PHARMEXCIL DIGEST- June 2025 : simplebooklet.com

Drugs formulations & BiologicalsBulk Drugs & Dr…VaccinesSurgi…Ayus…75.70 15.503.802.512.400 20 40 60 80Other Medicine Put Up For Retail Sale Other, Containing AntibioticsOther Organic Compounds : Cefadroxil And Its Salts, Ibuprofane,.....Vaccines For Human Medicine Mdcmnts Cntng Pencllns/Drvtvs Throf Wth A Pencl..62.983.883.772.612.5124.75 $MnUSA PHARMEXCIL DIGEST exportfacilitationdesk@pharmexcil.comUnlock the audio experience of Pharmexcil Digest Supported by Mr. Namit Joshi, Chairman, Mr. Bhavin Mehta, Vice Chairman, Mr. Raja Bhanu, DG,Pharmexcil greeting Mr Rajesh Agarwal, IAS, Special Secretary, Dept. of CommerceMr. Namit Joshi, Chairman, Mr. Bhavin Mehta, Vice Chairman, Mr. Raja Bhanu, DG,Pharmexcil greeting Mr. Amit Agrawal, IAS, Secretary, & Ms. Palka Sahni, Joint Secretary, IAS,Department of Pharmaceuticals JUNE 2025Region wiseExport Performance Overview - May 2025PRODUCTCATEGORYTherapeuticwiseMembersloginHomeExports34%Imports7.85 $MnCHINA P RP40%Category wiseTherapeutics wiseHSN CodeNAFTA37.63%EUROPE18.95%LAC6.83%AFRICA12.66%OCEANIA2.00%ASEAN5.40%S.ASIA3.88%WANA5.46 %CIS 3.36%NEA 2.57%1.%USA3.01%BRAZILCountry wiseComing SoonExport DashboardHon’ble Mr.Piyush Goyal, Minister of Commerce &Industry,Govt. of India advising EPCs on leveraging FTAs& addressing Sector challenges Hon'ble Ms. Barbara GoezinneVice Minister - Curative Care, Ministry of HealthNetherlands English हिंदी

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Sustained Growth, Global Trust: India’s Pharma Industry Sets New BenchmarksIndia’s pharmaceutical sector has once again demonstrated its strategic importance to the global healthcareecosystem. India's pharmaceutical exports reached $4.9 billion in April-May of FY26, this marks a strong 7.38%expansion compared with the same period last year, highlighting the industry's continued upward trajectoryand its key role globally. This growth is not just economic-it reflects sustained trust in India’s regulatorystrength, manufacturing excellence, and innovation-led approach. Congratulations to the Indian Pharmacopoeia Commission (IPC) on a remarkable stride in internationalengagement. The MoU with Fiji’s Ministry of Health and Medical Services strengthens global pharmacopeialalignment. This collaboration enables faster product registrations and builds institutional capacity acrossregions. With formal acceptance by 16 countries—including Fiji and Cuba in 2025, IPC’s global footprintcontinues to grow. Such recognition reinforces India's leadership in pharmaceutical standards and regulatoryscience. IPC stands as a trusted partner in promoting harmonization and innovation worldwide.Pharmexcil’s digital backbone remains instrumental in supporting exporters with timely services spanningRCMC issuance, Certificates of Origin, turnover certifications, and facilitation under the Market AccessInitiative. These tools empower Indian exporters to navigate global markets with speed and confidence. I amhappy to see the Council is coming up with Dashboards for Exports & Imports integrated with Pharmexcilwebsite.Delighted to share update on iPHEX 2025 with our valued member exporters, this upcoming edition hassurpassed 600 exhibitor stalls and is poised to host over 500 international buyers from more than 100countries. Scheduled for September 2025 in New Delhi, the event promises to be a dynamic showcase of India’spharmaceutical strength and global reach, further cementing its position as a trusted healthcare partnerworldwide. As we move forward, each milestone-be it trade, regulatory engagement, or pharmacopeialrecognition-reinforces India’s rising stature as a pharmacy to the world, a policymaker in public health, and apartner in global wellness.PH AR ME XC IL D IGE STForeword3ChairmanNamit Joshi

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Director GeneralRaja BhanuFollowing the resounding success of our two editions, we are delighted to present the June2025 edition of the Pharmexcil Monthly Digest. This issue captures key developments from Mayand highlights India’s progress in expanding market access, strengthening regulatorycooperation, and enhancing digital trade enablement.India’s biopharma industry is on a transformative path, projected to reach a market value of$16 billion by 2030, signaling its emergence as a global leader. This month, I was honored to beinvited as the Chief Guest at the Biopharma Leaders Conclave, a premier platform thatspotlighted India’s innovation ecosystem and strategic vision in biotechnology. In addition, Iattended the BIO International Convention 2025 in Boston, USA, where I engaged with globalbiotech leaders to foster cutting-edge collaborations and strengthen partnerships betweenIndia and the United States, driving forward a shared agenda for innovation and growth in lifesciences.As we gear up for iPHEX 2025 under Bharat Health (4–6 September 2025), preparations areunderway to launch a dedicated App for iPHEX 2025 to enhance visibility for Indian exporters.This platform will feature verified company listings, accreditations, and product showcases toenable direct, real-time interaction with overseas buyers.Our team is working on the EXIM data to showcase it in the form of dashboards, as one of theservice for member exporters to provide a glimpse of export trends, markets insights, topproducts and top countries etc.., expected to launch during the month of July 2025We extend our heartfelt appreciation to our member companies, institutional partners, and thePharmexcil team for their continued commitment. With each step forward, be it regulatoryengagement, trade facilitation, or digital innovation—we reaffirm our shared vision of India as aglobal leader in accessible, high-quality healthcare.PH AR ME XC IL D IGE ST4

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BULK DRUGS & DRUG INTERMEDIATES49.35%DRUGS FORMULATIONS & BIOLOGICALS33.57%SURGICALS15.25%Ayush & Herbals 1.83%PH AR ME X C I L D I GE ST6Category wise India’s Drugs & Pharmaceutical Imports(Share percentage) LinkPharmaceuticals Exports during the period May’25 was USD 49661.71 million and between 2024-25and 2025-26 there has been a growth of 4.81% .The average % change of exports between the periods of Apr - May FY25 & FY26 have been 4.88%.India’s imports during the period of May 2025-26 have increased by 9.49%. Imports during this periodhave been valued at USD748.45 million.The average % change of imports between of Apr-May FY 25 & FY 26 have been 6.30.%0 20 40 60 80Other Medicine Put Up For Retail Sale Other, Containing AntibioticsOther Organic Compounds : Cefadroxil And Its Salts, Ibuprofane,.....Vaccines For Human Medicine Mdcmnts Cntng Pencllns/Drvtvs Throf Wth A Pencl..62.513.913.742.462.44Top 5 Products of Pharmaceuticals Exports by Therapeutic wise (by share value in %):Link

