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CUTS INTERNATIONAL. Status presentation on BRCC project- Gujarat. 26 th June, 2012. Presentation P oints. About Raman Development Consultants (RDC) Overview of Pharma sector in Gujarat Team RDC- BRCC Project, Gujarat Regulations & Process in Pharma sector - PowerPoint PPT Presentation

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  • Status presentation on BRCC project- Gujarat26th June, 2012CUTS INTERNATIONAL

    RDC/ CUTS/ BRCC-Gujarat : 26-6-2012

  • Presentation PointsAbout Raman Development Consultants (RDC)Overview of Pharma sector in GujaratTeam RDC- BRCC Project, GujaratRegulations & Process in Pharma sectorSample framework of the research studyApproach and methodologyInterim findings of the studySocial, Environmental & Economical impact

    RDC/ CUTS/ BRCC-Gujarat : 26-6-2012*

    RDC/ CUTS/ BRCC-Gujarat : 26-6-2012

  • About RDC22 year old organization registered under Companys Act, 1956 Mission: Enhancing social and entrepreneurial capital of India and other developing countries. RDC has completed more than 800 projects and worked with all major donor agencies and government agencies in India across more than 25 states and also in 7 South Asian countries. Head Office at Ahmedabad, National Office at Delhi and representative offices in 9 states of IndiaFocused sectors: Public health, Infrastructure development and public-private partnership, Urban development, Governance & institutional development, Sustainable livelihood, Disaster mitigation.Services: Policy and strategy development, Behavioral/biological/ social Research, Monitoring & Evaluation, programme design and management, training and capacity building, system design,, MIS, communication/constituency building and developmentRDC/ CUTS/ BRCC-Gujarat : 26-6-2012*

    RDC/ CUTS/ BRCC-Gujarat : 26-6-2012

  • Overview of Pharma sector in GujaratIndias 2nd domestic Pharmaceutical unit estd. in 190742% of total Indian Pharmaceutical turnover with valued 4.3 billion US$ (21500 crore INR)35 to 46 % share in total Pharma production in India22 % of total export of the country60000 Employment in the sector6 Pharma sanctioned SEZs in the state37 Pharma Academic Institutes having 2375 students intake RDC/ CUTS/ BRCC-Gujarat : 26-6-2012*

    RDC/ CUTS/ BRCC-Gujarat : 26-6-2012

  • Pharma Licenses/Units in GujaratSource : FDCA - GujaratRDC/ CUTS/ BRCC-Gujarat : 26-6-2012*

    Sr. No.Types of PharmaceuticalLicensedUnitsProduction Units1.Allopathic439924392.Ayurvedic6686613.Cosmetics4193944.Homeopathic1616Total55023533

    RDC/ CUTS/ BRCC-Gujarat : 26-6-2012

  • Team RDC- BRCC Project- GujaratRDC/ CUTS/ BRCC-Gujarat : 26-6-2012*

    No.RDC TeamDesignation1.Rajendra JaniAdvisor2.Dr. Ketan GandhiTeam Leader3.Dr. Hardik Solanki (MD- P&SM)Project Coordinator4.Dr. Praksh Shelat (MD- Pharm)Team leader- Prescription analysis5.Ajay KananiTeam member6.Nazhat KhanTeam member7.Mehul BhatiaTeam member8.Five field researcher (MBA)

    RDC/ CUTS/ BRCC-Gujarat : 26-6-2012

  • Regulations- Policy, Act, Norm, AuthorityRDC/ CUTS/ BRCC-Gujarat : 26-6-2012*

    Pharmaceutical firmsPrivate HospitalsRegulations & AuthorityLicense: FDCALaunch of new drug in India: DCGoIClinical trial of new drug: CDSCODrug price control: NPPA/ DPCODrug patent: Patent actRegulations & AuthorityBombay nursing home act,1949Public trust act, 1950Company act,1956Hospital establishment act,1997Marketing & distributionUCPMP: All India Pharmaceutical Manufacturing AssociationMarketing & distributionMedical code of Ethics, 2002: MCIEnvironmentGMP (Schedule M under Drug & Cosmetic act, 1940): FDCAPollution control & monitoring: GPCBEnvironmentBio-Medical waste rule, 1998: GPCB

    RDC/ CUTS/ BRCC-Gujarat : 26-6-2012

  • Process of Pharmaceutical sectorRDC/ CUTS/ BRCC-Gujarat : 26-6-2012*Continue in next slide

    RDC/ CUTS/ BRCC-Gujarat : 26-6-2012

  • RDC/ CUTS/ BRCC-Gujarat : 26-6-2012*

    RDC/ CUTS/ BRCC-Gujarat : 26-6-2012

  • Approach and MethodologyRDC/ CUTS/ BRCC-Gujarat : 26-6-2012*

    RespondentSample sizeData collection toolApproachPharmaceutical firm- Manager/ Director/ CEO/ Accountant100Semi-structured questionnaire & collect best practices documentsScheduled interview with prior consent on tele-talk/ eMail/ personal visitPrivate Hospital- RMO/ Manager/ CEO/ Accountant100Semi-structured questionnaire & collect best practices documentsScheduled interview with prior consent on tele-talk/ eMail/ personal visitMedical Representative40Semi-structured questionnaireSnow ballingPrescription Analysis250Prescription of OPD PatientsXerox/ Digital photo with consent

