The Indian pharma industry has demonstrated spectacular growth based on its strength as a global generics manufacturer. Yet Indian pharma is not merely resting on its laurels. After shining through the COVID-19 pandemic and despite recent quality issues, the country’s pharmaceutical sector is looking to refocus its efforts on innovation and self-reliance. In conversation with PharmaBoardroom, leaders from India’s foremost industry organisations reflect on the trends and challenges facing Indian pharma.
The World’s Pharmacy
Thanks to its manufacturing prowess, low costs and skilled workforce, Indian has become known as the “pharmacy of the world” and is widely recognized for its leadership in generics with Indian pharma representing over 20 percent of the global generics supply by volume.
The Indian pharmaceutical industry further proved its capability during the COVID-19 pandemic when it supplied 174 million vaccine doses to nearly 96 countries and several United Nation (UN) agencies. “The collective effort not only led to a consistent supply of medicines globally but also highlighted India’s resilience and commitment to meeting global healthcare needs. This period reinforced the realization that India plays a pivotal role in supplying medicines,” says Sudarshan Jain, secretary general, Indian Pharmaceutical Alliance (IPA), which represents the interests of 24 leading Indian pharma companies.
Shift to Innovation
Yet in light of some of the vulnerabilities laid bare during the pandemic, such as the industry’s over dependence on Chinese APIs, and in alignment with the government’s Vision India 2047 plan to transform the country into a developed nation by 2047, Indian pharma is readjusting its priorities and looking to change its focus from cost-based to value and innovation-based pharmaceuticals.
The recent success in developing the COVID-19 vaccine showcases India’s potential in the innovation space
Sudasrshan Jain, IPA
“Innovation constitutes two-thirds of the global healthcare market space by value. India can play an important role in the evolving healthcare landscape,” says Mr Jain. To this effect, the Indian Government has recently announced a new pharma and medtech R&D policy aimed at encouraging R&D and transforming the Indian pharma and medtech industries.
“India can only achieve self-reliance in pharmaceuticals and medical devices by strengthening its research and development infrastructure that would drive the expansion of access to life-saving medicines and drugs and help India become a global pharmaceuticals and medical exports hub,” said health minister Mansukh Mandaviya when the plan was released earlier this year.
Mr Jain is confident about the country’s newfound focus on innovation. “The recent success in developing the COVID-19 vaccine showcases India’s potential in the innovation space. The policy framework should help to catalyse innovation from India.”
Breakthroughs such as the approval of India’s first home-grown CAR-T cell therapy, NexCAR19, from ImmunoACT, appear to confirm these ambitions while other government initiatives such as the 2018 Ayushman Bharat national health protection plan also support them by continuing to promote access within the country.
“India is committed to moving up the value chain from “Make in India” to “Discover and Make in India, for the world,” Jain affirms.
Building Self-Reliance
Despite being one of the world’s largest formulation suppliers, during the COVID-19 pandemic India’s over-dependence on China for its active pharmaceutical ingredients (APIs) became apparent.
Our aim is to significantly reduce our dependence on external sources by at least 25-30 percent
Daara Patel, IDMA
“About 30 years ago, we were reasonably self-reliant in our basic requirements. However, China began dominating this market by significantly reducing prices,” Daara Patel, secretary general of the Indian Drug Manufacturers’ Association (IDMA), the industry association of pharmaceutical companies based in India, laments.
With almost 65 percent of the country’s APIs coming from China, the Indian government launched a production linked incentive scheme in 2020 to encourage local manufacturing. Mr Patel recognises the effort involved in restoring Indian API production. “The government is initiating schemes to collaborate with us. However, the profit margins are not significantly attractive, dissuading many from entering this sector [APIs],” he argues.
“Nonetheless, there’s a historical expertise in this area that, with government support, can be revitalized,” says Patel, explaining that the industry’s goal is to continue to become more self-reliant. “Our aim is to significantly reduce our dependence on external sources by at least 25-30 percent. We have certain members entering this field while supporting those already engaged in manufacturing to scale up their capacities.”
Reinforcing Quality
Recent scandals such as deaths arising from the use of contaminated India-produced cough syrups have led to concerns about the quality of drugs produced in the country. Yet maintaining quality remains paramount for Indian pharma, says Jain, and the fact that the nation boasts the largest number of US FDA-approved plants outside of the US demonstrates this commitment. “With more than 600 US FDA-approved facilities, India has made significant strides in ensuring the quality of its medicines,” he maintains.
Patel underlines the role of IDMA in helping its members to meet global quality standards. “Recently, we’ve been revising the Good Manufacturing Practices (GMP), and IDMA was the sole association mandated by the CDSCO and DCGI to conduct nationwide meetings to sensitize manufacturers,” he says. For the secretary general of the organisation, bolstering quality is an ongoing effort. “While we’ve been devoted to maintaining quality, the objective is to ensure everyone comprehends and renews their pledge to excel further,” he claims.
The IPA’s general secretary explains that quality is one of the organisation’s main focus areas. “[We] focus on driving excellence in pharma by consistently elevating quality standards to position India as a global benchmark for excellence.”
