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WELCOME

WELCOME. Promoting Responsible Business in Pharmaceuticals and Private Healthcare Sector STATE LEVEL STAKEHOLDER DIALOGUE. CUTS INTERNATIONAL – RAMAN DEVELOPMENT CONSULTANTS PVT. LTD. PRESENTATION ON KEY FINDINGS: BRCC PROJECT- GUJARAT. 11 th September, 2012. Presentation P oints.

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WELCOME

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  1. WELCOME Promoting Responsible Business in Pharmaceuticals and Private Healthcare Sector STATE LEVEL STAKEHOLDER DIALOGUE RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

  2. CUTS INTERNATIONAL – RAMAN DEVELOPMENT CONSULTANTS PVT. LTD. PRESENTATION ON KEY FINDINGS: BRCC PROJECT- GUJARAT 11th September, 2012

  3. Presentation Points • A brief introduction to the project • A brief introduction to the Approach & methodology • Key Stakeholders • Findings of Pharma Sector – Environment Related Inquiry • Findings of Pharma Sector – Marketing & Distribution Related Inquiry • Findings of Private health care sector – Environment Related Inquiry • Findings of Private health care Sector – Marketing & Distribution Related Inquiry RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

  4. BRCC Project Overview Business Regulation and Corporate Conduct - BRCC Implementers: • Consumer Unity & Trust Society (CUTS International) • Norwegian Institute of International Affairs (NUPI) • Raman Development Consultants Pvt. Ltd. (RDC) – Gujarat State Partner Duration:April 2011 to December 2012

  5. BRCC Project • Sectoral Focus : • Pharmaceutical Sector • Private Healthcare Sector • Geographical Focus : • Andhra Pradesh • Gujarat • Himachal Pradesh • West Bengal

  6. Policy & Regulatory Framework Business Development Optimal Practical Facilitating Responsible Ethical Society friendly Environment friendly Inclusive Sustainable

  7. Business Regulation & Corporate Conduct Mandatory Regulation Guiding Benchmarks Government Conduct Society Environment

  8. Objectives of the Project • Address the regulatory and operational constraints faced by businesses in India. • Motivate firms to adopt ‘Responsible Corporate Conduct’. • Evolve a policy discourse between business community and policymakers to facilitate a policy environment that promotes business development in a sustainable manner. Thrust:Encouraging responsible corporate conduct and building optimal regulatory framework through focused, informed and continuous discourse among government, business and stakeholders

  9. Key Areas of Inquiry • Current Situation and gaps • Why have the regulatory safeguards not effective in addressing the gaps? • What should be done to make the regulatory safe guards work? • What role is expected from the industry collectives? RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

  10. Critical Issues in Pharmaceutical Sector • Environment Problem : • Current level of adverse environmental Impact • Why have the regulatory safeguards not worked where there are significant impacts ? • What should be done to make these regulation work, so that such adverse impacts can be minimized? • Marketing & Distribution Problem : • Current status of incentives provided by companies to doctors and chemist • Its impact on ‘Rational Use of Drugs’ • Why have these incentives continued despite regulations? • What can be done to ensure companies undertake their marketing supporting rational use of drugs? • Presence of expired drugs in the market? Reasons of presence in spite of regulations • What should be done to make betterment in the drug supply chain?

  11. Critical Issues in Private Healthcare Sector • Environment Problem : • Current status of bio-medical waste management practices by hospitals and diagostic service providers • If situation is problematic, explore why it is so despite regulations • How the situation can be corrected • Steps taken by hospital associations/industry bodies • What are the good practices? Drivers of good practices • Marketing & Distribution Problem: • Prevalence of ‘cuts/commission to doctors by diagnostic service providers • Why ‘cut/commissions’ exist in spite of regulatory safeguards? • How the situation can be corrected • Steps taken by hospital associations/other associations • What are the regulatory barriers? • Extent to which Standard Treatment Protocol are followed • Reasons for deviation and other non compliances • How it can be ensured hospitals promote alignment with Standard Treatment Protocols • Adequate measures by HCPs to respect and address diagnosis & treatment related queries of clients? • Any other self regulatory mechanisms in place?