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05.JUNE.2025: 5TH EDITION OF INDIA BIOPHARMA LEADERS CONCLAVE IN LE-MERIDIAN,HYDERABAD:PHARMEXCIL ACTIVITES Address by Dr Luisa Cikamatana, ActingChiefMedical Advisor, Fiji Ministry of Health &Medical Services indicated that the MoH isworking on the modus operandi for productregistrations and plant inspections for India.Presentation on “Indian Pharma : PotentialCollaboration with Fiji” by Mr. Murali Krishna,Director- Pharmexcil highlighted the strengths ofIndia as “Pharmacy of World” and expressedwillingness to work with Fiji ProcurementAuthority (FPBS). Requested to consider productapprovals of Australia and New Zealandautomatically. Mr.Raja Bhanu was invited as Chief Guest of theBiopharma Leaders Conclave. He emphasized that India’s Biopharma Rise India is ontrack to become a global biopharma leader, with itsmarket expected to hit $16 Bn by 2030. This growth isfueled by strengths in biosimilars, vaccines, andaffordable biologics. Strategic focus areas includeexpanding R&D in cutting-edge therapies, scalingmanufacturing capabilities, fast-tracking regulatorypathways, fostering global partnerships, and developinga skilled biotech workforce. Together, these effortsposition India as a hub for innovative, accessible, andlife-changing healthcare solutions.803.June.2025: Webinar on Opportunities in the Fijian Market- MoU between IndianPharmacopoeia Commission (IPC) and Ministry of Health & Medical Services (MoHMS),Republic of FijiDr Luisa CikamatanaThe webinar was organized jointly by the HighCommission of India, Fiji and Pharmexcil. Mr. RajaBhanu, Director General, Pharmexcil congratulatedboth sides for signing of MoU and invited Officialsfrom Fiji Pharmaceutical and Biomedical Services(FPBS) to grace the Bharat Health/iPHEX 2025 alongwith industry representatives from Fiji.In the opening remarks by H.E. Mr Suneet Mehta,High Commissioner of India to Fiji thankedPharmexcil for the support and stated that the MoUwill bring in greater prospects for supplying qualityand affordable generic medicines to Fiji. PH AR ME X C I L D I GE STDr. Vishal Rajgharia,Member CoA present and sought inputs on the registration of products and advantagesfor having SRA approvals and also on the Government procurement opportunities in Fiji.

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A courtesy meeting was held on June 10, 2025, with theSecretary, Department of Pharmaceuticals, along with Ms.Palka Sinha, IAS, Joint Secretary. The meeting wasattended by Mr. Namit Joshi, Chairman; Mr. BhavinMehta, Vice Chairman; Mr. Raja Bhanu, Director General;Pharmexcil and extended invitation for BharatHealth/iPHEX 2025. Deliberated on the Joint WorkingGroups with various countries and advised Pharmexcil toshare the inputs. Mr. Kamal Bhardwaj, Director,Pharmexcil also joined the meeting09.June.2025: Familiarization visit of 28Media journalists from Eastern & SouthernAfrica - visit to Pharmexcil, Mumbai As part of a familiarization initiative supported bythe Ministry of External Affairs (MEA), Pharmexcilhosted a 28-member delegation of journalistsfrom Eastern and Southern Africa on June 9, 2025,at its Regional Office in Mumbai. The session wasled by Mr. Rollins John, Director, and Mr.Sumantha Chaudhary, Adviser to Pharmexcil. Mr. John emphasized Africa’s strategic relevanceas a key export destination for Indianpharmaceuticals, citing sustained growth in theregion’s demand. He also highlighted theremarkable expansion witnessed between 2010and 2016, driven by the accessibility of affordablegenerics and strong trade partnerships. Mr.Chaudhary added that recent April 2025 tradedata pointed to encouraging signs of marketrecovery in select African countries.Highlights included India’s global pharmaceuticalcredentials, the country’s export performance inAfrica, and regulatory engagement mechanisms. Thesession also featured an overview of the upcoming"Bharat Health Global Expo 2025", underscoring theCouncil’s efforts to boost international collaborationand visibility. Journalists engaged in discussionscovering regulatory harmonization, market accesschallenges, and the evolving trade landscapebetween India and African nations.9In its concluding remarks, Pharmexcil reaffirmedits long-term vision to strengthen pharmapartnerships across Africa through joint ventures,technology sharing, and policy-level collaboration.Mr. John called for regulatory coherence and thereduction of high distribution costs, whichcontinue to restrict affordability and timely accessto medicines. He underscored that enhancedcooperation at institutional and governmentallevels would contribute to stronger healthcareoutcomes in Africa while enabling Indian exportersto deliver sustainable value to theregion.ollaboration and visibility. 10 June 2025: Meeting with Mr. Amit Agrawal,IAS, Secretary, & Ms. Palka Sahni, Joint Secretary,IAS, Department of Pharmaceuticals thPH AR ME XC IL D I GE STThe delegation received a comprehensive briefingon Pharmexcil’s mandate, its national presence, andIndia’s robust pharmaceutical and medical deviceecosystem.

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A courtesy meeting was scheduled on June 10, 2025. It wasattended by Mr. Namit Joshi, Chairman; Mr. Bhavin Mehta, ViceChairman; Mr. Raja Bhanu, Director General, Pharmexcil andextended invitation for Bharat Health/iPHEX 2025. Mr. KamalBhardwaj, Director, Pharmexcil also joined the meeting10.June.2025: Meeting with Mr.Rajesh Agarwal,IAS, Special Secretary, Dept. of Commerce12.June.2025: DirectorGeneral of PharmexcilCongratulates Mr.Rajeev Nannapanenion PrestigiousLeadership Honor.A follow up meeting was organizedon Bharat Health Global Expo2025, chaired by Mr.Nitin KumarYadav, IAS, Joint Secretary, DoC .Focusing on the need to startworking on the event. Key Points : Administrative Support interms of sending letters to theindustry and line ministriesFormation of Committees Tentative Program of theevent.EPCs role and responsibilities 10.June.2025: Meetingwith Mr.Sunil Barthwal,IAS, Commerce Secretary,Dept. of Commerce onBharat Health10A presentation was made byPharmexcil during the meeting tobrief the Commerce Secretary onthe concept of organizing acomprehensive event for thehealthcare sector—Bharat HealthGlobal Expo 2025. The proposalincluded bringing the flagshipevents of various EPCs under theambit of this consolidated platform.Mr. Nitin Kumar Yadav, IAS, JointSecretary, also apprised theCommerce Secretary of theimportance of such a unifiedinitiative and emphasized the needto bring key events like iPHEX underthe umbrella of Bharat HealthGlobal Expo 2025. The associatedExport Promotion Councils (EPCs)expressed their consent to organizetheir respective shows as part ofthe eventMr. K. Raja Bhanu, DirectorGeneral of Pharmexcil,felicitated Mr. RajeevNannapaneni for beingconferred with the “PharmaLeader of the Year” award forNACTO Hyderabad on theoccasion of prestigiousHyderabad ManagementAssociation (HMA) AnnualAwards Ceremony held on June7, 2025,Mr. Nannapaneni’s is awarded“Pharma Leader of the Year” forhis outstanding contributions tothe pharmaceutical sector, hisleadership in driving innovationand excellence, and his pivotalrole in shaping India’s globalreputation as a trusted hub forquality and affordablehealthcare solutions. 12.June.2025: VC with JS(DoC) Mr.Nitin KumarYadav, IAS – EPC Issues atVanijya Bhawan.PH AR ME XC IL D I GE ST

