The Department of Pharmaceuticals, in association with FICCI and other pharma organisations, is organising an international conference on pharmaceuticals in Mumbai on November 30, ahead of the proposed CPHI happening from next day, to showcase strength of Indian companies.
With a faltering economy, increased competition generated by generic drugs, skyrocketing costs of marketing blockbusters, and unsustainable R&D expenditures, pharmaceutical companies are looking for ways to reduce costs and improve the effectiveness of their drug discovery and development operations.
Health Canada, the drug regulatory and health department of Canada, is finalising new guidelines for Drug Master Filings (DMFs) in accordance with the International Conference on Harmonisation (ICH) standards. Even as more generic companies from India, China and Eastern European countries are in a drug master filing spree, the authority is planning to incorporate Certificates of Suitability (CEPs) of European drug regulator to simplify filing process, it is learnt.
Even as the government is busy modifying regulations for the pharmaceutical industry in India to improve the quality and safety of medicines, the excipients industry which has much to do with the quality and shelf life of drugs still remains an unregulated sector in the country.
Biovail Corporation announced a voluntary recall of certain lots of Ultram ER (extended-release tramadol hydrochloride) 100mg tablets from pharmacies and wholesalers. Biovail is taking this action as a result of certain lots being out-of-specification by approximately 1% with respect to maximum dissolution at the eight-hour mark. This minor dissolution variance does not impact patient health or safety.
Indevus Pharmaceuticals, Inc. has received an approvable letter from the US Food and Drug Administration for Nebido related to a New Drug Application (NDA) submitted to the US FDA in August 2007.
Indian Government has laid down Good Manufacturing Practices guidelines to be followed by manufacturing plants
Excipient is accelerating pharmaceutical formulation technologies and novel drug delivery system development consequently boosting the development of excipient industry. Indian pharmaceutical industry has rapidly narrowed the gap between world leading edge companies with innovative formulation R&D and its application