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6th Annual Pharma Legal & Compliance Summit, 2017

Lex Witness is pleased to present the 6th Annual Edition of Pharma Legal & Compliance Summit, 2017.

Date: 6th October, 2017
Venue: Novotel Juhu Beach, Mumbai

The Indian Pharmaceutical Market - A Background:
The Indian pharmaceuticals market is the third largest in terms of volume and thirteenth largest in terms of value, as per a report by Equity Master. India is the largest provider of generic drugs globally with the Indian generics accounting for 20 per cent of global exports in terms of volume. Of late, consolidation has become an important characteristic of the Indian pharmaceutical market as the industry is highly fragmented.

The Indian Pharmaceutical Sector has been one of the most dynamic areas when it comes to the impact of any legal or regulatory amendments that happen at minutest of the levels. We have seen the era of mergers and acquisitions in the past and times when the collaborative competition has taken a front running mode. With the GST as a major impactful amendment for the sector, one is yet to see how much it influences the dynamism of the sector. It is therefore imperative to have a debate and powerful discussion over the legal and regulatory aspects and derive successful mantras to take home.

Keynote Session: The Big Indian Pharma Regulatory Rhymes

  • The FDC Sagas
    • The 344 FDC Ban - Lessons & Learnings - Managing FDC related litigation & court matters
    • India as an FDC Market - Getting Future Ready - Overlaps between FSSAI & CDSCO Reins - The Classic Case of ORS

  • Pricing of Drugs - Whose Cap is it Anyway?
    • The NPPA Whips on Drugs & Medical Devices - Impact on R & D and Manufacturing
    • The Medical Devices Rules, 2017 Industry Implications and Action Required

  • Creating a 100% Compliant Business Environ
    • USFCPA - Impact Assessment
    • Importance of e-Discovery as a Tool, Litigation Risks wrt e-Discovery Preparedness
    • Global Employment related Compliance Challenges - Are you prepared enough?
    • Whistle Blower Protection | Managing Forensic Investigations | Enterprise Risk Management | Audit Lifecycle Management
    • Good Manufacturing Practices - Quality Control vs. Business Margins
    • Alliance for Integrity - A self-regulatory drive

  • UCPMP & MCI Guidelines
    • Prescription Guidelines - Capping on Sampling of Drugs
    • Power to Pharmacists - Salts Vs. Drug Names - UCPMP Code - on its way to become Mandatory?

  • Competition Law
    • CCI Warning to Druggists & Chemists Associations
    • Interplay between Regulatory and Competition for pricing of products - Merger Notifications to CCI

  • Demystifying the Biosimilars
    • Defining Number of Trials in case of Biosimilars - Lack Legislative Clarity for Biosimilars
    • The 180-day post-licensure notice for Biosimilar Litigation - CDSCO revised guidelines on similar Biologics

  • Clinical Trials
    • Demand for Compensations for the Affected - Justified Enough?
    • Recent Regulatory Changes - A leg up to the Indian Clinical Trials Industry?

  • The Tough Indian Pharma Turf 2017
    • GST impact on domestic business and its normalisation - Update on USFDA issues plaguing several companies. Continued pricing erosion in US business with consolidation of buyers increased competition and growth in emerging markets after stabilisation of currencies

  • The Global Games
    • Combating USFDA Pressures
    • FDI Fevers in Brownfield Projects - Standard Operating Procedure (SOP) for processing the FDI proposals by DIPP
    • Setting up Globally Compatible Regulatory Standards - Challenges facing seamless exports of Indian Drugs
    • Facilitating Import of Foreign Drugs - Concept of GDUFA - Disallowance of Reverse Engineering

  • More - Nice to Know
    • Fair Remuneration for Compulsory Licensing - Amendments to the Legal Metrology (Packaged Commodities) Rules, 2011
    • Industry's concern over issue of growing expired drugs with no set rules - Indian Health Care Payment Rates - Assessment

Registration Fees:

No. of Delegates


Law Firms & Solution Providers

International Law Firms & Legal Service Providers

1 Delegates

INR 10,000

INR 12,000

US $350

2 Delegates

INR 18,000

INR 20,000

US $325 per delegate

3 Delegates

INR 24,000

INR 27,000

US $300 per delegate

4 or more

INR 7,500 each



Taxes Extra as Applicable
Please Note:

  • 15% discount for first 25 registrations
  • 10% discount for Lex Witness Subscribers, SILF and ICCA Members
  • No two discounts can be clubbed together

The registration fee includes Summit Kit, access to all speakers' presentations, certificate of attendance and a complimentary copy of Lex Witness Magazine.

Ms. Bhupinder Kaur
Phone: 011-66569793, +91-9654155065

Ms. Neelima Maheshwari
Phone: 011-66569793, +91-8800841600

Lex Witness - India's 1st Magazine on Legal & Corporate Affairs
Unit No 426, 2nd Floor,
MG Road, Ghitorni,
New Delhi - 110030
Phone: 011-66569793

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