The probe is being conducted by the committee after the European Medicines Agency alleged that during inspections of GVK Biosciences, it found systemic falsification of ECGs
A six-member multi-disciplinary committee has been set up by the Centre to look into the alleged data manipulation at GVK Biosciences. The committee visited the company’s facility on Tuesday and has initiated a detailed investigation of the matter. The panel is expected to submit a detailed report to the government soon.
The probe is being conducted by the committee after the European Medicines Agency (EMA) alleged that during its inspections of GVK Biosciences, it found systemic falsification of ECGs for an extended period of time. Following this, the European Union banned the marketing of around 700 generic medicines for alleged manipulation of clinical trials conducted by GVK Bio.
Earlier, the French regulating agency French Medicines Agency (ANSM) had raised concerns on the reliability of the bio-equivalence (BE) studies conducted between 2008 and 2014 by GVK Biosciences.
“The government is pursuing the GVK Bio case. A six-member multi-disciplinary committee from various departments has been appointed to look into this issue. The fact-finding team visited GVK Bio facility yesterday,” said Sudhanshu Pandey, joint secretary, department of commerce, on the sidelines of the 11th annual meet of Pharmaceutical Export Promotion Council of India (Pharmexcil), held in Hyderabad.
Pandey, who is also part of the panel, said that the agenda of the panel is to look into the primary data and allegation of data integrity in full fairness. “We are looking into the allegation that ECGs were falsified. However, as alleged by the French regulator, no manipulation was found. We will be submitting a report to the government very soon,” Pandey said. Incidentally, the USFDA has also not found any systemic issues affecting the safety or efficacy of generics clinically tested at GVK Bio.
Incidentally, this is government’s second relook into GVK Bio issue after the Central Drugs Standard Control Organisation (CDSCO) did a preliminary investigation and claimed that there were no manipulation of data by the company. Eventually, the falsified allegation led to the Indian government to defer talks with the European Union on the Indo-EU free trade agreement (FTA).
“The government had earlier clarified and explained to the French regulator six times as the allegations were not scientifically justified,” Pandey said. However, there has been no response from the French regulator, he said.
Meanwhile, on the issue of multiple inspections on manufacturing facilities, the commerce ministry is mulling to have discussions with the drug regulators of South East Asian countries to bring in harmonisation of regulations for inspection of facilities.