TopicFixed-dose combination drugs
Topic: fixed-dose combination drugs
The NPPA observations came this week as it took up applications to fix the prices of 34 new drugs, most of which were fixed-dose combination medicines or drug cocktails.
The three drugs were banned in the first round of the govt’s FDC crackdown in 2007, and hundreds of others have been outlawed since.
The safety of these fixed drug combinations will be monitored regularly and any failure on the manufacturers' part to submit a periodic safety update will be deemed illegal.
The medicines that could be banned are antibiotics Orflaz, Nuforce 3 kit and Vaginobact, and hypertension drugs Telipril H and Ramtel H.
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In a consultation paper released Monday, SEBI said increasing reliance on unregulated ESG rating providers poses risks to investor protection, transparency & efficiency of markets.
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