PHARMEXCIL DIGEST March & April 2025 : simplebooklet.com

Welcome to a New Era of Pharmaceutical Export Excellence!Quality, Innovation, Affordability, and Accessibility—these pillars define the backbone of thepharmaceutical industry. India has emerged as a key force in this ecosystem, distinguished by cutting-edge manufacturing capabilities and an unwavering commitment to quality. As the industry confrontsevolving challenges, ranging from regulatory shifts to dynamic market trends, the need for strategic,well-informed decision-making has never been greater.Pharmexcil’s newsletter serves as a vital resource for India's pharmaceutical exporters, deliveringtimely, precise, and actionable intelligence. With global trade policies and regulatory frameworks incontinuous flux, this publication simplifies complex developments, offering insights into key regulatoryupdates, trade dynamics, government initiatives, and Council actions. More than just a compilation ofnews, it empowers stakeholders with clarity, ensuring they remain agile in an increasingly competitivelandscape.India continues to strengthen its position as the “Pharmacy of the World,” built upon decades ofexcellence in generics, bulk drugs, vaccines, and biosimilars. This reputation stems from relentlessinnovation, stringent quality standards, and a forward-thinking approach to research anddevelopment. Despite regulatory challenges, India’s pharmaceutical industry has shown resilience,achieving USD 30.46 billion in exports with 9.40% growth during FY 2024-25. Congratulations to theindustry for its dedication and excellence, reinforcing India’s position as the "Pharmacy of the World"and advancing global healthcare.The unwavering trust and active participation of our member companies are the driving forces behindour collective success, and I place my special thanks to the Members of Committee of Administrationin this context. Their dedication not only fuels individual achievements but also fortifies India’sstanding in the global healthcare ecosystem. We deeply appreciate your confidence in Pharmexcil, it isthis shared vision that propels the industry forward, despite uncertainty.I would also like to recognize the dedicated Pharmexcil team whose expertise and meticulous analysisensure that this newsletter remains insightful, relevant, and practical. Their ability to distill intricatetrade and regulatory information into a streamlined, accessible format makes this publication anindispensable tool for decision-makers.I hope this edition delivers valuable perspectives, inspires innovative strategies, and serves as acatalyst for India’s pharmaceutical expansion on the international stage. May it provide clarity andvision as we collectively pave the way for the future of global healthcare leadership.Namit JoshiPharmexcil Digest Page 1Foreword

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Welcome to the first edition of Pharmexcil’s Monthly Digest!At Pharmexcil, we are committed to empowering our valued member exporters by providingtimely, relevant, and strategic insights that support international trade and business growth. Thisbulletin serves as a vital resource, offering concise updates on regulatory developments, exporttrends, government notifications, and member achievements—all designed to help you navigatethe evolving pharmaceutical landscape with confidence.As India continues to strengthen its position as a global pharmaceutical leader, we remaindedicated to ensuring our stakeholders have the knowledge and tools needed to seize emergingopportunities. Through this initiative, we not only highlight key council activities but also bringforward industry voices, policy perspectives, and collective efforts toward expandinginternational market access.We sincerely appreciate the unwavering support of our member companies and extend ourgratitude to the Pharmexcil team for their dedication in curating this knowledge-drivenpublication. We hope this edition serves as a valuable guide in your global outreach journey.Here’s to continued success and growth!Raja BhanuPharmexcil Digest Page 2

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PHARMEXCIL03-11 MARCH 2025: ASEAN DELEGATION (VIETNAM, PHILIPPINES& MALAYSIA)ACTIVITIESIn a significant step towards strengthening the pharmaceutical tradeties between ASEAN region, Pharmexcil lead a 39-member companyBusiness Delegation to ASEAN countries commencing with Vietnam(Ho Chi Minh City) during 02-05.March.2025, Philippines (Manila)during 05-07 March.2025, and Malaysia (Kuala Lumpur) during08.March-11.March.2025.Vietnam: Associated with Vietnam Chamber of Commerce &Industry (VCCI) and hosted by Consulate General of India, “India-Vietnam Pharma Forum” Graced by Consul General Dr.VipraPandey,IFS & Mr.Tran, General Director, VCCI, HCM. Held B2Bmeetings with 70 companies from Vietnam.Health Sector in Vietnam is going through major changes, prioritizinglocal manufacturing. Delays in the product approvals perhaps meantfor the local manufacturing. Technical prowess to be improved forevaluation of High-end products/new molecules resulting in delaysfor product launches.Pharmexcil DigestPage-5

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“India-Philippines Pharma Forum” hosted by theEmbassy of India supported by Philippines IndiaBusiness Council (PIBC). Graced by H.E Harsh KumarJain,IFS, Ambassador, H.E Lokin, President/CEO,Philippines Pharma Procurement Incorporation(PPPI), Mr. Jhonny Chotrani, President, PIBC,Mr.Bhanu, DG Pharmexcil. Renewed MoU with Philippines PharmaProcurement Incorporation(PPPI) , the largestGovernment Procurement Agency. Mr.Raja Bhanu,Director General discussed scope of collaborationand medicine supplies in FDF & API with Hon. MariaBlanca, President/CEO of Philippines PharmaProcurement Incorporation (PPPI). Held B2Bmeetings with 125 companies from Philippines side.Philippines: Malaysia“India-Malaysia Pharma Forum” hosted by the HighCommission of India supported by Local pharmaassociations. Graced by High Commissioner HE BNReddy, IFS, Pn. Nik Salleh, Head, Generic Medicines,National Pharmaceutical Regulatory Authority(NPRA), Mr.Selvam, President (FICCIM), Mr.BhanuDG PharmexcilPharmexcil visit to Malaysia for the first time hasidentified market opportunities for Oncology. Localindustry sources mention shortage of medicinesand opportune time for supplies from India side.Held B2B meetings with 150 companies fromMalaysia. Had exclusive meeting with Dr. Azuana, Director,NPRA & team on the regulatory procedures,collaboration on medicine supplies. Delays inapprovals and plant audits were discussed andsought cooperation for fast track clearances. MetM/s. Pharmaniaga (lead importer) SCM Head,Mr.Affandi and explored the procurement model &supply sources. The Delegation was led by Mr.Raja Bhanu, DirectorGeneral and coordinated by Mr. Murali Krishna S,Director.Pharmexcil Digest Page-6

