The Bulk Drug Manufacturers Association (BDMA) will set up an all-India forum to monitor quality control for the pharma and biotech industry in the next three months. Making the concluding remarks at the two day international conference on Pharmacopeial Standards for bulk pharmaceuticals in Hyderabad, BDMA President Venkat Jasti said the proposed Forum will have experts representing the entire industry and would work on quality standards to be implemented in the bulk drugs segment.
The conference, he said, had discussed acceptance and implementation of the regulatory approaches recently evolved at the International Conference on Harmonisation (ICH) and the Pharmacopeial Discussion Group (PDG).
At the break-out sessions and group discussions, the delegates came up with suggestions on the four main topics of concern - Universal and specific tests, impurities, development of a new monograph and validation of analytical procedures and system suitability tests.
Venkat Jasti told Pharmabiz that the more than 250 delegates, including 25 participants from 10 foreign countries, had given their suggestions, which would be forwarded to the United States Pharmacopeia (USP) whose experts would prepare a comprehensive report. He expected to be ready in about six months.
The seminar also discussed a suggestion on the merger of pharmacopeia bodies around the world to form a single pharmacopeia. Jasti said it was not feasible, at least for the next 20 years.
According to some scientists, who attended the seminar, the entire discussions centred around USP and its regulatory guidelines, whereas the focus should have been on ICH and PDG guidelines. This might be because both ICH and PDG groups were dominated by US interests.
ICH is concerned with harmonization of technical requirements for the registration of pharma products among three regions -- the European Union, Japan and essentially the United States. The six ICH sponsors are the European Commission, the European Federation of Pharmaceutical Industries Associations, the Japanese Ministry of Health and Welfare, the Japanese Pharmaceutical Manufacturers Association, the Centers for Drug Evaluation and Research, FDA, and the Pharmaceutical Research and Manufacturers of America. The ICH Secretariat, which coordinates the preparation of documentation, is provided by the International Federation of Pharmaceutical Manufacturers Associations (IFPMA). The ICH Steering Committee includes representatives from each of the ICH sponsors and IFPMA as well as observers from WHO, the Canadian Health Protection branch and the European Free Trade Area.
The ICH guidelines are intended to assist, to the extent possible, in the establishment of a single set of global specifications for new drug substances and products. It provides guidance on the setting and justification of acceptance criteria and the selection of test procedures for new drug substances of synthetic chemical origin and new drug products produced by them and that have not been registered previously in the United States, the European Union or Japan.