Biopharmaceuticals manufacturer M.J. Biopharm Pvt Ltd is exploring the possibility of exporting its r-DNA human insulin to Europe, for which the company is awaiting clearance from the UK-based drug regulatory agency Medicines and Healthcare Products Regulatory Agency (MHRA).
M.J. Biopharm currently manufactures human insulin at its eight-lakh vials capacity manufacturing facility in Taloja, Maharashtra. Its partner company located in Europe supplies the bulk insulin crystals, which is later developed into insulin formulation at its plant. The company also manufactures animal insulin. The company has already begun exporting human insulin to South Africa, whose drug regulatory authority MCC has approved its facility. M.J. does not plan to export the animal insulin as it finds least acceptance abroad.
"We are already exporting our human insulin to South Africa. Once our plant gets the MHRA certification in 2005, we will begin our exports to Europe," said Dr. P.G. Shrotriya, director, technical, M.J. Biopharm. The advantage with MHRA certification being, the approval is valid for the entire Europe.
In India, the insulin manufactured by M.J. Biopharm is marketed by USV. Insulin market in the country is currently positioned at Rs. 121 crore. The insulin marketed by Eli Lilly, Novo Nordisk and Aventis Pharma in the country is imported, which forms 60 per cent of the current market. Companies like Wockhardt, Torrent, Sarabhai, USV, and Sun Pharma control the domestic human insulin market. The new player to enter the domestic human insulin market in the near future would be Biocon. Wockhardt is the only manufacturer possessing the technology to manufacture insulin formulation right from the scratch. Rest of the manufacturers import the bulk from abroad and formulate in India. Worldwide, three companies, one in USA and two in Europe, control the global market for human recombinant insulin, valued at over $ 3 bn.