Pharmexcil Digest - May 2025 : simplebooklet.com

ChairmanNamit JoshiPharmexcil Digest 3ForewordIndia’s Pharmaceutical Growth & Global Collaborations – Monthly DigestThe overwhelming response to Pharmexcil Digest reaffirms its significance for India'spharmaceutical exporters. This edition explores next-generation pharmaceutical technologies,expanding beyond exports to highlight industry innovations.A major milestone is the India-UK Free Trade Agreement (FTA) and Pharmexcil extends ourHeartfelt congratulations to Hon’ble Mr.PM Narendra Modi, Commerce & Industries Minister Mr.Piyush Goyal, and Commerce Secretary Mr. Sunil Barthwal. The FTA enhances supply chains,improves access to affordable medicines, and fosters foreign direct investment (FDI). It opensopportunities in contract development and manufacturing (CDMO), joint research, andpharmaceutical innovation.Pharmexcil continues to simplify essential processes through digital services, ensuring efficiencyfor industry stakeholders. Online services include RCMC application/renewal, Certificate of Originissuance, GST and Export Turnover Certification, and Market Access Initiative Schemecomponents.Global collaboration is key to India's leadership. My participation in "India Meets Brazil",organized by the Embassy of Brazil in India, reinforced trade relations and pharmaceuticalcooperation, ensuring high-quality, affordable medicines for global healthcare.On the regulatory front, discussions with DCGI emphasized the need for greater flexibility inExport NoC procedures, helping ease compliance challenges while maintaining India’scompetitive edge.With each edition, Pharmexcil Digest provides deeper insights and strategic direction for India’spharmaceutical industry, driving leadership in innovation, affordability, and excellence.

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Expanding Horizons: Pharma Trade & Market TrendsThe success of our first edition affirms its value in providing key insights for India’spharmaceutical exporters. We deeply appreciate the positive feedback from member companiesand the dedication of the Pharmexcil team in creating this publication.We are grateful for the support of Joint Secretary Mr. Nitin Kumar Yadav, IAS, Department ofCommerce, in addressing regulatory matters and organizing iPHEX 2025 under Bharat Health2025. This collaboration strengthens India's global pharmaceutical presence, fostering industrygrowth and international partnerships. A significant development includes my discussions withDr. Win Kyaing, Chairman MCCPMD, leading to MCCPMD’s consent to sign a MoU at BharatHealth/iPHEX 2025, expanding global pharmaceutical cooperation.Our interaction with Hon’ble Minister Mr. Piyush Goyal, Commerce & Industries Minister,emphasized emerging global opportunities and the creation of a facility to enhance Indianexporters’ visibility for overseas buyers. iPHEX 2025, scheduled for 4-6 Sep. 2025 under BharatHealth, will provide a B2B web platform for increased accessibility. Creation of an exclusive B2Bweb domain going forward for member companies offering enhanced accessibility and visibilityfor their products and services, along with accreditations, enabling overseas buyers to interactand place orders digitally.We appreciate pharma companies participating in iPHEX 2025, showcasing India’s excellence inpharmaceuticals and affordable healthcare solutions.Pharmexcil Digest remains committed to providing timely industry insights, fosteringcollaboration, and driving India’s global pharmaceutical leadership. Thank you for your support—we look forward to shaping the industry's future together.Director GeneralRaja BhanuPharmexcil Digest 4

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Region wise Export and Importperformance -April 2025NAFTAEUROPEAFRICALACASEANWANASOUTH ASIACISNEAOCEANIAUN39.46%18.55%12.41%6.47%5.14%5.21%3.95%3.47%2.28%1.99%1.07%7Pharmexcil Digest NEAEUROPENAFTAASEANWANALACOCEANIASOUTH ASIACISAFRICAUN42.12%38.19%11.89%5.20%1.05%0.44%0.35%0.33%0.25%0.11%0.08%Region wise Export performance (byshare value in %) LinkRegion wise Import performance (byshare value in %) LINKExportsNAFTA, EUROPE, and AFRICA are the three major regions for pharma exports, together accounting forapproximately 70.46% of total exports in April 2025.• NAFTA comprised 39.46% of total exports during April 2025, valued at USD 981.02 million, reflectinga decline of -5.68% compared to April 2024.• EUROPE (5.06%), LAC (5.95%), ASEAN (0.46%), WANA (15.64%), CIS (10.08%) all registeredpositively growth during April 2025 compared to April 2024.AFRICA (4.47%), NEA (-8.93%), OCEANIA (25.26%) exhibited mixed trends, with NEA regionexperiencing a contraction of -8.93%, followed by Africa with 4.47% growth, and Oceania showing thehighest growth of 25.26%. ImportsIndia’s total imports in 2024-25 amounted to 8,188.26 Mn USD, with April 2025 imports at 748.56 MnUSD. NEA held the largest share at 42.12% with 3,772.84 Mn USD, followed by Europe at 38.19% with2,774.68 Mn USD.NAFTA contributed 11.89% at 908.04 Mn USD, while ASEAN accounted for 5.20% at 479.71 Mn USD.LAC had a 1.05% share with 91.34 Mn USD, and WANA represented 0.44% at 53.54 Mn USD.Oceania held 0.35% with 40.76 Mn USD, South Asia 0.33% at 44.05 Mn USD, and Africa 0.25% at 12.59Mn USD. UN contributed 0.11% at 6.39 Mn USD, while CIS had the smallest share at 0.08% with 4.31Mn USD.

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APR-20 APR-21 APR-22 APR-23 APR-24 APR-250510152025USD BN15.5118.9120.6722.6224.2824.86Factors Driving Growth1.Rising Global Demand – Increased focus on healthcareand advancements in medicine.2.Regulatory Approvals – Streamlined processes forexport licensing.3.Technological Innovations – Enhanced manufacturingefficiency.4.Strategic Partnerships – Collaborations withinternational distributors.5.Economic Stability – Favorable financial conditionsboosting investmentsThe data reveals a steady year-over-year growth inpharmaceutical exports, with the most significantincrease observed between April 2020 and April 2021(22%). Following this peak, the expansion rate hasgradually stabilized, suggesting potential marketmaturity or the influence of external factors. Whileexports continue their upward trajectory, themoderating growth rate signals a shift in industrydynamics, highlighting the need for strategicadjustments to sustain momentum.Analysis of PharmaceuticalExport Trends (April 2020 -April 2025)LINK8Pharmexcil Digest Analysis of PharmaceuticalImports (April 2020 - April2025)LINKAPR-20 APR-21 APR-22 APR-23 APR-24 APR-2502468USD BN4.276.817.085.776.847.48While imports peaked in April 2021, they experienced aslight contraction in April 2023, followed by recovery insubsequent years. This volatility could be attributed toregulatory shifts, global supply chain dynamics, ordomestic production strategies. Despite thesefluctuations, the data confirms an overall upwardtrajectory, highlighting the continued necessity ofimports in supplementing local production andmeeting demand.Imports play a crucial role in ensuring a diverse anduninterrupted supply of pharmaceutical products.Encouraging imports fosters:Product Availability – Ensuring consistent supply ofessential medicines.Competitive Pricing – Expanding options to optimizecosts.Innovation Access – Introducing advanced formulationsfrom global markets.Resilience Against Disruptions – Mitigating risks fromlocal production constraints.

