Download - Status presentation on BRCC project- Gujarat

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


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


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


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)


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


Process of Pharmaceutical sector


Continue in next slide

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


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


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


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


Common observations


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.


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.


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.


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


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.


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.


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


Open space


Thank you


Download - Status presentation on BRCC project- Gujarat

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