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PUSHPA VIJAYARAGHAVAN DIRECTOR, SATHGURU MANAGEMENT CONSULTANTS PVT. LTD.
STRONG FOUNDATION
Industry rests on a foundation of sustainable scale and is now embarking on a journey of transformation
T
he most poignant “Make in India” success story, the Indian pharma industry has truly embodied the possibility of global impact with Indian manufacturing. The industry rests on a foundation of sustainable scale and has expanded access to quality drugs across the world and is now embarking on a journey of transformation to replicate this success across next-generation drugs and healthcare solutions.
ered not only cost competitiveness in global markets but also the overall engine of product development. Timely access to in-house developed APIs has also implied high participation in first-time generics. Similar to our contribution to total ANDA filings, our overall contribution to first-time generics (FTGs) has also remained at the 30 per cent threshold. This has been a driver of economic value given the relatively lower level of competition in FTGs and participation at the beginning of the price erosion curve. This high contribution to FTGs has also been a strong enabler of access to drugs due to enhanced affordability. Several of these FTGs have included complex chemistry as well as para IV filings with non-infringing claims or patent invalidation. Industry’s capability around both API route code chemistry and complex formulations have progressively expanded to enable India to today stand tall as the largest supplier of pharmaceutical drugs to highly regulated US and EU markets.
Extending global health priorities
India’s impact on expanding access to medicines and delivering on the promise of affordability is apparent in the most regulated markets of the world. It is also apparent at the other end – global public health. Akin to what Indian vaccine companies have achieved on enabling access Scale with a foundation of quality and research to routine immunisation for all children With leading Indian research institutions such as IICT Hy- in low and middle-income countries derabad, NCL Pune and ICT Mumbai providing early support (LMIC) with an aggregate capacity of on process development for high volume production of WHO prequalified manufacturing chemicals with application in global pharma, the inexceeding a billion doses, Indidustry forged a presence across the value chain. an pharma companies have “vertically While India is no longer a leading API exporter played a critical role in integrated to the world, route code chemistry and comthe global fight against presence has petitive API production still power the large HIV as well as viral powered not only base of backward integrated pharma compahepatitis. While the cost competitiveness nies at the forefront of the country’s formiglobal supply footprint in global markets but dable growth story in generics. Our analysis of antiretroviral drugs also the overall points to leading Indian pharma companies for HIV treatment is engine of product enjoying backward integration into API for ~ 70 relatively more discussed development” to 80 per cent of their ANDA portfolio compared and known globally, the imto an average of ~40 per cent for global counterparts pact on novel anti-viral used for with comparable scale. Of the 616 Drug Master Files filed with the treatment of Hepatitis B and HepUSFDA in 2019, Indian companies contributed to more than atitis C infections is often under-appreci50 per cent (~331). The vertically integrated presence has pow- ated. In 2014, Gilead voluntarily licensed
