CUTS INTERNATIONAL
STATUS PRESENTATION ON
BRCC PROJECT- GUJARAT
26th June, 2012
RDC/ CUTS/ BRCC-Gujarat : 26-6-2012
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
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RDC/ CUTS/ BRCC-Gujarat : 26-6-2012
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About RDC
• 22 year old organization registered under Company’s Act, 1956
• Mission: Enhancing social and entrepreneurial capital of India and
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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
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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
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RDC/ CUTS/ BRCC-Gujarat : 26-6-2012
Pharma Licenses/Units in Gujarat
Sr.
No.
Types of
Pharmaceutical
Licensed
Units
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
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Team RDC- BRCC Project- Gujarat
No.
RDC Team
Designation
1.
Rajendra Jani
Advisor
2.
Dr. Ketan Gandhi
Team Leader
3.
Dr. Hardik Solanki
Project Coordinator
(MD- P&SM)
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
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Regulations- Policy, Act, Norm, Authority
Pharmaceutical firms
Private Hospitals
Regulations & Authority
License: FDCA
Launch of new drug in India: DCGoI
Clinical trial of new drug: CDSCO
Drug price control: NPPA/ DPCO
Drug patent: Patent act
Regulations & Authority
Bombay nursing home act,1949
Public trust act, 1950
Company act,1956
Hospital establishment act,1997
Marketing & distribution
UCPMP: All India Pharmaceutical
Manufacturing Association
Marketing & distribution
Medical code of Ethics, 2002: MCI
Environment
GMP (Schedule M under Drug &
Cosmetic act, 1940): FDCA
Pollution control & monitoring: GPCB
Environment
Bio-Medical waste rule, 1998:
GPCB
RDC/ CUTS/ BRCC-Gujarat : 26-6-2012
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Process of Pharmaceutical sector
Continue in next slide
RDC/ CUTS/ BRCC-Gujarat : 26-6-2012
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RDC/ CUTS/ BRCC-Gujarat : 26-6-2012
Approach and Methodology
Respondent
Sample
size
Data 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 HospitalRMO/ 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
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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
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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
742
100
100
Total
RDC/ CUTS/ BRCC-Gujarat : 26-6-2012
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Status of field work
Sr.
No.
Sample
Size
Sample
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 %
Particulars
Status as on 18th June, 2012
RDC/ CUTS/ BRCC-Gujarat : 26-6-2012
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Common observations
Low proactivity for self regulation
Weak system of penalties for contempt of
regulation
No mechanism of incentives for next/good
practices
Cuts & commission is well accepted trade
practice
RDC/ CUTS/ BRCC-Gujarat : 26-6-2012
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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
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Interim findings (cont.)
Cuts and commission: well accepted trade and
practices
Accepted by Pharma firm as a marketing policy &
Doctors want solicitation
MRs 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
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Interim findings (cont.)
Bio-medical waste rule, 1998: Practice under BMW
management is not followed in true spirit.
Inadequate training of hospital staff & improper handling
Irregular monitoring from GPCB
No interaction between GPCB and private hospital
No 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
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Interim findings (cont.)
System of BMW service providers is not mature:
irregular service, high charge
Lack of healthy competition
Monopolistic nature
There 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 staff
Social 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
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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
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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
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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
Open space
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RDC/ CUTS/ BRCC-Gujarat : 26-6-2012
Thank you
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