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Pharmexcil submitted that the data is being shared at 6-digit HS code and requested for thedata at 8-digit HS code to enable prepare strategic interventions and also sought informationon export restrictions to Pakistan in respect of Pharmaceuticals.AiMED highlighted several issues and challenges faced by exporters, including the lack of anexpiry date on the Free Sale Certificate issued by CDSCO.CDSCO requested that any issues faced by exporters be communicated to them in a specificand detailed manner to enable prompt resolution.13.June.2025: 4th Monthly Review Meeting onPharma & Medical Devices Trade Performance,chaired by Mr.Rajesh Kumar, Deputy Secretary,DoC A meeting to review Pharma and MedicalDevices trade performance held under theChairmanship of Mr Rajesh Kumar, DeputySecretary (Pharma) held on 13.06.2025. Themeeting commenced with the Chairrequesting an update on the commentssolicited on the E&Y reports, along with thestatus of the remaining portion of InvestIndia’s questionnaire, with a deadline tosubmit within one week. During the discussion, the OPPIrepresentative recommended that theMinistry of Commerce considerincorporating HSN (Harmonized System ofNomenclature) codes in the WholesalePrice Index (WPI). This inclusion, though notcurrently practiced, was proposed toenhance insights into India’s productionlevels. 11PH AR ME XC I L D I GE ST14.June.2025: 103rd Meeting ofCommitee of AdministrationPharmexcil conducted its 103Committee of Administration on14.June.2025 and deliberated on theBharat Health/iPHEX 2025preparations, Finance Management,Appointment of Honorary Advisors,Delays with Shipping lines, HR Policymatters, and activities of ExportFacilitation Desk. rdChairman and CoA Membersappreciated the efforts of Mr. Murali,Director and team for bringing outPharmexcil Digest and also for theproposed Dashboards for Exports.

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The 2nd Policymakers’ Forum in New Delhi organizedby the Indian Pharmacopoeia Commission (IPC) underthe aegis of the Union Ministry of Health and FamilyWelfare, in association with the Ministry of ExternalAffairs.Aimed at promoting the recognition of the IndianPharmacopoeia and collaboration in India’s flagshipaffordable medicines initiative—the Pradhan MantriBhartiya Janaushadhi Pariyojana (PMBJP), the Forum isbeing organized by the Indian PharmacopoeiaCommission (IPC) under the aegis of the Ministry ofHealth and Family Welfare, in association with theMinistry of External Affairs. An international delegation of policymakers and drugregulators from 24 countries is participating in theforum. The event was also attended by Secretary,Ministry of Health and Family Welfare, Smt. PunyaSalila Srivastava; Secretary (South), Ministry of ExternalAffairs, Dr. Neena Malhotra; Drug Controller General ofIndia and Secretary-cum-Scientific Director, IPC, Dr.Rajeev Singh Raghuvanshi.This engagement builds on the momentum generatedby the First Policymakers’ Forum held in August 2024,which resulted in several participating countriesformally recognizing the Indian Pharmacopoeia as abook of standards for drugs. The growing internationalinterest in aligning with India’s regulatory frameworksreflects the credibility and scientific rigour of theIndian Pharmacopoeia, as well as India’s proactive rolein advancing global public health objectives.12Union Minister of State for Health &Family Welfare and Chemicals & Fertilizers,Smt. Anupriya Patel, delivered the keynoteaddress at the inaugural session of theSecond Policymakers’ Forum organised byIndian Pharmacopoeia Commission (IPC)and the digital book of IPC’s 15-yearjourney was also launched at the event. The Forum has brought togetherpolicymakers and senior drug regulatoryofficials from 22 countries (Liberia, Togo,Mali, Mauritania, Sierra Leone, Cameroon,Rwanda, Lesotho, Eswatini, Kenya,Botswana, Ethiopia, Comoros, Seychelles,Madagascar, Papua New Guinea, Zimbabwe,St. Lucia, St. Vincent & Grenadines, Cuba,Barbados, and Chile), along with twodelegates from the Caribbean Public HealthAgency (CARPHA)- Jamica and Canada,reaffirming India’s position as a valued andtrusted partner in the realm of global healthMr.Namit Joshi, Chairman Pharmexcilattended the 2nd Policymakers’ Forum andshared his perspective of harmonisation ofstandards with the Regulatory officials.PH AR ME XC I L D I GE ST16.June.2025: 2nd Policymakers’ Forumin New Delhi organized by the IndianPharmacopoeia Commission (IPC)

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16-19 June 2025 : Bio International Convention 2025 – Boston, USA PH AR ME XC IL D I GE STOpening ceremony led by:Dr. Jitendra Kumar (MD, BIRAC)Dr. Priya Kapoor-G Hingorani (MD, Miltenyi Biotec India)Strategic partnerships:A Letter of Intent signed between BIRAC and Miltenyi Biotec to establish a cutting-edge lab in India Global EngagementPavilion attracted top biotech leaders from the U.S., including Rahul Singhvi and others, fostering high-levelnetworking and deal-makingSupported by Pharmexcil,BIRAC and organized by 3SMG Events Pvt. Ltd, the pavilion is recommended for Indiancompanies seeking global exposure“Biotechnology is driven by collaboration, and there is no greater place in the world for industry, stakeholder, andadvocate partnership than the BIO International Convention. Here, innovators, scientists, patients, and investorscome together to turn small ideas into life-saving solutions, and at a time when the world needs big breakthroughs 13The 2025 BIO International Convention held fromJune 16–19 at the Boston Convention &Exhibition Center. It’s the world’s largest biotechgathering, drawing 20,000+ leaders from 72countries to accelerate breakthroughs in health,agriculture, and sustainability. The India Innovation Pavilion at BIO USA 2025 inBoston comes as a vibrant showcase of India'sbiotech prowess. Located at Booth #3285, itopened on June 16 with record attendance andhas become a key hub for global collaboration.Mr.Raja Bhanu, Director General participated in theevent and interacted with the Biotech leaders aimed atfostering innovation, facilitating the industry andcontinued engagements/ partnerships with USA.Pavilion Highlights20+ leading Indian exhibitors including:BIRAC, Pharmexcil,Int’l Contract PharmaAssociation,Gates Foundation-Birac,Lupin Biotech,VeedaLifesciences,Himedia Laboratories,Bioneeds India Pvt.Ltd.,Laurus Bio,Miltenyi Biotec,PandorumTechnologies,Virchow Biotech Pvt. Ltd., AdvyChemical,Viruj Pharma,Hi-Tech Hospital,Valerian ChemPvt. Ltd. ,Ipca Laboratories,Mediclone Biotech,GenextGenomics,Jssate StepThe convention is poised to meet the moment and help deliver better, longer lives for people in the U.S. andaround the world.”The event is inclusive of 180+ sessions and 1,100+ speakers covering topics i.e AI in drugdiscovery, Next-gen cell and gene therapies, Global biotech investment trends, Patient-centered innovation,60,000+ partnering meetings expected, making it a major hub for deal-making.DRIVING INDIA'SPHARMACEUTICAL EXPORTSWITH INNOVATION AND GLOBALCOLLABORATION

