India is now being recognized as a country of first choice for its quality of expertise and infrastructure in clinical trials. The global clinical research organizations(CROs) which have had an impression about India as a 'Country of Contingency' because of its reports on a large number of unforeseen events during human studies is changing its opinion. The country is now getting noticed for its quality of the trial site and the data generated from here, Dr Agnes Schiewe, director clinical research Ecron Acunova told Pharmabiz.
With the European Medicines Agency (EMEA) Pediatric Regulations enforcement, many developing countries including India will now see a rise in trials on children. The new enforcement calls for all European pharma companies to develop a pediatric investigation plan for all new molecules if they are for the development of drugs for children. They will need to have a sound pediatric plan process in plan right from the start of their research efforts or else permission and license for manufacture and marketing will not be issued, said Dr Schiewe.
India too needs a regulation in place to seek the confidence of the international sponsors. Despite no enforcements, the country has been viewed as important site for the conduct of many global studies only because of its high degree of medial investigators who will need to be trained on a regular basis on the Good Clinical Practices protocol. Lack of adherence to GCP guidelines is a serious violation during an international trial, she added.
In the case of Ecron Acunova which was formed after the acquisition of Ecron GmbH, Europe by Manipal AcuNova in November 2007, the company has developed a common standard operating procedures for its operations in Germany and India. The company provides end-to-end services for phase-I to IV clinical research including Clinical Trial Management, Clinical Data Management, PK/PD services and Central Lab at Munich and Bangalore.