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A video conference chaired by Ms. Gayatri Nair (DoP) set the agenda for the upcoming India-Saudi Arabia webinar on pharmaceutical collaboration, hosted by Invest India with Saudi Arabia'sMISA and LCGPA. Ms. Lakshmi Prasanna, Sr.Director highlighted the SFDA president's 2023 Indiavisit and emphasized boosting Indian medicine registrations in Saudi Arabia. Suggestions includeddetailed deliverables and planning in-person sessions to strengthen bilateral ties.07 MARCH 2025: HYBRID MEETING ON THE INDIA-ARMENIA BUSINESS FORUM IN THE PHARMACEUTICALSECTORThe India-Armenia Business Forum in the Pharmaceutical Sector, organized by the Indian Embassyin Armenia with Pharmexcil, focused on strengthening bilateral trade, exploring opportunities,and fostering regulatory collaboration. It featured 148 Indian and 45 Armenian pharmacompanies, a presentation on India's pharma sector, and discussions on regulatory harmonization,market access, and healthcare collaboration. The hybrid format enabled impactful engagementsaimed at improving healthcare and promoting innovation.12 MARCH 2025: SEMINAR ON “INDIA-JAPAN PARTNERSHIP TOKUSHIMA” ORGANIZED BY EMBASSYOF INDIA, TOKYOThe Embassy of India in Japan organized a seminar on"India-Japan Partnership Tokushima" to celebrateTokushima Day, attended by Ambassador H.E. Mr.Sibi George and Governor H.E. Mr. GotodaMasazumi. The event emphasized enhancing India-Japan ties, particularly with Tokushima Prefecture, intrade, investment, tourism, and human resources.Mr. Bhanu, DG Pharmexcil, highlighted India'spharmaceutical strengths, inviting Japanesecompanies to explore CDMO opportunities andcollaboration in biosimilars.03 MARCH. 025: VC MEETING OF INDUSTRY STAKEHOLDERS REGARDING COOPERATION INPHARMACEUTICALS AND MEDICAL DEVICE INDUSTRY WITH THE KINGDOM OF SAUDI ARABIA HOSTED BYDOPPharmexcil Digest Page-7 21 March 2025: Opportunity Africa: Business Synergies for India organised by Andhra Chamber ofCommerce :The Andhra Chambers of Commerce organized aseminar on "Opportunities in Africa Region,"graced by Chief Guest Mr. Jayesh Ranjan, IAS,Special Chief Secretary, Industry & Commerce, ITDepartments, Government of Telangana.Representatives from African embassies, includingZambia, Kenya, and Uganda, highlighted tradepotential and investment opportunities,encouraging industries to explore setting up units.Mr. Raja Bhanu, Director General of Pharmexcil,provided an overview of Pharmexcil's initiatives inAfrica and emphasized India's significant role insupplying affordable antiretroviral (ARV)medicines to the region.

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Pharmexcil, in collaboration with the Ministry of Commerce and Industry and Indian missions in Zambia,Tanzania, and Ethiopia, organized Buyer Seller Meets:India Zambia Pharma Business Forum (Lusaka, March 24, 2025)India Tanzania Pharma Business Forum (Dar Es Salaam, March 27)India Ethiopia Pharma Business Forum (Addis Ababa, April 1, 2025)A delegation of 62 pharmaceutical companies participated. Events in Zambia and Tanzania attracted over 200delegates, including representatives from the Ministry of Health, regulatory authorities, and private industry. The Ethiopia event took place on April 1, 2025, graced by Hon’ble Health Minister H.E. Dr. Mekdes Daba, H EAnil Rai Ambassador of India to Ethiopia, H.E. Dr. Zeleke Temesgen Commissioner, Ethiopia InvestmentCommission, Mr.Bhavin Mehta ,Vice Chairman, Pharmexcil, Hon’ble Ms. Heran Gerba, Director General ,EFDA,and Mr.Kamal Bharadwaj,Director, Pharmexcil and deliberated on strengthening India-Ethiopia trade realationsand greater market acces. B2B meeting held with over 200 delegates from Ethiopia.24 MARCH-01 APRIL 2025: AFRICA DELEGATION (ZAMBIA, TANZANIA AND ETHIOPIA)Pharmexcil Digest Page 8

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Pharmexcil Digest Page 9 Mr.Namit Joshi, Chairman Pharmexcil welcomed the business delegation. Discussion took place onthe present trade from India with the Netherlands in pharmaceutical products, access to genericmedicines for Netherlands & EU, collaboration opportunities & the barriers that pharma companiesencounter and the requested the Netherlands Government to facilitate trade and greater marketaccess to medicines. Ms. Barbara Goezinne, Vice Minister shared that India and Netherlands shareexcellent trade relations and the country is looking to engage with India on sourcing the genericmedicines and ensure uninterrupted supply chain.Mr.Bhanu, DG sought cooperation for the fast track approvals for both product approvals andfacility audits. The delegation met representatives from Sun Pharma, Cipla, MSN, Aurobindo,Hetero, Mylan etc as the existing suppliers.25 MARCH 2025: MEETING WITH HIGH-LEVEL MINISTERIAL DELEGATION FROM NETHERLANDS LED BY HON'BLEMS. BARBARA GOEZINNE, VICE MINISTER, CURATIVE CARE, MINISTRY OF HEALTH, WELFARE AND SPORT INGARDEN ROOM, TAJ KRISHNA, HYDERABAD29 MARCH 2025: STAKEHOLDER CONSULTATION MEETING WITH DCGIPharmexcil hosted a Stakeholder Consultation with DCGI onthe new export NoC Directive, joined by Chairman & ViceChairman of Pharmexcil, President of IDMA, BDMA,industry majors and about 250 companies virtually.Discussions covered NoC simplification, challenges likehalted exports of specific APIs, and proposals forstreamlined processes. Exporters had to obtain a ProductRegistration Certificate from the importing country’s FDA orCDSCO approval, making shipments more complicated andslower. This led to delays in exporting APIs used for clinicaltrials and regulatory filings, prompting industrystakeholders to request exemptions for recognized APIs andthe creation of a distinct category for unapproved drugsthat required multiple NoCs.Additionally, the industry pushed for automated approval mechanisms, streamlined processes forNDPS drug exports, and improved online platforms to enhance efficiency. Companies also advocatedfor shelf-life flexibility for unapproved drugs and the acceptance of alternative forms ofdocumentation to support export NoCs.

