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Wockhardt Limited has launched India's first recombinant human insulin product.
With this it has become the fourth company in the world - and the first outside US and Europe - to develop, manufacture and market this life-saving drug used in diabetes management.
India also has now become the first Asian country to develop this complex technology.
"This is a technology breakthrough not only for Wockhardt but for India. Worldwide, there are only three manufacturers of recombinant human insulin. Wockhardt is proud to have put India on the global map," says Habil Khorakiwala, Chairman, Wockhardt.
In India, 90 per cent of insulins used are derived from pigs or cows. The Indian government has been making efforts since the early 1970s to manufacture insulin. Unfortunately, these efforts have not successful.
Nearly 90 per cent of insulins sold in India are derived from slaughtered pigs and cows. Most insulin consumers, however, are unaware of the animal origin as these insulins bear labels like 'human' and 'semi-synthetic.'
All insulins sold in India today are imported either as finished vials or as concentrates which are converted into vials through third parties.
Currently, the market in India for insulin is valued around Rs 250 crore (Rs 2.50 billion).
Today, India has the world's largest population of diabetics, with an estimated 30 million people suffering from the disease. According to the World Health Organisation, India will have about 57 million people with diabetes in India by 2025. That is about the size of the population of Britain or France.
Globally, the WHO has estimated that by 2025, the number of people with diabetes worldwide will more than double from 140 million to 300 million.
Recombinant human insulin is made by synthesising the gene which is responsible for the production of insulin in human pancreas and inserting (combining) it into the DNA of a micro-organism.
When this micro-organism multiplies, it makes several copies of the gene. Each micro-organism becomes a factory that produces insulin in large quantities. It is now possible to multiply these factories in desired numbers and command each cell to produce the desired product at a precise time.
The single-most advantage of using recombinant human insulin is that it has identical amino acid sequence as that of naturally produced insulin in the human body.
Also, animal insulins are produced by crushing pancreas extracted from pigs and cows procured from slaughter houses, which then becomes fraught with the risk of transmitting infections and causing allergic reactions.
Worldwide, recombinant human insulin is slowly taking over animal insulin, as recombinant human insulin is physically, chemically and biologically identical to the natural human insulin.
Moreover, the methods of manufacturing large quantities of pure recombinant human insulin are scientifically superior and there is little risk of transmitting viral infections of known and unknown etiology.
"Recombinant human insulin avoids infections like bovine spongiform encephalitis (BSE), transmissible spongiform encephalitis (TSE), Creutzfeldt Jakob Disease (CJD) and other neurological disorders associated with insulins derived from animals," says Dr Maharaj Sahib, Director, Genomics & Biotechnology Research, Wockhardt.
Wockhardt has also used the latest yeast-based technology which is superior to the older technology based on E coli bacteria.
Wosulin, Wockhardt's recombinant human insulin brand, was approved by the regulatory authorities after it proved its efficacy and safety in clinical studies involving 350 diabetic patients. The entire process took 18 months.
Wockhardt is manufacturing Wosulin at its Rs 150 crore (Rs 1.50 billion) biotechnology park in Aurangabad. The facility, designed according to US FDA standards, will also house new biotechnology products that are currently under various stages of development.
Three companies, one in United States and two in Europe, today control the global market for human recombinant insulin valued at over $3 billion.
In a pre-emptive move, multinational drug companies in India cut their insulin prices in India by 35 40 per cent in January 2003 and the current price ranges from Rs 145- Rs 262 per unit. Wockhardt has decided to offer its recombinant human insulin at Rs 129 per unit.
"For Wockhardt and for me personally, Wosulin is a 10-year-old dream come true and a vindication of our decision to venture into pharmaceutical biotechnology in the early 1990s," says Khorakiwala.
Wockhardt has been aggressive in the sector of diabetes management. Last year, it jumped 11 positions in diabetes therapy in the Indian market.
Wockhardt Hospitals, which is part of the Wockhardt group, recently established the Wockhardt Diabetic Clinic to holistically manage all aspects of diabetes and its numerous complications.
Wockhardt Hospitals has a long-term alliance with Harvard Medical International, the international arm of Harvard Medical School.
The alliance gives Wockhardt access to the knowledge and practices at Harvard - affiliated institutions like the Joslin Diabetes Center at Boston.