SynopsisIndian drugmakers are stepping up to help the US combat a critical shortage of ifosfamide injection, a vital chemotherapy drug. Leading companies like Zydus, Cipla, Alkem, and Aurobindo Pharma are in discussions to supply the medicine. The US FDA has reached out to Indian pharmaceutical bodies, seeking manufacturers capable of producing the drug in various strengths to ensure availability for cancer patients.AgenciesIndian drugmakers are stepping up to help the US combat a critical shortage of ifosfamide injection, a vital chemotherapy drug. Leading companies like Zydus, Cipla, Alkem, and Aurobindo Pharma are in discussions to supply the medicineNew Delhi: A clutch of Indian drugmakers are gearing up to supply ifosfamide injection, a critical chemotherapy drug, to the US after the American authorities sought India's help to ward off an impending shortage of the medicine used in cancer treatment. "Discussions are moving at a frantic pace with leading Indian drugmakers," a top industry insider told ET.Viranchi Shah, national spokesperson at Indian Drug Manufacturers' Association (IDMA), confirmed the development and said Zydus, Cipla, Alkem and Aurobindo Pharma's GLS are among the frontrunners as they already have a presence in the US and produce this molecule.Also Read: Drugmakers yet to see gains from government's minimum import price policyIDMA has informed the Indian government about the potential suppliers, but it's not involved in discussions or negotiations between the companies and the US government or the Indian government, Shah said. "IDMA's role is limited to identifying members who have the capability and would be interested in supplying this product. We have sent circulars to all our members and are connecting the reliable Indian companies with the government," he said.Shah believes the US side is moving fast in evaluating the options from the list of companies to ensure availability of the widely used drug, underlining why speed and quality of response are non-negotiable.In a communication to Indian pharmaceutical industry bodies dated June 18, the US Food and Drug Authority's India office said it was reaching out to request assistance in identifying manufacturers that may be able to supply ifosfamide injection in 1g and 3g strengths to help address an ongoing drug shortage in US.Also Read: Govt eyes fast-tracking local production of high-end medical devicesThe FDA said it would appreciate information on manufacturers currently producing or capable of producing these products for any market, adding that products approved and marketed outside the US would also be of interest.While its first preference was for products manufactured at FDA-registered facilities, the agency said it would also welcome information on supply from facilities that may not be FDA-registered but have a demonstrated history of good regulatory compliance.ET has seen the document.India has roughly 10,500 pharmaceutical manufacturing units, of which over 350 are FDA-registered and certified. "The Indian pharmaceutical industry supplies nearly a fifth of the world's generic medicines and ranks third globally by volume, making it one of the most reliable partners the US can turn to in a crisis," an industry person said.Read More News on...moreless