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14Th e rec en t con su lt ation o n the Indi a- EU Fr ee Tr ad e Agr ee ment (FTA)sa w active en ga gement fr om both P harmexcil lea dership and industryre pr esentativ es . Key attendees inc luded Mr . Ra ja Bhanu , DirectorGe ne ral, Ms. La ks hm i P ra sanna, Sen io r D ir ector, and Mr . R ollins,Di re ctor from Pharmexci l. In du st ry pa rticipati on fe at ured Mr . V ij ay Sh ahan d Mr . Vish al Raj gh ar ia, Me mb ers of CoA, a long w it h Ms . Sa ng eetha,V Pfr om He tero. The m ee ti ng provide d a pl at form to ali gn on cr iticalre gu latory and ma rk et access iss ue s i mpacting the ph ar maceuti ca lse ct or’s glob al competit iv eness.Am on g th e pr iority reco mm endations sub mi tt ed f or i nclusion in theFT A’ s P harma Annexure were : th e re co gnition of U K MH RA as aRe fe rence R eg ulatory A ut hority to en ha nce reg ul at ory con ve rgence,ac ce ptance of for ei gn c om pa rator products in b io eq uivalence (BE)st ud ies to s tr ea mline approva l processes, and exped it ed t im el ines forre gu latory su bm issions and reviews . The in dustry al so a dv oc ated fo r feeex em ptions o n mino r vari at io ns and either t he elimina ti on or e xt ensionof th e s un set cla us e t o e ns ure reg ul atory s ta bility and s us tained mar ke tac ce ss.24 June 2025 : Consultation on the India-EU Free Trade Agreement (FTA)chairedby Mr. Alex Paul Menon, IAS, Development Commissioner of MEPZ and Track Leadfor the SPS and TBT Chapters.th

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The Confederation of Indian Industry (CII) Telangana hosted its inaugural“Pillars of Protection” conference in Hyderabad, focusing on safety inpharmaceutical and chemical manufacturing. The event broughttogether key government officials and industry leaders to emphasize theintegration of safety into every stage of industrial operations—fromplanning to execution and maintenance.Chief Guest Mr. Y Nagi Reddy, Director General of Telangana FireDisaster Response, highlighted the need for mandatory annual fire safetyaudits, especially in the pharma sector, citing over 100 major fireincidents in the past decade. He stressed that safety must be embeddedas an organisational culture, not just a compliance requirement. Thedepartment’s deployment of fire-fighting robots and exploration ofdrone technology reflect its commitment to innovation in emergencyresponse.Mr.B Raja Gopala Rao, Director ofFactories, emphasized that safety shouldbe treated as a core pillar alongsideproduction and quality. DirectorGeneral, Pharmexcil Mr.K Raja Bhanulinked safety to India’s global reputation,noting that pharma exports have surgedto $30 billion and are projected to reach$70 billion by 2030.Dr Vinay Kumar Gupta from CDSCOstressed that even minor safety lapsesduring inspections can lead to majorimprovements. Mr. Nikhil Chakravarthi, Director at theCommissionerate of Industries,underscored Hyderabad’s globalprominence in pharma and biotech,with 40–50% of FDA-approved facilitieslocated in the city. He advocated foradvanced risk assessment tools likeHAZOP and Failure Mode Analysis, andthe adoption of emerging technologiessuch as AI, IoT, drones, and digitaltwins to enhance safety.1525.June.2025: CII Telangana- Conference on Safety Protocols in Pharma & ChemicalManufacturing: PH AR ME XC IL D IGE STHe highlighted risks such as product contamination and theimportance of proper sampling environments.CII Telangana Chairman R Sivaprasad Reddy noted the state’scontribution of 35% to India’s pharma production and 32% toexports. He emphasized the role of awareness programs like FarmMonitor in promoting safety and compliance.Chakravarthi AVPS and M Goutham Reddy called for leadership-driven safety culture, stressing that CEOs must champion safetyinitiatives. The Bhopal gas tragedy was cited as a cautionary taleunderscoring the need for proactive safety management.The conference aimed to foster best practices in EHS, regulatorycompliance, risk mitigation, and incident prevention, whilepromoting a collaborative approach to building safer, moreresilient manufacturing environments.

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Grant of marketing authorizations for the dossiers filed by generic companies takes longer than usual.Products usually takes over 3 years to be approved at ANVISA. In comparison, most of the countries in theSouth American region, including Mexico, grants approval in 12-24 months.Measure- Such requirements may be rationalized and harmonized in line with the Global requirements. Themarket authorization processes should be fast-tracked for Indian pharma companiesData requirement: As ANVISA is a member of ICH organization, pharma industry would expect moreharmonization activities with ICH and global regulations such that a balance is ensured between datarequirements and quality medicines distributed in Brazil. Measure – request ANVISA to harmonize guidance in line with US/EUMutual Recognition Agreement with Brazil is in discussions and it would open greater market access forPharmaceuticals Meeting joined by Mr.Rollins John,Director,Pharmexcil25.June.2025: VC chaired by Ms. Monica Gaur, Director & Nodal Officer for Brazil forpreparation of the review meeting to be held by Commerce SecretaryAs part of Pharmexcil’s strategic engagement withemerging markets, a focused presentation on thepharmaceutical landscape of Australia and New Zealand forFY25 was delivered during a recent meeting. Ms. LakshmiPrasanna, Senior Director, and Mr. Prashanth, JointDirector,Pharmexcil led the session, offeringcomprehensive insights into the evolving market dynamics,regulatory frameworks, and India’s current tradeperformance with both countries.27 June 2025 : VC chaired by Ms. Petal Dhillon, JS,DoC, to discuss India’s bilateral trade with Australiaand New Zealand, Vanijya Bhawan, New Delhi.th16Mr.Murali Krishna S ,Director joined the meeting from Pharmexcil and flagged the following issuesalong with possible measures :The presentation covered a wide array ofcritical focus areas, including a detailedoverview of market potential for Indianpharmaceutical products, segment-wiseanalysis across patented, generic, and over-the-counter (OTC) drugs, and growing opportunitiesin the generics and biosimilars space. Keydiscussion points also highlighted prevailingtrade trends, regulatory procedures, market-entry challenges, and bottlenecks affectingIndian exporters. The session concluded withsuggested avenues for regulatory cooperationand commercial collaboration. Post the virtualconference, both presentations were formallysubmitted to the Oceania Division for furtherconsideration.PH AR ME XC IL D I GE ST26.June.2025: Mr. Anurag Khera, Group Vice President & Head-Corporate Affairs, GlenmarkPharmaceuticals met Mr.Raja Bhanu, Director General and team at HQ office. Welcomed the efforts putin by the Pharmexcil Team to bring the Pharmexcil Digest, suggested to include more data points like YTD,policy changes and offered his participation for export review meetings for sharing the market accessissues. DG expressed thanks for sharing his suggestions and welcomed the suggestions and conveyedthanks for visiting HQ.

