• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Manufacturing
    • Packaging
    • Development
    • Compliance
    • Top 25
    • Directory
    • Microsites
    • Events
    • More
  • Magazine
  • News
  • Manufacturing
  • Packaging
  • Development
  • Compliance
  • Top 25
  • Directory
  • Microsites
  • Events
  • Current / Back Issue
    Features
    Editorial
    Columns
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Subscribe Now
    Advertise Now
    Top Features
    Small Innovators & Niche CROs

    Focus on Science

    Rapid and Data Rich Chromatographic Method Development

    Preparing Your Post Pandemic Talent Strategy

    How Modern Near-Infrared Came to Be
    Breaking News
    Online Exclusives
    Industry News
    Collaborations & Alliances
    Promotions & Moves
    Trials & Filings
    Financial Reports
    Bio News & Views
    Custom Sourcing News
    Packaging & Tracking
    CRO News
    Live From Shows
    Top News
    Nanoform, Aprecia Partner to Advance 3DP Nanomedicines

    KemPharm Receives $10M Milestone for FDA Approval of Azstarys

    Valneva Focuses on Bilateral Discussions to Supply COVID-19 Vax

    Syneos, Medable Partner for New Decentralized Capabilities

    CSafe Global Appoints SVP of Technology and Innovation
    APIs
    Aseptic Processing
    Cleaning Validation
    Clinical Trial Materials
    Cytotoxics and High Potency Manufacturing
    Equipment
    Excipients
    Extractables and Leachables
    Facilities
    Fill/Finish
    Lyophilization
    Parenterals
    Process Development
    Process Validation
    Risk Management
    Scale-up/ Technology Transfer
    Solid Dosage/ Creams/ Ointments

    Evotec to Build Second Biologics Mfg. Facility in Toulouse

    Abenza Chooses North Carolina for New Biologics Manufacturing Site

    Catalent Adds Cryogenic Capabilities at Philadelphia Facility

    Recro, Ensysce Expand Development and Manufacturing Partnership

    Metrics Names Stephanie Emory Associate Director of Pharma Development
    Capsules
    Cold Chain Management
    Injectables
    Logistics
    Serialization
    Solid Dosage / Semi-solids
    Supply Chain
    Vials

    TraceLink Introduces Opus Platform

    Obituary Notice: Russell “Russ” Haines

    Catalent Adds Cryogenic Capabilities at Philadelphia Facility

    Cryoport Acquires Critical Transport Solutions Australia

    PharmParts – This Makes Sense!
    Analytical Services
    Bioanalytical Services
    Bioassay Developement
    Biologics, Proteins, Vaccines
    Biosimilars
    Chemistry
    Clinical Trials
    Drug Delivery
    Drug Development
    Drug Discovery
    Formulation Development
    Information Technology
    Laboratory Testing
    Methods Development
    Microbiology
    Preclinical Outsourcing
    R&D
    Toxicology

    Nanoform, Aprecia Partner to Advance 3DP Nanomedicines

    KemPharm Receives $10M Milestone for FDA Approval of Azstarys

    Valneva Focuses on Bilateral Discussions to Supply COVID-19 Vax

    Syneos, Medable Partner for New Decentralized Capabilities

    Valneva’s Inactivated, Adjuvanted COVID-19 Vax Achieves Positive Data
    Filtration & Purification
    GMPs/GCPs
    Inspections
    QA/QC
    Regulatory Affairs
    Validation

    Unifying Quality Manufacturing to Drive Speed, Collaboration, and Compliance

    Ensuring Pharma Manufacturing Quality

    What Will Change at FDA for 2021?

    RBQM Comes of Age: COVID as a Catalyst for Change

    Post-Pandemic Regulations
    Companies
    Categories
    Corporate Capabilities
    Add New Company
    Contract Service Directory Companies
    PCI Pharma Services

    Syngene

    Alcami

    Almac Group

    Reed-Lane
    Companies
    News Releases
    Posters
    Brochures
    Services
    Videos
    Case Study
    White Papers
    Jobs
    Contract Service Directory Companies
    Adare Pharma Solutions