  12. Stakeholders for Pharma Sector • Government Department • Health and Family Welfare Department • Gujarat Pollution Control Board • Food and Drug Control Administration • Commissioner of Industries • Associations of Pharmaceutical Industry including Small, Medium and Large Scale Manufacturers (Formulation and Bulk drug Industries) & Other related stakeholders • IDMA • Indian Pharmaceutical Association • Pharma Export Council • Ahmedabad Chemist Association • Gujarat State Medical Representatives Association

  13. Stakeholders for Pharma Sector • Industrial Associations • Gujarat Chamber of Commerce and Industry • Associated Chambers of Commerce and Industry of India (ACCII) • FICCI • ASSOCHAM • Local GIDC Associations • District Level Industrial Associations • Academic Institutions • Individual Pharmaceutical Firms • Civil Society Organizations • Media • Community residing in proximity of Pharma Units

  14. Stakeholders for Private Healthcare Sector • Government Department • Health and Family Welfare Department • Gujarat Pollution Control Board • Medical Associations • Gujarat Medical Council • Indian Medical Association • Ahmedabad Medical Association • Private Hospitals • Biomedical waste management units • Academic Institutions • Civil Society Organization • Media • Consumers availing services of private hospitals

  15. Approach and Methodology RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

  16. Status of Field Work RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

  17. Findings of Pharma Sector – Environment Related Inquiry RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

  18. Findings of Phase I: Pharma Firms • Good Manufacturing Process (GMP) • 93.33 % firms are aware, 83.08 % respondents all elements of GMP as below: • Disposal of sewage & wastes in conformity with requirement of SPCB, • Standard operating procedures for sampling, Inspecting and testing of raw materials, • Verification of environmental procedures, • Filling products in powder form exercised with special care so as to avoid contamination of environment • Filter installed to retain dust and protect the local environment RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

  19. Difficulties and Expectations of Pharma firms to follow GMP RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

  20. Contribution of the Pharma industry to the environmental impacts • 33.33 firms discuss it in board room meeting • 86.48 % ensure compliance to env. Practice even in outsourcing through contract or encouragement RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

  21. Contribution of the Pharma industry to the environmental impacts • 82.86% respondents expects different regulatory laws and implementation according to nature of the unit and size of firms • 65.33 % firms does not have dedicated Environment Management Department • 98.48 % did not receive any assistance from government RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

  22. Social responsibility of Pharma firms • 81.43 % firms covered under survey does not have CSR policy • Out of the firms which reported doing some CSR activities, half of them reported doing it out of individual philanthropic sentiments • 91.78 % reported being Unaware of NVGs RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

  23. Pharma Associations.. • India Drug Manufacture’s Association (IDMA) • Large and medium firms highly adhere regulatory compliance of the different segments of the pharma sector in the state while small firms adhere at medium level. • Lack of awareness among firms/ association and financial constraints reported as among major difficulties to adhere regulatory requirements of GMP by firms • Government should consider providing financial support and should keep firms interest also in mind while formulating such regulations • IDMA does interact with government and other stakeholders on different issues of pharma RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

  24. Findings of Pharma Sector – Marketing & Distribution Related Inquiry RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

  25. Marketing & Distribution • Use of Medical Representatives was reported as a major strategy for M&D by 73.24 % firms • 68.42 firms reported awareness on Code of Medical Ethics Regulations, 2002 • 57.50% of firms reportedawareness on Uniform Code for Pharmaceutical Marketing Practices RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

  26. Marketing & Distribution • 41.18 % firms reported sponsoring events for doctors • 77.42 % of firms reported that Doctors ask MRs for gifts during their visits • 68.57% firms reported considering it as bad conduct to ask for gifts • 40% firms reported indulging into distribution of gifts/incentives in order to maximize profit and gain new markets, while 24.44 % think that it is ‘essential to survive’ RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