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17The Hon'ble Commerce Minister held a comprehensivemeeting with Export Promotion Councils across diversesectors to discuss ways to boost exports, leverage FTAs,and address sector-specific challenges. Emphasised value addition, market diversification, andcollaborative efforts to strengthen India's exportmomentum, fuel greater job generation and economicgrowth.Advised EPCs to actively contribute inputs for FTAsproposed to be signed with various countries and alsooptimise the utilisation of the FTA signed recently30.June.2025: Meeting with ExportPromotion Councils & Industry Associationson Export Strategy, FTAs and SEZ ActMr.Namit Joshi, Chairman Pharmexciljoined the meeting chaired byHon’ble Mr.Piyush Goyal, Minister ofCommerce & IndustryMr.Joshi extended greetings andrequested Hon'ble Minister to gracethe Bharat Health Global Expo and weare greatful for giving his consent.

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Define product category Determine submission type: new authorization, variation, renewal, co-marketing, etc.Check eligibility for special procedures:Orphan Drug Status (ODS)Fast Track (FTP)Temporary authorization (tempA)Article 13 or Article 14 TPA routesCover Letter: Include product details, application type, scientific justification, and documentlistMandatory Forms:Application type-specific (e.g. new authorization, variation)Manufacturer InformationGMO declaration (if applicable)Status of Foreign ApplicationsHealthcare Professional/Patient Info (IHP/PI)Packaging details (mock-ups or PDFs)Certificates: GMP, GCP inspection summaries, licensesRisk Documents: RMP, PVP, Nitrosamine assessmentOther: CVs of experts, Decisions from foreign authorities, Environmental Risk AssessmentElectronic submission (preferred): o eCTD via Swissmedic eGov Portal o Must follow Swiss eCTD Validation CriteriaPaper submission options:Paper original + eDok copyFully paper-based (less common)Use Swissmedic cover sheets and dividers18P H A R M E X C I L D I G E S TSwitzerlandRegistration Procedure Pre-Submission PlanningAssemble Module 1 – Administrative DocumentsChoose Submission FormatCompile Technical Modules 2–5Module 2: Overviews & summaries (Quality, Nonclinical, Clinical)Module 3: Quality (e.g. composition, manufacturing, specifications)Module 4: Nonclinical study reportsModule 5: Clinical trials, bioequivalence, literatureFollow CTD structure and Swiss-specific numbering. Ensure clear cross-referencing and indexing.

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Submission & ConfirmationSubmit via eGov Portal or by post (depending on chosen format)Swis smedic confirms receipt (for certain types like FTP, advertising)Track application status via eGov PortalRespond to Swissmedic QueriesPrepare responses to: List of Questions (LoQ) Preliminary decisionsInclude a cover letter with clarifications and justificationsTimeline: 60 days for formal issues; adhere strictlyAuthorization OutcomeDecision Issued: With or without conditionsIf approved: Product placed on market Fulfill post-approval obligations (e.g. PSUR, RMP updates)Lifecycle ManagementSubmit variations (e.g. quality, safety, labeling changes)Extensions, renewals, or non-renewalsDiscontinuation notificationsMarket surveillance obligations Registration Procedure ( Link )P H A R M E X C I L D I G E S T19

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Dossier PreparationIncludes administrative, technical,quality, and clinical documents.Must comply with ASEAN CommonTechnical Dossier (ACTD) or ICH-CTD format.Evaluation ProcessCouncil Review (if required)Final Decision & ApprovalPost-Marketing Surveillance& RenewalSubmit dossier to DAVDAV classifies the applicationand assigns evaluators.Initial screening checks completenessand compliance.Experts assess quality, safety, efficacy,and regulatory documentation.Additional information may berequestedThe Advisory Council forMarketing Authorizationprovides independentassessmentMay request further clarificationor studies.Compliance monitoring, periodicreviewRenewal applications submittedwithin 12 months before expiry.If approved, MarketingAuthorization Certificate is issued.If rejected, the applicant mustrevise and resubmitRegistration Guidelines (Link)VietnamP H A R M E X C I L D I G E S T20Submission & Classification

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SWEDEN, SWITZERLAND & SLOVEKIAREGULATORYUPDATES June 1 2025 Swiss medic updates the requirements forapplications for authorisation of conjugated pneumococcalvaccines.Swissmedic has revised requirements for conjugated pneumococcal vaccines basedon accumulated real-world data and international experience. Vaccine efficacy studiesremain the gold standard, but immunogenicity-based extrapolation may be acceptedfor efficacy demonstration. Applicants must provide comparative immunogenicitydata and justify immunobridging strategies, considering potential efficacy risks.Special focus is placed on younger adults and immunosuppressed individuals,requiring effectiveness data for these subgroups. Additionally, real-worldeffectiveness data and planned post-authorisation studies must be submitted. (Link)“Standards in Motion: Regulatory Clarity for Pharma Exporters”21June 1 2025 Shortening the deadlines for indication extensions for Orbis Type A and acceleratedOrbis Type B.Swissmedic has accelerated processing times for indication extensions under Orbis Type A and acceleratedOrbis Type B procedures. This update enhances the Orbis Project’s efficiency, making international regulatoryprocesses more attractive. Revised deadlines will enable faster patient access to innovative medicines.Updated guidance on marketing authorization deadlines takes effect from June. (Link)June 2 2025 Sweden needs a national strategy for collecting plasma for pharmaceuticalmanufacturing.Sweden aims to enhance self-sufficiency in plasma for pharmaceutical manufacturing by establishing a nationalactor responsible for its availability. Key measures include expanding plasma collection sites, creating a nationalprocurement model linking plasma collection with medicine supply, and ensuring continuous monitoring ofplasma availability. A clear national strategy is needed to coordinate efforts efficiently and strengthen supplysecurity. The Swedish National Board of Health and Welfare and the Medical Products Agency emphasize theneed for structured follow-up systems and donor access optimization. These steps will support the productionof vital medicines like immunoglobulins and coagulation factors. (Link)P H A R M E X C I L D I G E S TJune 2 2025 The Swedish Medical Products Agency wants pharmacies to have increasedopportunities to act in the event of a drug shortage.The Swedish Medical Products Agency is investigating measures to allow pharmacists to replace medicinesduring shortages under specific conditions. It is also assessing the feasibility of breaking drug packaging todistribute medicines to multiple patients.

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22PH AR ME XC I L D I GE STSwiss medic is inviting public comments on ICH Guideline E21 regarding the inclusion of pregnant andbreastfeeding individuals in clinical trials. Stakeholders in Switzerland can submit feedback untilSeptember 15, 2025, via the provided ICH feedback form. The guideline outlines best practices, ethicalconsiderations, and regulatory principles for participation timing, data collection, and trial planning.(Link)June 5 2025 Public consultation on ICH Guideline E21 “Inclusion of Pregnant and BreastfeedingIndividuals in Clinical Trials” launched in SwitzerlandLegal and practical frameworks must be established before implementing these changes with theagency overseeing substitution decisions. The final report will be submitted by 15 February 2026,shaping policies to enhance Sweden’s medicine supply. (Link)