    Almac Group

    Reed-Lane

    Alcami

    Quotient Sciences
    Webinars
    Live From Shows
    • Magazine
      • Current / Back Issue
      • Features
      • Editorial
      • Columns
      • Editorial Guidelines
      • Subscribe Now
      • Advertise Now
      • Enewsletter Archive
      • Digital Edition
    • Directory
      • Companies
      • Categories
      • Corporate Capabilities
      • Add Your Company
    • Manufacturing
      • APIs
      • Aseptic Processing
      • Cleaning Validation
      • Clinical Trial Materials
      • Cytotoxics and High Potency Manufacturing
      • Equipment
      • Excipients
      • Extractables and Leachables
      • Facilities
      • Fill/Finish
      • Lyophilization
      • Parenterals
      • Process Development
      • Process Validation
      • Risk Management
      • Scale-up/ Technology Transfer
      • Solid Dosage/ Creams/ Ointments
      • cGMP Manufacture
    • Packaging
      • Capsules
      • Cold Chain Management
      • Injectables
      • Logistics
      • Serialization
      • Solid Dosage / Semi-solids
      • Supply Chain
      • Vials
    • Development
      • Analytical Services
      • Bioanalytical Services
      • Bioassay Developement
      • Biologics, Proteins, Vaccines
      • Biosimilars
      • Chemistry
      • Clinical Trials
      • Drug Delivery
      • Drug Development
      • Drug Discovery
      • Formulation Development
      • Information Technology
      • Laboratory Testing
      • Methods Development
      • Microbiology
      • Preclinical Outsourcing
      • R&D
      • Toxicology
    • Compliance
      • Filtration & Purification
      • GMPs/GCPs
      • Inspections
      • QA/QC
      • Regulatory Affairs
      • Validation
    • Top 25 Pharma & BioPharma
    • Contract Pharma Direct
    • Breaking News
    • Online Exclusives
    • Slideshows
    • Experts Opinions
    • Surveys
      • Outsourcing Survey
      • Salary Survey
    • Glossary
    • Videos
    • Podcasts
    • White Papers
    • Infographics
    • Contract Pharma Conference
      • Contract Pharma Conference
      • Speakers
      • Exhibitors
      • Conference Sessions
    • Supplier Microsite
      • Companies
      • News Releases
      • Posters
      • Brochures
      • Services
      • Videos
      • Case Study
      • White Papers
    • eBook
    • Webinars
    • Events
      • Industry Events
      • Live from Show Events
      • Webinars
    • Classifieds / Job Bank
      • Classifieds
      • Job Bank
    • About Us
      • About Us
      • Contact Us
      • Advertise With Us
      • Privacy Policy
      • Terms of Use
    India Report

    India to Track API Packs

    India is mulling a shakeup in the regulations governing the distribution of pharmaceutical products.

    India to Track API Packs
    Related CONTENT
    • Softweb Solutions
    • Biopharma Over 20 Years
    • Industrial Equipment Auctions and Liquidations
    • AGC Biologics Strengthens Global Footprint
    • West and SCHOTT Enter Packaging Partnership
    S. Harachand, Contributing Editor11.20.19
    India’s health ministry has recently released a set of draft rules aiming to implement quick response (QR) code on the labels of all active pharmaceutical ingredient (API) packs manufactured in and imported to the country. At each level of packaging, the coding that stores all essential information—manufacturer location, batch number, date of expiry, etc.—is readable with software applications that can facilitate the tracking and tracing of the product. Such a system will help regulators and companies determine the authenticity and identity of a particular drug product.

    The so-called track and trace system, which ensures the authenticity of drug packs has become the new global standard for pharmaceutical drug distribution.

    Utilizing the 2D barcode technology, the system makes it harder for counterfeit drugs to enter the pharmaceutical supply chain. The authenticity of each pack is checked by entering its unique identifier number into a repository system at the time of manufacture. The unique identifier can be verified against its entry in the storage system at one or more points in the supply chain. As this simple technology makes the distribution system more transparent, it becomes easier for authorities to locate at exactly which point fake drugs infiltrated the distribution system.

    QR code will become mandatory for API manufacturers and importers to track-and-trace the ingredients used to make medicines in India, the health ministry announced through a notification issued in the official gazette in August.

    The government is proposing to make necessary amendments in the currently governing Drugs and Cosmetics Rules, 1945 to incorporate the new rules as a subset. The revised rules will come into force on the date of their final publication in the gazette, according to the notification.

    Meanwhile, India’s ministry of commerce is planning to implement an online system that traces and authenticates pharmaceutical export packages from April 1, 2020, reports said.

    The online system is envisaged to help manufacturers and merchant traders to generate and utilize tertiary and secondary level coded data in a user-friendly manner. It will act as a single-window integrated system that enables the tracing of an exported pharmaceutical product.

    Exporting companies have welcomed the decision hoping that the initiative will solve a myriad of problems currently hampering track and trace.

    Low-cost production hub
    The global pharmaceutical packaging market is booming. Reports forecast that the medicine packs market will double in size to $149 billion in the next ten years’ time.

    India’s pharma packaging market, which relies heavily on plastic packaging, is passing through a transformational phase.

    The demand for glass tubing is growing to unprecedented levels as Indian drug makers are increasingly launching injectable drugs both for domestic and overseas markets. They are looking at low competition-high margin generic injectable drugs. In addition to FDA approvals, the growth is accelerated by innovative drugs and formulations such as biosimilars, cancer drugs and vaccines.

    Several multinationals have already identified India as hub of low-cost production of packaging materials. 