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10Pharmexcil Digest Pharmexcil Activities “Brazil Meets India: Health and Regulatory Ecosystem,” held on 2ndMay 2025 at Embassy of Brazil in New Delhi under the leadership ofH.E. Kenneth Felix Haczynski da Nóbrega, Ambassador of Brazil toIndia, to promote collaboration between Brazil and India in thehealth sector, strengthening existing agreements and fostering newbusiness collaborations, particularly in the areas of ContractManufacturing Organizations (CMOs) and the co-development ofinnovative molecules. Discuss Regulatory Affairs and Challenges between Brazil and Indiaand address the impact of new Brazilian regulations and highlightthe institutional support the Embassy can provide to both Indian andBrazilian companies."Brazil Meets India: Health Regulatory Ecosystem" 02 May 2025The event brought together influential voices from the health andpharmaceutical sectors of both nations, creating a valuable platform fordialogue, collaboration, and strategic partnerships. It was especiallymeaningful to welcome representatives from regulatory authorities,leading pharmaceutical companies, and key trade organizations. Theopening remarks by Dr. Vikrant Pandey, Resident Commissioner ofGujarat Bhawan, set the tone for a forward-looking exchange.H.E Kenneth da Nóbrega emphasized the strengthening of Brazil-Indiarelations, particularly in sectors such as healthcare and pharmaceuticals.Ambassador Nóbrega has consistently highlighted the deepeningbilateral ties between the two nations, focusing on shared values,mutual trust, and collaborative efforts in various domains.Mr. Namit Joshi Chairman of Pharmexcil, underlined the council’s crucialwork in promoting Indian pharmaceutical exports, supporting exporters,and advancing bilateral market access between India and Brazil.The event also underscored the growing strength of Brazil–Indiapharmaceutical relations. India’s rising exports to Brazil signal trust in itspharmaceutical capabilities, while imports from Brazil into Indiademonstrate the balanced and mutually beneficial nature of this tradepartnership. This two-way flow is not only a commercial success—it is asymbol of our nations’ shared vision for global health security andequitable access to quality medicines."Brazil Meets India” joined by Mr.Namit JoshiMs Rafaela KusterMs Ana Carolina Paz Ms Laura Castanheira Mr. Rahul Chadha

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Mr. Raja Bhanu, Director Generalmet Mr.Akhilesh Singh, Counselor,Indian Embassy, USAThe 5th South Asia Regional Chapter Meeting, opened by Dr. Suresh Bhojraj, USP South Asia RegionalChapter Chair, reaffirmed the importance of collaborative stakeholder engagement in enhancing APImanufacturing quality and achieving regional pharmaceutical self-reliance. Dr. Bhojraj emphasized theneed for the chapter to evolve into a more dynamic, outcome-oriented platform, while Dr. Girish KapurSenior VP, and USP India Site Head, showcased USP Hyderabad’s advanced capabilities and globalintegration. Dr. Kishor Mogulluru, Associate Director, provided the context for the meeting, aligning itwith India’s policy goals and highlighting the initiative’s multi-phase approach. Dr. Annu Uppal, Director,Scientific Affairs, outlined key quality issues identified through research and outreach, includingpharmaceutical water quality, cross-contamination, nitrosamine impurities and cleaning validation-setting the stage for solution-driven discussions.11Meeting with the First Secretary, Embassyof India in USA, Washington DC, 03 May2025 Mr. Raja Bhanu, Director General met Mr.AkhileshSingh, Counsellor, Commerce, Indian Embassy, USAand discussed matter pertaining to tariffs andimpact on the pharmaceutical industry. Thispreparatory meeting focused on strengthening tradeframeworks, addressing regulatory challenges andenhancing India’s global pharmaceutical presence.As India’s pharmaceutical exports continue to grow,such engagements play a vital role in reinforcingtrade partnerships and ensuring sustainable industryexpansion.Pharmexcil Digest Pharmexcil Activities USP Convention 2025, in the Bethesda North Marriott Hotel & Conference Centre, Rockville,Maryland, USA, 05-08 May 2025

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12Pharmexcil Digest Pharmexcil Activities In his closing remarks, Dr. Chaitanya, Director IGRA from USP reflected on the journey since thechapter’s inception in 2020 and acknowledged the regional platform’s unique ability to tailor globalquality standards to local needs. He appreciated the leadership of Dr. Bhojraj and contributions fromall stakeholders, reaffirming USP’s commitment to strengthening South Asia’s API manufacturingecosystem. Key next steps include development of a practical SME toolkit, expanded trainingprograms, continuation of regional roundtables and policy-level coordination to guide the 2025–2030 strategic roadmap for API self-reliance.During the breakout session moderated by Dr. Rajiv Desai, Senior Technical Advisor, IndianPharmaceutical Alliance provided valuable insights on Indian Pharmaceutical Industry. The DirectorateGeneral of Drug Administration (DGDA), Bangladesh, highlighted the country's dependence on importedAPIs and requested technical assistance and regional collaboration to build domestic capabilities. DrChandrasekhar Ranga, Director IGRA & Deputy Drugs Controller, The Central Drugs Standard ControlOrganization (CDSCO) emphasized the need for better industry-regulatory dialogue to address outdatedmonographs and evolving manufacturing practices. Mr. Raja Bhanu Director General, PHARMEXCIL suggested USP to establish a feedback platform forindustry-reported issues, modeled on their export-linked issue tracker. The IDMA, represented by Mr.Dara Patel, Secretary General highlighted environmental compliance as a key challenge in APImanufacturing, citing inadequate pollution control infrastructure. He urged USP’s support for bestpractices in effluent treatment and policy advocacy for green chemistry and sustainability. Dr NitishSharma, Assistant professor from NIPER Ahmedabad underscored the need for early-stage riskassessments for nitrosamines and leachables, while the ABLE Foundation stressed responsible solventuse should be science-led rather than economically driven, urging for education-focused interventions.

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13Program OverviewThe United States Pharmacopeial Convention (USP) held its 2025 Convention Meeting from 5–8 May 2025, bringing together representatives from across the health and science ecosystem to launch the2025–2030 cycle. The Convention Meeting served as a platform for USP's Voting Member Delegatesto cast their votes on critical governance matters, including the election of the Council of Experts andthe Board of Trustees for the 2025–2030 cycle. Additionally, the meeting included discussions onproposed resolutions aimed at guiding USP's strategic direction over the next five years. Pharmexcil's response to the USP resolutions for 2025-2030.Resolution II: Expanding Access to Quality-Assured Biologic Medicines GloballyHarmonizing regulations for biologics, especially biosimilars, is crucial to ensuring affordable andequitable access, particularly in low- and middle-income countries. India, as the "Pharmacy of theWorld," aspires to lead in the biosimilar space with a robust framework and an expanding portfolio ofapproved biosimilars. Streamlined regulatory processes and global alignment would greatly benefitregional manufacturers by minimizing duplication and speeding up approvals.USP could view India as a strategic partner in advancing global biosimilar accessibility, leveraging itsregulatory expertise and manufacturing capabilities. Pharmexcil is eager to collaborate with USP inidentifying market enablers, addressing capacity-building requirements and bridging skill gaps amongexporters. Together, we can empower quality advocates like USP to ensure broader access to safe,effective, and affordable biosimilars worldwide.Resolution III: Enhancing the Global Pharmaceutical Supply Chain's ResilienceThis initiative aligns well with Pharmexcil’s efforts to bolster the pharmaceutical sector. Currently, weare analyzing demand-side data for APIs in regulated and Row markets. This supports India's aim tostrengthen domestic API production while minimizing reliance on neighboring nations for essentialraw materials and KSMs.USP’s advanced expertise in data analytics and risk-based frameworks can contribute significantly. Wewelcome collaboration with USP in demand forecasting, identifying high-risk API’s prone to shortagesand developing strategic plans. Such efforts would not only aid manufacturers but also influencefuture policy-making and investment strategies. Pharmexcil and its member companies stand to gainimmensely from such a partnership.Resolution VII: Enhancing Regulatory Systems WorldwideIndia is undergoing a significant regulatory transformation, including the nationwide rollout of revisedSchedule M to improve GMP compliance across all pharmaceutical manufacturers. This resolutionoffers an excellent opportunity to support these efforts through USP’s global scientific and regulatorystrengthening initiatives.While Pharmexcil is not a regulatory authority, we actively contribute to industry preparedness andquality advancement. USP’s technical expertise, capacity-building tools and tailored dissemination ofglobal best practices can make a substantial impact. We remain committed to supportingcollaborative initiatives that enhance regulatory systems and ensure the sustainability ofpharmaceutical quality systems.Pharmexcil Digest

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14Pharmexcil Digest Meeting with Dr. Ajay Kumar, Minister (Commerce), Embassy of India, USA in theEmbassy 09 May 2025Mr. Raja Bhanu, Director General, engaged indiscussions with Dr.Ajay Kumar, Minister(Commerce) Indian Embassy, USA to addresskey issues related to pharmaceutical exports.As part of the preparatory meeting held atthe Embassy of India (EOI), USA, the dialoguefocused on strengthening trade facilitation,regulatory alignment, and market access forIndian pharmaceutical products. Key Outcomes:Election of Leadership: USP announced the newly elected members of its Council of Experts and Boardof Trustees for the 2025–2030 cycle, who will play pivotal roles in setting standards and guiding USP'smission.Adoption of Resolutions: Delegates reviewed and adopted several proposed resolutions that willinfluence USP's focus areas, including enhancing global health through quality standards andstrengthening the supply chain for medicines. Stakeholder Engagement: The Convention facilitated input from members on critical areas of USPgovernance, ensuring that diverse perspectives inform the organization's strategies and initiatives. The discussions aimed to enhance bilateral cooperation, streamline export processes, andaddress challenges faced by Indian exporters in the evolving global pharmaceuticallandscape. This engagement underscores India's commitment to ensuring compliancewith international standards while reinforcing its position as a reliable supplier of high-quality pharmaceutical products worldwide.