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CDSCO elaborates procedure to be followed by stakeholders for disposal ofexpired/unused drugs.(Dt:2 June 2025)ndPharmexcil urges exporters to participate in EXIM Bank’s Annual Exporter Survey(Dt: 3 June 2025)rdEU Council adopts compromise position on pharma reforms.(Dt:5 June 2025)thGovt intensifying focus on excipient manufacturing under PLI scheme to breakimport dependency.(Dt: 9 June 2025)thCDSCO, DAHD to form JWG to monitor use of antimicrobials in animals. (Dt: 10June 2025)thIndonesia seeks Swiss investment in health, pharma sectors. (Dt: 15 June 2025)thIndian pharma firms not copying products, India respect IP rights, says Goyal. (Dt:15 June 2025)thDGFT invites applications for export of pharma grade sugar under restricted quotato regulate & boost pharma exports. (Dt: 19 June 2025)thIndia schedules oral hearing in anti-dumping probe on Chinese imports of MIPA. (Dt:24 June 2025)thIndia tighten grip on Chinese imports with anti Dumping duty on six products (Dt:25 June 2025)thPLI Scheme Powers Pharma, Food Processing Sectors; MSMEs Yet To Gain Traction(Dt: 26 June 2025)thIndian pharma speeds up access to global therapies while targeting treatment gaps.(Dt: 28 June 2025)thIDCGI responds on clarifications sought by Pharmexcil on export NOC guidancedocument. (Dt: 28 June 2025)thPharmexcil, USP discuss collaboration on biosimilar accessibility, building resilientsupply chain.Dt: 28 June 2025)thPharmexcil Digest provides timely updates, including market trends, regulatoryadjustments, and global trade insights, to keep industry informed and ahead of thecurve in a fast-changing business. Pharma News Pharma NewsP H A R M E X C I L D I G E S T23

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Share the list of drug products manufacturing permissions issuedby State licensing Authority SLA/FDA including antibiotics, FDCsand their premixes for Veterinary use. (Dt:05 June 2025) thAntimicrobial Resistance AMR Mitigation. (Dt:05June 2025)Seeks to impose Anti-Dumping Duty on imports of“Vitamin -A Palmitate” originating in or exported fromChina PR, European Union and Switzerland. (Dt:06June 2025) thFixation of one new Standard Input Output Norms (SIONs)at SION A-3686 under 'Chemical and Allied Product'(Product Code 'A'). write heading in short Dt:10 June2025)NotificationsRollout of ‘Source from India’ on Trade ConnectePlatform for all Status Holders. (Dt:13 June 2025) thUse of ICETABs for efficient export examination andclearance (Dt:19 June 2025)Govt. proposes 5-year Anti-Dumping Duty on imports ofPotassium Tertiary Butoxide (from China PR & USA) and SodiumTertiary Butoxide (from China PR). (Dt:24 June 2025) thGrant of WHO-GMP COPP through ONDLS portal. (Dt:25June 2025) thPH AR ME XC IL D I GE STNotifications24

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REVISED SCHEDULE M AND EXCIPIENT QUALITYExcipient quality is not a formality: As India strengthens its regulatory framework through the revised Schedule M, ensuring thequality of pharmaceutical excipients has become a critical compliance and safety prioritywww.reallygreatsite.comExcipients, though inactive, play an active role in patient safety. Recent global incidents haveshown that relying solely on supplier-issued Certificates of Analysis (CoA) can be misleading.Undetected impurities, inconsistent manufacturing practices, and non-pharma-gradematerials have contributed to batch failures, recalls, and serious reputational damageWhat Schedule M now expects:The updated guidance calls for end-to-end quality assurance, including independentverification, risk-based assessment, and traceability — particularly for high-risk materials likeglycerin, propylene glycol, and sorbitol. These ingredients pose a greater risk ofcontamination or adverse effects in pharmaceutical products. These excipients often requiremore stringent quality controls and risk management strategies. The emphasis is no longerjust on documentation, but on demonstrable quality built into the processPH AR ME XC I L D I GE STA shift toward proactive quality:To support this shift, many manufacturers rely on the public standards and scientificresources of the U.S. Pharmacopeia (USP). As an independent, not-for-profit organizationwith over 200 years of leadership in pharmaceutical quality, USP offers: ·5,000+ documentary standards ·4,000+ reference standards ·350+ excipient reference standards, including those for high-risk ingredients These tools are aligned with global best practices and recognized by the US FDA and otherregulators globally. They help companies of all sizes including MSMEs, meet evolvingcompliance requirements while ensuring product safety. Whether you serve local orinternational markets, adopting independent verification practices strengthens your qualitysystems and supports long-term regulatory readiness. Want to learn more or keep up with future updates? Visit: To support this shift, manymanufacturers rely on the public standards and scientific resources of the U.S. Pharmacopeia(USP). As an independent, not-for-profit organization with over 200 years of leadership inpharmaceutical quality, USP offers: ·5,000+ documentary standards ·4,000+ reference standards ·350+ excipient reference standards, including those for high-risk ingredients Excipient Division United State Pharmacopeia, Rockville, USA

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26Indian Pharmacopoeia Gains International RecognitionThe Indian Pharmacopoeia (IP), officially designated under the Drugs and Cosmetics Act of 1940, continuesto strengthen its global footprint as a trusted standard for drug quality. Published by the IndianPharmacopoeia Commission (IPC), IP sets authoritative benchmarks for medicinal product quality in Indiaand is gaining increasing recognition overseas.Through coordinated efforts by the IPC, the Ministry of Health& Family Welfare, and other government agencies, several countries have now formally accepted the IP as areference standard for pharmaceuticals. These include Afghanistan, Ghana, Nepal, Mauritius, Suriname,Nicaragua, Bhutan, Mozambique, Solomon Islands, Sri Lanka, Nauru, Malawi, Guyana, Fiji, and Cuba.Many of these recognitions are supported by Memoranda of Understanding (MoUs), legislativeamendments, or formal notifications from national regulatory authorities, acknowledging IP’s value inimproving medicine quality, regulatory transparency, and affordability.PH A R ME X C IL D I GE S T

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PH AR ME XC I L D I GE ST27This expansion signifies a major step forward in India’s efforts to contribute to global public healththrough pharmacopoeial cooperation. Ongoing discussions with additional countries signal agrowing international confidence in IP’s scientific rigor and quality standards.The Indian Pharmacopoeia Commission (IPC)has signed a Memorandum of Understandingwith Cuba's Center for State Control ofMedicines and Medical Devices (CECMED),signaling a significant step forward in globalpharmacopoeial collaboration. Under thisMoU, Cuba will recognize the IndianPharmacopoeia (IP) for pharmaceutical qualitycontrol and accept Certificates of Analysis givenby Indian producers based on IP standards,avoiding the need for redundant testing. The agreement also allows Cuban authorities to get IP reference and impurity standards at reasonablecosts, so improving regulatory efficiency and promoting more access to safe, quality-assured, andinexpensive medications in the country. This collaboration supports India's growing status as a reliablepartner in global healthcare standards improvement.Source: IPC Update June 16, 2025 (IP Recognition)