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Pharmexcil DigestPage 10The meeting was joined by Mr.Rajeev Wadhawan, Advisor (Cost), Ministry of Health& Family welfareDr Rajeev Singh Raghuvanshi, Drugs Controller General(India) Mr Binay Kumar Samantray, Deputy Drugs Controller(India), CDSCO (Hq)Mr.Naveen Mehta, Assistant Drugs Controller (India),CDSCO (Hq) Mr.Namit Joshi, Chairman, Pharmexcil Mr.Bhavin Mehta, Vice Chairman,PharmexcilMr.R K Agrawal, President, BDMA Dr.Viranchi Shah, President ,IDMA Mr.Raja Bhanu, Director General, Pharmexcil Mr.Subba Reddy, Managing Director,Virupaksha Labs Mr.Devesh Malladi, MD, Embio Dr.P.V.Appaji, Chairman, Meenaxy Pharma Stakeholders emphasized the need for timely approvals from CDSCO and state licensing authorities,with a recommended five-day timeframe for those of SRA certified sites. They also proposed acentralized online repository for product and facility approvals, differentiation between commercialand exhibit batches for faster clearance, and explicit website revisions to clarify manufacturing licenseapplications. 04 April 2025: CoA Meeting of Pharmexcil09 April 2025:Meeting chaired by HCIM with EPC’s in VanijyaBhawan, New Delh10 April 2025:Invitation as Guest of Honor for the 19 Edition of PharmaTech Expo & LabTechExpo in Parade Ground, Sector 17, ChandigarhthMr Raja Bhanu, Director General participated in the meetingalong with Mr Kamal Bhardwaj, Director,R/o Delhi andsubmitted the reprsentaions and on going issues with theHCIM w.r.t the Export NoC/Regulatory and other issues facedby member exporters. Sought support for Bharat Health2025 scheduled for 04-06 Sep.2025 at Bharat Mandapam,New DelhiMr Raja Bhanu, Director General attended the19 Edition of PharmaTech Expo & LabTech asGuest of Honor for the inauguration and also to participated in the Panel discussion on “RevisedSchedule M - Gap Analysis”thThe Committee of Adminstration meeting held on 04.April.2025 and deliberated on the BharatHealth 2025,space requirements and allied sectors joining the event. Concerns with respect toExport NoC for unapproved /new APIs and also FDFs were dsicussed.

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11.April.2025: The Korea Pharmaceutical Import and ExportAssociation (Chairman Ryu Hyung-sun) announced on the 11ththat it has agreed to cooperate with the Pharmaceutical ExportAssociation -PHARMEXCIL (Chairman Namit Joshi), whichparticipated in the CPHI JAPAN 2025 exhibition in Tokyo, Japanon the 10th. The two sides agreed to sign a business agreementon the stable supply of essential medicines at the BHARATHealth Expo event to be held in India in September. "The Indianpharmaceutical market is expected to grow to about $130billion (about 189 trillion won) by 2030," said Chairman RyuHyung-sun, adding, "Through the signing of this MOU, it isexpected that exports of high-quality Korean medicines to Indiawill increase, and exchange and cooperation such aspharmaceutical trade and investment joint projects betweenthe two countries will be further activated, such as securing astable supply chain of essential medicines in Korea."Korea Pharmaceutical Import and Export Association and India PharmaceuticalExport Council (PHARMEXCIL) discuss expansion of pharmaceutical trade11 April 2025: Meeting with Federation of Pharmaceutical and Allied Products MerchantExportersMr.Sandeep Modi, Secretary, FPME met Mr Raja Bhanu, Director General and sought support onthe Export NoC clearances, and other matters relating to recognition of Indian Pharmacopeia,Banking Charges, Rupee trade etc.16 April 2025:2 Monthly Meeting to review the trade performance of Pharma and MedicalDevices chaired by Mr.Nitin Kumar Yadav, JS, DoCndMr.Nitin Kumar Yadav Joint Secretary, IAS chaired the meeting and deliberated on the issuesconcering exports and reasons for the dip in few countries and requested the industry to come upwith strategies for emerging markets and also preparatory measures for facing tariffs globally.Discussion centered around the directive of Export NoC and its impact on businesess, delays inapprovals by DCGI leading to loss of first mover advantage, Online CoPP system etc. Mr.Bhanu, DGPharmexcil along with representatives from Aurobindo Pharma, Granules Pharma, Mylan Labs,MSN Pharma , Nosch Labs Mr.Nipuj Jain ,Member of CoA joined the meeting.Page 11Pharmexcil Digest22 April 2025: VC meeting on Sector Specific Strategy for achieving 1 TrillionMerchandise Exports in Vanijya Bhawan, Conference Room No. 321, New DelhiThe meeting was convened under the Chairmanship of Shri Nitin Kumar Yadav, JS, EP(Pharma) and Dr.Tamanna Chaturvedi, Vice President of Invest India made a presentation on outlining the Pharma exportsof major HSN codes from India and imports of other countries vis a vi potential supplies from India.Regulatory challenges, especially for market access and patent-related exports, were seen as majorhurdles. MSMEs face additional issues such as inverted duty structures and ambiguous interestsubvention policies. Support from the government is critical in easing these burdens and enhancingIndia’s competitiveness globally. t

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Pharmexcil DigestPage 12Action points included incentivizing API-based manufacturing under the PLI scheme,negotiating preferential terms under FTAs, safeguarding export data, reviewing regulatorybottlenecks, and addressing pricing and compliance issues such as the Minimum Import Price(MIP) and anti-dumping duties.There was also an emphasis on forging international MRAs (Mutual Recognition Agreements)and addressing localization requirements through partnerships or profit-sharing models.Feedback from the industry will be collected via a structured questionnaire from Invest India toensure alignment and implementation of these strategies. Mr. Raja Bhanu, DG; Ms LakshmiPrasanna, Sr Director, Mr Murali Krishna, Director and Mr Rollins John,Director joined fromSecretriat. Dr.Venkatesh, Mr.Bharat Desai, Dr.Vishal Rajgharia ,Members of the CoA joined themeeting.23 April 2025: RIS in partnership with the Embassy of Mexico in India, Delhi is organising thePublic Lecture by Dr Gabriela Ramos, Assistant Director-General for the Social and HumanSciences, UNESCO, on the topic of "AI and Ethics" in Casuarina Hall, India Habitat Centre, NewDelhi.Mr Raja Bhanu, Director General participated virtually in the Public Lecture by Dr GabrielaRamos, Assistant Director General for the Social and Human Sciences, UNESCO, chaired by Dr V.K. Saraswat, Member, NITI Aayog organized by RIS in partnership with the Embassy of Mexicoin India, New Delhi is organising the on the topic of "AI and Ethics" at the Casuarina Hall, IndiaHabitat Centre , New Delhi.24 April 2025: Meeting organised by Pharmexcil & NSF, UK on Nutraceuticals/DietarySupplement/OTC Drug Manufacturers in HyderabadThe meeting highlighted the need for better global positioning, with India currently holding justa 2.5% share (ranked 10th). Two key strategic frameworks were proposed: the C6 strategy—focusing on country identification, cost competitiveness, compliance with trade barriers, andbranding; and the P6 strategy—focusing on high-potential products, current performance,production surplus, trade policies, and value addition opportunities.To strengthen exports, India must scale up production and diversify exports of high-potentialmedicaments, including products containing penicillins, hormones, and steroids. It was notedthat the world import demand is rising, but India has not yet tapped into many of theseopportunities.