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15Pharmexcil Digest CDSCO: Dr Rajeev Singh Raghuvanshi, DCGI, CDSCOPHARMEXCIL:Mr Namit Joshi, ChairmanMr Bhavin Mehta, Vice ChairmanMr Rollins John, DirectorOfficials from the Pharmaceuticals Export PromotionCouncil of India (Pharmexcil) extended sincere thanksto the Drugs Controller General of India (DCGI) for therelease of the new Guidance Document for Export NoObjection Certificates (NOCs). The document provides a clear and structuredframework outlining the procedures for obtainingNOCs for the export of approved and unapprovednew drugs, excluding narcotic drugs and psychotropicsubstances (NDPS) as well as drugs classified asbanned in India.Meeting with DCGI held on 08 May 2025 on the New Export NoC System: Clarifications Sought by Pharmexcil on Export NOC Guidance Document: During the meeting with the Drugs Controller General of India (DCGI), Pharmexcil officials raisedspecific points requiring clarification to ensure smooth implementation and understanding of therecently released Guidance Document for Export No Objection Certificates (NOCs). The clarificationssought and the responses received from the DCGI are summarized below:1. Requirement of COPP/FSC in Absence of Registration Certificate: Pharmexcil sought clarity onthe situation where Certificate of Pharmaceutical Product (COPP) or Free Sale Certificate (FSC) istypically required for registering an Active Pharmaceutical Ingredient (API) or Formulation in theimporting country.The DCGI responded by referring to Clause 5(c) of the Guidance Document, which includesprovisions for R&D purpose as under. c) R & D Batches: API: The API / Bulk drug’s Pharmacopeial status in IP/USP/BP/JP/EP may besubmitted.Page 2 of 6 guidance document & (or) Importing. Further, if formulation of the said API is approvedin SRA country (United States/European Union Member States/ Canada/Japan/Australia/Switzerland) country & (or) India may be submitted.Formulation: Approval status of any SRA Country (United States/ European Union Member States/Canada/ Japan/Australia/Switzerland) & (or) Importing country may be submitted. 2. Recognition of Registration Certificate in Case of Third-Party Exports: A clarification was alsosought under Clause 5, particularly regarding third-party exports. In scenarios where the destinationcountry is Senegal, but the goods are routed through France (a transition country), there wasambiguity about whether the registration certificate from Burkina Faso would be considered validby ADC at Port/Airport. The DCGI clarified that in such cases, the registration certificate of the finaldestination country (i.e., Burkina Faso) will be accepted for the purpose clearance at Port/Airport.The transition through another country (such as France) does not affect the validity of thedestination country’s regulatory approval for export purposes.

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16 3. Unapproved Formulations in India and SRA Substitutes: Under Clause 5 pertaining to FinishedFormulations, a new provision has been introduced to address situations where the formulationintended for export is not approved in India. This scenario often arises when the importing countrylacks a mature or functional regulatory authority. The DCGI explained that in such cases, the approvalof the formulation in any of the Stringent Regulatory Authorities (SRAs) will be considered sufficient.The six SRAs referenced typically include agencies such as the US FDA, EMA, Health Canada, etc.4. Use of Existing Approvals by Other Applicants: The final point of clarification was regarding thetransferability of product approvals across different applicants. Specifically, Pharmexcil inquiredwhether an existing approval for an API or formulation obtained by one company could be used byanother company to support its NOC application.The DCGI affirmed that the approval is considered to be product-specific and granted by the agency,rather than being restricted to the original applicant. For example, if Amoxicillin+Clavunate 1125 mgsachet has already been registered by another manufacturer in the importing country, any othercompany can submit this registration certificate (obtained directly from the agency) as part of theirexport application. This certificate will be reviewed by Indian regulators for NOC issuance, providedthe product remains the same.Pharmexcil Digest VC chaired by Mr. Nitin Kumar Yadav, IAS, JS, DoC, to review the trade performanceof the Pharmaceutical and Medical Devices sectors. 13 May 2025The meeting, chaired by Mr. Nitin KumarYadav, IAS, Joint Secretary, EP (Pharma),addressed challenges and opportunities inexport growth, market competitivenessand regulatory support. While exports aregenerally increasing, some productcategories are seeing declines, promptingthe need for targeted interventions. Risingimports from key countries are creatingcompetitive pressures, leading topotential market share losses. Key issuesdiscussed:Regulatory Support: Essential for exporters to navigate evolving international standards.Geopolitical Shifts: Affecting bulk drug exports due to increasing localization efforts.Policy Implementation: Disparities between central policies and state-level execution impactlicensing and export procedures.Trade Data Concerns: Discrepancies in export-import figures, particularly with theNetherlands, raise concerns over trade deficits.Market Stability: The low-cost generic drug market remains stable, but high-value exportsface uncertainties.

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Meetings with Embassy of India in Croatia and HALMED(Croatian agency for Medicinal Products & MedicinalDevices) held on 19 & 20 May 2025India ranks third globally in pharmaceuticalproduction by volume, with a vast network ofmanufacturers. PHARMEXCIL serves as the apexexport council, supporting a large member base.India exports 30 million USD worth ofpharmaceuticals to Croatia, while the total marketsize stands at 2 billion USD. HALMED inspectors may visit plants or importers inCroatia, but inspections only occur if a product isfiled for registration.HALMED oversees only pharmaceuticalauthorization, ensuring compliance with regulations.The EU and Croatian pharmacopoeias are connected,while Indian Pharmacopoeia is relatively new andrecently formalized.Croatia follows EU decisions on pharmaceuticalshortages, importing only EU-compliant or parallelmarket products.Ireland, unlike Croatia, has independentpharmaceutical import regulations.Dr. Vishal Rajgarhia, Member CoA Pharmexcil invitedHALMED to participate in IPHEX/Bharat Health,where representatives from 60 countries areexpected. HALMED suggested routing the invitethrough its ministry director.HALMED’s Adrijana Ilić Martinac stated that IndianPharmacopoeia can gain recognition faster if aproduct is filed using IP standards, ensuringautomatic recognition upon registration.17Pharmexcil Digest "iPHEX-2025 will serveas a global platform toshowcase India'spharmaceuticalcapabilities, fosteringinnovation andinternationalpartnerships." –Pharmexcil Official"The discussion focused on enhancing bilateral tradebetween India and Austria, recognizing Austria as akey European market with high potential forcooperation.Austria as an Importing Partner: The AustrianAssociation expressed strong interest in Indianpharmaceutical products, acknowledging India'sglobal presence and supply capabilities.Opportunities for Collaboration: a. Indiancompanies can play a role in addressing medicineshortages in Austria and the EU, and explorepartnerships in CMO/CDMO. b. Austria can serve asa hub for Indian pharmaceutical companies toexpand into Europe.Indian Pharmacopoeia: The association suggesteddiscussing its integration at the EMEA level in theNetherlands.IPHEX Participation: Austrian companies will beidentified for participation and encouraged to joinExpos in Europe.Market Overview: Austria is a fast-growing marketand ranks third in EU GDP, with healthcare spendingat 11.2% of GDP and medicinal productexpenditures at €3.6 billion.Actionable: 1. We need to invite PHARMIG to IPHEX2. Identify the members of Austria for IPHEX3. See potential for Austria as Hub Meetings with Embassy of India in Austria, & AustrianPharmaceutical Industry Association held on 13 May 2025

