Is India reliable? Addressing challenges in the pharma industryIs India reliable? Addressing challenges in the pharma industry

Indian pharmaceutical industry, historically known for its dominance in the production of small molecules, is now on the cusp of establishing itself as a major supplier in the large molecule and biologics space. Despite being dubbed as the “pharmacy of the world,” the country faces ongoing challenges in establishing itself as a reliable manufacturing hub. 

At CPHI India, Rhonda Duffy, chief operations officer (COO) at Biocon Biologics spoke to BioProcess Insider emphasizing the country’s need to realign its approach with global standards, particularly leadership, infrastructure, and investment. 

“India needs to move away from its British heritage and colonial mindset,” Duffy said. “It’s time to move beyond old practices and focus on reliability, which is the key to attracting foreign investment.” 

Comparing the country to smaller nations like South Korea, she pointed out that India’s manufacturing capabilities often fall short of international standards. 

“It’s about marketing ourselves as a country. We need to show that we can consistently meet high standards [...] Big pharma companies are hesitant to risk high-value raw materials here, unless we can guarantee reliability.” 

“We need to set a standard and prove ourselves – it's the only way those big guys are going to come to India,” she added. 

Moreover, Indian firms have repeatedly faced scrutiny from the US Food and Drug Administration (FDA) due to lapses in quality control, data integrity, and operational practices, further damaging the country’s reputation. 

Another significant challenge, Duffy pointed, was the lack of strong leadership in India’s pharmaceutical sector. 

“The smartest people I’ve ever worked with are in India, but the leadership skills – really poor. We need leaders who can inspire their teams, not just command them. We need to focus on building leaderships from the shop floor to the c-suite, helping people understand not just what they do but why they do it.” 

Furthermore, she talked about the cultural barriers Indians face in creating meaningful strategic partnerships. “The Indian ethos to success is to do it yourself. Founder-led companies rarely rely on others. It’s about being number one, unlike in Europe.” 

“When I headed a Danish firm, it was seen as a huge strength to be able to show vulnerability and humility. And it was a proud thing to say, ‘I actually don't know how to do this, but my team does.’ I am yet to see this attitude in India.” 

Most importantly, Duffy criticized the lack of tangible support from Indian government agencies. “There should be a government agency specifically set up to promote India’s pharma capabilities, but right now it feels like there’s no tangible action. We need a more visible effort to say, ‘Come to India, we can do this,’” she said. 

“What we must get right about India is reliability. It’s about getting ourselves to a standard, keeping that standard, and proving we are a reliable supplier.”