India Pharma Outlook Team | Wednesday, 12 August 2026
The latest developments across drug regulation, R&D and healthcare expansion signal important shifts in the global and Indian pharmaceutical industry.
India’s drug regulator has called for comprehensive reviews of globally unapproved drugs entering the country through international clinical trials.
At the same time, Zydus Lifesciences targets a FY28 US launch for saroglitazar, with peak sales potential of USD 200 million, reflecting growing opportunities for Indian pharma companies in global markets.
Amgen’s planned Science and Innovation Center in Hyderabad and Bristol Myers Squibb’s continued US manufacturing expansion. Meanwhile, Philips India’s focus on healthcare, AI and R&D strengthens India’s role in the global innovation ecosystem.
These developments could reshape the current pharma industry, by strengthening regulatory standards, accelerating innovation, expanding manufacturing capacity.
India’s drug regulation framework will take a stricter approach toward drugs that have undergone global clinical trials. The DCGI said several companies have sought permission to import and market such drugs based on Phase 3 global clinical trials.
The regulator clarified that these products qualify as “independent new drugs” in India and require comprehensive evaluation of their applicable clinical and non-clinical data. The review will assess safety and quality through evidence such as animal pharmacology and toxicology data before human-use considerations.
However, new drugs that no regulator has assessed and validated still require prior regulatory approval. The Central Licensing Authority, CDSCO, has also granted case-by-case waivers for capital-intensive Phase 3 trials and adopted non-animal methods to reduce preclinical toxicology timelines and investment.
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Zydus Lifesciences is preparing for an early FY28 US launch of saroglitazar and expects the novel therapy to generate more than USD 200 million in peak sales after an initial build-up period. The company linked the trend to an expanding patient pool and rising demand for treatment in the targeted indication. The drug targets both fat and sugar metabolism by activating PPAR enzymes, helping reduce triglycerides and improve insulin sensitivity.
Zydus also continues to expand its R&D pipeline. It received approval for a Phase 3 desidustat trial for sickle cell disease with ICMR, while another novel drug, usnoflast, has entered a Phase 2b trial involving 240 ALS patients.
“For Saroglitazar, we believe an FY28 launch, around April. The first two years will be a build-up phase, with limited contribution, and we will look at it more from an investment perspective. But as the product scales up, we are optimistic it to cross $200 million,” said Sharvil Patel, MD, Zydus Lifesciences.
For Q1 FY27, Zydus reported Rs 8,017 crore revenue, up 2 per cent year-on-year, while EBITDA rose 8 per cent to Rs 1,929 crore and net profit increased 36 per cent to Rs 939 crore. The company expects FY27 capex of Rs 1,500-1,600 crore and retained its double-digit growth and 24 per cent EBITDA-margin guidance.
Amgen plans to establish a new Science and Innovation Center at Genome Valley in Hyderabad, strengthening the company’s R&D presence in India. The facility should become operational in 2027 and will expand Amgen’s global R&D network to eight laboratories.
The new center will complement Amgen’s existing innovation site in Hyderabad and will connect wet-lab research more closely with scientific innovation, data and technology. The new facility therefore adds another major global pharma R&D operation to Hyderabad’s growing life sciences cluster.
“The new center in Genome Valley expands the way we integrate experimental science with data and technology across our global research capabilities and complements our strong U.S.-based Research and Development footprint,” said Jay Bradner, MD, executive vice president of Research and Development, Artificial Intelligence and Data at Amgen
Bristol Myers Squibb continues to strengthen its healthcare and pharma manufacturing footprint through USD 2.3 billion investment in a new manufacturing campus in Houston, Texas. The latest project forms part of the company’s broader strategy to expand domestic production, support its medicine pipeline and build long-term manufacturing capacity.
“This investment reflects our confidence in America's continued leadership in biopharmaceutical innovation,” said Christopher Boerner, Board Chair and CEO of Bristol Myers Squibb.
The roughly 600,000-square-foot Generation Park campus will create nearly 500 skilled jobs. BMS plans a flexible and modular manufacturing platform that can adapt as the company’s pipeline and commercial requirements change. The company invested approximately USD 10 billion in R&D in 2025, reinforcing its continued focus on developing new medicines.
Philips India is increasing its focus on healthcare infrastructure, artificial intelligence and R&D as it strengthens the country’s role within its global operations. The company employs nearly 8,500 people in India, representing about 12.5 per cent of its global workforce.
Its Indian operations now contribute products and technologies to global markets, with software developed in India featuring in one out of every two Philips machines sold worldwide.
Philips expects rising healthcare infrastructure spending, including investments in district hospitals and primary healthcare centres. This is to create opportunities across diagnostic imaging, cardiac care, connected care and personal health. The company also sees opportunities in sleep and respiratory care as awareness of sleep-related disorders grows in India.
