Rivals may nip at Ranbaxy’s US spoils
BANGALORE: Several copycat drugmakers in India are looking to chip away at market shares of Ranbaxy Laboratories Ltd, currently under probe by US drug regulators and government departments, before a decision comes on lifting the ban on the exports of 30 of its medicines into the US.
The probe is a fallout of the September 16 ban imposed by the US Food and Drug Administration on the sale of the 30 generics made in Ranbaxy’s Dewas and Paonta Sahib plants because of alleged deficiencies in manufacturing practices there.
The immediate threat is to Ranbaxy’s exports under the US President’s Emergency Plan for AIDS Relief (PEPFAR), mostly to African countries. Under the PEPFAR, the Gurgaon-based company exported three anti-retrovirals (ARVs) - zidovudine, lamivudine and nevirapine - used in the treatment of HIV/AIDS, worth $8.9 million last year.
The PEPFAR secretariat instructed country teams and implementing partners on September 22 that funds may only be used to procure these drugs produced by alternative manufacturers and tentatively or fully approved by the US Department of Health and Human Services or the FDA.
Other Indian companies such as Aurobindo Pharma and Cipla are the first ones likely to benefit from this as they are some of the biggest suppliers under the $1.9-billion allocation for medicines and distribution as part of the overall $15 billion programme up to year-end.
The PEPFAR was launched in 2003 to combat global HIV/AIDS by the US government, which has already provided $18.8 billion under the programme. A reauthorisation of up to $48 billion for HIV/AIDs, tuberculosis and malaria over the next five years is pending before US policymakers.
BANGALORE: Several copycat drugmakers in India are looking to chip away at market shares of Ranbaxy Laboratories Ltd, currently under probe by US drug regulators and government departments, before a decision comes on lifting the ban on the exports of 30 of its medicines into the US.
The probe is a fallout of the September 16 ban imposed by the US Food and Drug Administration on the sale of the 30 generics made in Ranbaxy’s Dewas and Paonta Sahib plants because of alleged deficiencies in manufacturing practices there.
The immediate threat is to Ranbaxy’s exports under the US President’s Emergency Plan for AIDS Relief (PEPFAR), mostly to African countries. Under the PEPFAR, the Gurgaon-based company exported three anti-retrovirals (ARVs) - zidovudine, lamivudine and nevirapine - used in the treatment of HIV/AIDS, worth $8.9 million last year.
The PEPFAR secretariat instructed country teams and implementing partners on September 22 that funds may only be used to procure these drugs produced by alternative manufacturers and tentatively or fully approved by the US Department of Health and Human Services or the FDA.
Other Indian companies such as Aurobindo Pharma and Cipla are the first ones likely to benefit from this as they are some of the biggest suppliers under the $1.9-billion allocation for medicines and distribution as part of the overall $15 billion programme up to year-end.
The PEPFAR was launched in 2003 to combat global HIV/AIDS by the US government, which has already provided $18.8 billion under the programme. A reauthorisation of up to $48 billion for HIV/AIDs, tuberculosis and malaria over the next five years is pending before US policymakers.