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18Pharmexcil Digest Meeting with Dr Win Kyaing, Chairman of theMyanmar Chamber of Commerce forPharmaceutical and Medical Device (MCCPMD)14 May 2025Meeting chaired by Mr. Nitin Kumar Yadav, IAS, JS, DoC with CDSCO, DoHFW, Pharmexcil,Ayushexcil, and EPCMD to discuss the issues of Pharma Industry Exporters in Room No.441, Vanijya Bhawan, Delhi 16 May 2025The meeting, chaired by Mr. Nitin Kumar Yadav, IAS, Joint Secretary, EP (Pharma), with CDSCOofficials Mr. B K Samantaray, Deputy Drugs Controller and Mr. Naveen Mehta, Assistant DrugsController deliberated on the regulatory challenges in pharmaceutical exports with the NewExport NoC, including regulatory approvals, documentation complexities, and internationalcompliance. Discussions focused on streamlining approval processes, easing exportrestrictions, and establishing a uniform policy for deemed exports. Significant proposalsincluded allowing alternative documentation for countries without formal drug registrationsystems, improving shelf-life compliance to prevent delays, and introducing a ticket-based/responsive system for faster regulatory resolutions. Industry representatives also highlightedthe need for certified translation alternatives, clearer guidance on banned API exports, andconditional NOCs to minimize disruptions during manufacturing site transitions. It wasemphasized to have better dissemination of export guidelines, removal of redundant NDPSpermissions, broader acceptance of foreign API registrations, and formalized policies forexport sample approvals. The meeting underscored the importance of structuredcollaboration between regulatory bodies and industry stakeholders, aiming for morepredictable and transparent export operations.Dr Win Kyaing, Chairman of the Myanmar Chamberof Commerce for Pharmaceutical and Medical Device(MCCPMD) met Mr.Raja Bhanu, Director General anddiscussed the possibilities of trade cooperation infast-track approval for pharmaceutical products andpossibilities of signing an MoU with MCCPMD.Invited Myanmar industry participation in BharatHealth scheduled from 04-07.Sep.2025 at BharatMandapam, New Delhi .MCCPMD expressed itsconsent to sign the MoU at Bharat Health. Joined byMr.Murali Krishna S,Director,PharmexcilMr. Raja Bhanu, Director General met DrWin Kyaing, Chairman MCCPMD.MCCPMDexpressed its consent to sign the MoU atBharat Health

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19Mr. Raja Bhanu, Director General of Pharmexcil,participated in the CII Telangana Pharma & Life Sciencesevent & highlighted Telangana’s significant role in thepharmaceutical sector. As the second-largest contributor topharmaceutical exports, Telangana continues to strengthenits presence in global markets through innovation andregulatory excellence. His address emphasized the need toenhance industry collaboration, streamline regulatoryframeworks and drive sustainable growth to further solidifyIndia’s leadership in pharmaceutical exports. Mr.AVPSChakravarthy, Convenor-CII,Telangana Pharma & LifeSciences Committee lead the discussions of Life SciencesPanel.Annual General Body Meeting of FOPE atRoseate House, Aerocity, Delhi 24 May 2025 Mr. Raja Bhanu, Director General, attended as the Guest of Honourat the 18th FOPE Annual General Meeting (AGM), where hecommended FOPE’s proactive role in strengthening thepharmaceutical MSME sector. His address emphasized theimportance of innovation, regulatory compliance, and internationalmarket access, providing meaningful direction for industrystakeholders.Highlighted the critical need for MSMEs to adopt advancedtechnologies, streamline regulatory processes, and enhance globalcompetitiveness, vision for India’s expanding pharmaceuticalfootprint underscored the country’s commitment to quality,sustainability, and strategic collaborations in the global market.Applauded FOPE’s proactive role in strengthening thepharmaceutical MSME sector and shared his vision for enhancingIndia’s global pharma footprint. His valuable suggestions oninnovation, compliance, and international market access providedmeaningful direction for industry stakeholders.First Meeting of the CII Telangana Pharma & Life Sciences Panel 2025–2026 in CII-SohrabjiGodrej Green Business Centre, Hyderabad 21 May 2025Pharmexcil Digest

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20Pharmexcil Digest Hon’ble CIM meeting with EPC’s 27 May 2025 Meeting convened under the Chairmanship of Hon'ble Commerce & Industries Minister Mr.PiyushGoyal on the Centralised Export Trade Portal, to bridge the gap in Trade Information. Dignitariesinclude Mr.Jitin Prasada, Hon'ble State Minister for Commerce & Industries Minister, Mr. SunilBarathwal, Commerce Secretary, Mr.Ajay Badoo, DGFT, Mr.L S Srinivas, Additional Secretary, DoC.The HCIM advised that portal should incorporate intuitive and interactive features such as live chat,AI-driven query resolution, and matchmaking tools to facilitate real-time engagement betweenglobal importers and Indian exporters. A verified, searchable database of Indian exporters, includingproduct profiles, certifications, and capacity details, should be integrated to help importers identifysuitable suppliers efficiently. The portal should serve as a one-stop destination for all trade-related information-market insights,regulatory guidelines, incentive schemes, logistics facilitation, and contact points in Indian Missionsand EPCs-to bridge the existing information gap.Mr.Raja Bhanu, DirectorGeneral ,Pharmexcil joined themeeting virtually and informedthat Council is preparing a webportal incorporating the B2Bplatform with real time productshowcasing and services andcommunication with overseasbuyers. Mr.Kamal ,Directorjoined the meeting in person

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21Pharmexcil Digest 1.Mr. Oybek Elmuratov, First Deputy Chairman2.Mr. Sagdullaev Nodirbek, Chief specialist 3.Mr. Qahramon Karimbaev, Chief specialistEmbassy of Uzbekistan, Inda:1.Mr. Khurshdibek Samiev Trade CounsellorPharmexcil:1.Mr. Raja Bhanu, Director General 2.Mr. Vishal Rajgarhia (Finecure Pharmaceuticals Limited), COA Member3.Mr. Murali Krishna, Director4.Mr. Rollins John, Director A VC meeting was held on 29 May 2025 between representatives of the Embassy of the Republic ofUzbekistan in India and the Director of the Pharmaceutical Development Agency, Uzbekistan toexplore avenues of bilateral cooperation in the pharmaceutical and healthcare sectors betweenUzbekistan and India.During the meeting, several key points were discussed:The participants explored potential collaborations between pharmaceutical companies in India andUzbekistan, with a focus on fostering mutually beneficial partnerships. Discussions were held onattracting investments from Indian pharmaceutical companies into Uzbekistan to support thedevelopment of the sector and strengthen economic ties between the two countries.An invitation was extended to Pharmexcil and its member companies to participate in upcomingbusiness and investment forums in Tashkent, aimed at promoting greater engagement andcollaboration. Pharmexcil raised issues pertaining to registration of products and clarity regardingentry into Uzbek market. The meeting also focused on facilitating B2B partnerships at iPHEX 2025 .Meeting with Pharmaceutical Development Agency, UzbekistanParticipants: Director of the Pharmaceutical Development Agency, Uzbekist

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23Pharmexcil Digest Exclusive event co-hosted by Mr. Gareth Wynn Owen- British Deputy HighCommissioner- Andhra Pradesh, Telangana and Rephine UK in Deputy HighCommissioner’s Residence, Banjara Hills, HyderabadAn exclusive event, co-hosted by Mr. Gareth Wynn Owen, British Deputy High Commissioner forAndhra Pradesh, Telangana and Rephine UK, was held at the Deputy High Commissioner’sResidence in Banjara Hills, Hyderabad. The gathering brought together industry leaders todiscuss critical advancements in pharmaceutical manufacturing, digital transformation andglobal trade opportunities.Mr. Murali Krishna S, Director, participated in the event and shared key insights on the evolvingtrade relationship between India and the UK in the backdrop of India-UK Free Trade Agreement.His remarks emphasized the importance of fostering stronger partnerships, regulatoryalignment, and sustainable growth in pharmaceutical exports. The highlight of the evening was apowerful panel discussion, moderated by Dr. Eduard Cayón, Rephine, featuring: Mr. Krishna Venkatesh, Dr. Reddy’s Laboratories Mr. Prabhakar Duwuri, Sri Krishna Pharmaceuticals Mr. Ashutosh K Sinha, Neuland LaboratoriesThe event facilitated high-impact discussions on driving excellence in pharma manufacturingthrough quality, innovation using technology. Strengthening international collaboration, offeringvaluable perspectives for industry stakeholders.India-UK FTA -Prospects Mr. Jayant Tagore, MD, Synthokem Labs interacting with Dr.Eduard,CSO, Rephine joined by Mr.Murali ,Director, Pharmexcil appraisingthe scope & benefits of India-UK FTA for Pharma industry