    Schott, a leading specialty glass manufacturer, announced an additional “multimillion-euro figure” investment to build a new glass tank at its tubing manufacturing plant in Jambusar, Gujarat in June.
    Last year, the German glass major made significant investments at the site including the construction of an additional tank.

    The new facility will be built and equipped with the latest state-of-the-art machinery featuring the big data approach, perfeXion. The process, which has been rolled-out globally by Schott since 2017, ensures 100% quality control of each tube on the line by using cameras, laser and IR inspection systems.

    The capacity expansion has been done keeping in view of the very high demand for premium pharmaceutical packaging and tubing. The increased production capacity at Jambusar will be utilized to supply the rapidly growing domestic and Asian market, Schott said.

    The company expects to start production of pharmaceutical Fiolax tubing from the new tank in the second half of 2020.

    The high hydrolytic resistance of Fiolax borosilicate glass tubing makes it an ideal material for primary packaging of medicines. It has been established as the gold-standard material for pharmaceutical containers. In India, Flolax is primarily used to manufacture glass vials and ampoules. The Jambusar facility will combine Indian and European technologies and local skills, according to Schott. 


    S. Harachand
    Contributing Editor

    S. Harachand is a pharmaceutical journalist based in Mumbai. He can be reached at harachand@gmail.com.
    Related Searches
    • Pharma
    • expansion
    • track-and-trace
    • api manufacturers
    Suggested For You
    Softweb Solutions Softweb Solutions
    Biopharma Over 20 Years Biopharma Over 20 Years
    Industrial Equipment Auctions and Liquidations Industrial Equipment Auctions and Liquidations
    AGC Biologics Strengthens Global Footprint AGC Biologics Strengthens Global Footprint
    West and SCHOTT Enter Packaging Partnership West and SCHOTT Enter Packaging Partnership
    Keynote: FDA’s Continuous Manufacturing Journey: Past, Present and Future Keynote: FDA’s Continuous Manufacturing Journey: Past, Present and Future
    Vetio Animal Health Vetio Animal Health
    QPS Expands Global Footprint QPS Expands Global Footprint
    Quality Metrics Feedback Quality Metrics Feedback
    Saudi Arabia 2019: Building a Comprehensive Compliance Strategy Saudi Arabia 2019: Building a Comprehensive Compliance Strategy
    FDA Extends CRADA with CluePoints FDA Extends CRADA with CluePoints
    Ajinomoto Bio-Pharma Services gives you The Power To Make Ajinomoto Bio-Pharma Services gives you The Power To Make
    NIIMBL, FDA to Advance Innovation in Bio Manufacturing NIIMBL, FDA to Advance Innovation in Bio Manufacturing
    FDA Accepts RedHill Biopharma’s NDA for Talicia FDA Accepts RedHill Biopharma’s NDA for Talicia
    The FDA Gets Stricter with E&L Oversight, Can the Industry Keep Up? The FDA Gets Stricter with E&L Oversight, Can the Industry Keep Up?

    Related India Report

    • Injectables Firms Expand Capacity

      Injectables Firms Expand Capacity

      CDMOs see steriles demand grow.
      S. Harachand, Contributing Editor 11.17.20

    • Supply Chain Woes Vex Markets

      Supply Chain Woes Vex Markets

      Indian players ramp up chloroquine production
      S. Harachand, Contributing Editor 09.09.20

    • HCQ Comes Center Stage

      HCQ Comes Center Stage

      Indian players ramp up chloroquine production
      S. Harachand, Contributing Editor 05.05.20


    • Supply Chain
      Oral Solids Makers Face Corona Heat

      Oral Solids Makers Face Corona Heat

      CDMOs fear supply disruptions, price increases.
      S. Harachand, Contributing Editor 03.04.20

    • Biosimilars
      The Similar Mantra

      The Similar Mantra

      Early birds bet big on biosimilars.
      S. Harachand, Contributing Editor 01.28.20

    • R&D
      Indian Firms Ramp Up R&D

      Indian Firms Ramp Up R&D

      Accelerating on research spend.
      S. Harachand, Contributing Editor 10.15.19


    • Cytotoxics and High Potency Manufacturing
      Highly Potent Expansions

      Highly Potent Expansions

      CDMOs see HPAPI demand rising
      S. Harachand, Contributing Editor 09.16.19

    • The Orphan Promise

      The Orphan Promise

      New policy on rare disease treatments likely soon
      S. Harachand, Contributing Editor 06.13.19

    • Biologics, Proteins, Vaccines
      Ebullient Bio CMOs

      Ebullient Bio CMOs

      Firms see rich dividends from biosimilars
      S. Harachand, Contributing Editor 05.07.19


    • R&D
      Strategic Discovery

      Strategic Discovery

      CROs top offerings with biology skills.
      S. Harachand , Contributing Editor 10.10.18

