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THE NATIONAL VOLUNTARY GUIDELINES (NVGS)

THE NATIONAL VOLUNTARY GUIDELINES (NVGS). IICA-GIZ Business Responsibility Initiative Sector Guidelines for the Pharmaceutical Sector 30 October 2014. Pharma sector trends| Reputational risks.

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THE NATIONAL VOLUNTARY GUIDELINES (NVGS)

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  1. THE NATIONAL VOLUNTARY GUIDELINES (NVGS) IICA-GIZ Business Responsibility Initiative Sector Guidelines for the Pharmaceutical Sector 30 October 2014

  2. Pharma sector trends| Reputational risks . At present the Indian pharmaceutical industry has about 300 large units, 1700 medium-size units and about 8000 small-scale units throughout the country. India currently exports drug intermediates, Active Pharmaceutical Ingredients (APIs), Finished Dosage Formulations (FDFs), Bio-Pharmaceuticals, Clinical Services to various parts of the world. The export industry stands at USD 9.1 billion. The domestic Pharma Industry has recently achieved some historic milestones through a leadership position and global presence as a world class cost effective generic drugs' manufacturer of AIDS medicines India’s position as a strong player in the global pharmaceutical market had been under attack for some time with the notion that Indian drug makers also produce and export spurious drugs. The Centre has decided to conduct an all India survey on the extent of availability of spurious and not-of-standard quality drugs in the country. It is expected to be a broad-based survey covering 42,000 samples belonging to 15 therapeutic groups.

  3. Pharma sector trends| Policy Highly regulated sector: various policies, laws, institutions Policy/law set at national level and implemented by state Detailed yet complicated regulatory framework (N & S legislation/institutions) Stringent GMP enforcement (Schedule M, D&C Act 1940) Strict government price regulation (DPCO, 2013) The implementation of the TRIPS Agreement will give rise to factors that can put access to medicines out of reach for millions of people in the developing world. To truly improve access to medicines in India, we will need to continue to work together to advance sustainable policy solutions to healthcare financing, infrastructure, and human resources challenges, among others, rather than focus on compulsory licences or other ways of undermining patent protection of innovative medicines.

  4. Trends in BR reporting in the sector In a study conducted by PWC and commissioned by the IICA-GIZ Business Responsibility Initiative, the first set of BRRs of the top 100 listed companies were analysed, out of which 5 are pharmaceutical companies.

  5. background An introduction to the NVGs National Voluntary Guidelines – the relevance to your sector

  6. Society Environment Economy Definitional Clarity An all-encompassing framework

  7. NVGs: BACKGROUND

  8. Essence of the NVGs Competitiveness-responsibility-development go together

  9. Consultations and Consensus Process as important as content

  10. NVGs: Structure • Glossary of terms used

  11. PRINCIPLES NVGs: The nine principles Indivisibility of principles key to linking competitiveness, responsibility and development impact.

  12. Implementation guidance Four pillars of Implementation Components of Implementation Guidance

  13. Implementation guidance Steps

  14. Disclosure Framework

  15. Objective of BRR

  16. Report and Reporting Reporting Report

  17. Sector Guidelines

  18. Rationale for Sector Guidelines

  19. Key Components of proposed structure of the guidelines

  20. Thank you Neha Kumar, GIZ

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