Britain’s health regulator, Medicines and Healthcare products Regulatory Agency (MHRA), has come out in support of ‘made in India’ drugs.
In a recent move, European Union banned 700 generic medicines for alleged manipulation of clinical trials conducted by Indian company GVK Biosciences, but MHRA doesn’t agree fully to the ruling. “There is no evidence to suggest that these medicines are not safe and ineffective and people should continue to take their medicines,” MHRA’s spokesperson told HT via e-mail.
While UK is a member of the EU, all decisions made by the European Commission on the recommendation of the European Medicines Agency (EMA) are binding for all member states.
However, UK’s health regulator has decided to allow the marketing of selective number of drugs, out of the banned 700 drugs, which are deemed to be critical to the UK’s supply chain and their alternative sources are not readily available.
EU’s drug regulator, EMA, had examined the marketing authorisation given to over 1,000 generic drugs from EU member nations on the basis of bio-equivalence studies conducted by GVK Bio during the period between 2004 and 2014.
{{/usCountry}}EU’s drug regulator, EMA, had examined the marketing authorisation given to over 1,000 generic drugs from EU member nations on the basis of bio-equivalence studies conducted by GVK Bio during the period between 2004 and 2014.
{{/usCountry}}For over 300 of them, sufficient supporting data was available. But the inspection revealed “data manipulation of electrocardiograms (ECGs) during the conduct of some studies of generic medicines, which appeared to have taken place over a period of at least five years,” EMA said in a statement earlier.
The ban is expected to hit Indian exports worth Rs 6,300 crore, according to the estimates by commerce ministry’s drug export arm, Pharmaceutical Export Promotion Council of India (Pharmexcil). Moreover, it will be for the first time that exports to EU will show a negative growth.