India is awaiting confirmation from the European Union (EU) to resume the negotiations for the proposed free trade agreement, Parliament was informed on May 11.
The action is being taken as a result of an inspection of Semler's bioanalytical facility in Bangalore conducted between September 29, 2015, and October 9, 2015, USFDA said.
Drug maker Alkem Laboratories today said it will submit 'suitable clarifications' to the European Medicines Agency (EMA) over a decision by the drug regulator to review two drugs for which clinical trial studies were conducted by the Mumbai-based firm.
The statement came days after the two sides failed to made the much-awaited announcement on resumption of long stalled negotiations for a free trade agreement as many bottlenecks still remain.
"Currently India and EU are constructively engaged to sort out regulatory issues between the two countries and expand and strengthen technical co-operation on good manufacturing practices (GMP)," Minister of State for Fertilisers Hansraj Gangaram Ahir said in a written reply in the Lok Sabha.
Senior officials of India and the European Union are expected to hold discussions tomorrow on the stalled negotiations for the proposed free trade agreement.
Of the 24 proposals which were on the agenda of the FIPB, 11 fell under the automatic route due to the new policy announced earlier this month, a Finance Ministry official said.
Sitharaman said India believes that there should be free trade "but is it just India which is questioned on free trade. I would like to know how many countries actually completely follow the principles of free trade".
India, on Wednesday, expressed concern over EU's ban on medicines clinically tested by GVK Biosciences, saying it could lead to 'adverse campaign' about clinical trials done in the country.
Indian Prime Minister Narendra Modi's office wrote to the E.U. Trade Commissioner to intervene when the ban on around 700 pharmaceutical products was formalised in May, two government sources in New Delhi said.
Chief negotiators of India and the EU were scheduled to resume the negotiations on the Broadbased Investment and Trade Agreement (BTIA) this month.
The European Union has banned the marketing of around 700 generic medicines for alleged manipulation of clinical trials conducted by India's pharmaceutical research company GVK Biosciences.
GVK Biosciences and Australia-based Akaal Pharma have extended collaboration for supporting clinical studies for the latter's novel AKP-11 ointment for treating psoriasis.
Medivir is a research-orientated pharma firm with focus on infectious diseases and oncology.
German drug regulator has welcomed the European Medicine Agency's (EMA) decision to suspend the marketing authorisation of around 700 generic drugs subjected to clinical trials by India's GVK Biosciences.
Contract research organisation GVK Biosciences has inked a pact with US-based Onconova Therapeutics to develop new drugs for treatment of cancer.
Andhra Pradesh health minister DL Ravindra Reddy said that there is no evidence to prove the participation of GVK Bio Sciences and the investigations are being carried on to punish the guilty.