    • HPAPI Outsourcing Likely to Gain Traction

      HPAPI Outsourcing Likely to Gain Traction

      A number of highly potent drugs will soon fall into the generic domain
      S. Harachand, Contributing Editor 09.11.18

    • Packaging Majors Expand Base in India

      Packaging Majors Expand Base in India

      India’s pharma packaging market is growing at a faster pace than other world markets
      S. Harachand, Contributing Editor 03.09.18


    • Acquisition Spree

      Acquisition Spree

      Indian firms topped the list of aggressive bidders even as the frenzy of deal making in the global generics space passes into
      S. Harachand, Contributing Editor 01.30.18

    • Drug Delivery
      Growing NDDS Portfolios

      Growing NDDS Portfolios

      Generic drugs on novel delivery platforms
      S. Harachand, Contributing Editor 10.11.17

    • Supply Chain
      Marketing Code Round The Corner

      Marketing Code Round The Corner

      Proposal to limit giveaways; offenders face product ban
      S. Harachand, Contributing Editor 09.01.17

    Trending
    • Franco Negron Named CEO Of ApiJect Systems America
    • Carton Service Launches Custom Green Packaging Solutions
    • Valneva Focuses On Bilateral Discussions To Supply COVID-19 Vax
    • Thermo Fisher Acquires PPD For $17.4B
    • PRA Health Sciences Expands Pharmacovigilance Services
    Breaking News
    • Nanoform, Aprecia Partner to Advance 3DP Nanomedicines
    • KemPharm Receives $10M Milestone for FDA Approval of Azstarys
    • Valneva Focuses on Bilateral Discussions to Supply COVID-19 Vax
    • Syneos, Medable Partner for New Decentralized Capabilities
    • CSafe Global Appoints SVP of Technology and Innovation
    View Breaking News >
    CURRENT ISSUE

    April 2021

    • Small Innovators & Niche CROs
    • Focus on Science
    • Rapid and Data Rich Chromatographic Method Development
    • Preparing Your Post Pandemic Talent Strategy
    • How Modern Near-Infrared Came to Be
    • Securing Your API Supply Chain: Three Keys to Success
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    Ashland Supports the Nature Conservancy Forest Restoration Effort to Help Plant a Billion Trees
    Martin Bauer Announces Installation of Agile Filling System at Bethlehem, PA Facility
    PepsiCo and Ingredion Begin Pilot Partnership with Soil and Water Outcomes Fund
    Coatings World

    Latest Breaking News From Coatings World

    AkzoNobel Shareholders Approve Final Dividend at Annual General Meeting
    PPG Maintains EcoVadis Gold Rating
    Sustainable Plastics Will Make Up More Than 15% of Production by 2030
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Getinge Receives FDA Clearance for Multiple Products
    Study Shows Benefits of CCHD Screening Using Masimo SET Pulse Oximetry
    TEAM Technologies Acquires ViruDefense
    Contract Pharma

    Latest Breaking News From Contract Pharma

    RDIF, Minapharm to Make Over 40M Doses of the Sputnik V Vaccine in Egypt
    Bora Pharmaceuticals Completes Health Canada Inspection
    Nanoform, Aprecia Partner to Advance 3DP Nanomedicines
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Johnson & Johnson Reports Sales Increase in First Quarter of 2021
    THG Launches Recycling Program in UK
    Knoll Printing & Packaging Commits to a Healthy Ocean and Planet
    Happi

    Latest Breaking News From Happi

    L’Oréal Successfully Defends Itself In Patent Infringement Lawsuit
    TFF Names 2021 Honorees for Lifetime Achievement Perfumer and Hall of Fame
    Ashland Donates $20,000 To Help Plant Trees
    Ink World

    Latest Breaking News From Ink World

    Kumon North America Adds Speedmaster XL 106 from Heidelberg
    Acrylic Resins Market Worth $21.9 Billion by 2025: MarketsandMarkets
    SE-DA Invests in Kornit Presto S
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Ashland commits to forest restoration
    Epson upgrades SurePress demo facility
    Xeikon helps converters navigate toner and inkjet
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Savaré Strengthens Technical Support for the Americas
    FiberVisions, Avgol Partner with Polymateria
    High-Tech Conversions Launches Wipes Dispenser
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    FDA Clears Orthofix's 3D-Printed FORZA Titanium TLIF Spacer System
    Patients Conclude Clinical Visits in Knee Osteoarthritis Treatment Study
    SeaSpine Begins Limited Rollout of WaveForm TO 3D-Printed Interbodies
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Identiv, Ameta International Announce US, Canadian Distribution Partnership
    Adesis Achieves ISO 9001:2015 Certification
    Louis Widmer SA Complies with EU Anti-Counterfeiting Directive with Zebra Technologies’ Solution

    Copyright © 2021 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login