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 The Federation of Pharma Merchant Exporters (FPME) has inaugurated its new office in Mumbai, where key stakeholders gathered to discuss pressing issues affecting India’s pharmaceutical export sector.
The event was inaugurated by Bhavin Mukund Mehta, vice-chairman of the Pharmaceuticals Export Promotion Council of India (Pharmexcil), and brought together senior FPME office bearers, including president Kamlesh Shah, joint secretaries Sandeep Modi and Dharmesh Kharwar, and managing committee members Apurva Shah, Hemil Shah, Kirit Doshi, and Rajesh Bhomavat. Shashi Menon conducted the proceedings of the event.
In a detailed discussion, FPME identified several urgent policy and operational hurdles that threaten to undermine the competitiveness of India’s pharmaceutical exports, particularly those undertaken by merchant exporters, who account for approximately 30% of the country’s USD 25 billion pharma exports.
A Central issue raised was the labelling restrictions imposed by an internal Central Drugs Standard Control Organization (CDSCO) memo. This policy limits exports of products labelled "For Indian Market Only," severely affecting small exporters and tarnishing India’s image as a reliable global supplier. The Federation warned that such measures have unintentionally handed advantages to competing nations.
Additionally, FPME highlighted customs challenges, particularly inconsistent practices at Indian ports. Despite clearance from the Assistant Drugs Controller (ADC), customs officials frequently demand unrelated documentation such as Certificates of Analysis (COA) and WHO-GMP certificates, delays that hinder export timelines and inflate compliance costs.
A strong recommendation was made to elevate the global recognition of the Indian Pharmacopoeia (IP). FPME pointed out that exports of medicines marked under IP standards are being wrongly held back under the assumption that such products are meant only for domestic markets. This misinterpretation, they argued, undermines India’s ability to project IP as a credible international standard, despite its acceptance by various foreign clients.
Another critical concern involved the mandatory cough syrup testing introduced after the Gambia incident. FPME proposed a shift to a risk-based testing model, citing that over 99% of such products pass tests without issues. Current requirements disproportionately burden small-volume exporters and make certain shipments commercially unviable.
FPME also weighed in on the recent directive from the Drugs Controller General of India (DCGI), which mandates the digitization of the WHO-GMP Certificate of Pharmaceutical Product (CoPP) through the Online National Drugs Licensing System (ONDLS). As per the circular dated June 25, all applications are to be submitted online starting July 15, 2025, with no physical submissions permitted. Following industry feedback, the deadline has been extended to August 15, 2025.
While supportive of digitization, FPME recommended a consultative and phased implementation to ensure that micro, small, and medium enterprises (MSMEs) are not adversely affected. Stakeholders cited operational readiness and onboarding challenges as significant risks if the rollout is rushed.
Throughout the discussions, FPME leaders emphasized the pivotal role of merchant exporters in India's pharma ecosystem. They not only support India's pharmaceutical manufacturing units, especially MSMEs, by ensuring consistent production cycles but also help in penetrating smaller, underserved international markets. This has a direct bearing on employment, economic growth, and foreign exchange earnings.
“FPME members are at the forefront of delivering high-quality, affordable medicines to less penetrated regions. They play a key role in supporting India’s ‘Make in India’ vision and enhancing the nation’s image as an ethical and dependable pharma exporter,” said an FPME spokesperson.
The Federation also made a strong case for inclusion in all government consultations related to export policy, citing the fact that merchant exporters file 60–70% of all shipping bills each month.
Since its inception five years ago, FPME has achieved several milestones like secured MSME status for trader-exporters, advocated for single-port registration for pharma exports across India, played a key role in easing export restrictions during the Covid-19 pandemic, increased representation of merchant exporters in Government decision-making bodies. Looking ahead, FPME urged exporters to adopt long-term and self-reliant strategies with focus on market research.
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