    RDC/ CUTS/ BRCC-Gujarat : 26-6-2012

  • Sample size for Pharma sectorSource : Department of Pharmaceutical, GoI- 2010RDC/ CUTS/ BRCC-Gujarat : 26-6-2012*

    Sr. No.Place of studyTotal Pharma. units% of TotalSample frame1. Ahmedabad51146.4452. Vadodara33230.1203. Bharuch12111.0154. Valsad13612.315Total1100100100

    RDC/ CUTS/ BRCC-Gujarat : 26-6-2012

  • Sample size for Private hospitalRDC/ CUTS/ BRCC-Gujarat : 26-6-2012*

    Sr. No.Place of studyTotal Private Hospital% of TotalSample frame1. Ahmedabad51068.7702. Vadodara21028.3203. Bharuch131.784. Valsad91.22Total742100100

    RDC/ CUTS/ BRCC-Gujarat : 26-6-2012

  • Status of field workStatus as on 18th June, 2012RDC/ CUTS/ BRCC-Gujarat : 26-6-2012*

    Sr. No.Particulars Sample SizeSample achieved%1.Pharmaceutical Firms1002020 %2.Private Hospitals1002020 %3.Medical Representatives403075 %4.Prescription Collection2509035 %

    RDC/ CUTS/ BRCC-Gujarat : 26-6-2012

  • Common observationsRDC/ CUTS/ BRCC-Gujarat : 26-6-2012*

    RDC/ CUTS/ BRCC-Gujarat : 26-6-2012

  • Interim findings Good Manufacturing Process (GMP): Majority of firms are aware about the GMP but general consensus is low rate of compliance in the different segments.

    Safe environmental initiative: It is common belief that only bulk drug production units are responsible for environmental pollution. Setups for effluent treatment is not sufficient in the plant or not in working condition.

    Regulations: low proactivity for self-regulation, weak system of penalties leading to unethical practice.Firms are in favor of strict implementation of regulations with generation of transparency in the system. RDC/ CUTS/ BRCC-Gujarat : 26-6-2012*

    RDC/ CUTS/ BRCC-Gujarat : 26-6-2012

  • Interim findings (cont.)Cuts and commission: well accepted trade and practicesAccepted by Pharma firm as a marketing policy &Doctors want solicitationMRs are the instrument for cut practices

    Discussion about cut practices: no formal sector is willing to discuss about cuts and commission but talking is place in informal settings.

    RDC/ CUTS/ BRCC-Gujarat : 26-6-2012*

    RDC/ CUTS/ BRCC-Gujarat : 26-6-2012

  • Interim findings (cont.)Bio-medical waste rule, 1998: Practice under BMW management is not followed in true spirit.Inadequate training of hospital staff & improper handlingIrregular monitoring from GPCBNo interaction between GPCB and private hospitalNo regulation or formal body that monitor the practice of hygiene/ universal precautions maintenance by hospitals

    Expressed need for facilitation meetings & training: early dialogue from GPCB is welcomed with aim to improve access to health and safe practices. RDC/ CUTS/ BRCC-Gujarat : 26-6-2012*

    RDC/ CUTS/ BRCC-Gujarat : 26-6-2012

  • Interim findings (cont.)System of BMW service providers is not mature: irregular service, high chargeLack of healthy competitionMonopolistic natureThere is a need for separate study in service providersMedical code of Ethics,2002: no mechanism in place to ascertain whether in-house or empanelled doctors comply this regulation.There is continuous inherent distress between doctors and administration & other support staffSocial capital is fragmentedRational use of drugs: there is sectorial gap between behavior of doctors and rational use of drugsRDC/ CUTS/ BRCC-Gujarat : 26-6-2012*

    RDC/ CUTS/ BRCC-Gujarat : 26-6-2012

  • Social impact of violation of business responsibilitySocial responsibilities are forgotten in Pharma firms as the budget which would be for CSR is being spent for MarketingBusiness values are changing, cuts & commission is well accepted trade practiceSelf regulation is becoming second responsibility for the sectorDoctor-patient relationship has lost its spirit, patient has become a costumer for doctor.RDC/ CUTS/ BRCC-Gujarat : 26-6-2012*

    RDC/ CUTS/ BRCC-Gujarat : 26-6-2012

  • Environmental impact of violation of business responsibilityIgnoring environmental importance in the name of Pharma is a non polluting industryNon availability or inadequate waste treatment and disposal facility, discharge of polluted and hazardous Pharma waste in river or land by small and scattered units.

    RDC/ CUTS/ BRCC-Gujarat : 26-6-2012*

    RDC/ CUTS/ BRCC-Gujarat : 26-6-2012

  • Economic impact of violation of business responsibilityViolation of Business Responsibility is responsible for inflationPatients are paying high cost for medicines - Cost effective health is now dream for poorThe prevailing marketing practices in the sector has lost the competition benefits to consumersSchemes for C & FA, Gifts for stockiest, Discount for distributors, commissions for doctors and benefits to chemists, but not any/minimal concession for consumers

    RDC/ CUTS/ BRCC-Gujarat : 26-6-2012*

    RDC/ CUTS/ BRCC-Gujarat : 26-6-2012

  • Open spaceRDC/ CUTS/ BRCC-Gujarat : 26-6-2012*

    RDC/ CUTS/ BRCC-Gujarat : 26-6-2012

  • Thank youRDC/ CUTS/ BRCC-Gujarat : 26-6-2012*

    RDC/ CUTS/ BRCC-Gujarat : 26-6-2012

    *

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