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Drugs formulations & BiologicalsBulk Drugs &…SurgicalsAyush…84.70 10.043.202.0424-Apr 25-AprDrugs formulations & BiologicalsBulk Drugs & Drug IntermediatesSurgicalsAyush & HerbalsVaccines010203040506070Value in USD Mn51.9166.496.587.3024India’s pharmaceutical exports to the UK in FY 2024-25 are projected at USD 830.18 million, growing 17.74%.Drugs Formulations & Biologicals lead with USD 703.18 million (84.70% share, 15.69% growth), while BulkDrugs & Intermediates rose 38.88% to USD 83.41 million. Surgicals and Ayush & Herbals expanded, butvaccine exports fell 69.59%, reflecting market shifts.In April 2025 vs April 2024, Drugs Formulations & Biologicals increased 28.10% to USD 66.49 million. BulkDrugs & Intermediates grew 10.90%, while Ayush & Herbals surged 59.88%. Surgicals declined 9.15%, andvaccines remained stagnant, likely due to reduced approvals.Pharmexcil Digest Category wise India ExportsPharmaceutical products to UK (value sharein %) - FY 2024-25Comparative Analysis of April 24 vs. April25 Exports (Value in USD Mn) UK -INDIA EXIM DATA 0 5 10 15 20 25 30 35Other medcne put up for retail sale n.e.sOther anticancer drugsOther nonsteroidal antiinﬂamatory, analgestics and antipyratic drugsOther antibioticsAmoxycilline & its saltsPsyllium husk (isobgul husk)Absorbent cotton woolOthers cellulose,its chemcl drvtvsMedicaments of ayurvedic systemOther25.1231.951.285.704.693.682.202.820.532.061.111.330.700.690.590.450.130.41Top 10 Pharmaceutical Products Exports to UK (April 24 & April 25 in$mn)Apr 24Apr 25(Link)

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25Drugs formulations & Biol…Bulk Drugs & Dr…Surgicals67.40%25.52%6.96%24-Apr 25-AprDrugs formulations & BiologicalsBulk Drugs & Drug IntermediatesSurgicalsAyush & HerbalsVaccines0246810Value in USD Mn3.699.812.603.850.68India’s pharmaceutical imports from the UK in FY 2024-25 grew 12.85% to USD 430.15 million, drivenby demand for specialized products. Bulk Drugs & Intermediates dominated at USD 290.12 million(67.45% share, 10.47% growth), while Drugs Formulations & Biologicals totaled USD 110.58 million(15.86% growth). Surgicals, Ayush & Herbals saw moderate growth, but vaccines dropped 22.54%,indicating sourcing strategy shifts.In April 2025 vs April 2024, Bulk Drugs & Intermediates rose 8.62% to USD 25.48 million, while DrugsFormulations & Biologicals grew 11.45% to USD 9.80 million. Surgicals and Ayush & Herbals showedminor increases, but vaccines declined 34.29% to USD 0.38 million, reinforcing reduced annualimports.0.0 0.5 1.0 1.5 2.0 2.5Gonadotrophins and luteinising hormone: ---- Othersterile laminaria and sterile laminaria tents; sterile absorbable surgicalMixed vaccines for: - - - Cultures of micro-organisms (excluding yeast)-- Vitamins A and their derivatives""Other:Surgical tools: ----Forceps, forcep clamps, clips, needle holders, introducersOther Amino acide DerivativesOther surgical instruments & appliancesCell cultures, whether or not modiﬁed - - Placebos and blindedOther penicillins & thr drvtvs wth a pentcillianic acid strctr slts thereof2.022.200.050.940.830.570.030.340.070.250.070.240.230.180.050.170.020.110.140.11Pharmexcil Digest Category Wise India’s importsPharmaceutical products from UK(value share in % )- FY 2024-25 Comparative Analysis of April 24 vs.April 25 Imports (Value in USD Mn) UK -INDIA EXIM DATA Top 10 Pharmaceutical Products Importing from UK (April 24 & April25 in $mn)Apr 24Apr 25(Link)

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Comprehensive Registration Procedure for PharmaceuticalProducts: Navigating UK MHRA Guidelines26Determine the Registration PathwayChoose between National, Mutual Recognition, Decentralized, orInternational Recognition Procedure (IRP)IRP applies if the product is already authorized by a trustedregulatorPharmexcil Digest Prepare the ApplicationSubmit via MHRA Portal (Link)Use eCTD (Link)Include ASMF if applicable (Link)Conduct Pre-Submission ChecksValidate eCTD submission using MHRA-approved tools (Link)Ensure compliance with UK MDR 2002 and ICH guidelines (Link)Submit the ApplicationProvide product details, manufacturing site information, and supportingdocuments Pay applicable fees based on product type and registration pathway(Link)MHRA Review & AssessmentProvide product details, manufacturing siteinformation, and supporting documents Pay applicable fees based on product type andregistration pathway (Link)Approval & Post-Market ObligationsReceive Marketing Authorization (MA) ifsuccessful(Link)Maintain compliance with post-market surveillanceand pharmacovigilance requirements (Link)Renew authorization periodically (Link)Registration procedure

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Key RegulatoryUpdatesGlobalCompliance &Market ExpansionDigitalTransformation inPharmaTrade & PolicyDevelopmentsIndustryFeedback &Policy RevisionsMSME & GMPComplianceUpdatesFew Pharma Firms Apply for Schedule M Extension AfterSeeking More Time; Govt. Urges Urgent Action. (Dt: 01 May2025) CDSCO adds tooltips in its online platforms for legal forms tosupport stakeholders. 01 May 2025DGFT seeks feedback on major export policy realignmentfollowing Finance Act 2025 amendments. 05 May 2025DTAB ratifies extension of timeline for revised Schedule Mimplementation for MSMEs. (Dt: 07 May 2025).Ethiopian Food and Drug Authority revises GMP Rules,mandates re-inspection every 3 years. (Dt:12 May 2025)India has not accepted 'data exclusivity' demand by UK toprotect generic drug firms. (Dt:12 May 2025)Pharmexcil initiates high-level discussions with key ASEANnations to strengthen pharma trade.(15 May 2025)LUB asks Centre to extend deadline till 2026 end forimplementing revised Schedule M for cos below Rs. 50 croreturnovers. (Dt: 16 May 2025) The government invites Pharma firms to submit the data forceiling price review.(Dt:17 May 2025)Indian pharma industry feedback sought to explore Kuwaitipharma market potential. (Dt:13.05.25)In this newsletteryou can expect:May Month- 202528Pharmexcil Digest PHARMEXCIL DIGEST provides a curated selection of industrynews, keeping professionals informed about key developmentsin pharmaceuticals. Covering regulatory updates, market trends,and global trade insights, this digest ensures timely access toessential information shaping the sectorPharma News

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Inviting comments on Revised Guidelines onSimilar Biologics- Regulatory requirements forMarketing Authorization in India, 2025 draftedby CDSCO. (Dt:06 May 2025) Prohibition on Import or transit of all goodsoriginating in or exported from Pakistan-Insertion of Para 2.20A of Foreign Trade Policy(FTP) 2023. (Dt: 02 May 2025) Harmonization ofSchedule-Il (ExportPolicy), ITC (US) 2022with amendmentsintroduced vide FinanceAct, 2025. (Dt: 19 May2025) Seeks to continueimposition of Anti-Dumping Duty onimports of “SodiumCitrate” originating in orexported from China PR.(Dt: 08 May 2025) Regulatory NotificationsAmendment in theNotification No. 63-1994-Customs (N.T) dated21.11.1994 in respect ofLand Customs Station,Raxaul. (Dt: 23 May 2025) Inviting comments on Revised Guidelines onSimilar Biologics- Regulatory requirements forMarketing Authorization in India, 2025 draftedby CDSCO. (Dt:06 May 2025) 29Pharmexcil Digest Clarification onComprehensivePermission for ImportedProducts under Rule104A, Drugs & CosmeticsRules 1945. (Dt:26.05.25)Restoration of RoDTEPfor AAs, SEZs & EOUsfrom 01 June 2025. (Dt:26.05.25)STRoDTEP ScheduleAlignment with CustomsTariff Act Changes from01.05.2025 (Dt: 26.05.25)Notifications

