INDIAN PHARMACEUTICAL INDUSTRY WITH THE FOCUS ON THE INSULIN ANTI DIABETIC EXPORTS TO USA
INSULIN (ANTI-DIABETIC) INTRODUCTION Insulin is a hormone secreted by the pancreas and it is needed to metabolize sugar i. ... Diabetes can be caused by inadequate insulin secretion (insulin sensitivity) or by the insulin’s inability to metabolize sugar (insulin resistivity). Dependent on the insulin shortfall in a person’s body, one may or may not need external insulin supplements. Thus, diabetes is of 2 types: Insulin dependant and insulin non-dependant. ... Insulin dependant diabetes often starts in childhood and the patient needs to take a daily dosage of insulin for a lifetime. The first successful insulin preparations came from cows (and later pigs). The bovine (cow) and porcine (pig) insulin were purified, bottled, and sold. Bovine and porcine insulin worked very well for the vast majority of patients, but some could develop an allergy or other types of reactions to the foreign protein (a foreign protein is a protein which is not native to humans). In the 1980s technology had advanced to the point where one could make human insulin. The advantage would be that human insulin would have a much lower chance of inducing a reaction because it is not a foreign protein (all humans have the exact same insulin, so it does not act as a foreign protein). ... In simple terms, the human gene which codes for the insulin protein was cloned (copied) and then put inside of bacteria. A number of tricks were performed on this gene to make the bacteria to constantly make insulin. TYPES OF INSULIN Insulin is classified according to how long the insulin works. There are several types of insulin, listed here in order of rate of action. Be aware that duration of insulin action varies by individual, activity level and location of injection. Types and Duration of Action of Insulin’s Type of Insulin (Trade Names) Supplier Appearance Begins Working Peak Activity All Gone Short Acting Lispro (Humalog®) Eli Lilly Clear 10 - 15 minutes 30 - 60 minutes 4 hours Aspart (NovoLog®) Novo Nordisk Clear 10 - 15 minutes 30 - 60 minutes 4 hours Regular (Actrapid, Velosulin®) Eli Lilly and Novo Nordisk Clear 30 minutes 2 - 4 hours 4 - 8 hours Semilente Novo Nordisk Cloudy 1 - 2 hours 2 - 5 hours 8 - 12 hours Intermediate Acting NPH (Insulatard®) Eli Lilly and Novo Nordisk Cloudy 2 - 4 hours 6 - 8 hours 12 - 15 hours LENTE® 3 parts Semilente to 7 parts Ultralente Eli Lilly and Novo Nordisk Cloudy 1 - 2 hours 6 - 12 hours 18 - 24 hours Long Acting ULTRALENTE® Eli Lilly and Novo Nordisk Cloudy 4 - 6 hours 8 - 15 hours 18 - 24 hours Lantus Aventis Clear 4 - 6 hours No peak 24+ hours Pre-Mixed (Action Varies) NPH/Regular 70/30 or 50/50 are common mixes Eli Lilly and Novo Nordisk Cloudy 30 minutes Varies 18 - 24 hours Source: Understanding Insulin-Dependent Diabetes, 8th Edition by H. ... Inhaled insulin, currently in Phase III clinical trials for treatment of Type1 and Type 2 diabetes, also is expected to assume an important role in diabetes disease management. Consisting of a hand-held inhalation device that delivers insulin as a fine, aerosol powder to the lungs for systemic distribution, inhaled insulin will be a convenient and noninvasive alternative to injections.While work on oral insulin is getting lots of attention in the press, drug companies are more quietly bringing to market new designer insulins that provide greater blood sugar control with fewer problems. Researchers have succeeded in genetically engineering these new insulins by changing the order of the amino acids that make up human insulin. Because of this, the insulin molecules interact with each other differently, changing how our bodies absorb these new insulins. Known as insulin analogs, these new drugs give us the opportunity to fine-tune their use. An insulin analog that can be taken immediately before eating to cover a meals glucose load is already available. ... Rapid Acting Insulin Analogs The first insulin analog to hit the market was insulin lispro, sold by Eli Lilly and Company as Humalog. ... Its called lispro because in this insulin analog, two amino acids, lysine and proline have different positions on the beta chain of the insulin molecule than they do in regular human insulin. This change in the position affects how the insulin molecules interact, resulting in faster absorption from the injection site and quicker onset of action than regular insulin. While insulin lispro is the only insulin analog sold anywhere today, this is likely to change soon as insulin manufacturers rush other insulin analogs to the market. Three companies manufacture almost all of the worlds insulin supply. DOMESTIC PHARMACEUTICAL INDUSTRY The pharmaceutical