about DR.
Promega unveils GloMax Galaxy Bioluminescence Imager for illuminating protein dynamics in real time
US-based Promega Corporation, a life-sciences research partner dedicated to providing intuitive tools that empower scientists to innovate, has unveiled the new GloMax Galaxy Bioluminescence Imager.
Qiagen launches QIAcuityDx digital PCR system for clinical testing in oncology
Qiagen N.V. has announced the launch of the QIAcuityDx Digital PCR System, a pivotal addition to its digital PCR portfolio now expanding into clinical diagnostics.
Thermo Fisher introduces iCAP MX Series ICP-MS to simplify trace elemental analysis
Thermo Fisher Scientific Inc. has launched the Thermo Scientific iCAP MX Series ICP-MS to simplify trace element analysis with inductively coupled plasma mass spectrometry (ICP-MS).
Singleron, Bioscreen to enhance access to single cell multi-omics solutions for Indian researchers
Singleron Biotechnologies, a leading innovator in single cell multi-omics solutions, has announced a strategic partnership with Bioscreen, a renowned distributor of advanced life science products in India.
IIT Madras identifies enhanced drug delivery method for eye treatments
Researchers at the Indian Institute of Technology Madras (IIT-M) have demonstrated how drugs injected in the human eye can be better delivered to the target region through ‘convection caused by mild laser heating’.
IIT Madras develops indigenous POCUS scanner for sports injury diagnosis
A team of researchers at the Indian Institute of Technology Madras (IIT-M) has developed an indigenous portable Point-of-Care-Ultrasound (POCUS) Scanner for sports injury diagnosis and management.
Practo strengthens Board with appointment of TVG Krishnamurthy and Dr Alexander Kuruvilla
Practo has appointed two new directors to its board: TVG Krishnamurthy and Dr Alexander Kuruvilla.
Dr R N Gupta steps in as National President of Indian Pharmaceutical Association
Dr R N Gupta has been elected as the National President of the Indian Pharmaceutical Association (IPA), the oldest and largest association of pharmaceutical professionals in the country, for the term 2024 - 2026 (October 1, 2024 - September 30, 2026).
QR678 brings medtech leader Sridhar Ranganathan to advisory board
QR678, a pioneering company dedicated to revolutionising hair and skin science through groundbreaking research and innovative solutions, has announced the appointment of Sridhar Ranganathan to its Board of Advisors.