Looking to give a further push to the exports of pharmaceutical products from India to Europe, the European Directorate for Quality of Medicines (EDQM) has in principle agreed to extend observer status to India and forge a definite agreement with the Indian Pharmacopoeia Commission (IPC).
The two-member high-powered delegation of the EDQM headed by its director recently held extensive talks with Union health minister Dr Ambumani Ramadoss, higher officials of the ministry, members of the scientific body and top brasses of the IPC during their two-day visit to India recently in this regard.
The team led by director Dr Susanne Keitel also visited the IPC lab and other facilities to take a first hand look at the working of the Indian standard setting system and decided to set up joint mechanism to work further on finalising the mutual agreement, sources said.
``We had fruitful and extensive discussions between the top officials on both the sides and worked out details for the agreement which will definitely be a shot in the arm for the Indian pharma exporters in future,'' sources at the IPC said. The delegation was reportedly was so impressed by the Indian system and its standard documents while the Minister and other senior officials expressed keen interest in working along with the EDQM.
The delegation also visited the National Institute of Biologicals which will be working on preparing standards for the biological products to be included in the Indian Pharmacopoeia. Both the sides have set up a joint study group to further take the efforts in the direction of collaboration through regular assessment and studies.
The European Pharmacopoeia represents 34 countries in Europe and the EDQM would now submit its recommendations and discuss the details with the member countries before finalising the agreement. High-level delegations from India will also be visiting Europe in this regard, as preliminary rounds of interactions are over now.
Countries like China and Japan now enjoy the observer status with the European standard-setting body which has been keen to bestow the same status on India as it is perceived as an emerging power in the pharmaceutical arena. India already has collaboration with USP Convention of United States and a similar tie-up is being worked out with Britain too.
The EDQM publishes the European Pharmacopoeia and is involved in harmonization and coordination of standardization, regulation, quality control of medicines, blood transfusion and organ transplantation in Europe.