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Dr.Srinivas Oruganti,Ph.D, FRSCDirector, Dr. Reddy'sInstitute of Life SciencesFlowing Towards Sustainability: Role of Flow Chemistry & ContinuousManufacturing in Strengthening Indian Pharma EcosystemEmerging technologies like flowchemistry, process intensificationplatforms, and real-time monitoringsystems are defining how chemicaland pharmaceutical manufacturingcan be reimagined for the future.Against this background, there iscertainly a need to reposition thepharmaceutical manufacturinglandscape. Typically, the lifecycle ofa novel drug from its invention toclinical trials to approval requiresthe identification of the right routesfor synthesis. Similarly, bringing anactive pharmaceutical ingredient(API) to market as a generic druginvolves neither just copying normere demonstration of theinnovator’s route of synthesis.Innovation in chemical processdevelopment plays a pivotal role inthe development of any generic APIand offers a strategic vantage pointto any pharmaceutical company inits efforts to carve out a niche foritself in the ever-challenging genericdrug market. It is, however,important to recognize that on thewide and holistic canvas of ageneric API development, aninnovative and sustainable chemicalprocess is rarely the one thatrequires a global restructuring ofthe known synthetic route or abrute-force inclusion of an exoticchemical transformation. Indeed, anefficient synthetic route to an APIevolves through a continuousprocess of incrementalimprovement and gradualsimplification of the existingchemical processes to the API andrelated intermediates.Molecular complexity of an API isoften derived from its key startingmaterials (KSMs). The latter couldbe oxygen- and nitrogen-richheterocycles, contain fluorine andother halogens, or have a single ormultiple chiral centres.A notable step in this direction was theDRILS – Pharmexcil Flow Chemistryworkshop, supported underPharmexcil’s CSR grant. The workshoptrained several students fromengineering, chemistry and pharmacydisciplines. The curriculum wasdesigned to emphasize not only thefundamentals of flow chemistry, butalso its application in promotingenvironmentally sustainablemanufacturing practices. The impact ofthis initiative was two – fold: building atechnically capable workforce andinstilling a strong ethos of sustainabilityin early career professionalsHow flow chemistry, continuousmanufacturing and deployabledigital instrumentation willstrengthen leadership of Indianpharmaceutical manufacturing, andsustain its momentum throughinnovation and supply chainsecurity.Securing India’s PharmaBackboneIndian pharmaceutical industry hasrightfully earned its reputation asthe ‘Pharmacy of the World’. Itsformulation capabilities, cost-effective scalability, and regulatorycredibility have positioned it as aglobal supplier of essentialmedicines. The pharmaceuticalmanufacturing ecosystem hascatered affordable and accessiblequality medicines to multiplegeographies across the world.Yet, behind this success lies acritical vulnerability. Presently asignificant portion of the chemicalbuilding blocks required forpharmaceuticals manufactured inIndia is imported. This does create a concern forsupply chain security and potentialprice fluctuations, which can affectIndia’s commitment to quality andaffordable medicines. This importdependence creates structuralexposure to global supply shocks,pricing instability, and geopoliticalrisk.The need for newer regulatorynorms, commitment tosustainability and modernization ofcurrent manufacturing capabilitiesis also being increasinglyrecognized.30Pharmexcil Digest Future Tech: Green & Flow Chemistry

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31 An ideal route to an API or its KSMsplaces emphasis on satisfying sevenkey concepts.It is, however, important torecognize that on the wide andholistic canvas of a generic APIdevelopment, an innovative andsustainable chemical process israrely the one that requires a globalrestructuring of the knownsynthetic route or a brute-forceinclusion of an exotic chemicaltransformation. Indeed, an efficientsynthetic route to an API evolvesthrough a continuous process ofincremental improvement andgradual simplification of the existingchemical processes to the API andrelated intermediates.Molecular complexity of an API isoften derived from its key startingmaterials (KSMs). The latter couldbe oxygen- and nitrogen-richheterocycles, contain fluorine andother halogens, or have a single ormultiple chiral centres. An idealroute to an API or its KSMs placesemphasis on satisfying seven keyconcepts:i.The need for the route to beconvergent, ii.Having as manychemo-/biocatalytic steps in thereaction sequence as possible, iii.An overall reduction in thenumber of steps compared to theexisting synthetic routes, iv.Ensuring that the chemicaltransformations envisaged arerobust and scalable, v.Making a conscious effort toavoid using reagents, solvents, andreaction conditions that are knownto be hazardous, vi.Patentability, vii.Adherence to the twelveprinciples of green chemistry ingeneral.A strong integration of processengineering modernization withgood route design often becomesthe right recipe for efficient,sustainable, safe, and cost-competitive manufacturing of anyAPI or its KSM.Flow chemistry is being increasinglyrecognized as a key enabler of thistransformation. It providesexceptional control over reactionparameters, enables safer executionof hazardous transformations, andsupports real-time processadaptability. The compact nature,modular footprint, customizabilityand inherent safety characteristics ofcontinuous flow reactors make themideal for localized, high-performancemanufacturing environments.Further they allow better thermaland mass transfer efficiency, whichminimizes impurity formation andfacilitates higher consistency inproduct quality from one batch toanother.Flow chemistry is particularly suitedfor novel reaction pathwaysinvolving photochemical,electrochemical, and microwave-driven systems. This expands thesynthetic toolbox available forcomplex APIs and naturally alignswith the principles of greenchemistry by loweringenvironmental impact throughreduction of solvent usage, reactionvolumes, and waste generation...Flow Chemistry and ContinuousProcesses: From Legacy toLeadershipWhile batch manufacturing haslong been the industry standard,its inherent limitations are at oddswith the demands of modernpharma that demand greaterflexibility, safety, and scalability.Traditional batch processes, whilefamiliar, are inherentlysegmented, slow, and scale-dependant. Materials move fromreactor to crystallizer toformulation units with manualinterventions and risk ofdowntime at every stage. Thisintroduces risk, inefficiency, andvariability.Flow chemistry emerges as atransformative alternative. Byexecuting reactions in compactclosed-loop reactors, flowchemistry redefines howhazardous or complex chemicaltransformations can be handled.Chemistries (such ashalogenation, cyanation, anddiazotization), which werepreviously outsourced due to riskor inefficiency, can now behandled safely and efficiently in-house. Continuous microreactorsoffer tighter control, fasterkinetics, and higherreproducibility, all whileminimizing energy use, wastegeneration and physical footprint.The transition does not stop atsafer reactions. When coupledwith continuous manufacturing,flow chemistry unlocks a newparadigm of integratedoperations. Rather than handlingsynthesis, purification, andformulation in disconnectedstages, continuous systems link Pharmexcil Digest

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32 An ideal route to an API or its KSMsplaces emphasis on satisfying sevenkey concepts.It is, however, important torecognize that on the wide andholistic canvas of a generic APIdevelopment, an innovative andsustainable chemical process israrely the one that requires a globalrestructuring of the knownsynthetic route or a brute-forceinclusion of an exotic chemicaltransformation. Indeed, an efficientsynthetic route to an API evolvesthrough a continuous process ofincremental improvement andgradual simplification of the existingchemical processes to the API andrelated intermediates.Molecular complexity of an API isoften derived from its key startingmaterials (KSMs). The latter couldbe oxygen- and nitrogen-richheterocycles, contain fluorine andother halogens, or have a single ormultiple chiral centres. An idealroute to an API or its KSMs placesemphasis on satisfying seven keyconcepts:i.The need for the route to beconvergent, ii.Having as manychemo-/biocatalytic steps in thereaction sequence as possible, iii.An overall reduction in thenumber of steps compared to theexisting synthetic routes, iv.Ensuring that the chemicaltransformations envisaged arerobust and scalable, v.Making a conscious effort toavoid using reagents, solvents, andreaction conditions that are knownto be hazardous, vi.Patentability, vii.Adherence to the twelveprinciples of green chemistry ingeneral.A strong integration of processengineering modernization withgood route design often becomesthe right recipe for efficient,sustainable, safe, and cost-competitive manufacturing of anyAPI or its KSM.Flow chemistry is being increasinglyrecognized as a key enabler of thistransformation. It providesexceptional control over reactionparameters, enables safer executionof hazardous transformations, andsupports real-time processadaptability. The compact nature,modular footprint, customizabilityand inherent safety characteristics ofcontinuous flow reactors make themideal for localized, high-performancemanufacturing environments.Further they allow better thermaland mass transfer efficiency, whichminimizes impurity formation andfacilitates higher consistency inproduct quality from one batch toanother.Flow chemistry is particularly suitedfor novel reaction pathwaysinvolving photochemical,electrochemical, and microwave-driven systems. This expands thesynthetic toolbox available forcomplex APIs and naturally alignswith the principles of greenchemistry by loweringenvironmental impact throughreduction of solvent usage, reactionvolumes, and waste generation...Flow Chemistry and ContinuousProcesses: From Legacy toLeadershipWhile batch manufacturing haslong been the industry standard,its inherent limitations are at oddswith the demands of modernpharma that demand greaterflexibility, safety, and scalability.Traditional batch processes, whilefamiliar, are inherentlysegmented, slow, and scale-dependant. Materials move fromreactor to crystallizer toformulation units with manualinterventions and risk ofdowntime at every stage. Thisintroduces risk, inefficiency, andvariability.Flow chemistry emerges as atransformative alternative. Byexecuting reactions in compactclosed-loop reactors, flowchemistry redefines howhazardous or complex chemicaltransformations can be handled.Chemistries (such ashalogenation, cyanation, anddiazotization), which werepreviously outsourced due to riskor inefficiency, can now behandled safely and efficiently in-house. Continuous microreactorsoffer tighter control, fasterkinetics, and higherreproducibility, all whileminimizing energy use, wastegeneration and physical footprint.The transition does not stop atsafer reactions. When coupledwith continuous manufacturing,flow chemistry unlocks a newparadigm of integratedoperations. Rather than handlingsynthesis, purification, andformulation in disconnectedstages, continuous systems link Pharmexcil Digest

