India is often called the ‘Pharmacy of the World’ as it is the largest supplier of low-cost generics, vaccines and affordable medicine. According to a report by Statista, in the financial year 2023, the country exported pharmaceuticals worth over 25 billion U.S. dollars. Moreover, in terms of volume, Indian drugs comprised of 20 percent of the global generic drug exports, out of which North America had the largest share.

During the CPHI & PMEC India 2023 press briefing, Dr. S V Veeramani, Chairman, Pharmexcil & Chairman and Managing Director, Fourrts emphasised that the Indian pharmaceutical industry is on a compelling growth trajectory, evidenced by an 8 percent year-to-date increase in exports and a remarkable 29 percent surge in October alone.

Financial Express.com got the opportunity to speak to Dr. Veeramani and he talked about the global reception of Indian pharmaceuticals, challenges and scope, impact of substandard drugs, among others. Excerpts:

What are some of the recent trends that you have noticed with respect to drug export, what more needs to be done in this segment?

The recent trend shows a significant surge in enthusiasm among Indian pharmaceutical companies for exports. For instance, demand for stalls at events like IPACs and CPHI reflects overwhelming interest, with waiting lists for participation. There’s a notable shift towards an export-oriented focus, evident in the high number of members in Pharma exports compared to domestic marketing. This enthusiasm extends to active participation in international delegations, with the Latin America delegation already seeing substantial registration numbers.

To sustain and enhance this positive momentum, it’s crucial to expand offerings beyond basic generics. The emphasis should be on providing complex generics, specialty generics, and value-added formulations. Diversifying into biologicals could further amplify our export potential. While some countries like Japan and South Korea are eagerly awaiting Indian pharmaceutical exports, challenges, such as China’s policies, require careful consideration. The key to continued growth lies in innovation and meeting the unique demands of different markets.

India is actively participating in numerous global markets. Which markets hold significant importance for India as an exporter, and what therapeutic areas are experiencing a notable surge in export activities?

Certainly, there is a notable interest in oncology, respiratory diseases, and diabetology, with substantial demand for products in these therapeutic areas from India. While our focus extends to multiple countries, the United States stands out as a primary focus, receiving approximately 33 percent of our exports, totaling over 8 to 9 billion dollars. We are actively expanding our presence in the European markets and South Africa as well.

In light of recent quality concerns in the pharmaceutical industry, particularly with players like Gambia or Maiden Pharma, how is Pharmexcil safeguarding its reputation amidst a mix of regulated and unregulated entities?

Certainly, while it might seem that these concerns are widespread due to repetitive coverage in various papers, the reality is that only a few instances exist. However, some entities are projecting this disproportionately, potentially harming the Indian pharmaceutical industry’s interests. To counter this, we are actively working to educate pharmaceutical exporters through over 10 planned seminars across India, focusing on quality, compliance, and patient safety. These seminars cover crucial aspects such as the purchase of CPMs, the importance of quality by design, and the necessity for validation. We’ve already conducted sessions in more than six centers, and this ongoing process aims to enlighten and educate pharma exporters.

Moreover, the government, including bodies like CDCSO and the Ministry of Health, is taking proactive measures. Audits of various facilities are underway, with risk-based inspections being conducted. Additionally, Schedule M is being upgraded, aligning it closer to WHO and GMP standards. This enhancement is expected to elevate the overall processing standards in the industry. The commitment to these initiatives reflects a concerted effort to address concerns and uphold industry standards.

Following recent instances, the USFDA has heightened scrutiny on monitoring and compliance, potentially impacting the pharmaceutical industry’s morale. How does this affect the industry?

No, it doesn’t have a negative impact. The pharmaceutical industry is committed to learning and meeting rigorous standards. We aim to produce world-class products globally. When the USFDA provides feedback, we embrace it positively, working to enhance our testing processes. The USFDA commissioner has highlighted India’s significance in pharmaceutical supplies, expressing the desire for India to succeed to benefit the US public. It’s an ongoing process, and challenges are viewed as opportunities for improvement.

While we excel in formulations, our position in APIs lags behind, and given the global emphasis on the “China plus one” strategy, particularly for APIs, what steps should be taken to enhance our capabilities in API formulations?

As mentioned, the need for importing substitutes led to the introduction of the PLI scheme, where products for export to China were identified. Many companies have engaged in this initiative. However, there is a challenge as China aims to reduce prices, potentially affecting the competitiveness of Indian companies. To address this, we are urging the government to impose anti-dumping duties on these specific products under the PLI scheme, as China’s pricing strategy may hinder opportunities for Indian companies. Efforts are underway to bring this matter to the forefront.

What are the current challenges confronting Indian drug manufacturers, and what actions can be taken by both regulators and the industry to address and improve these challenges?

Concerning India, there are two facets: established companies and small and medium enterprises (SMEs). Small enterprises, in particular, need to enhance their manufacturing site standards. The government is working to provide funding for this purpose. Additionally, every company, regardless of size, requires support for research and development (R&D). Increasing support and subsidies for innovation-focused R&D could significantly benefit the industry.

As the global “pharmacy of the world” for generics, there’s a growing emphasis on transitioning to innovative drugs for rare diseases. Despite challenges like high costs and patent issues, how can the industry leverage its success in generics to tap into opportunities for biologics, orphan drugs, and other innovative treatments?

The regulations for biologics in India need a thorough review and simplification, aligning with global standards. Worldwide, certain restrictions on biologics should also be addressed. Given the extended gestation period and substantial investment required for biological companies, there’s a need for an enhanced regulatory environment. Encouraging more companies to venture into biologics will necessitate increased funding, including public funding and greater involvement of venture capital in this sector.

Do you believe that a collaboration through public-private partnerships between the government and industries could play a pivotal role in developing drugs for rare diseases, considering the high burden of such diseases in our country?

Earlier, with institutions like Hindustan Antibiotics, such collaborations were suggested for new drug discovery, a venture requiring significant investment. However, it poses challenges, such as the need for government to select partnering companies to avoid favoritism concerns.