Merchant Exporters Make a Blunt Case for India’s Pharma Diversification at PharmaCore India 2026
A frank, experience-ground panel on de-risking India’s pharma export dependence on the US reveals a consensus: the opportunity is vast, the barriers are largely self-inflicted, and the MSME merchant exporter — long overlooked in the policy imagination — holds a decisive role in India’s next export leap, Munjuluri UV Ramesh of Neo Science Hubreports from Jio Centre, Mumbai
There was no diplomatic evasion in Pavilion 2 on Wednesday afternoon. The panel discussion that brought together three of India’s most experienced pharmaceutical merchant exporters at PharmaCore India 2026 dispensed with the standard conference courtesies early, and spent the better part of an hour in frank, often pointed territory: the uncomfortable arithmetic of India’s export geography, the regulatory contradictions that handicap its own MSMEs, the precise geographies that represent the next decade’s growth, and the stubborn but correctable habits of Indian pharma suppliers that lose them business before a single vial crosses a border.
The session, titled “De-risking Pharma Exports: Reducing US Dependence and Expanding Global Markets through Merchant Exporters,” was moderated by Mr. Dharmesh Khanwar, Director of NGB Laboratories and a senior figure within the Federation of Pharmaceutical and Allied Products Merchant Exporters (FPME). The panellists were Mr. Shailesh Patel, Director of Flagship Biotech International Pvt. Ltd.; Mr. Sandeep Modi, Founder-Director of Infugen Pharma Pvt. Ltd. and Vice President, FPME; and Mr. Hemil Shah, Founder of Prahem Laboratories.
The context for the conversation, Khanwar made clear in his opening, was not merely theoretical. India’s largest export market remains the United States, accounting for over 30 per cent of pharma exports in the April-February period of FY26 — a concentration that, as panellists elaborated at length, represents a structural vulnerability in an era of tariff volatility, regulatory uncertainty, and geopolitical disruption that India’s industry can no longer afford to treat as background noise.
From US Dependence to Market Plurality
Khanwar opened with the central strategic question to Shailesh Patel: given that Indian industry built much of its manufacturing capacity with the US market as its reference point, is the time now ripe for a decisive rebalancing toward Africa, ASEAN, CIS, and Latin America?
Patel’s answer was calibrated and specific. Rather than the usual broad advocacy for “emerging markets,” he identified a precise seven-market cluster as the most viable near-term alternative to the US: the five largest European Union economies — France, Italy, Germany, Spain, and the United Kingdom — combined with Saudi Arabia and the UAE. The argument was structural: plants built to US and European quality standards can serve these markets without fundamental infrastructure change; Saudi Arabia and UAE offer superior pricing compared to most emerging markets; and critically, currency risk in the Gulf is minimal. “The risk of devaluation is very less there. Your money is secure,” Patel said. “Putting all these parameters together, I would bet very heavily on Saudi Arabia and UAE.”
The framing was instructive. Patel’s point was not that Africa or ASEAN are unworthy of attention, but that the fastest yield on existing capacity lies in markets that already respect the compliance investments Indian manufacturers have made. This is a manufacturer’s logic, not an idealist’s geography.
Modi’s Reform Agenda
Where Patel offered market strategy, Sandeep Modi offered something sharper: a policy indictment. Modi, who brings both the ground-level experience of running a 30-year export operation across 25-plus countries and the policy perspective of his FPME vice-presidency, identified three reforms as most urgently needed — and his framing of the first was deliberately provocative.
India’s pharmaceutical regulatory framework, he argued, has created what he called an “apartheid” between domestic and export market products — a structural division that serves no quality purpose and imposes real costs on small exporters. “One world, one product, one quality, one standard,” he said, citing a Reliance Life Sciences presentation slide that articulated the principle India’s own regulators have so far declined to adopt. Under the current system, domestic and export manufacturing permissions are treated as separate regulatory categories, creating bureaucratic friction that disproportionately burdens MSMEs. “I don’t know why this divide is created. If Zone 4 stability is there, do we require a separate stability for Zone 1, Zone 2? But internal hurdles for growth to small MSMEs have been created and this needs to be addressed.”