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33link these operations into a single,streamlined process. This not onlyreduces human intervention but alsoembeds real-time quality control intothe very fabric of production.For India, this shift from batch tocontinuous manufacturing is nolonger just a technologicaladvancement – it is a strategicrequirement. In a nation tasked withbalancing domestic therapeutic needsand international supplycommitments, continuousinfrastructure enables a form ofresponsive manufacturing thatadjusts to demand, instead of merelyforecasting it. It transformspharmaceutical output from staticcapacity to dynamic capability.This paradigm also finds real-worldresonance in advanced biologics andmRNA manufacturing, whereuninterrupted synthesis andpurification workflows have deliverednew levels of agility, consistency, andregulatory compliance. In India, suchcapability will be foundational tofuture-readiness.Building Capability for India’s FutureNo transformation in pharmaceuticalmanufacturing, however advanced itstechnology may be, can sustain itselfwithout a parallel transformation inhuman capital. Successful adoption offlow chemistry and continuousmanufacturing does not dependmerely on infrastructure andequipment. It requires a newgeneration of chemists, engineers,and process scientists who aretrained to navigate the convergenceof chemistry, digital systems, andprocess intensification.Recognizing this imperative, the FlowChemistry Technology Hub at Dr.Reddy’s Institute of Life Sciences(DRILS) was established with supportfrom the Government of Telangana,Dr. Reddy’s Laboratories, and LaurusLabs. The Hub serves as a neutral,cross-industry platform to accelerateknowledge transfer, provide access toindustrial-grade equipment, andfoster real-world problem-solvingskills in a controlled, innovation-focused environment.This effort complements DRILS’ largercapacity building ecosystem. Throughstructured initiatives like theFundamentum course, DRILS hastrained over 200 students fromacademia and more than 80 industryscientists in the principles andapplication of flow chemistry andcontinuous processing. The tutorialsblend theory with hands-on reactortraining and cover various aspects ofsafety mapping, instrumentcalibration and reaction optimizationin order to ensure that the traineesgraduate with both conceptual clarityand operational readiness.This quiet but deliberate investmentin capability development reflects ashift in outlook. India is not merelypreparing to adopt globaltechnologies - it is moving ahead tomaster, modify, and lead them. As thepharmaceutical sector embracesmodern manufacturing, institutionslike DRILS are laying the foundationfor self-sustaining, deeply skilledinnovation pipelines that willunderpin India’s industrialcompetitiveness for decades to come.Digital Instrumentation andProcess ControlAt the heart of every reliablecontinuous manufacturing systemlies a robust network of advancedinstrumentation and processanalytical technology (PAT) tools.These systems are not justsupplementary in nature - they arefoundational in ensuring consistentquality, operational stability, andregulatory compliance. Whether it ismaintaining precise control overtemperature gradients, optimizingflow rates for complex multiphasereactions, or monitoring impurityprofiles in real time, digitalinstrumentation serves to transformsubjective oversight intomeasurable, traceable control.In flow and continuous setups, everysecond of operation counts, andevery fluctuation, if unchecked, cancascade into deviations, batchfailures, or compliance breaches.Hence, the importance of inlinesensors, digital flow meters, thermalprobes, pH monitors, turbiditydetectors, and spectroscopy-basedanalysers cannot be overstated.These instruments, when integratedwith distributed control systems(DCS) or supervisory control anddata acquisition (SCADA)frameworks, enable continuousvisibility and oversight of key processparameters.Critically, the focus in regulatedpharmaceutical environments is noton speculative artificial intelligenceor opaque algorithmic systems.Instead, the emphasis is ondeployable digital systems,technologies that are validated,explainable, and aligned with goodmanufacturing practices (GMP).These systems are Pharmexcil Digest

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34engineered to function reliably withinthe constraints of GxP environmentsand offer not just data, but actionableinsights with audit-ready traceability.When paired with carefully calibratedfeedback loops, such systems allowmanufacturing plants to operate in astate of predictive control. Instead ofwaiting for deviations to triggeralarms ex post facto, these platformsenable real-time corrections, adjustingflow rates, reagent concentrations, orreaction times dynamically. Thissignificantly reduces waste, minimizesrisk, and ensures that quality is notinspected into the product after-the-fact, but built into the process fromthe start.Furthermore, digital instrumentationsupports advanced capabilities such asdigital twins, historical trend analysisand multivariate process control(MVPC). It empowers processengineers and quality control teams torun simulations, validate changesvirtually, and implement continuousimprovements with minimaldisruption.As Indian pharma moves towardglobally harmonized quality standards,the integration of smartinstrumentation and reliable digitalcontrol layers will define the readinessof our manufacturing systems, not justfor today’s production goals, but forthe complexity, scale, and speed thatthe future will demandRedefining SCM throughSustainable ChemistryFlow chemistry and continuousmanufacturing are not incrementalimprovements. Pharmexcil Digest They represent a paradigm shift inhow pharmaceutical productionsystems are conceived, operated,and scaled. Unlike traditionalupgrades that address only individualbottlenecks, these technologiesrewire the manufacturingarchitecture itself, creating anecosystem that is inherently modular,safer to operate, and capable ofembedding quality directly into theprocess.In the context of today’s globalizedmarkets and volatile geopoliticallandscape, the resilience of India’spharmaceutical supply chain is notmerely a logistics challenge, it is atechnological imperative. Withincreasing expectations forsustainability, traceability, andcompliance from global regulatoryagencies and customers alike, Indiamust look beyond volume-drivenstrategies and build systems that areintelligent, adaptive, and self-correcting.Flow chemistry enables safe andlocalized execution of high-risk orresource-sensitive chemistries thatwere earlier either outsourced orconsidered unviable. Continuousmanufacturing, in turn, integratesthese chemistries into uninterruptedproduction pipelines that respond inreal time to both quality feedbackand market dynamics. Together, theyallow companies to move fromreactive capacity planning toproactive, demand-aligned supplyexecution.The result is a redefined vision ofsupply chain management (SCM),one no longer cantered aroundwarehousing, scale economies, orlow-cost labour, but on sustainablechemistry as the strategic backbone. In this framework, flow andcontinuous systems do not merelysupport SCM; they transform itinto a chemistry-driven value chaincharacterized by minimal waste,minimal downtime, and maximumresponsiveness.India’s opportunity is to lead thisredefinition, not just as amanufacturing destination, but asa knowledge powerhouse thatfuses scientific innovation withoperational agility. Flow can be anenabler to redefine supply chainmanagement as a sustainablechemistry movement, one thatprioritizes both innovation andresilience at its core.The views or the opinionsexpressed in this article are solelyof the author's; and do notnecessarily represent those of Dr.Reddy’s Institute of Life Sciences

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Regulatory UpdatesKenya’s Pharmacy and Poisons Board (PPB) Reaffirmscommitment to Safe, Quality Health ProductsThe Pharmacy and Poisons Board (PPB) faces Challenges like informaldistribution, falsified products, industry resistance, and digitization barriers,threatening public health and Kenya’s WHO Maturity Level 3 (ML.3) status. Toaddress this, PPB is strengthening regulations, enhancing surveillance, andimproving inter-agency coordination. Expanding public awareness,accelerating digital transformation, and incentivizing compliance will supportenforcement. These efforts aim to protect health, streamline oversight, andadvance Kenya’s pharmaceutical regulation. (Link)35May 13 2025| Nisticò (AIFA): “High drug prices in the US are the resultof a completely privatized healthcare system”Robert Nisticò highlights that the U.S. drug pricing system drives uphealthcare costs, while Italy's National Health Service, supported by AIFA,secures some of the lowest prices in the OECD. However, risingpharmaceutical expenditures in Italy necessitate governance reforms toprioritize genuine innovation that delivers measurable therapeutic benefits.(Link)May 14 2025| Summary table of new drugs and extension ofindicationsThe summary table lists newly approved drugs and extensions of indicationsfrom the Italian Medicines Agency's latest negotiations. It includes orphandrugs like Hyptacopan for paroxysmal nocturnal haemoglobinuria and newchemical entities like Tenecteplase for acute ischemic stroke. Generic drugsand parallel imports, such as Ramucirumab for gastric carcinoma, are alsoincluded. Some drugs, like Vydura for migraine, were classified as innovative.The document highlights Italy’s evolving pharmaceutical landscape andpricing strategies.(Link)May 14 2025| AIFA Board of Directors approves reimbursement of 11drugsThe Italian Medicines Agency approved reimbursement for 11 drugs, includingthe orphan drug Fabhalta for paroxysmal nocturnal hemoglobinuria, fournew chemical entities like Fruzaqla for metastatic colorectal cancer, andVydura for migraines. Two generics, Alfacalcidolo Doc and Beclometasone eFormoterol Doc Generici, along with the parallel import drug Cyramza forgastric cancer, were also included. Three drugs—Cosentyx, Pirfenidone Teva,and Xtandi—received expanded therapeutic indications.(Link)Pharmexcil Digest Regulatory updates

