Marck Biosciences has received an approval from South African Medicines Control Council for six products manufactured at its Small Volume Parenterals (SVP) facility at Kheda. The South African market, at around USD 3.8 billion (2011), is growing at 6 per cent and is expected to reach $7 billion in 2018, with generics accounting for 60 per cent of the volume.
The MCC approval will also enable Marck Biosciences to achieve immediate access to key markets including Namibia, Botswana, Zimbabwe, Swaziland, Lesotho, Zambia, Malawi and Madagascar. MCC approval is expected to result in waiver of inspection by the authorities of these countries and an easier registration of certified products. For Marck Biosciences, the approval carries the opportunity of accessing some of Africa’s most stable growth economies.
The Medicines Control Council is a statutory body that oversees the regulation of medicines in South Africa. Its main purpose is to ensure that all medicines that are sold and used in South Africa are safe, therapeutically effective and consistently meet acceptable standards of quality.
MCC-South Africa’s certification is also recognised by 43 participating authorities of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S). This may facilitate export by Marck Biosciences of certified SVP to PIC/S participating authorities as well as non-PIC/S authorities who accept GMP certificates from PIC/S participating authorities.
Bhavesh Patel, Managing Director, Marck Biosciences, said, “The MCC-South Africa approval for our Kheda facility will provide further impetus to our current expansion efforts in the African region and PIC/S countries. We would also augment our efforts by our own filing and licensing with new partners in SA. I see strong revenue potential in these under-served markets and we believe that we can make a quantum contribution to healthcare products in these countries.”
Six products have obtained approvals from MCC-South Africa, including Sterile Water For Injections BP 5/10 ml; Ciprofloxacin Eye Drops 5/10 ml; Timolol 0.25 per cent Eye Drops 5/10 ml; Timolol 0. 50 per cent Eye Drops 5/10 ml; Lidocaine Injection BP 1 per cent 5/10 ml and Lidocaine Injection BP 2 per cent 5/10 ml.
EP News Bureau – Mumbai