His second reform priority was the establishment of GDP-compliant warehouses dedicated to merchant exporters, funded through the Department of Pharmaceuticals’ existing but underutilised special purpose vehicle budget for pharma exports. COVID-era precedent, he argued, demonstrates this is achievable: “COVID time, what did the government do? Maximum testing to reduce the risk of spreading the virus. Here we have not increased quality testing for exports. We need random testing at customs, so that people are aware of quality.”
Third, and most structurally significant: rupee trade. Modi’s argument here had a directness that cut through the usual hedged language around de-dollarisation: Africa’s growth as an export destination is being throttled not by demand or quality issues but by the dollar scarcity of African importing nations. “In Africa, every country is struggling to make dollars. Why can’t we make rupee trade a reality? If only rupee trade is implemented properly, Africa can go three times.” He cited the RBI’s existing Nostro account framework as adequate in design but a “joke” in implementation — the infrastructure exists; political will and banking-sector execution are missing. The implication for India’s $130 billion pharma export target by 2030 was stark: US dependency could fall below 15 per cent if rupee trade and Africa market development are properly unlocked.
Modi also flagged a subtler but significant reputational problem: the asymmetric public reporting of product quality failures in India, whereby large company recalls are characterised as “recalls” while MSME failures are branded “not of standard quality” — with no denominator (total units tested) ever published. “That has created a negative impact in the minds of international buyers,” he said. “We need to highlight what good has been done rather than only highlighting not-of-standard quality.” It was the kind of observation that only someone who has spent years sitting across the table from foreign buyers would know to make.
Shah on What Buyers Actually Want
The most practically counter-intuitive insight of the session came from Hemil Shah, whose operations span more than 50 countries. Asked what overseas buyers value most — price, speed, trust, compliance, or flexibility — his answer reordered the conventional wisdom.
Price matters, he conceded, but it is not the first filter that serious importers apply. “If you ask international customers what is the challenge they face from Indian suppliers, the first answer is: timely reply.” The failure mode Shah described is ruinously common: Indian suppliers quote multiple prices, complete preliminary negotiations, and then fail to produce clean, complete documentation in time — or at all. “After you finalise pricing, you have done everything, all activities done — then they face issues getting documents from Indian suppliers.”
His prescription for new exporters was to stop presenting themselves as “merchant exporters” — a category that carries an instinctive price-premium suspicion — and instead position as growth partners, arriving at a new market relationship with all manufacturer documentation, GMP certificates, country-specific regulatory alignments, and product registrations already prepared. He used Kenya as an illustrative example: a properly prepared India-Kenya market entry means arriving with all Kenyan regulatory requirements pre-researched, manufacturing partners aligned, and documentation ready before the first commercial conversation. “That is what any distributor values — how reliable you are, how well prepared you are. Price will be second option.” This is not idealism; it is competitive intelligence from a practitioner who has watched Indian exporters lose contracts they should have won.
Khanwar added an observation that Shah’s answer prompted: in FPME’s membership, several exporters who speak Spanish, Portuguese, or Arabic are achieving results in Latin America and GCC markets that their English-only counterparts cannot replicate. “Please start learning the language of the geography you are targeting.”
Market Selection: The Crossfire Round
In a rapid-fire crossfire exchange, each panellist named their top geography for the next five years. The answers were revealing in their diversity and internal logic.
