- Lupine's API research helped propel the Indian pharmaceutical sector to global competition.
- After 2005, the research got a new direction; Various drug forms including cephalosporins were worked on.
- Successive innovations led to lower drug doses and easier-to-use inhalers instead of injections.
By the time liberalization began in India in 1991, global giants had gained a huge lead. So Indian companies had to go a long way to match them. therefore, In India1991 must be considered a starting point in any clinical evaluation of innovation in companies.
The same applies to Indian pharmaceutical companies. Lack of public funding for private basic research, Scientist And Indian pharmaceutical companies successfully competed with global rivals despite adverse conditions such as low returns on investment in public institutions such as the Council of Industrial Research and weak governance of universities. Lupine Pharma Innovation:
Critics called it 'reverse engineering' and 'copycat
Lupine's research activities best exemplify this process. This process started soon. This work was expanded first to Lupine's project in Aurangabad and then to Mandideep. Here the company started developing the active pharmaceutical ingredients, i.e. the basic raw materials, required for drug manufacturing.
Although critics called it 'reverse engineering' and 'copying', it played an important role in the evolution of the industry after the Patent Act. This law made it possible to develop manufacturing processes that did not infringe patents. India emerged as a global supplier of active pharmaceutical ingredients in the 1980s, and by 2024, India accounted for approximately 32 percent of global active pharmaceutical ingredient production volume.
Lupine invested in studying the process chemistry, chemical structure and synthesis routes of existing drugs. One such product is Captopril. By the early 1990s, Indian companies such as Lupine had reverse-engineered captopril and made it available at only 5 percent of the price of the original product.
Formulations developed
A major breakthrough in Lupine's research came in 2005 when oral and injectable cephalosporin drugs were approved by the US Food and Drug Administration. For this, Lupine's research and development teams drew on their expertise in the active pharmaceutical ingredients in cephalosporins.
They developed oral and injectable forms of the drug. Patent hurdles had to be overcome in this process. Also, precise control of the manufacturing process is necessary to ensure the availability and stability of the drug in the body.
Lupine's research and development team then developed products targeting long-term treatment areas such as cardiovascular disease and diabetes drugs. These areas later became prominent in Lupine's US generics portfolio. By the end of the decade, lupine had received more than 75 approvals for generic drugs in the United States. In the decade that followed, the company filed 129 basic drug registrations and 186 brief new drug applications, creating one of the most extensive generic drug product chains among Indian companies.
Towards innovative products
The technology of delivering medicine to the body Dr. Desh brothers Gupta and Himadri Sen, head of Lupine's drug-formulation research and development department, were particularly interested. In 2000, Sen joined Lupine after a decade of guiding Ranbaxy's US journey. Dr. According to both Desh brothers Gupta and Sen, this was an important step towards more innovative products.
The series of pediatric products developed around Suprax allowed the company to use existing information to innovate without having to start clinical trials from scratch for drug approval. The Antara brand opportunity also showed the same path. Although these products were classified as 'incremental innovations', they filled unmet needs that were important to doctors and patients.
Transformed into a respirator
Some of these products made it possible to take the same 2-times-a-day pill as 1-times-a-day. Some products have turned an injectable drug into an easy-to-use inhaler. These early innovations served as the foundational steps for such a specialty drug business, which further allowed Lupine to diversify its business beyond being limited to generic drugs. These excerpts are taken from the book Made in India: The Story of Desh Bandhu Gupta, Lupine and Indian Pharma by Manish Sabharwal and Sundeep Khanna. This book is published by Juggernaut.