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Pharmexcil Digest GVB LIFE SCIENCES PVT LTD3751Drugs formulations & BiologicalsYANASHA PHARMA PVT LTDCSBS HEALTHCARE PVT LTDNEWPHARMA ORIGIN PVT LTDASIEL CHEM PHARMAPADMASHREE ENTERPRISESAMARPIT GROUPSAMARPIT GROUPSIMILIS PHARMA INDIA LLPIGNATURE PHYTOCHEMICALINDUSTRIES PVT LTDSARV PHARMKBM PHARMACEUTICALTRESINDE BIOTECHSUNNYCOCOCREATE GLOBAL TECHNOLOGIES PVT LTDPRIVET PHARMAPAC HEALTHCARE LLPWESTPOLE IMPEXAUREOSTEM RESEARCH PVT LTDARUSK PHARMA PVT LTDBIORA GLOBAL LLPHEALTHSPARK PHARMA PVT LTDP K PHARMA VENTURESVAKRATUNDA INTERNATIONAL PVT LTDMATRIX UNIVERSAL PVT LTDTHE MOLECULEZCHOUDHARI IMPEXAPOLLO INGREDIENTS LIMITEDSWERINE HEALTHCAREMEDNEX PHARMA LLPMEDILATINA FARMA PVT LTDGANA SREE SAI PHARMACEUTICALS &DISTRIBUTORSEXYLONE LIFESCIENCE PVT LTDMEDVIXX PHARMACEUTICALSBRISKINN SOLUTIONS PRIVATE LIMITEDGENAIDE PHARMACEUTICAL PVT LTDM S SURGICALSNOVASIS HEALTHCARE PVT LTDFORTUNE HEALTHCARE PRODUCTPVT LTDBIOVONIC HEALTHCARE PVT LTDCENT CURE PVT LTDAQUA CHARGE LIFESCIENCE LLPERIS BIONXT PRIVATE LIMITEDKUREASIA PHARMA PVT LTDSAVIOUR CAPS PRIVATE LIMITEDNYSA BIOMED PRIVATE LIMITEDVIBCARE HEALTHCARE PRIVATE LIMITEDUNIGROW PHARMACEUTICALSHERBS NUTRIPRODUCTS PRIVATELIMITEDMEDIBLUE LIFESCIENCESYOGI MEDICAL AGENCY

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Members can interact via chat only (nocalls) during working hours (10 AM - 6:30)PM, weekdays) for real-time assistance,clarifications, and updateOnline Services39Pharmexcil Digest Online services +91 8977024106 – Handles queries related to theMarket Access Initiative (MAI). +91 8977025106 – Covers Certificate of Origin(CoO), RCMC, Events & Regulatory Guidance.tes on Government Schemes and policies.Pharmexcil Help Desk10AM- 6:30 PM11.07.2024The Pharmexcil Helpdesk WhatsAppservice, launched on July 11, 2024,enhancing communication for membersby providing dedicated contact points:Appointments of AdvisorsDGFT Matters Customs and GST Advisor-dgftmatters@pharmexcil.comadvisor-gstcustoms@pharmexcil.comMarket Access Initiative:Product Registration Plant inspectionPatent filingBA/BE StudiesClinical TrialsMAI Applications Recommended -May MonthRecommended to DoC-19Returned-13 Certificate of Origin COO-(Non Preferential): Members can obtain COO onlineTime for Issuance (same day)No.of COO's issued : 176 (Month of May)RCMC MEMBERSHIP Registration/RenewalRCMC's issued month of May : 70 CompaniesClick here to Apply for NewMembership/RenewalPharmexcil has appointed Advisors foraddressing the matters relating to DGFT,Customs & GST. Member companies facing issues/requiringadvise on DGFT, Customs & GST can nowavail the services by sending request to thefollowing email ids

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Levy of Health Cess on medical devices:Under the AdvanceAuthorisation scheme, all customs duties are exempted forinputs required for exports. However the Health Cess (5%)continues to be levied on medicinal products significantlyimpacting the company’s cost structure and financialviability. The export of output taxes for antisera finishedgods remains non-claimable.International defaulters names to be published on EPCwebsite: Many importers in various countries do not pay toIndian exporters and then the same importers buy fromother pharma exportersOFAC countries: Banks do not issue Bank Realisationcertificate for proceeds from OFAC related countriesRODTEP against Advance License: RODTEP against AdvanceLicenses have been withdrawn which leads to weakening ofIndian exports as KSM or API sourced from China constitutemay be 50% but we lose out remaining 50% of Inputs.Inverted Duty Structure: Because of inverted duty structurelot of money is stuck in the hands of MSME Pharmamanufacturers. Raw Material is taxed at 18% whereasFinished Product is taxed at 12%. MSME pharma do nothave 50% Value Addition leading to accumulated GST creditin the books of MSME which leads to Financial constraintsand hinders growth of MSME Pharma.EPDMS System maintained by RBI: Banks even PSU Banksofficers sometimes makes mistakes in adjusting exportproceeds as well deemed export proceeds which leads tonon-issuance of Bank Realization certificate. Due to non-issuance many receivable are still outstanding in theEPDMS list of RBI, which leads to receiving of notices fromEnforcement Directorate. Also small deductions such asoverseas bank charges are not adjusted by Banks despiteExporters justification. Also EPDMS list is askingdocuments pertaining to 2000 when it was unheard ofsuch RBI list.DGFT & BanKING ISSUES PHARMEXCIL REPRESENTATION TO THEMINISTRY OF COMMERCEKey issues include:Mitigation measuresInverted Duty Structure to berationalised at either 18% or 12%as deemed fit. Banks should be given power to domanual entries if any mistakes havebeen committed in the past by thesame branch. Secondly EPDMS listshould ask for documents pertainingto 2017 and therein afterRBI to instruct all Banksworking in India to issueBRC in case of Drugs andPharmaceuticalsA list by Pharmexcil can bepublished after duediligence and seeing thepharma exporter hasexhausted all methods torecover moneyDGFT to resume RODTEPagainst AdvanceAuthorisationSeeking Exemption from HealthCess and addressing Export TaxChallenges (Heading 9018-9022).Aligning the Health Cessexemption with the BCDexemption would be fair andconsistent with the principles ofthe scheme40Pharmexcil Digest

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Please ensure that your response reaches us by June 7 2025, toenable us to consolidate and submit the data within the stipulatedtimeline. Questionnaire for Pharma 2025thWe kindly request your cooperation in reviewing the attachedquestionnaire and providing the requisite information whereverpossible (country wise, product wise) at the earliest.We wish to inform you that we have received a communication fromthe Department of Commerce regarding the trillion-dollar trade targetfor the pharmaceutical sector. This was discussed during apresentation by Invest India before Mr.Nitin Kumar Yadav,IAS, JointSecretary, on 22nd April 2025 at Vanijya Bhawan, New Delhi.In this regard, Invest India has developed a sector-specificquestionnaire to gather relevant data from stakeholders. Thecompleted questionnaire is to be submitted to the EP (Pharma)Division, Department of Commerce.Subject: Request for Data Submission – Trillion-Dollar Trade Target forPharma Sector- Submit inputs by 07 June 2025S U B M I T Y O U RFEEDBACK Dear Members, Greetings from Pharmexcil!Disclaimer: The content in this newsletter/DIgest is for informational purposes only and is not intended as professional advice. While we strive to ensureaccuracy, we cannot guarantee the completeness or timeliness of the information provided. Any views or opinions expressed are solely those of the authorand do not necessarily reflect the views of Pharmexcil. You may reach out to exportfacillitationdesk@pharmexcil.com for more information/to share yourviews/inputsPharmexcil Digest 41FEED BACK

Pharmexcil Digest - May 2025

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