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Union Minister of State for Health & Family Welfare and Chemicals & Fertilizers Smt. AnupriyaPatel delivers keynote address at the inaugural session of Second Policymakers’ Forum.The Forum aims to strengthen global collaboration on drug standards and access to affordablemedicines.An international delegation of policymakers and drug regulators from 24 countries isparticipating in the forum organized by the Indian Pharmacopoeia Commission (IPC) under theaegis of the Union Ministry of Health and Family Welfare, in association with the Ministry ofExternal Affairs.Under the visionary leadership of Prime Minister Shri Narendra Modi, India has emerged as aglobal hub for affordable healthcare solutions and continues to deepen its partnerships withnations through knowledge-sharing, capacity-building, and health diplomacy: Smt. Patel.“70% of WHO's total vaccines are sourced from India; 14% of generics imported by the US comefrom India”SECOND POLICYMAKERS’ FORUM ORGANISED BYINDIAN PHARMACOPOEIA COMMISSION (IPC) D U R I N G J U N E 1 6 – 1 9 , 2 0 2 528

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The digital book of IPC’s 15-year journey was also launched at the event. Union Minister of State forHealth & Family Welfare and Chemicals & Fertilizers, Smt. Anupriya Patel, delivered the keynote addressat the inaugural session of the Second Policymakers’ Forum organised by Indian PharmacopoeiaCommission (IPC), here today. Aimed at promoting the recognition of the Indian Pharmacopoeia andcollaboration in India’s flagship affordable medicines initiative—the Pradhan Mantri Bhartiya JanaushadhiPariyojana (PMBJP), the Forum is being organized by the Indian Pharmacopoeia Commission (IPC) underthe aegis of the Ministry of Health and Family Welfare, in association with the Ministry of External Affairs.An international delegation of policymakers and drug regulators from 24 countries is participating in theforum. The event was also attended by Secretary, Ministry of Health and Family Welfare, Smt. Punya SalilaSrivastava; Secretary (South), Ministry of External Affairs, Dr. Neena Malhotra; Drug Controller General ofIndia and Secretary-cum-Scientific Director, IPC, Dr. Rajeev Singh Raghuvanshi.The Forum has brought together policymakers and senior drug regulatory officials from 22 countries(Liberia, Togo, Mali, Mauritania, Sierra Leone, Cameroon, Rwanda, Lesotho, Eswatini, Kenya, Botswana,Ethiopia, Comoros, Seychelles, Madagascar, Papua New Guinea, Zimbabwe, St. Lucia, St. Vincent &Grenadines, Cuba, Barbados, and Chile), along with two delegates from the Caribbean Public HealthAgency (CARPHA)- Jamica and Canada, reaffirming India’s position as a valued and trusted partner in therealm of global health. This engagement builds on the momentum generated by the First Policymakers’Forum held in August 2024, which resulted in several participating countries formally recognizing theIndian Pharmacopoeia as a book of standards for drugs. The growing international interest in aligning withIndia’s regulatory frameworks reflects the credibility and scientific rigour of the Indian Pharmacopoeia, aswell as India’s proactive role in advancing global public health objectives.P H A R M E X C I L D I G E S T29

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30P H A R M E X C I L D I G E S TIn her keynote address, Smt. Patel emphasized India’s commitment to ensuring equitable access toquality-assured medicines and stressed the importance of regulatory harmonization in facilitating globalhealth equity. She also highlighted that “under the visionary leadership of Prime Minister Shri NarendraModi, India has emerged as a global hub for affordable healthcare solutions and continues to deepen itspartnerships with nations through knowledge-sharing, capacity-building, and health diplomacy.”Underlining the importance of the Jan Aushadi Kendras, Smt. Patel stated that “our Jan Aushadhi Kendrasare the shining examples of India’s commitment to provide quality and affordable medicines to all ourcitizens. Jan Aushadhi has been one of the most powerful instruments of bringing down the out-of-pocketexpenditure of our citizens.”Highlighting India’s strides made in the direction of providing vaccines, Smt. Patel stated that “Indiacontinues to be a leading supplier of vaccines. As much as 70% of WHO's total vaccines are sourced fromIndia.” She further emphasized that “during the COVID-19 pandemic, India started the Vaccine Maitriinitiative and supplied vaccines to more than 100 friendly countries which depicts India’s deep sense ofresponsibility towards global health and its intention of helping friendly countries in the times of distress.”Smt. Patel also added that “India continues to be a leader in drug manufacturing, especially when it comesto the generic medicines. 14% of generics imported by the US come from India while India also has themaximum number of US FDA (Food and Drug Administration) recognized drug manufacturing plants.” Shefurther underlined that “70% of our generics are exported to the highly regulated markets and ourpharmacopeial regulations are regularly visited to meet the global benchmarks.”Smt. Patel further stated that “we have retained the WHO’s Global Benchmarking Tool (GBT) framework,Maturity Level 3 (ML3) status which reflects the robustness of India's regulatory framework. Presently, 15countries in the world recognise Indian Pharmacopeia as a book of standards for drugs, Cuba recentlybecoming the 15 country to recognise the Indian Pharmacopeia.” She added that “it is not just aregulatory step, but a move towards bringing more alignment in the quality standards, expanding accessto safe and effective drugs and making trade in pharmaceuticals smoother than ever before.”thSmt. Patel reaffirmed that “we are committed to helping our partner countries by way of communicatingand planning” and “hope to continue to work together to advance the regulatory collaboration andpromote the recognition of the pharmacopeial standards so that we can strive fast towards the sharedgoal of ‘Health for All’.”Addressing the gathering, Union Health Secretary, Smt. Punya Salila Srivastava stated that “Indiasubscribes to the vision of "One Earth, One Health " and is committed towards goal of universal healthcoverage which is also one of our primary health goals. To fulfil this, we have established more than 1.75lakh Ayushman Arogya Mandirs (formerly known as Health and Wellness Centres) where free drugs anddiagnostics are provided.” She also talked about India’s health assurance scheme, Ayushman BharatPradhan Mantri Jan Arogya Yojana (AB PM-JAY) that provides a health coverage of up to 5 lakhs per familyand caters to the 40% population of the country and highlighted that “in 2004, the share of out-of-pocketexpenditure in total health expenditure was 70%, which has come down to 40% today.” Health Secretary further underlined that the increased availability of free drugs and diagnostics has beenenabled by the production of generic medicines, noting that the number of free medicines provided atsub-health centres has risen from 36 to 106 over the past decade. She emphasized the role of AMRITpharmacies in offering affordable branded medicines and medical devices, and noted that the forum willserve as a platform for bilateral cooperation, knowledge sharing, and future collaboration.