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Pharmexcil DigestPage 13The session trained exporters and Customs officers on filing online refund applications viaICEGATE, the CBIC’s national e-filing platform. Officials present included Ms. Sarita Girish(Pharmexcil), Mr. Ranu Juyal, Mr. Farah, and Mr. Hans Raj (Customs).ICEGATE enables electronic submission of Bills of Entry, Shipping Bills, e-payments, and IGSTrefunds, serving over 12.5 lakh users. Mr. Ranu Juyal explained the Customs RefundableApplication, highlighting two components: Re-assessment Application and Refund Application. Re-assessment of Bills of Entry is mandatory before filing a refund claim, after which a pre-filledrefund form is generated. Starting March 31, 2025, only online refund applications will beaccepted, with rare exceptions at the Customs Commissioner’s discretion. Exporters must submitseparate applications for each Bill of Entry, though portal simplifications are in progress. Fordelays, exporters can reach the ICEGATE Helpdesk using their Ticket Number. The sessionconcluded positively, answering queries and encouraging further engagement via email for asmoother transition to automated refunds.24 April 2025: Interactive session with trade and officers of customs for filing/processing theonline refund application in light of the automation of refund process with effect from 01st April202530 April 2025: Consultation seeking inputs on "Export Promotion Mission" A meeting under the chairmanship of the Commerce Secretary Mr.Sunil Barthwal held on 30 April 2025,to hold consultations on the implementation of the Export Promotion Mission (EPM). Mr.Ajay Badoo,DFGT presented the overview of the Export Promotion Mission and the components under the NiryatProtsahan and Niryat Disha initiatives. EPCs are requested to provide the framework and the incentivemechanism focused to MSMEs, for those of NTBS/NTMs and address the disabilities.Mr.Murali Krishna S, Director Pharmexcil joined the meeting and requested for restoring the MAI benefitwith out any cap / scale up the benefit of MAI upto 500 crores in line with the new definition of MSME. Itis also requested to consider Regional iPHEX (for instance iPHEX LAC in Argentina and inviting buyers fromother LAC countries) and in incentivizing buyers from the neighboring countries.Dr.Vinay Kumar ,Assistant Drugs Controller graced the event as Chief Guest. Ms.Lakshmi Prasanna gave thewelcome note followed by a presentation by Mr.David Trosin,Group Tecnical Director ,NSF on ensuringexcellence and quality in nutraceuticals in 2025.A strong quality ecosystem involving manufacturers,regulators, certification bodies, and laboratories is essential to ensure safety and efficacy. The Governmentof India reimburses 50% of certification costs for nutra and herbal products under the MAI Scheme tosupport compliance. The discussion involved manufacturers, industry experts, regulators, and NSFrepresentatives, highlighting the need for government intervention to boost global competitiveness.Dr.Gayatri ,Deputy Director participated as Panelist and shared the incentives available for nutraceuticalproducts29.April.2025: Mr.Raja Bhanu, Director Generalmet Prof.Dr,Taruna Ikrar, Chairperson ofIndonesian Food and Drug Authority and soughtsupport of fast track product approvals

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123456MEMBERS ACHIVEMENTSJubliant Pharmova arm salisbury facility gets USFDAEstablishment Inspection ReportUSFDA concludes inspection at Shilpa Medicare Raichur unit& Shilpa Medicare receives US approval for VareniclineTablets, 0.5 mg and 1 mgStrides Pharma sciences singapore arm to acquire100 percent stake in AMEXEL & Strides Pharmaapproves demerger from Arco LabsStrides Pharma shares rose 2.8% on BSE after proposing to acquire Amexel Pte. Ltd. to expand inIndia, China, and Southeast Asia. The company continues to strengthen its global presence in genericmedicines. Strides Pharma will demerge from Arco Labs, following board approval, creating a newentity focused on life sciences and manufacturing solutions. The new company will leverageadvanced technology and domain expertise.Zydus Lifesciences has secured final US FDA approval to manufacture Methenamine Hippurate TabletsUSP, 1 gram, for urinary tract infection prevention. The medication generated $32.6 million in US salesas of January 2025. This approval boosts Zydus' presence in the US pharmaceutical market, bringing itstotal approvals to 419. Production will take place at the company’s Ahmedabad facility.Zydus Lifesciences bags USFDA approval for Urinary tractinfection drugJubilant Pharmova's subsidiary, Jubilant Cadista Pharmaceuticals Inc., has received an establishmentinspection report from the US FDA for its solid oral formulations facility in Salisbury, Maryland. The FDAclassified the inspection as voluntary action indicated and confirmed its closure. The facility is notexpected to manufacture any productsShilpa Pharma Lifesciences Ltd passed a US FDA inspection at its Raichur facility marking its secondconsecutive clean review. Approval for generic Varenicline Tablets (0.5 mg and 1 mg) for smokingcessation. The US market for this product is valued at approximately $203 million.Sovereign Pharma gains EU approval for aseptic andterminally sterilised injectable productSovereign Pharma has received EU approval for aseptic and terminally sterilised products,including vials, ampoules, cartridges, and pre-filled syringes (PFS). This marks a significantmilestone in the company's commitment to quality, safety, and global healthcare excellence. Thecompany has also received approval from ANVISA, Brazil's Ministry of Health, and MHRA USFDA grants QIDP designation to Venus RemediesNovel Polymyxin B formulationsVenus Remedies has received a Qualified Infectious Disease Product (QIDP) designation from theUS FDA for its investigational antibiotic, VRP-034, which is designed to treat bloodstreaminfections caused by specific polymyxin B-susceptible strains in adults. The QIDP status allows forpriority FDA review, potential fast-track designation, and additional market exclusivity.Pharmexcil Digest Page 14

