Renowned as the “pharmacy of the world”, India’s thriving pharmaceutical sector stands at the forefront of pioneering innovation, particularly in delivering life-saving medications at economical rates.

Distinguished as the chief purveyor of generic drugs, India boasts an extensive production portfolio encompassing 60,000 diverse generic brands spanning 60 therapeutic domains. Its contribution constitutes a noteworthy 20 per cent of the worldwide supply of generics. A standout triumph in the medical realm is India’s role in ensuring affordable HIV treatment, a narrative that has reverberated across borders. This dedication extends to providing more than 50 per cent of Africa’s generic drug requirements and satisfying nearly 40 per cent of the U.S. generic demand. In a milestone achievement, India claimed the top spot as the primary pharmaceutical supplier to Africa in 2018, furnishing a substantial share of the continent’s pharmaceutical imports.

Integral to this ascent is the active encouragement from governmental and regulatory bodies, propelling manufacturers to unveil efficacious generic drugs, thereby nurturing the growth of the pharmaceutical market. The integration of cutting-edge 3-D printing technology has revolutionised the production landscape, facilitating the creation of generic medications with diverse release profiles and flavors. Consequently, the prevalence of generic drugs within the pharmaceutical domain has witnessed a commendable surge.

The interplay of factors such as the abbreviated patent lifespan and the compressed interval for new drug refilings has fomented an environment conducive to multiple companies entering the generic drug arena, fostering heightened competition that, in turn, drives down prices. Moreover, the augmentation of healthcare accessibility and the burgeoning health awareness among the populace further galvanize the trajectory of the pharmaceutical industry.

Illegitimate pharmaceuticals: A pervasive challenge in India

The persistent problem of illicit pharmaceuticals has posed a significant and enduring challenge within the Indian context. As of 2018, the Central Drug Standard Control Organisation (CDSCO) brought to light a disconcerting statistic, revealing that nearly 4.5 per cent of all generic drugs circulating within the domestic market were deemed substandard. Adding to this concern, recent developments in November 2022 underscored the issue further, when regulatory bodies conducted a random sampling of 1,487 drug specimens, uncovering that an alarming 6 percent (83 samples) exhibited substandard quality.

While the United States boasts a robust quality control framework alongside routine quality evaluations, India’s narrative unfolds quite differently. The landscape here is marred by widespread corruption, creating a pathway for acquiring drug licenses through bureaucratic and even political channels. The inadequacies in India’s drug control protocols are exacerbated by constraints in funding, resources, and personnel, thus amplifying the challenges at hand.

At a grassroots level, an additional menace compounds the issue: the presence of vendors peddling counterfeit medicines. These sellers, often operating within retail spheres, source substandard pharmaceuticals from dubious suppliers. Adding to the complexity, unscrupulous chemist shops unlawfully distribute these counterfeit drugs, misleadingly utilising the branding of legitimate pharmaceutical companies, which remain oblivious to these unlawful activities. Although combatting this multifaceted problem extends beyond the purview of individual pharmaceutical companies, it becomes imperative to curtail such practices promptly, given their potential to tarnish the reputation of the implicated pharmaceutical entities.

Evolving Landscape of Generic Pharmaceuticals

In recent research, the global market for generic drugs demonstrated a substantial value of USD 390.57 billion in 2020, with projections estimating an ascent to approximately USD 574.63 billion by 2030. This trajectory reflects a commendable compound annual growth rate (CAGR) of 5.59 per cent, spanning the years between 2021 and 2030.

The global appetite for pharmaceuticals sourced from India continues to surge. Notably, India’s stake in the U.S. generic pharmaceutical market is on a rapid incline, paralleled by an accelerated expansion in the number of enterprises and production facilities catering to the U.S. market. Heightened emphasis on bolstering regulatory prerequisites, elevating healthcare infrastructure, and augmented government investment in research and development collectively augur well for the pharmaceutical sector.

Concerted government efforts and innovative approaches

In a concerted endeavor, the government has embarked upon a collaborative initiative with state authorities to comprehensively inspect pharmaceutical manufacturing units nationwide. Simultaneously, a notification from the central authority mandates that manufacturers of drug formulations specified in Schedule H2 incorporate a bar code or quick response (QR) code on primary packaging labels, or secondary packaging labels if primary space is limited. This measure, effective from August 2023, facilitates authentication through data or information retrievable via software applications.

Government entities have spearheaded several campaigns to heighten public awareness regarding the availability of generic medications. A prime illustration is the Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP), where PMBJP Kendras across the nation provide accessible and affordable quality generic drugs and implants. This program, operational in every Indian state, resonates strongly among individuals within moderate to low-income brackets, offering them cost-effective access to reputable medicines.

Fortifying commitment through vigilant measures

With an unwavering dedication to offering secure and high-quality pharmaceuticals, the Indian Pharmaceutical Alliance (IPA)- affiliated companies have orchestrated a series of targeted actions aimed at achieving excellence in product quality. Over the past few years, IPA has diligently pursued the following endeavors:

•Benchmarking the quality standards of Indian pharmaceuticals in a global context.

•Formulating precise guidelines and best practices in pertinent domains, meticulously reviewed by regulatory bodies worldwide, including the FDA.

•Enhancing and nurturing the competencies of quality professionals within Indian pharmaceutical establishments.

A promising future awaits

Amidst the ongoing initiatives orchestrated by the government and the steadfast commitment demonstrated by the IPA, Indian enterprises are poised to expand their global footprint, bolstering their manufacturing prowess to cater to the escalating worldwide demand. The horizon beckons a significant role for Indian pharma in the global healthcare landscape, transcending the realm of affordability to consolidate India’s stature as a preeminent global hub for crafting innovative and top-tier pharmaceuticals.

Through audacious strategic strides across uncharted territories, diverse product landscapes, and emerging technologies, Indian generic manufacturers are poised to reassert their standing as premier suppliers of cost-effective, high-quality medications on a global scale. Vital to this transformative endeavor is the effective communication of this overarching vision, underscoring an unwavering dedication to quality.

Such communication forms the linchpin connecting the aspirations of manufacturers with the expectations of those who place their trust in these pivotal medicines. This symbiotic relationship between manufacturers and beneficiaries is pivotal in shaping a promising and luminous future.

Views expressed by Nikkhil K Masurkar, CEO, Entod Pharmaceuticals

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