How Lupin's research grew from active ingredients to new drugs, and Indian pharma with it
An excerpt from a book traces how Lupin moved from reverse-engineering drugs to US-approved generics and specialty products after liberalisation in 1991.
India began liberalisation in 1991. By then the world's big companies had moved far ahead, so Indian firms had a long way to go to catch up. That is why 1991 has to be the starting point for judging innovation in Indian companies.
The same holds for Indian drug makers. There was no government funding for private basic research, state bodies such as the Council of Scientific and Industrial Research gave poor returns on the money invested in them, and university administration was weak. Despite all this, Indian pharmaceutical companies competed successfully with rivals worldwide.
Lupin's research is a good example of this journey. It began early. Work was first expanded at Lupin's plant in Aurangabad and then at Mandideep, where the company started developing active pharmaceutical ingredients, the basic raw materials used to make drugs.
Critics called this "reverse engineering" and "copying", but after the patent law it played an important part in the industry's growth. The law made it possible to devise production processes that did not infringe patents. India emerged as a global supplier of active pharmaceutical ingredients in the 1980s, and by 2024 its share of the world's production of these ingredients had reached about 32 per cent.
Lupin invested in understanding the process chemistry, chemical structure and synthesis routes of existing drugs. One such drug was captopril. By the early 1990s, Indian companies such as Lupin had reverse-engineered captopril and were offering it at just 5 per cent of the price of the original product.
Lupin's big leap in research came in 2005, when its oral and injectable cephalosporin drugs won approval from the US Food and Drug Administration. Lupin's research and development teams drew on their expertise in cephalosporin active ingredients to do this. They developed oral and injectable forms of the drugs. This meant getting past patent hurdles, and it also needed precise control over the production process to ensure how much of the drug becomes available in the body and how stable it remains.
The team then developed products for long-term treatment areas such as heart and blood vessel diseases and diabetes drugs. These areas later became the most important in Lupin's portfolio of generic drugs in the US. By the end of the decade, Lupin had received more than 75 approvals for generic drugs in the US. In the following decade, the company filed drug master files for 129 drugs and 186 abbreviated new drug applications, and built the broadest generics product range among Indian companies.
Dr Desh Bandhu Gupta and Himadri Sen, head of Lupin's drug delivery research and development department, took a special interest in drug delivery technology. Sen joined Lupin in 2000 after guiding Ranbaxy's journey in the US for a decade. According to both, this was an important step towards more new products.
A range of children's medicines built around Suprax opened a path to innovation using existing knowledge, meaning fresh clinical trials were not needed for approval. The opportunity with the Antara brand showed the same route. These products were called "incremental innovation", yet they met unmet needs of doctors and patients.
Some of these products made it possible to take once a day a tablet that had to be taken twice a day. Others turned an injectable drug into an easy-to-use inhaler. These early innovations laid the foundation of the specialty drugs business, so that Lupin was no longer limited to generics and could diversify.
The excerpts are taken from the book Made in India: The Story of Desh Bandhu Gupta, Lupin and Indian Pharma by Manish Sabharwal and Sundeep Khanna, published by Juggernaut.