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78910Alembic Pharma receives USFDA final approval forPantoprazole Sodium InjectionAlembic Pharmaceuticals received final US FDA approval for Pantoprazole Sodium to treatgastroesophageal reflux disease and erosive esophagitis. The approved ANDA matches WyethPharmaceuticals' Protonix I.V. Alembic now holds 221 USFDA ANDA approvals.Finecure Pharmaceuticals Ltd has achieved US-FDA approval, showcasing their dedication toexcellence and global healthcare innovation. This milestone was made possible through thesteadfast support of their team, partners, and stakeholders, remain committed to Making LivesHealthierFinecure Pharmaceuticals Ltd proudly announces its US-FDA approvalWest Bengal Chemical Industries Ltd. (WBCIL) has beenawarded the "National Intellectual Property Award2024"WBCIL for its exceptional contributions in patent-led innovation, IP commercialization, and exportexcellence in Active Pharmaceutical Ingredients (APIs) got National Intellectual Property Award. Theaward, presented by Union Minister Shri Piyush Goyal, places WBCIL and Indian MSMEs on the globalpharma innovation map.Pharmexcil Digest Page 15Laurus Labs bets on cell and gene therapies, eyesCDMO roleLaurus Labs is investing in disruptive technologies to expand beyond its core expertise. Thisdecision, made during a board meeting, focuses on supporting startups and academicresearch in innovative scientific areas. The goal is to foster collaboration and driveadvancements in fields where the company lacks expertise.“"We warmly invite memberexporters to showcase theircompany’s achievements on thePharmexcil website every month.We are delighted to feature theseaccomplishments in our newsletter,further amplifying their visibilityand impact within the industry.".”Celebrating Excellence

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DGFT eases compliance burden as pharma exportersface hurdles in advance authorization closure Clickthe LINKMarch 2025DGFT notifies new SION for metronidazole gel tofacilitate ease of doing business. Click the LINKCDSCO eases rules, pharma firms can now get 1-year NoC online via Sugam portal Click the LINKDGFT seeks industry feedback on proposedamendments to "stock and sale" exportauthorization for SCOMET items Click the LINKPanel recommends programme for uniform highstandard drug regulation nationwide. Click the LINKCommerce ministry seeks inputs from industry toaddress challenges posed by non-tariff barriers.Clickthe LINKCentre brings in Boilers Bill to help bulk drugmanufacturers. Click the LINK"Quality is the cornerstone of success, butthriving pharma exports take it to a whole newdimension."DGFT extends deadline for filing Annual RoDTEPReturnCDSCO launches online system for SMEs to submitapplication for extension on Revised Schedule Mimplementation. Click the LINKThe government will end RoDTEP benefits for exportsunder Advance Authorizations, SEZs, and EOUs fromFebruary 6, 2025. Exporters must adjust to this policyshift aimed at aligning with global trade norms. Clickthe LINKApril 2025Pharma Exemption from Tariffs Highlights GenericMedicines' Role Click the LinkDoP notifies establishment date of NIPER CouncilClick the LinkCDSCO Revised Classification Drafts for cardio andneuro medical devices, seeking industry feedback bymonth-end. Click the LinkManufacturers urged to apply online for extension oftimeline for revised Schedule M Click the LinkNPPA revises ceiling price of diagnostic agentfollowing DoP's review order. Click the LinkGujarat FDCA to strengthen drug quality control withprocurement of 25 advanced handheldspectrophotometers Click the LinkIndian pharma moving towards Green Pharma 2.0where AI, digital twins, sustainable molecule designprevail Click the LinkFOPE urges NPPA to reconsider ceiling prices allowing5 decimal points for low priced drugs Click the LinkIndia's API industry at a key juncture, guided by globalsupply chain dynamics & shifting regulatory landscapeClick the LinkOnline stall reservation for iPHEX and Bharat Healthbegins Click the LinkIndia streamlines pharma trade compliance withrevised fee structure for import monitoring systemsClick the Link.Pharma Exports Cross $30 bn, Domestic Market Grow8.4 pc to Rs 2.2 Lakh CroreLinkBulk drug imports decline 15.7 per cent in February.LinkPHARMAP 2025 brings together global pharma leadersto discuss innovation and drug safetyLinkTariff shockwaves on China cause short-term agonybut will extend global cooperation in long-term: Dr LiJin.Link DGFT introduces new field in eBRCs to track serviceexports from May 1LinkMSMEs poised to capture global generics & biosimilarsmarkets through collaborative efforts: FPMELinkPakistan activates ‘emergency measures’ for pharmaneeds amid trade halt with India after Pahalgam attackLinkPharma NewsPage 16Pharmexcil Digest

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New Online Export NOC System on Sugamportal- CDSCO 07 March 2025(Click the Link)Customs to notify the fifth tranche of tariffconcessions under India-Mauritius CECPA28 March 2025. (Click the Link) (Click the ExcelLink)Government Extends RoDTEP Support forExports Until February 5, 202520 March 2025(Click the Link)March & April 2025 NotificationKey circulars, policy updates, and government notificationsImpacting pharmaceutical ExportsCustoms to notify the fourth tranche of tariffconcessions under India-UAE CEPA28 March 2025 (Click the Link) (Click Excel link)CUSTOMS, DGFT & CDSCO NotificationsOnline application for extension of time tocomply with Revised Schedule M on ONDLSportal 24 March 2025DGFT Operationalizes Global Tariff and TradeHelpdesk. (Click the Link)Customs(Circular) 8 April 2025 Click the Link)Prohibits to Import, manufacture, sale,distribution and use in any food producinganimal rearing system of drug formulationscontaining “Chloramphenicol or Nitrofuransdrugs" with immediate effect 02 April 2025 (Click the Link )Manufacturing and marketing ofunapproved FDC's 11 April 2025 (Click the Link )Updates to CAROTAR, 2020 and Section 28DAof the Customs Act, 1962 Click the Link.Key Highlights from the Finance Minister'sBudget Speech 2025-26 Click the Link.Amendments to the Goods Imported(Conditions of Transhipment) Regulations, 2025 Click the Link.Anti-Dumping Duty on Acrylic Solid Surfacesfrom China Click the Link.New SION for Export of Doxycycline 100 mgDispersible Tablets Click the LinkAnti-Dumping Duty on Acrylic Solid Surfacesfrom China Click the Link.Pharmexcil Digest Page 17