industry comprises of roughly 24000 manufacturing units and provides employment to approximately 33 lakh people. ... The total capital investment in the pharmaceutical industry was Rs. ... The country’s exports stood at Rs. ... (Source : OPPI) The leading 250 pharmaceutical companies control 70 per cent of the market with the market leader having a share of around seven per cent. ... India is one of top five manufacturers of bulk drugs in the world and is among the top 20 pharmaceutical exporters in the world. The industry manufactures almost the entire range of therapeutic products and is capable of producing raw materials for manufacturing a wide range of bulk drugs from the basic stage. GROWTH OF PHARMACEUTICAL INDUSTRY (Rs. ... 00 Source : OPPI Before looking up at the domestic insulin industry we should have an understanding of the SWOT analysis of the Indian Pharmaceutical industry. SWOT ANALYSIS OF THE INDIAN PHARMACEUTICAL SECTOR Strengths • Cost Competitiveness • Well Developed Industry with Strong Manufacturing Base • Well Established Network of Laboratories and R&D infrastructure • Access to pool of highly trained scientists, both in India and abroad. ... • Lack of strong linkages between industry and academia. • Lack of culture of innovation in the industry • Low medical expenditure and healthcare spend in the country • Inadequate regulatory standards • Production of spurious and low quality drugs tarnishes the image of industry at home and abroad. ... • Contract manufacturing arrangements with MNCs • Potential for developing India as a centre for international clinical trials • Niche player in global pharmaceutical R&D. Threats • Product patent regime poses serious challenge to domestic industry unless it invests in research and development • R&D efforts of Indian pharmaceutical companies hampered by lack of enabling regulatory requirement. ... • Drug Price Control Order puts unrealistic ceilings on product prices and profitability and prevents pharmaceutical companies from generating investible surplus. ... • Lowering of tariff protection EXPORT PERFORMANCE OF INDIA IN THE PHARMACEUTICAL SECTOR Exports* (Rs. ... 00 * Excluding medicinal castor oil TOP COUNTRIES OF EXPORTS OF INDIAN PHARMACEUTICALS Name of the Country 1999-2000 IRAN 180 USA 672 BRAZIL 163 RUSSIA 493 VIETNAM 141 GERMANY 325 CHINA 137 HONG KONG 356 ITALY 151 NIGERIA 258 SPAIN 129 U. ... Crores) Source : CHEMIXCIL Exports form a vital component of the growth strategy of most Indian pharmaceutical companies. The industry has made rapid strides in this area in the last few years and export sales of companies such as Ranbaxy have been growing at a faster rate than their domestic sales. The compounded annual growth rate of pharmaceutical exports over the last five years has been more than 20 per cent although in 1999-2000, exports grew by 11 per cent. ... On a country-wise basis, India’s five largest export markets are USA (Rs. ... While overall pharmaceutical exports have grown in 1999-2000, India’s exports to a few of its leading markets have declined. For instance, according to a CHEMEXCIL report, India’s pharmaceutical exports to USA have declined to Rs. ... 5 crores and exports to China have declined to Rs. ... Notwithstanding the decline in exports to some key markets, India’s export prospects remain bright. As against a global pharmaceutical industry of over $300 billion, India’s export sales are in the region of $1.5 billion The potential for growth is enormous, a 20 per annual growth in exports over the next five years will take the overall export figure to $4 billion by 2005. ... DIABETES IN INDIA The changing lifestyle of the Indian people and increase level of stress faced by the people has resulted in Diabetes assuming pandemic proportions in the country. India as of now has 50 million diabetic patients and the number is expected to increase to double by 2020. Reusable pens and pre-filled syringes are the popular mode of insulin delivery across the world. In India, it is the injectible vial that is more popular for the obvious reasons of cost Market Size in India Insulin is an emerging market, with India having the largest number of Diabetics in the world. The domestic market size of Anti-Diabetic drugs is estimated to be Rs2. ... Of this, 41% of the market is for insulin formulations wherein demand is growing 26%yoy. Biosynthetic human insulin that till recently was prohibitively costly and beyond the reach of many has been brought at par with porcine (pig) derived insulin (Rs145 for 10 ml vial). Human insulin is the first of the biogenetically engineered products ever to be produced in the world.Eli Lilly was the company that discovered Human Insulin(called ‘Humulin’) way back in 1981.