The Indian pharmaceutical industry’s strength in manufacturing processes has roots in historical patent laws. Under the Patents and Designs Act of 1911, new drugs enjoyed product patent rights for 16 years, giving multinational corporations (MNCs) an upper hand in India’s pharma space. Indian companies, however, focused on refining manufacturing processes—an area in which they excelled. The landscape shifted significantly with the introduction of Section 5 of the Patents Act, 1970, which effectively abolished product patents for drugs and only recognised patents for specific manufacturing processes. Thanks to these changes and India’s inherent strength in process innovation, domestic pharma firms flourished from the late 1970s onwards. Although product patent protections were reinstated in January 2005 when India joined the World Trade Organization (WTO), Indian pharmaceutical companies continue to excel in formulation science, combining innovation in process development with cost-effective manufacturing.

Indian firms have also embraced prodrug strategies, where chemical modification of active pharmaceutical ingredients (APIs) improves absorption and efficacy. Additionally, the industry has made strides in excipient technology, developing multifunctional excipients that enhance solubility, stability and patient compliance while reducing the risk of adverse reactions.

Despite being pharmacologically inactive, excipients critically influence a drug’s efficacy, safety and shelf life. However, introducing novel excipients can complicate regulatory approval, leading many manufacturers to opt for established excipients already included in pharmacopeial monographs. Still, new excipients continue to emerge. One example is recombinant human hyaluronidase (rHuPH20), a glycosylated protein that facilitates the absorption of oncology drugs like MabThera (rituximab).

India’s scientific community has taken the lead in nanotechnology-based delivery systems, which offer greater control over drug release kinetics and targeting. There has also been meaningful progress in sustained-release formulations, reducing dosing frequency and improving patient adherence.

Recently, Indian researchers have contributed to mRNA-based therapeutics by demonstrating how cell-penetrating peptides (CPPs)—short amino acid sequences—can efficiently deliver mRNA into cells. This advancement paves the way for novel treatments in areas like cancer immunotherapy and infectious diseases.

Despite these achievements, India still lags in novel therapeutic approaches, largely due to insufficient industry-academia collaborations. Transferring research breakthroughs from academic labs to the commercial sector requires exclusive licensing deals, technology transfer offices and robust support structures like industry-sponsored centres of excellence and incubators. A dedicated core committee that brings together government, academia and industry would help monitor progress and maintain momentum.

In an effort to address such gaps, the Indian government released a draft R&D policy in October 2021 aimed at catalysing innovation in pharmaceuticals. However, this policy must be bolstered through tax incentives, grants and strategic investments in research infrastructure. A conducive environment that nurtures advanced technology platforms—not merely traditional methods—is critical to accelerating pharma R&D.

International models, such as the Life Sciences Innovation Hub at the Massachusetts Institute of Technology (MIT), showcase the impact of strong industry-academia linkages. MIT’s technology transfer office, which issued over 400 patents and 100 licence agreements in FY21 alone, operates in tandem with an industrial liaison programme that brings thousands of companies to the campus every year. Closer to home, partnerships between multinational corporations and Indian institutes like IIT Delhi are beginning to yield promising startups—though India’s collaborative ecosystem still trails that of more developed nations.

Though India’s pharmaceutical sector has firmly established itself in the global generics market, the next frontier—innovation in drug formulation and R&D—remains challenging. By embracing cutting-edge technologies, investing in research talent and forming stronger ties between industry and academia, India can meet these challenges head on.

As formulation science and innovation gather pace, the country appears well-positioned to further cement its status as a global leader in the pharmaceutical domain.

This article is authored by Saransh Chaudhary, president, Global Critical Care, Venus Remedies Ltd and CEO, Venus Medicine Research Centre.