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DRUGS FORMULATIONS & BIOLOGICALS68NEW MEMBERS ADDED FORMARCH & APRILSUN MOON PHARMACEUTICALS PVT LTDJAIWIK BIOTECH PVT LTDVITALDEW PHARMACEUTICALS PVT LTDL'AMAR LIFESCIENCES & BIOTECH PVT LTDSHAH TC DISTRIBUTION LLPAKRITI PHARMACEUTICALS PVT LTDJPEE DRUGSNATHAN PHARMA PVT LTDJAGANNATHCHEMICAL AND PHARMACEUTICALWORKS PVT LTDMECOSON PHARMACEUTICALS PVT LTDPARB PHARMACEUTICALS PVT LTDHAMAX HEALTHCARE LLPSARVA PHARMACEUTICALS PVT LTDBDR PHARMACEUTICALS INTERNATIONAL PVT LTDCENTURY NOVA DRUGS PVT LTD4CARE LIFESCIENCE PVT LTDSUCANTIS BIOTECH PVT LTDOLIVE PHARMASCIENCE PVT LTDQALYS PHARMA LLPPRAMUKH SWAMI PHARMA LTDSWISS GARNIERS BIOTECH PVT LTDUMANG ENCAPSULATION SOLUTIONS PVT LTDBEREF PHARMACEUTICALS PVT LTDINLINE PHARMACEUTICALS PVT LTDSYNTHETIC MOLECULES PVT LTDATMAN PHARMA PVT LTDRAVAXO BIOTECH PVT LTDGLESSOM COSMED PVT LTDVASU ENTERPRISESMETINA PHARMACEUTICALS PVT LTDAETHER LIFECARE LLPUDVELL THERAPEUTICS PVT LTDOVERSEAS PHARMACEUTICALHERTIZ PHARMA PVT LTDMEDYUR PHARMACEUTICALS LTDCALIAN HEALTHCAREAKAAY PHARMACEUTICALSCHANDRA BHAGAT PHARMA LTDHNV PHARMA LTDVANTRIO HEALTHCARE PVT LTDGARICON LIFE SCIENCESSG ENTERPRISESVISION EXPORTSINNMEDICS GLOBAL PHARMA PVT LTDMEDCELL PHARMA PVT LTDMARTEL OVERSEASALLOTAB HEALTHCARE LLPTASHI PHARMANS PHARMACEUTICALSDAKSH PHARMAVEDZON HEALTHCARE PVT LTDSHORYANSH PHARMACEUTICALSBIOFIYA HEALTHCARE LLPFORTUNE PLUS AGENCIESDEEKNISC SERVICES & SOLUTIONS PVT LTDVK PHARMACEUTICALSAIDONAK HEALTHCARE PVT LTDASPK INTERNATIONAL TRADEANAIZA LIFESOLUXCTION SPACE LLPMEDISPARK HEALTHCARE LLPFLAVOCAST HEALTHCARE LLPBIOREACH PHARMA EXPORT PVT LTDPage 18Pharmexcil Digest

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New Export NoC DirectiveThe Indian pharmaceutical industry is facing significant challenges due tothe new export NoC system, which is causing delays and business losses. Key issues include:Export NoC Directive: The new directive requires a Product Registration Certificate from theimporting country's FDA or CDSCO approval, complicating exports. Product Registration Certificate: Obtaining this certificate involves extensive documentation,posing a trade barrier.Export of APIs: APIs for clinical trials and DMF/ANDA filings face approval delays.API Export Exemption: Requesting exclusion of APIs from the export NoC directive.Pharmacopeial API Treatment: Suggesting recognized APIs be considered approved for export.Category for Unapproved Drugs: Proposing a distinct category for unapproved drugs withmultiple NOCs.Timely Approvals: Emphasizing the need for expedited approvals from CDSCO and StateLicensing Authorities.Automated Approval: Suggesting automated approval for certified sites within 5 working days.Streamlining NDPS Drug Export: Recommending elimination of redundant procedures for NDPSdrug exports.Leveraging Online Platforms: Utilizing existing online platforms for NDPS drugs.Online Central Repository: Creating a central repository for product and facility approvals.Shelf-Life Flexibility: Requesting flexibility in shelf-life restrictions for unapproved drugs.Adherence to Guidelines: Urging strict adherence to existing guidelines by Assistant DrugControllers.Website Clarification: Revising the official website to include the application process formanufacturing licenses.Alternative Evidence for Export NoC: Proposing acceptance of alternative evidence for exportNoCs.Third-Country Exports: Requesting permission for exports to third countries.Separation of Batches: Differentiating between commercial and exhibit batches for expeditedclearance.The industry seeks prompt resolution of these issues to maintain its global reputation and ensuresmooth trade operations.Export NoCSyestem PHARMEXCIL REPRESENTATION TO THEMINISTRY OF COMMERCE & DCGIPharmexcil Digest Page 20

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Inverted Duty Structure: Because of inverted dutystructure lot of money is stuck in the hands of MSMEPharma manufacturers. Raw Material is taxed at 18%whereas Finished Product is taxed at 12%. MSME pharmado not have 50% Value Addition leading to accumulatedGST credit in the books of MSME which leads to Financialconstraints and hinders growth of MSME Pharma.DGFT & BanKING ISSUES PHARMEXCIL REPRESENTATION TO THEMINISTRY OF COMMERCEPharmexcil Digest Page 21Key issues include:Mitigation measuresInverted Duty Structure to berationalised at either 18% or12% as deemed fit.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. Banks should be given power to domanual entries if any mistakes havebeen committed in the past by thesame branch. Secondly EPDMS listshould ask for documentspertaining to 2017 and therein afterInternational defaulters names to be published on EPCwebsite:Many importers in various countries do not pay to Indianexporters and then the same importers buy from otherpharma exportersA list by Pharmexcil can bepublished after duediligence and seeing thepharma exporter hasexhausted all methods torecover moneyOFAC countries: Banks do not issue Bank Realisationcertificate for proceeds from OFAC related countriesRBI to instruct all Banksworking in India to issueBRC in case of Drugs andPharmaceuticalsRODTEP 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.DGFT to resume RODTEPagainst AdvanceAuthorisationLevy 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.Seeking 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 scheme

