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Home » Authors » T.V. Padma

Articles by T.V. Padma

India's new biosimilar guidelines draw mixed reviews from pharma

May 9, 2016
By T.V. Padma
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.
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Tackling counterfeit drugs, India bolsters track-and-trace efforts

May 4, 2016
By T.V. Padma
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.
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Tackling counterfeit drugs, India bolsters track-and-trace efforts

May 4, 2016
By T.V. Padma
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.
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CRO Semler smacked with WHO, FDA letters citing data manipulation

May 2, 2016
By T.V. Padma and Cornelia Zou
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.
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Emcure's warning letter highlights ongoing data integrity issues in India

April 21, 2016
By T.V. Padma
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."
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Emcure’s warning letter highlights ongoing data integrity issues in India

April 20, 2016
By T.V. Padma
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.”
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Biocon gains key toehold in Japan with glargine approval

April 13, 2016
By T.V. Padma
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.
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Biocon gains key toehold in Japan with glargine approval

April 12, 2016
By T.V. Padma
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.
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India's ban on FDC drugs takes biopharma industry by surprise

March 30, 2016
By T.V. Padma
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.
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India's ban on FDC drugs takes biopharma industry by surprise

March 30, 2016
By T.V. Padma
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.
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