Facing an acute shortage of human albumin, the medicines regulator in India's Maharashtra state has written to all blood banks instructing them to provide plasma to the company that produces the most of the product in the state, Reliance LIfe Sciences, in a step that along with imports may ease the situation.
The Indian Directorate of Revenue Intelligence arrested 6 people, including the owners of three pharmaceutical companies, for possession and distribution of pseudoephedrine.
Two leading Indian drug firms once again face quality in manufacturing issues with the U.S. FDA, leading in this case to voluntary recalls even as both face extensive remedial actions to bring plants back into the good graces of the regulator.
Scientists in India are looking to further widen their footprint in drug delivery manufacturing, getting in on one of the early floors of a promising technology in the field: nanocrystals. And the researchers say their method is more advanced than that of the small number of countries also involved in the burgeoning arena, giving them what could be a leg up as crystallization becomes a marketable platform.
India's Dr. Reddy's Laboratories says it is poised to move well beyond its core basic generics business into complex products and biosimilars as it looks to widen its reach globally with a focus on the U.S. market.
Three of Mylan-run drug manufacturing operations in India have been cited in a U.S. FDA warning letter for quality violations that included a failure to set procedures aimed at preventing microbiological contamination and on the use of torn gloves..
India's Controller of Patents has turned down a compulsory license application by Lee Pharma to make a version of AstraZeneca's Onglyza, citing competing substitutes already in the market and patent terms, the Economic Times reported.
When EU regulators banned about 700 products from India over concerns that clinical trials by an Indian CRO were flawed, it put an estimated $1 billion worth of Indian exports at risk. But Europe says it is sure the problems can be worked out after Indian Prime Minister Narendra Modi started playing tough by cancelling discussions over restarting trade negotiations.
Japan's Mitsui & Co., a broad based trading conglomerate, has bought a stake in Hyderabad-based Keimed, India's top drug and medical supplies wholesaler, entering a market that is rich in promise but fraught with regulatory hurdles.
An advisory body to India's health ministry has made a recommendation that favors price caps on cardiac stents based on price lists sent by manufacturers, the Economic Times reports.