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REGULATORYUPDATESThe FDA focuses on industry personnel creating human prescriptionmedication labeling, including FDA-approved patient labels,prescribing information, and scientific data for safe and efficientusage.Link@reallygreatsiteUSAApril 8, 2025| Martin A Makary M.D., M.P.H, New Commissioner ofFood and Drugs - Food and Drug Administration Dr. Martin Adel Makary, the 27th Commissioner of Food and Drugs,oversees the FDA portfolio and executes the Federal Food, Drug, andCosmetic Act. With over 250 peer-reviewed scientific articles andnumerous awards, Makary has worked at Johns Hopkins University andJohns Hopkins Carey Business School LinkMarch 10, 2025| FDA’s Labeling Resources for Human PrescriptionDrugsPApril 10, 2025| FDA Announces Plan to Phase Out Animal TestingRequirement for Monoclonal Antibodies and Other DrugsThe FDA is replacing animal testing in drug development withadvanced, human-relevant methods to enhance safety and efficiency.AI-based models, organoid toxicity testing, and global safety data willrefine or replace traditional animal trials. Updated guidelines willsupport companies in submitting non-animal safety data. Theseinnovations aim to accelerate drug development while maintainingrigorous safety standards.LinkApril 17, 2025| FDA Commissioner Makary Announces New Policy onIndividuals Serving on FDA Advisory Committees:FDA Commissioner Martin A. Makary has restricted pharmaceuticalcompany representatives from serving on FDA advisory committees toenhance public trust. The policy aims to reduce industry influence,prevent conflicts of interest, and emphasize patient and caregiverperspectives. These committees provide independent expert advice onscientific and policy matters. While company employees can't be officialmembers, they can still attend and share their views.LinkApril24,2025|Oncology(Cancer)/Hematologic MalignanciesApproval NotificationsFDA does not issue approval announcements for every approval or druglabel update that occurs in oncology and hematologyLinkMarch 25, 2025|MHRA launches new monthly safety bulletinand redesigned safety alertsThe new MHRA Safety Roundup provides a monthly summary of thelatest safety advice for all medicines, medical devices, and healthcareproducts regulated by the MHRA, as part of our 3-year strategy toimprove safety communications.LinkApril 10, 2025| Fezolinetant ▼ (Veoza): risk of liver injury; newrecommendations to minimise riskFezolinetant treatment is associated with a risk of drug induced liverinjury. New recommendations have been introduced to minimise thisrisk. Liver function should be monitored before and during treatmentin all patients taking fezolinetant. Fezolinetant should be avoided inpatients with known liver disease or at a higher risk of liverdisease.LinkApril 24, 2025| Short-acting beta 2 agonists(SABA) (salbutamol and terbutaline):reminder of the risks from overuse in asthmaand to be aware of changes in the SABAprescribing guidelinesApril 04, 2025|SAHPRA joins the MedicalDevice Single Audit ProgrammeSAHPRA has joined the Medical Device SingleAudit Programme (MDSAP), an internationalaudit programme aimed at improving efficienciesin the regulation of medical devicemanufacturers. As an affiliate member, SAHPRAwill expand its ability to monitor manufacturingof medical devices beyond its borders. Thismembership will improve SAHPRA's regulatoryreach and enable it to leverage resources fromother MDSAP participants to audit and monitorquality standards by medical devicemanufacturers globallyApril 15, 2025| MedTech regulatory reform and the importanceof partnershipsThe UK's 10 Year Health Plan relies on medical technologies, requiringbalanced regulation to ensure safety while fostering innovation. TheMHRA's Innovative Devices team collaborates with stakeholders toHealthcare professionals and patients are remindedof the risk of severe asthma attacks and increasedmortality associated with overuse of SABA with orwithout anti-inflammatory maintenance therapy inpatients with asthma. Healthcare professionalsshould be aware of the change in guidance that nolonger recommends prescribing SABA without aninhaled corticosteroid.LinkApril 29, 2025| MHRA Safety Roundup: April 2025Summary of the latest safety advice for medicinesand medical device usersLinkMarch 04, 2025| SAHPRA Strategic Plan 2025 and2026 – 2029 and 2030SAHPRA's 2025–2030 Strategic Plan emphasizesensuring access to safe, effective, and high-qualityhealth products. With a vision to be an agile andglobally recognized regulator, it aims to enableaccess across South Africa. SAHPRA is committed tonavigating the evolving regulatory landscape withresilience and innovation. This plan reaffirms itsdedication to safeguarding public health andenhancing healthcare outcomes.Linkadvance transformative technologies. The UKCentres of Excellence for Regulatory Science andInnovation (CERSIs) aim to strengthen futureregulatory systems. Seven CERSIs recently met todiscuss goals, challenges, and collaborationstrategies.LinkPharmexcil Digest Page 22

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Compliance and RegulatoryDocumentation (Link)Electronic SubmissionRequirements (Link)For official guidance, refer to theFDA Registration Portal.Click the Link for moreinformation: USFDA Drug approvalprocessForeign Facility RequirementsU.S. Agent DesignationForeign manufacturers mustappoint a U.S. agent tofacilitate communication withthe FDA.The agent is responsible for:Responding to regulatoryinquiries.Assisting in inspections andsubmissions.Importer IdentificationEach facility must identifyimporters associated with theirdrug products.FDA Import Alerts may apply tonon-compliant facilities.Conduct Clinical Trials- Phase I: Safety and dosage(small group)- Phase II: Efficacy and sideeffects (larger group)- Phase III: Confirmation,monitoring, comparison(large-scale)Submit IND (InvestigationalNew Drug) Application- Preclinical data- Manufacturing information- Investigator details- Clinical study protocols↓30-Day FDA Review Period- No clinical hold → Proceed totrialsRegister Facilities with FDA- Manufacturing- Packaging- Labeling↓Submit Common TechnicalDocument (CTD)- Through FDA's ElectronicSubmissions Gateway (ESG)↓FDA Review- Evaluate safety, efficacy,labeling, manufacturing qualityDrug Listing Requirements:OverviewDrugs need to be registeredwith Structured ProductLabelling (SPL) format.(link)Submission ProcessAssign a National Drug Code(NDC): (Link)1.Prepare Labeling Data: (Link)2.Upload SPL Files (Link)3.Submit via FDA’s eDRLS portal.(Link)Special ConsiderationsPrescription & OTC Drugsrequire different regulatorypathways.Biological products undergoadditional scrutiny.Identify Product Category &Application Type↓Conduct Preclinical Studies- Assess safety and toxicity- Comply with GoodLaboratory Practice (GLP)Drug Approval- Authorized for marketing in the U.S.↓Post-Marketing Surveillance- Pharmacovigilance- Annual reports- Supplemental applications- FDA inspections and auditAll domestic and foreign establishments involved in the manufacture, repacking, orre-labelling of drugs for U.S. distribution.Facilities involved in biologic, prescription, and over-the-counter (OTC) drugproduction. (Link)WHO NEEDSTO REGISTER??Process OverviewCreate an FDA Account: Register online via the FDA’s Electronic Drug Registration and Listing System(eDRLS) (Link)Submit Required Information:Facility name, location, and ownership details.Type of pharmaceutical products manufactured.Annual Renewal: Maintain registration with annual updates by December 31.Key Compliance FactorsAdherence to Good Manufacturing Practices (GMP)Facility inspections and compliance audits.Your paragraph textComprehensive Guide to USFDA PharmaceuticalRegistrationPharmexcil Digest Page 23