Modi chose Africa without qualification — volume, potential, and the rupee-trade opportunity he had just argued for. Patel chose Saudi Arabia and UAE — pricing discipline, currency stability, government-controlled procurement systems with transparent tendering and preferred-pricing mechanisms for audit-compliant facilities, and faster registration processes. Shah chose Latin America and Middle East, with particular emphasis on the Gulf given current regional political dynamics that he argued would accelerate pharmaceutical demand. Khanwar added ASEAN and CIS — with an important caveat on the latter: Russia, Belarus, and other larger CIS markets carry significant payment risk under current US embargo conditions. “Unless you get an advance payment, making supply to them is full of risk.”
On individual country picks, the panel’s choices were sharp: Modi would explore Somalia (absent from his current portfolio, and representing a frontier bet on Africa’s medical access expansion); Patel would target Australia (a market consistently overlooked because of its 26-million population, but offering government-controlled transparent tendering, excellent pricing visibility, and an upcoming facility upgrade that would meet its regulatory requirements); Shah made perhaps the most strategically sophisticated pick — Japan, on the grounds that a single JFDA (Japan’s pharmaceutical regulatory agency) product registration unlocks fast-track or homologation access to 70 to 80 countries across Africa, Latin America, the Caribbean, and Southeast Asia. “With one registration in Japan, you can cater to almost 70 to 80 countries.”
High-Risk Payment Markets and the Iran Problem
Asked which market carries the highest payment risk, the panel’s responses illuminated the real-world mechanics of global pharma trade that are rarely discussed in formal industry fora. Modi identified Africa in general because of endemic dollar scarcity — and noted from his own experience in Mozambique that India’s diplomatic apparatus is not adequately deployed to leverage the trade relationships India already has. India is Mozambique’s largest export partner, yet the Indian ambassador on the ground was, in Modi’s account, not assertively communicating Indian exporters’ payment challenges to Mozambique’s trade ministry. “That confidence — the dadagiri that China is doing today — we need that,” he said, using the Hindi term for forceful assertion, not bullying. “Only when that comes, we can get the representation we need.” Shah identified Iran — a market with genuine pharmaceutical need and the financial resources to pay, but with payment channels essentially blocked by US sanctions. “Getting payment from Iran is a real task.”
The Dosage Form Frontier
A question on the fastest-growing global demand categories produced the session’s most forward-looking technical exchange. Khanwar himself identified biologicals and biosimilars as the critical gap in the merchant exporter’s current portfolio — and, notably, the segment where collaboration between merchant exporters and manufacturers is most urgently needed. He referenced the scale of the opportunity with a single number that silenced the room: Keytruda (pembrolizumab), one biosimilar molecule, generates approximately $31–32 billion in annual sales — more than the combined exports of India’s top ten pharmaceutical companies. “Just one product of biosimilar is equivalent to the whole pharma industry of India, top ten. That is where the future is.”
Patel pointed to prefilled syringes and auto-injectors as the dosage form where structural demand is accelerating fastest, citing the semaglutide (Ozempic/Wegovy) phenomenon as the proximate cause of a broader shift: “All the prefilled syringe manufacturers are occupied.” The underlying driver, he argued, is not just one molecule but a secular shift across the medical community toward patient-safety-optimised drug delivery — a shift that favours prefilled formats over vials and ampoules regardless of the therapeutic category. Shah reinforced the point more bluntly: sterile products — injectables, eye drops, powder-for-injection, and biological vials — are the category where Indian competition from low-cost imitators is structurally protected for the next 15 to 20 years, because building sterile and oncology manufacturing capability in most of the target markets is simply not viable at current volume levels. “If I am an Indian entrepreneur going into manufacturing, I will look for sterile products.”
The GIFT City Idea and the Logistics Park Vision
Among the panel’s more substantive structural proposals was Modi’s advocacy for GIFT City (Gujarat International Finance Tec-City) to be given an explicit mandate to facilitate pharmaceutical merchandise trading — specifically, the ability to import APIs or semi-finished products from China or other sources, process or repackage them in a designated trade zone, and re-export to third markets. Singapore performs this function at scale for global pharma trade; Modi argued that GIFT City or a dedicated Maharashtra logistics and warehousing park could replicate it, enabling merchant exporters to access merchandise trade flows that currently bypass India entirely. “We have many members who buy from China and sell to Africa, buy from the Middle East and sell to Latin America. That is a huge number. But banking terms make transactions very difficult.” Khanwar noted that FPME has a position paper and a working team already assembled to make this vision operational.
