Centre to take up GVK Bio’s case
Centre to take up GVK Bio’s case. France’s drug regulator’s rejection of GVK Bio’s clinical trials would further slowdown the Indian drug exports to European countries.
Pharma industry fears negative impact on drug exports
Industry captains fear loss of export business as this kind of incidents will create doubts in the minds of international buyers
Hyderabad: France’s drug regulator’s rejection of GVK Bio’s clinical trials would further slowdown the Indian drug exports to European countries. “We estimate the immediate loss to the country’s exports would be about $1 billion,” Dr PV Appaji, Director General, Pharmexcil told media on the sidelines of a BDMA event here.
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It would further dampen the reputation of the Indian pharmaceutical industry in the international market, he added. Industry captains also fear loss of international business as this kind of incidents will create doubts in the minds of international buyers.
“We are already hit in the US markets as some of the company’s products are banned for lack of good practices,” said a pharma industrialist requesting for anonymity. In a similar incident recently, WHO had suspected the sale and distribution of drugs for which the clinical trials were conducted by Chennai-based Quest Life Science.
At a time when the country is slowly recovering after getting hit by US FDA, these kinds of incidences further trouble the industry. Worried over the global aggression against Indian pharma sector, the Union government is understood to have taken it serious and decided to take up the issue with the respective embassies.
In fact, the ministry of commerce is considering 'commercial and legal' action against the European Union if the EMA does not rethink its decision. Appaji said the pharmexcil has limited knowledge about the service part, “To my knowledge, the commerce ministry has called for the information from the connected people and expected to take it up with the concerned governments.”
Earlier, GVK BIO stated that the company respects the conclusions of the French authority, but believes it was a matter of interpretation and was hard to conclude that ECGs were manipulated and claims its clinical development unit was inspected over 25 times by various regulatory agencies including UK-MHRA, ANSM, USFDA, DCG of India, ANVISA (Brazil), WHO, MOH Turkey, with no reported critical findings.