  27. Findings from MR study • 80% of MR reported that that meeting with the doctors is primarily a part of marketing strategy • Based on the responses, the value addition through the meetings by MRs can be classified as follows: • Information related to new drugs in market (60%) • Information on latest development in pharma industry (37.14%) • Building good relationship between Doctors and pharmaceutical firms (48.17%) RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

  28. Findings from MR study • 85.7% MRs reported being asked by Doctors for any kind of gifts/incentives during their visit • Reporting about the motive of asking for gifts/incentives, major reasons reported were: • To promote product (54.28%) • Giving time to MR to meet (28.51%). • 40% MRs reported that it is a regular practice to give gifts to doctors, while 60 % reported that gifts are distributed only on special occasions • 54.28 % MRs reportedawareness about UCPMP RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

  29. Findings from Pharma Association.. • India Drug Manufacture’s Association (IDMA) & & Associated Chambers of Commerce and Industry of India (ACCII) • Both association do not have specific mechanism to monitor marketing strategy of member firms. • Both are aware of Code of Medical Ethics Regulations, 2002 and also were in favor of it • Both association are unaware of Uniform Code for Pharmaceutical Marketing Practices. RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

  30. Findings from PharmaAssociation.. Ahmedabad Chemist Association • Incentive regime – reasons are commercial motivation of doctors and weak regulatory framework • Increasing number of companies and number of products is the main challenge faced by ACA • MR's working with different pharmaceutical firms often create pressure on chemists to increase sale of their products • Chemists often sell over the counter (OTC) drugs without prescription • Prescriptions often contain expensive medicines in spite of the availability of cheaper generic version • Aware about Medical Ethics Regulations, (Professional conduct, Etiquette and Ethics) 2002 formulated by Medical Council of India (MCI) and The Uniform Code of Pharmaceuticals Marketing Practices RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

  31. Findings from PharmaAssociation.. Medical Representative Association • Gifts are distributed on regular basis not on only some special occasion. Such gifts are booked by pharma firm under “Gratification” head • Aware about Medical Ethics Regulations & The Uniform Code of Pharmaceuticals Marketing Practices • Incentive regime” in pharma industry is contributed mainly by business strategy of pharma industry, commercial motivation of doctors, and weak regulatory framework • Fix remuneration would be more stable option for MRs • Regulatory set-up is not sufficient and optimal enough to ensure responsible and ethical corporate conduct on the part of Pharmaceutical Firms • GSMRA never had interaction with any other body RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

  32. Findings of Private Health care sector – Environment Related Inquiry RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

  33. Private Hospital study results • Coverage of private hospitals under study • 69.33 % of private hospitals reported following some guidelines/code of conduct for providing optimal healthcare service to the patients • 79.73% reported maintaining patient satisfaction record and want it be mandatory. Same % of respondents mentioned it to be mandatory. RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

  34. Private Hospital study results • In term of interactions with SPCB, 53.52% found it as “OK, the way it is”, while 32.39 felt there is a “need for improvement” • In terms of interactions with state health administration and 40.91 % find it as “OK, the way it is” while 33% reported that there is a “need for improvement” • 80.82% private hospitals reported that they are not part of any association of hospitals RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

  35. Private Hospital study results: BMW • 98.65 % private hospitals are aware of BMW rule 1998 • Various mode through which the Hospitals manage BMW were found reported as follows: • Through private BMW service provider – 78.21 % • Though common BMW treatment facility – 17.95 % • Stand alone facility in hospital- 1.28 % • 33.33% reported that there is a need for improvement in BMW rules RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

  36. Private Hospital study results: BMW • Almost all (>99%) the hospitals reported that their staff has undergone the training on BMW. About half of these (50%) reported undergoing process oriented training • 82.43% private hospitals reported having some specific mechanism in place to carry out quality assessment of BMW • 71.62% hospitals reported submitting periodic reports on BMW management, mainly to SPCB RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

  37. Private Hospital: BMW: Difficulties & Expectations RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

  38. Private Hospital study results • 65.75 % hospitals reported having a CSR policy in place • 89.04% private hospitals reported providing free of cost/concessional treatment to BPL or poor patients • 83.10 % hospitals reported no awareness about NVGs RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

