STATUS PRESENTATION ON BRCC PROJECT- GUJARAT 26 th June, 2012 CUTS INTERNATIONAL.
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Transcript of STATUS PRESENTATION ON BRCC PROJECT- GUJARAT 26 th June, 2012 CUTS INTERNATIONAL.
Status presentation on BRCC project- Gujarat
26th June, 2012
CUTS INTERNATIONAL
Presentation Points
About Raman Development Consultants (RDC)
Overview of Pharma sector in Gujarat
Team RDC- BRCC Project, Gujarat
Regulations & Process in Pharma sector
Sample framework of the research study
Approach and methodology
Interim findings of the study
Social, Environmental & Economical impact
RDC/ CUTS/ BRCC-Gujarat : 26-6-2012 2
About RDC• 22 year old organization registered under Company’s 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 India
• Focused 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 development
RDC/ CUTS/ BRCC-Gujarat : 26-6-2012 3
Overview of Pharma sector in Gujarat
India’s 2nd domestic Pharmaceutical unit estd. in 1907
42% of total Indian Pharmaceutical turnover with valued
4.3 billion US$ (21500 crore INR)
35 to 46 % share in total Pharma production in India
22 % of total export of the country
60000 Employment in the sector
6 Pharma sanctioned SEZs in the state
37 Pharma Academic Institutes having 2375 students
intake
RDC/ CUTS/ BRCC-Gujarat : 26-6-2012 4
Pharma Licenses/Units in Gujarat
Sr. No.
Types of Pharmaceutical
LicensedUnits
Production Units
1. Allopathic 4399 2439
2. Ayurvedic 668 661
3. Cosmetics 419 394
4. Homeopathic 16 16
Total 5502 3533
Source : FDCA - Gujarat
RDC/ CUTS/ BRCC-Gujarat : 26-6-2012 5
Team RDC- BRCC Project- Gujarat
No. RDC Team Designation
1. Rajendra Jani Advisor
2. Dr. Ketan Gandhi Team Leader
3. Dr. Hardik Solanki (MD- P&SM)
Project Coordinator
4. Dr. Praksh Shelat (MD- Pharm)
Team leader- Prescription analysis
5. Ajay Kanani Team member
6. Nazhat Khan Team member
7. Mehul Bhatia Team member
8. Five field researcher (MBA)
RDC/ CUTS/ BRCC-Gujarat : 26-6-2012 6
Regulations- Policy, Act, Norm, Authority
Pharmaceutical firms Private HospitalsRegulations & AuthorityLicense: FDCALaunch of new drug in India: DCGoIClinical trial of new drug: CDSCODrug price control: NPPA/ DPCODrug patent: Patent act
Regulations & AuthorityBombay nursing home act,1949Public trust act, 1950Company act,1956Hospital establishment act,1997
Marketing & distributionUCPMP: All India Pharmaceutical Manufacturing Association
Marketing & distributionMedical code of Ethics, 2002: MCI
EnvironmentGMP (Schedule M under Drug & Cosmetic act, 1940): FDCAPollution control & monitoring: GPCB
EnvironmentBio-Medical waste rule, 1998: GPCB
RDC/ CUTS/ BRCC-Gujarat : 26-6-2012 7
Process of Pharmaceutical sector
RDC/ CUTS/ BRCC-Gujarat : 26-6-2012 8
Continue in next slide
RDC/ CUTS/ BRCC-Gujarat : 26-6-2012 9
Approach and MethodologyRespondent Sample
sizeData collection tool Approach
Pharmaceutical firm- Manager/ Director/ CEO/ Accountant
100 Semi-structured questionnaire & collect best practices documents
Scheduled interview with prior consent on tele-talk/ eMail/ personal visit
Private Hospital- RMO/ Manager/ CEO/ Accountant
100 Semi-structured questionnaire & collect best practices documents
Scheduled interview with prior consent on tele-talk/ eMail/ personal visit
Medical Representative
40 Semi-structured questionnaire
Snow balling
Prescription Analysis
250 Prescription of OPD Patients
Xerox/ Digital photo with consent
RDC/ CUTS/ BRCC-Gujarat : 26-6-2012 10
Sample size for Pharma sector
Sr. No.
Place of study
Total Pharma. units
% of Total
Sample frame
1. Ahmedabad 511 46.4 45
2. Vadodara 332 30.1 20
3. Bharuch 121 11.0 15
4. Valsad 136 12.3 15
Total 1100 100 100
Source : Department of Pharmaceutical, GoI- 2010
RDC/ CUTS/ BRCC-Gujarat : 26-6-2012 11
Sample size for Private hospital
Sr. No.
Place of study
Total Private Hospital
% of Total
Sample frame
1. Ahmedabad 510 68.7 70
2. Vadodara 210 28.3 20
3. Bharuch 13 1.7 8
4. Valsad 9 1.2 2
Total 742 100 100
RDC/ CUTS/ BRCC-Gujarat : 26-6-2012 12
Status of field work
Sr. No.
Particulars Sample
SizeSample
achieved%
1.Pharmaceutical Firms
100 20 20 %
2. Private Hospitals 100 20 20 %
3.Medical Representatives
40 30 75 %
4.Prescription Collection
250 90 35 %
Status as on 18th June, 2012
RDC/ CUTS/ BRCC-Gujarat : 26-6-2012 13
Common observations
RDC/ CUTS/ BRCC-Gujarat : 26-6-2012 14
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 15
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 16
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 17
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 providers
Medical 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 fragmented
Rational use of drugs: there is sectorial gap between behavior of doctors and rational use of drugs
RDC/ CUTS/ BRCC-Gujarat : 26-6-2012 18
Social impact of violation of business responsibility
1. Social responsibilities are forgotten in Pharma firms as
the budget which would be for CSR is being spent for
Marketing
2. Business values are changing, cuts & commission is
well accepted trade practice
3. Self regulation is becoming second responsibility for the
sector
4. Doctor-patient relationship has lost its spirit, patient has
become a costumer for doctor.
RDC/ CUTS/ BRCC-Gujarat : 26-6-2012 19
Environmental impact of violation of business responsibility
1. Ignoring environmental importance in the name of
‘Pharma is a non polluting industry’
2. Non 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 20
Economic impact of violation of business responsibility
1. Violation of Business Responsibility is responsible for
inflation
2. Patients are paying high cost for medicines - Cost
effective health is now dream for poor
3. The prevailing marketing practices in the sector has lost
the competition benefits to consumers
4. Schemes 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 21
Open space
RDC/ CUTS/ BRCC-Gujarat : 26-6-2012 22
Thank you
RDC/ CUTS/ BRCC-Gujarat : 26-6-2012 23