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ChairmanMr. Namit JoshiDirector Centrient Pharmaceuticals India Pvt Ltd Mr. Bharat Desai Managing DirectorBharat Parenterals LimitedDr. A.R. VenkateshCEO Global Pharma Healthcare Pvt. Ltd.Dr. Meera Gandhi Managing DirectorVital Healthcare Pvt. Ltd. Mr. Brijesh Patel DirectorMakcur Laboratories Ltd.Mr. Siddharth Daga CEO Vins Bioproducts LtdMr. Devang Shah DirectorAadivighnesh Chem Pvt LtdCOMMITTEE OF ADMINISTRATION (2024-26)Mr. Bhavin A PatelPartnerMediwin PharmaceuticalsMr. Amit Chawla DirectorMcW Healthcare Pvt. Ltd.Vice ChairmanMr. Bhavin Mehta DirectorKilitch Drugs India Ltd Mr. Vijay ShahDirectorStallion Laboratories Pvt. Ltd.Mr. Niraj DoshiDirectorAccusynthSpeciality Chemicals Pvt. Ltd.Dr. Viranchi Shah DirectorSaga Lifesciences LimitedMr. Shashank SanduCEO Sandu Brothers Pvt. Ltd.Mr. Kamlesh Patel Managing DirectorWest Coast pharmaceuticalworks LtdDr. Vishal RajgarhiaDirector Finecure PharmaceuticalsLimitedMr. Tushar AnilDirector Emil Pharmaceutical Industries Pvt. Ltd.Mr. Raja Bhanu, Director General & Member SecretaryPHARMEXCILMr. Nitin Kumar Yadav IASJoint SecretaryMinistry of Commerce & IndustrySpecial InviteeMr. Bala Subba ReddyExecutive DirectorVirupaksha Organics LtdMr. Nipun JainDirectorPharmchemMr. Nikunj GoswamyManaging DirectorJai Radhe SalesCO-OPTED MEMBERSPharmexcil Digest Page 25Your paragraph text

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FORMATION OF WORKING GROUPSFORMATION OF WORKING GROUPS +91 8977024106 – Handles queries related tothe Market Access Initiative (MAI). +91 8977025106 – Covers Certificate of Origin(CoO), RCMC, Events & Regulatory Guidance.tes on Government Schemes and policies.11.07.20204Pharmexcil Help DeskThe Pharmexcil Helpdesk WhatsAppservice, launched on July 11, 2024,enhances communication formembers by providing dedicatedcontact points:10AM- 6:30 PMMembers can interact via chat only (nocalls) during working hours (10 AM -6:30) PM, weekdays) for real-timeassistance, clarifications, and updateWith a view to have active engagement with industry, Council under the leadershipof Chairman & Vice Chairman formed the Working Committees to handle theconcerns of the industry and also to build export strategies for greater market accessfor pharmaceuticals globallyMember companies are advised to reach out subject Committees Heads for sharingthe concerns/suggestions/inputs for taking up the matter with concernedDepartment appropriately Pharmexcil Digest Page 26

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We wish to inform you that we have received acommunication from the Department of Commerceregarding the trillion-dollar trade target for thepharmaceutical sector. This was discussed during apresentation by Invest India before Shri Nitin KumarYadav, Joint Secretary, on 22nd April 2025 at VanijyaBhawan, New Delhi.In this regard, Invest India has developed a sector-specific questionnaire to gather relevant data fromstakeholders. The completed questionnaire is to besubmitted to the EP (Pharma) Division, Departmentof Commerce.We kindly request your cooperation in reviewing theattached questionnaire and providing the requisiteinformation wherever possible (country wise,product wise) at the earliest.Please ensure that your response reaches us by May5th 2025, to enable us to consolidate and submitthe data within the stipulated timeline.Questionnaire for Pharma 2025Subject: Request for Data Submission – Trillion-DollarTrade Target for Pharma Sector-Submit inputs by05.May.2025FEEDBACK S U B M I T Y O U RSubject: Request for Inputs - Review of All IndustryRates (AIR) of Duty Drawback for the year 2025-Date Extended till 10.May.2025The Government of India is reviewing the 2025 AllIndia Rates (AIR) of Duty Drawback, focusing onCustoms and Central Excise duties on export goods.Member companies are requested to providecomplete export data for April–September 2024,detailing all inputs used in the manufacturingprocess. Only Customs Duty on inputs and CentralExcise duty on petroleum products should beincluded; other taxes like IGST, CGST, SGST, or Anti-Dumping Duty should be excluded.The data should represent exports from small,medium, and large manufacturers, certified by bothmanufacturers and Chartered/Cost Accountants.Relevant supporting documents, such as Bills ofEntry, Shipping Bills, and excise invoices, mustaccompany the submission. Data should also beprovided in Annexure II (Excel format).Members are encouraged to share their views andsuggestions for rationalizing entries in the AIRDrawback Schedule, including those not previouslycovered, with proper justification. Submissionsshould be sent by 10.May.2025 to dbk.dbk@gov.inwith a copy to support@pharmexcil.com, enablingconsolidation and timely submission to theCommittee.Dear Members,Greetings from Pharmexcil!Pharmexcil Digest Page 27Disclaimer: 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 theauthor and do not necessarily reflect the views of Pharmexcil. You may reach out to exportfacillitationdesk@pharmexcil.com for more information/toshare your views/inputs

PHARMEXCIL DIGEST March & April 2025

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