  39. Findings from Private Health care Association • Associated Chambers of Commerce and Industry of India (ACCII): • Challenges relating to the Private Healthcare and Pharmaceutical Sectorwere reported as mainly - • Nexus between private health care and pharma sector, • Increasing cases related to unethical practices from the part of private health care system • Profit oriented approach of private health care sector • Lack of regulatory framework to ensure responsible conduct from private health care sector • Aware about NVG and BMW rules • For Long term solution of BMW issues Consistent and better informed government regulations, strict enforcement of regulations and self regulations are key strategies RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

  40. Findings from BMW Service Providers • Large hospitals perform “fair” for BMW management while medium and small hospitals perform “poor’ • Less willingness of hospitals to manage BMW • Waste received from hospitals are segregated properly • SPCB performance was described as ‘good’ RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

  41. Findings of Private Health Care Sector – Marketing & Distribution Related Inquiry RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

  42. Private Hospital study results: • 75. 68 % hospitals reported no awareness about UCPMP • 77.03 % reported being aware of Medical Ethics Regulations, 2002 • 45.71 % hospitals reported having mechanisms in place to ascertain their in-house and/or empanelled doctors follow such guidelines • 64.38 % hospitals are in favor of support mandatory prescription audit while 32.88 % are not in favor of it. • 83.78 % hospitals reported not having any specific instrument to guide doctors on medicine prescriptions and allowed doctors to prescribe medicine at their discretion RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

  43. Private Hospital study results: • 60.27 % private hospitals does not have any in-house guideline on Rational Use of Drugs in the hospitals • 49.32% hospitals favored mandatory STP for private hospitals while 50.68% did not favor it • 75% hospitals reported existence of a nexus between hospitals and pharma industry, necessary for two interdependent business entities. • On questioning hospitals about what they consider as determinants of unethical behavior in private healthcare in state, following major responses were reported: • 25.23 % - weak regulatory framework • 23.42 % - incentives by pharma firms • 22.52 % - commercial motivation of doctors RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

  44. Private Healthcare Association.. Ahmedabad Medical Association: • The AMA does neither have any state/locality-specific regulatory instruments (code/manual/guidelines etc.) put in place for the private healthcare providers/doctors to follow nor does they have any monitoring mechanisms to ascertain its compliance • Unaware of NVG and UCPMP, aware of Medical Ethics Regulations, 2002 • Lack of communication between government and private hospitals is the key issue faced by Private health sector • AMA does not developed any specific instrument (policy/code/manual/guideline etc.) for its member doctors on medicine prescriptions nor on rational use of drugs • STP should be mandatory for doctors/ private hospitals • State health/local health administration should do prescription audit, and private healthcare sector should disease registry RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

  45. Findings from Prescription Analysis • Coverage: 145 prescriptions from different hospitals in Ahmedabad • In Subscription part: • Gender and age of patient were mentioned in 13.8% prescriptions • Address of the patient was not mentioned in any the prescription • T for tablet and Inj for injection mentioned in all • Dose of drug was not completely written in 75.8% of prescription • Duration of treatment were not mentioned in 84.13% of prescription • Direction of use of drug was not properly mentioned in 77.24%case • In all 81.37% prescription were illegible RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

  46. Findings from Prescription Analysis • In 37.24 % prescriptions 1-2 drugs were prescribed • In 42.07 % prescriptions 3-4 drugs were prescribed • In 20.69 % prescriptions 5 or >5 drugs were prescribed RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

  47. Findings from Prescription Analysis RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

  48. EmergingMessages • Stricter monitoring and effective implementation of rules and regulation by regulators • More, systematic and mandatory efforts for Capacity building of all stakeholders and leadership by state • Systematic efforts to promote increased self regulation with associated sizeable incentives • Industry collectives to take up a more proactive role in effective implementation of regulations • Increased inter-sectoral dialogues for environmental issues due to pharma and private health care firms • Mechanism to curb unethical practices in the sector • Combination of negative and positive incentives for firms for compliances to rules and regulations RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

  49. Thank You RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

  50. Status of Field Work

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