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31PH AR ME X C I L D I GE STA commemorative digital publication marking IPC’s 15-year journey was launched during the event. Thetechnical session featured presentations on the role and progress of the Indian PharmacopoeiaCommission (IPC), the regulatory mechanisms of the Central Drugs Standard Control Organization(CDSCO), and the implementation and impact of the Pradhan Mantri Bhartiya Jan Aushadhi Pariyojana(PMBJP).Over the four-day program (June 16–19, 2025), delegates will engage in technical sessions focused onpharmacopeial standards, India’s regulatory landscape, and successful public health schemes. In addition,site visits to IPC’s state-of-the-art laboratories in Ghaziabad, a Jan Aushadhi Kendra in Agra, as well asleading pharmaceutical and vaccine manufacturing and R&D facilities in Ahmedabad, have been arrangedto provide delegates with first-hand exposure to India's robust scientific and regulatory systems.Shri Rajiv Wadhawan, Advisor (Cost), Ministry of Health & Family Welfare; Dr. Ranga Chandrasekhar, JointDrugs Controller; and Shri Ravi Dadhich, CEO of the Pharmaceuticals & Medical Devices Bureau of Indiaand senior officers of the union government were present on the occasion.Press Release: Press Information Bureau : Courtesy

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MembersAchievements NATCO Hyderabad Honored as 'PharmaLeader of the Year' at HMA AnnualAwards 2025 on 07.06.25Aurobindo Pharma arm gets MarketingAuthorization in UK for DyrupegGlenmark Pharma launches lung cancertreatment drug Tevimbra in IndiaCentaur Pharmaceuticals Achieves USFDAMilestone with Zero Observations atLifeSan Clinical Research on 16 June 2025thP H A R M E X C I L D I G E S TMembers Achievements32Disclaimer: The content in this newsletter/DIgest is for informational purposes only and is not intended as professional advice. While westrive to ensure accuracy, we cannot guarantee the completeness or timeliness of the information provided. Any views or opinionsexpressed are solely those of the author and do not necessarily reflect the views of Pharmexcil. You may reach out toexportfacillitationdesk@pharmexcil.com for more information/to share your views/inputs

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Nutraceutical ProductsBioven IngredientsBB FormulationsAAA EximJeeva Organic Pvt Ltd RSA Herbal Pharmaceuticals Pharmaceuticals Formulation14S. Zhaveri Pharmakem Pvt LtdUnijules Lifesciences LtdNikvin Healthcare (India) Pvt Ltd Eamon Drugs Pvt Ltd Saintlife Pharmaceuticals Ltd HLL Lifecare Ltd Vitaegiss Wellness Pvt Ltd Kitten Enterprises Pvt Ltd Ravi Pharmaceuticals Pvt Ltd Carewell Global Labs Pvt Ltd R K Life Care INCVrindavan Global9Pharmaceuticals Services1Chemrobotics Pvt Ltd Revive Formulations India Pvt Ltd Agrosaf Pharmaceuticals Pvt Ltd GROWEQUAL Indian Genomix Pvt Ltd API's / Bulk Drugs2Triveni Engineering and Industries Ltd Pharmaceutical Products24Glatzo Pharmaceuticals Pvt LtdRajhans PharmaceuticalEmad PharmaWilymed Pharmaceuticals Pvt LtdAgrowers Pvt LtdUnicure PharmaceuticalsBlack Jaguar EximMeditab WorldwideApex PharmaZorg Life Sciences (India) Pvt LtdMazorat Pharma Pvt LtdKemox Labs IncWinsome Medicare Pvt LtdTanisi PharmaChemo Biological LimitedShree Nextgen Pharmacare Pvt Ltd Igla Devices Pvt LtdAllied Chemicals and Pharmaceuticals Pvt LtdVPD Medi India Pvt LtdOrange Healthcare Abn Pvt Ltd Meghdoot PharmaVyaghra Health Foods Pvt Ltd Medford Pharmaceuticals LLPPerformance Products and Services Anicare Pharmaceuticals Pvt Ltd PH AR ME XC I L D I GE STNew MembersTHE NUTRITIONRavi Biolife Pvt Ltd 33Welcome NewMembersDisclaimer: The content in this newsletter/DIgest is for informational purposes only and is not intended as professional advice. While westrive to ensure accuracy, we cannot guarantee the completeness or timeliness of the information provided. Any views or opinionsexpressed are solely those of the author and do not necessarily reflect the views of Pharmexcil. You may reach out toexportfacillitationdesk@pharmexcil.com for more information/to share your views/inputs

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Market Access Initiative:Product Registration Plant inspection Patent filing BA/BE StudiesClinical TrialsMAI Applications Recommended -June MonthRecommended to DoC-. 17Returned-.35ONLINE SERVICESCertificate of Origin COO-(Non Preferential): Members can obtain COO onlineTime for Issuance (same day)No.of COO's issued : 159 (Month of June)RCMC MEMBERSHIP Registration/RenewalRCMC's issued month of June : 50 CompaniesClick here to Apply for NewMembership/RenewalMembers can interact via chat only (nocalls) during working hours (10 AM - 6:30)PM, weekdays) for real-time assistance,clarifications, and updatePharmexcil Help DeskThe 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.comPharmexcil 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 idsExport Performance Certificate /GST : ( Offline)Members can obtain certificateTime for Issuance (24 hrs)No.of Certificate 's issued : .32 (Month of June) Coming soon online +91 8977024106 – Handlesqueries related to the MarketAccess Initiative (MAI). +91 8977025106 – Covers Certificate ofOrigin (CoO), RCMC, Events &Regulatory Guidance.tes onGovernment Schemes and policies.PH AR ME XC IL D I GE ST34Online Services

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Pharmexcil wishes to bring to light a significant issue faced by certainpharmaceutical companies, particularly those engaged in overseaspartnership for granting the right to commercialize the products in overseasterritory receive profit share from overseas partners. The issue in question isthe appropriate classification and treatment of such profit share under theprovisions of the Central Goods and Services Tax (CGST) Act, 2017. There is currently an ambiguity as to whether such profit share qualifies asconsideration towards supply of services or if it is in the nature of upwardrevision of price subsequent to export of goods. The lack of uniformity intreatment has led to interpretational challenges and inconsistent taxpractices across the industry, including issuance of summons and underCGST Act. In light of the above, the current GST legislature on classification of profitshare received by pharmaceutical companies as consideration against supplyof services, the challenges faced by industry, and our recommendation forclarifying the classification and refund admissibility through the circular. Given the implications on compliance, tax liability, and contractualstructuring, a formal clarification from your good office would be immenselyhelpful in guiding the industry and ensuring consistent application of the law. We look forward to your kind consideration and an early response in theinterest of ensuring legal certainty and industry-wide compliance.Representation: Request for seeking clarification on the classification of profitshare received by pharmaceutical companies as consideration against supply ofservices. 35PH AR ME XC I L D I GE STPHARMEXCIL Representation to Central Board of Indirect Taxes &Customs

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38 Pharmexcil team is currently working on a data-driven initiative to transform EXIM (Export-Import) data into dynamic, user-friendly dashboards. Designed as a strategic service for memberexporters, this platform aims to deliver actionable insights that help unlock new opportunities inglobal trade. Key Features of the DashboardExport Trend Analysis: Interactive visuals showcasing export growth, patterns, and fluctuationsover time.Market Insights: In-depth data on emerging and high-performing international markets.Top Exported Products: A clear view of top-performing products segmented by volume, value,and growth rate.Leading Destination Countries: Country-wise breakdowns highlighting demand, trends, andtrade potential.Data Filters & Comparisons: Tools to customize views based on products, regions, timelines, andperformance metrics. Member Value PropositionEnables smarter trade decisions based on real-time insightsStrengthens competitiveness by identifying target marketsEnhances transparency and strategic planning among exportersComing SoonThis service is expected to launch in July 2025, aligning with key trade cycles andproviding timely intelligence for mid-year reviews. It will serve as a cornerstone offering toempower member exporters with data-backed foresight in a rapidly evolving global landscape.

PHARMEXCIL DIGEST- June 2025

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