Q&A: The New Entrant, the Japan Homologation Strategy, and the Rupee Trade Imperative
The audience Q&A crystallised three threads worth noting. An FPME founder-member proposed establishing FPME representative offices in key African capitals — Nairobi was cited — to facilitate in-country relationship building, technology transfer facilitation, and real-time regulatory intelligence. Modi responded warmly, connecting the idea to FPME’s existing Expo Farm initiative, a global exhibition platform for merchant exporters, and committed to brainstorming it formally. A first-generation merchant exporter seeking product and market entry guidance was advised to begin with medical devices and disposables — lower regulatory barriers, faster registration, established global demand — before graduating to finished formulations, where partnering with one or two manufacturers and serving as their dedicated market-entry partner is the recommended starting model. And the Japan homologation strategy that Shah had outlined in the crossfire round was elaborated for the audience: the JFDA registration pathway enables fast-track or waiver registration in a documented list of countries spanning Africa, Latin America, the Caribbean, ASEAN, and even some Gulf states. Panama, Guatemala, Costa Rica, Trinidad, Guyana, Mexico, Colombia, Canada, Australia — all either accept or fast-track JFDA-registered products. For an MSME with limited regulatory budgets, this is arguably the highest-leverage single regulatory investment available.
Closing Assessment
FPME, which has made path-breaking representations to Pharmexcil, the Ministry of Health, the Ministry of Finance, DGFT, Customs, and other bodies on issues concerning pharmaceutical merchant exporters, has been the consistent advocate for the MSME segment of India’s export ecosystem — a segment whose role in reaching underserved markets is fundamentally different from, and complementary to, that of large pharma majors. What Wednesday’s panel added to that institutional advocacy was granularity, urgency, and a collective voice shaped by decades of market experience across six continents.
India’s Commerce Secretary has recently asked the pharmaceutical industry to reduce dependence on critical raw materials from China and find export destinations beyond the United States to navigate global uncertainties — a call that arrived, somewhat late, from the policy establishment. The merchant exporters at PharmaCore India 2026 have been living this argument for years. They do not need to be convinced. They need regulatory barriers removed, rupee trade made real, GIFT City weaponised for pharma trade, and the domestic-export quality apartheid abolished. The pharmacies of the world’s poorest countries are waiting. The question is whether India’s regulatory imagination can match its commercial ambition.
PANEL AT A GLANCE
Moderator: Mr. Dharmesh Khanwar, Director, NGB Laboratories; FPME Panellists: Mr. Shailesh Patel — Director, Flagship Biotech International Pvt. Ltd. | 25+ years, pharma manufacturing and global exports; strengths in outsourcing, regulatory affairs and strategic marketing Mr. Sandeep Modi — Founder-Director, Infugen Pharma Pvt. Ltd.; VP, FPME | 30+ years; 25+ countries; 100+ products; WHO-GMP certified partners Mr. Hemil Shah — Founder, Prahem Laboratories | 50+ countries; expertise in biosimilars, contract manufacturing and global business development
KEY POLICY PROPOSALS FROM THE SESSION
One world, one product, one quality — abolish the export-domestic regulatory bifurcation | GDP-compliant warehousing parks for merchant exporters, funded via DoP’s existing export promotion budget | Rupee trade operationalisation with RBI Nostro framework — critical enabler for Africa 3x growth | Random quality testing at customs for export consignments | GIFT City mandate for pharmaceutical merchandise trade | FPME representative offices in key African trade capitals | Japan JFDA registration as a multi-country homologation lever for MSMEs
