NEW DELHI – India's revised draft guidelines for biosimilars have drawn mixed reactions. The country's pharma industry has, in broad strokes, welcomed the increased clarity and more rigorous conditions in the revised guidelines, but the Organisation of Pharmaceutical Producers of India, comprising largely foreign pharma firms, said the new rules could compromise patient safety.
HYDERABAD, India – India is strengthening its “track and trace” system for drugs by making it mandatory to put online information about barcodes on the packing of drugs being exported.
HYDERABAD, India – India is strengthening its "track and trace" system for drugs by making it mandatory to put online information about barcodes on the packing of drugs being exported.
HYDERABAD, India – A number of drug companies in India may have to repeat expensive clinical trials after Bangalore-based contract research organization (CRO) Semler Research Center Pvt. Ltd. received warnings from both the World Health Organization (WHO) and the FDA in April over data manipulation.
NEW DELHI – The U.S. FDA has rapped yet another Indian pharma company with a warning letter that drew attention to "significant violations of current good manufacturing practice (cGMP) regulations for finished pharmaceuticals."
NEW DELHI – The U.S. FDA has rapped yet another Indian pharma company with a warning letter that drew attention to “significant violations of current good manufacturing practice (cGMP) regulations for finished pharmaceuticals.”
NEW DELHI – Taking another step toward international expansion, Indian pharma major Biocon Ltd. has secured its first approval in Japan for its biosimilar insulin glargine.
NEW DELHI – Taking another step toward international expansion, Indian pharma major Biocon Ltd. has secured its first approval in Japan for its biosimilar insulin glargine.
NEW DELHI – India has banned 344 fixed-dose combination (FDC) drugs, including several antibiotics and painkillers and syrups with codeine, stating that they "involve risk to humans," they have safer alternatives available or they have no therapeutic justification.
NEW DELHI – India has banned 344 fixed-dose combination (FDC) drugs, including several antibiotics and painkillers and syrups with codeine, stating that they "involve risk to humans," they have safer alternatives available or they have no therapeutic justification.
