In a statement to Outsourcing-Pharma addressing the incident, GVK Bio explained that a reactor malfunctioned, resulting in a fatality of a contract employee. The incident occurred at the company's site in Nacharam, a neighborhood in Hyderabad.
The Times of India initially reported what it described as an explosion at the plant early last week.
“Investigation is ongoing to determine the root cause and implement any preventive plans. No other GVK Bio employee was injured and since the incident occurred in an isolated reactor block, the rest of the facility is functioning normally,” according to GVK Bio.
The contract research organization (CRO) has four research facilities in India and one in Morgan Hill, California, which it acquired when it purchased Aragen Bioscience in 2014.
GVK Bio provides a range of formulation and analytical services, including stability studies as well as clinical supply and manufacturing of exhibit batches. The company has a team of more than 2,100 scientists.
The incident follows a US Food and Drug Administration (FDA) inspection of GVK Bio's cGMP analytical service laboratory located at the company's Mallapur Campus in Hyderabad. The inspection resulted in zero 483 observations with the company receiving a No Action Indicated (NAI) compliance status.
The FDA was unable to provide any further information.
GVK Bio data concerns and drug ban
As Outsourcing-Pharma reported in 2014, the European Medicines Agency (EMA), at the request of the European Commission, previously opened a review into findings that GVK Bio employees falsified clinical trial data.
Hundreds of drugs tested by GVK Bio were eventually banned from sales in the European Union after an inspection by the French regulatory agency, ANSM, revealed electrocardiograms (ECG) were falsified in nine clinical trials.
“The systematic nature of the data manipulations of ECGs, the extended period of time during which they took place and the number of members of staff involved highlight critical deficiencies in the quality system in place at GVK Bio's clinic in Hyderabad,” according to the European Medicines Agency (EMA) document.
The two-year ban was enacted in July 2015 by the then acting head of the European Union's Health and Consumers directorate, Ladislav Miko. Several other countries banned drugs tested by the company, including the US FDA, which in April 2016 alerted the industry to data concerns.
The decisions were criticized by Pharmexcil India, a council established by India’s Ministry of Commerce and Industry for the promotion of Pharmaceutical exports, which said ANSM “did not give any scientific evidence to show that data was manipulated.”