The Indian pharmaceuticals market has several unique characteristics that have contributed to its steady growth as well as recognition. Firstly, the country’s grip on the branded generics market is its biggest strength. India is the only country to have the highest number of United States FDA-approved plants for generic drug manufacturing outside the north American country. Generic drugs are the pharmacologically equivalent versions of branded drugs and have the same dosage, intended use and other qualities as the original drug. In 2015, India earned over 21 billion U.S. dollars through biosimilars in the prescribed drug market. Another crude indicator of generic market success was when Kiran mazumdar-Shaw- the founder of the country's largest biopharmaceutical company was named as one of the richest self-made women in the country in 2019.
Secondly, the industry has many local players who have created their niche through early investments and new formulation development capabilities. Notably, six domestic firms including Aurobindo, Cipla, Desano, Emcure, Hetero Labs and Laurus Labs have UN-backed Medicines Patent Pool to manufacture anti-AIDS medicine for over 112 countries in the developing markets. Moreover, due to healthy competition and generic productions, the prices of drugs from Indian manufacturers are extremely low compared to global prices. Even though India ranks tenth globally in terms of pharma production value, it comes in third by production volumes.
In 2018, the country’s export value of drugs and pharmaceuticals amounted to over one trillion rupees. This impressive record has also lead to some major foreign investments in the sector along with several key M&A deals. The government has also been keen on backing the sector through various policy implementations. There are plans in place to regulate drug prices and approvals through the “Pharma Vision 2020” program along with the Drug Price Control Order initiated in 2013. Under this vision, there are several manufacturing plants being setup across the country, generating employment and further impetus to the sector. This, combined with the National Health Protection Scheme (Ayushman Bharat Yojana) and an increased health expenditure, along with rising cooperative agreements with global pharma companies have given domestic companies a new boost.
However, these developments do not come without a cost and the Indian pharma sector also has some challenges ahead. A lack of focus and funding for new drug R&D along with patent regulations had curtailed innovation in the industry. The intellectual property protection authorities in the country seem to place generics above APIs, leading to high volume of raw material imports from other countries like China to manufacture Indian generic drugs. Yet, with aligned efforts from industry players and the government, India has the potential to lead the industry in developing economies.