Pharmaceuticals & Medical Devices

Snapshot of Pharmaceuticals & Medical Devices

Synopsis

Pharmaceuticals and Medical Devices

Pharmaceuticals
  • 3000 pharma companies (2019) with 10,500 manufacturing units
  • 500 different API’s manufactured in India
  • India exports vaccines to 150 countries
  • 60,000 generic brands across 60 therapeutic areas
  • The cost of manufacturing in India is approximately 33% lower than that of U.S.A
  • Indian Pharmaceutical industry can improve its global market share to 7% by 2030 from 3.6% by value and break into top 5 markets in the world from its current ranking of 11th
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Medical Devices
  • India is one of the top 20 global medical device markets and 4th largest market in Asia. The market size is expected to reach $50 billion by 2025.
  • The medical devices market consists of medical disposables and consumables, medical electronics, hospital equipment, surgical instruments, implants and Diagnostic Reagents.
  • Medical Devices include: cardiac stents, drug eluting stents, catheters, intra ocular lenses, bone cements, heart valves, scalp vein set, orthopedic implants and internal prosthetic replacements.
  • Around 80% of medical devices in India are imported.
  • Up to 100% FDI allowed in manufacturing of medical devices/equipment's.
  • Central government is planning to streamline procedure for obtaining environment clearance by API units.
  • Growth Driver
    • Skilled manpower having capacity to make devices under Make in India initiative.
    • Growing R&D opportunities with presence of prominent contract research organisations.
    • Ageing population and increasing life expectancy rate can induce home based healthcare services.
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  • No 1

    global provider or generic medicines

  • 2nd

    largest pharmaceutical and biotech workforce in the world

  • 2nd

    largest number of US FDA approved facilities

  • 3rd

    largest market in terms of volume

  • INR 400

    crore funds allocated (2020-2025) for promotion of Medical Device parks

Pharmaceuticals
  • Gujarat accounts to one third share in India's pharma market.
  • 130 USFDA approved units.
  • 628 WHO GMP manufacturing units.
  • Over 4.5 lakh product licenses issued.
  • Pharma industry registered an annual turnover of $7.6 billion in 2018-19.
  • Pharma companies have applied for registration of 180 new units to be set up in Gujarat in 2018.
  • $1.1 billion allocated to Health and Family Welfare department by government of Gujarat in Budget 2020-21.
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Medical devices
  • Prior to Medical Device Rules, Gujarat has registered 170 medical device units under the Central Licensing Approval Authority (CLAA) scheme.
  • Upcoming medical devices park in Rajkot, Gujarat will encourage production and reduce import dependency on the global market.
  • The proposed medical device park would be a geographic cluster of surgical & medical device manufacturing, research and R&D testing laboratories.
  • The cost of production comes down due to usage of common facilities in a park and local players become price competitive globally.
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Gujarat Government Initiatives
  • Revised the timeline for grant of manufacturing licenses to 60 days
  • Single window portal for issuance of manufacturing license and product license implemented by FDCA
  • 50% of fees/costs incurred for obtaining various Quality control approvals
  • Deendayal Pradhan Mantri Jan Aushadhi Kendra – 52 generic medicine stores launched, with 500+ more to be added
  • Scheme of assistance for Biotechnology (BT) industry under Gujarat State Biotechnology Policy (2016-21)
  • Promotion of generic drugs by giving them preference in government purchases
  • Support in obtaining approvals such as ERP, ISO certification and WHO GMP certification
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Growth Driver

  • Ease of Doing Business

    Introduced drug manufacturing license software , which enables the regulator to efficiently process the approval and renewal of applications received. Timelines for granting and renewal of manufacturing licenses to make the process quicker for drug manufacturers

  • Global Competitiveness

    Vast talent pool with presence of strong academic institutions provides an edge to Gujarat at global level. Cluster driven approach facilitates clinical research trials

  • Strong R&D support

    Key R&D segments include clinical research, genetic engineering, drug research and development

  • Policy Support

    Giving impetus to SME’s for installing ERP system, to obtain ISO and WHO GMP certification. Pharmaceuticals & Medical Devices identified as one of the thrust sectors in Gujarat Industrial Policy 2020

Quick Facts

2nd

highest no of export oriented companies in India (649) until 2018-19

4815

manufacturing licenses issued for allopathic, homeopathic, ayurvedic and cosmetic drugs

40%

of India’s contract research organizations are based in Gujarat

  • India’s first pharmacy college, L. M. Pharmacy College (1947) in Gujarat, offers diploma, degree and master’s programmes.

  • Major R&D centres in Gujarat

    • Torrent Research Centre
    • Zydus Research Centre
    • Sun Pharma Advanced Research Company Ltd (SPARC)
  • 40% of India’s Contract Research Organizations are based in Gujarat

Major Investors

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Pharmaceuticals & Medical Devices Hub

Advantages
  • World class infrastructure for medical device & pharma manufacturing
  • Promote Exports
  • Accelerate commercialization of new technologies
  • Conducive business environment
  • Enable surgical start up to collaborate with industries

Investment Opportunities

Medical Tourism World

Class treatment at affordable price

Pharmaceutical machinery

Strong engineering sector to produce pharma machinery

Contract Research and Manufacturing Services

Highest CRAMS in India

Success Stories

Source:India Surging ahead report, Exports Data by Directorate General of Foreign Trade(Statistics division) Annual report by Department of Pharmaceuticals 2019-20| Annual report by Department of Pharmaceuticals 2019-20 | Gujarat FDCA | Industries & Mines Department, Government of Gujarat | $ = US DollarRead More
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