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Shardul Nautiyal, Mumbai May 17 , 2025
Indian companies are proactively expanding their presence in Rest of the World (ROW) markets, which offer strong demand for affordable, quality healthcare and relatively less competition. The ROW markets, particularly in regions such as Central America, Southeast Asia, and Africa present significant untapped potential, informs Nilesh Patel, managing director, Kashmik Formulation.

He further adds that Kashmik Formulations plans to capitalize on this by obtaining product and facility registrations in accordance with each country’s regulatory framework. We are also building strategic alliances with credible local partners to ensure effective market penetration and distribution.

Ahmedabad based Kashmik Formulations Pvt. Ltd was started in the year 2017 as a manufacturer, exporter, and distributor of pharmaceutical goods. Its core product portfolio includes antibiotics, antacids, pain management, and anti-allergy medications. The company has recently ventured into the anti-diabetic segment and plan to introduce lifestyle-focused therapies for obesity and cardiac wellness.

The company currently has a strong presence across India and has recently started its operations in Nigeria. Over the coming years, its focus will be on expanding both domestically and globally, with a strategic emphasis on ROW markets that also offers a more conducive regulatory environment.

Talking about the regulatory challenges and affordability challenges, Patel pinpoints that the pharmaceutical industry operates within a highly regulated environment.

Patel explains, “On the regulatory front, the Drug Price Control Order (DPCO) plays a crucial role in making essential medicines affordable. However, the price caps imposed can limit profitability, which in turn affects the industry's ability to reinvest in research, innovation, and the development of new therapies.”

In terms of affordability, volatility in raw material prices makes it difficult to maintain margins, especially when selling prices are fixed. At the same time, adhering to stringent quality benchmarks such as GMP compliance, stability studies, and rigorous testing protocols adds to the cost burden. Striking a balance between maintaining quality and keeping products affordable is a persistent challenge.

Talking about the evolving global regulatory environment, Patel says, “The global shift towards stringent regulatory oversight is a welcome move that enhances product safety and efficacy. At Kashmik, we uphold GMP certification through regular audits, workforce training, thorough documentation, and real-time monitoring. We’re also integrating digital tools to ensure traceability, reduce human error, and boost overall compliance.”

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