State Level Findings - West Bengal

Report
Findings and Inferences from projectBRCC (West Bengal)
National Policy Forum
8th October 2012, New Delhi
Prithviraj Nath
CUTS Calcutta Resource Centre
[email protected]
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Overview of Pharmaceutical Sector
 The genesis of Indian pharmaceutical industry is always traced back to 1901 West
Bengal when scientist Acharya Prafulla Chandra Ray laid the foundation stones of
Bengal Chemical & PharmaceuticalWorks Ltd (BCPL).
 West Bengal saw the advent of many new pharmaceutical manufacturers during 1970s
with the advent of the Patents Act and also encouraging Industrial policy by Govt. Of
India.
 In 2005 product patent was first introduced and GMP was also introduced during this
time.
 West Bengal saw a gradual decline in numbers of manufacturing units from around
1100-1200 in early 90’s to 550 -600 in early 2000s to just around 166 at present.
(Source: Directorate of Drug Control,West Bengal)
 Most of the firms, around 120, are situated in and around Kolkata, around 40 firms are
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located in North & South 24 Parganas and the rest in other districts of West Bengal.
Overview of Healthcare Sector
 The growth in private healthcare started picking up since the 1990s and
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introduction of National Health Policy 2002(Govt. of India) and PPP policy
2006(Govt. of West Bengal) boosted it.
The total number of health units in the State is roughly around 2000 (leaving
out sub-centres) including both private and public units.
The number of private hospitals outnumber the public hospitals in the state by
more than triple, while the proportion of hospital beds show a absolute
reverse statistics with the government figures being more than double the
private counterparts.
The average number of private health care institutions (excluding physician’s
chambers) is 0.58 per 10,000 population in the municipal areas of West Bengal
Kolkata has emerged as the healthcare hub in eastern India with around 121
leading nursing homes and 63 large hospitals. There are roughly 188 diagnostic
centres in and around Kolkata.
Other districts with appreciable presence of private healthcare are North &
South 24 Parganas, Howrah, Hooghly, Bardhaman and East & West Midnapur.
Methodology for the survey
 Sample Composition:
 Pharmaceuticals - 50
 Bulk drug manufacturers - 5
 Formulations – 45
 Private Hospitals ( 2:2:1 ratio was attempted) - 50
 Big Hospitals (more than 100 beds) - 22
 Medium Hospitals (30 -100 beds) - 16
 Small Hospitals (15-30 beds) – 12
 Medical Representatives - 40
 Sectoral Associations – 6
 Govt. Authorities and regulatory bodies-3
 Local Community – 6
 Prescriptions Analysed-305
 Research Tools: (a) Questionnaire Survey (b)Focus Group Discussion
 Districts covered: Kolkata, North & South 24 Parganas,Nadia,
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Bardhaman,Jalpaiguri,Siliguri,Howrah.
Macro Level issues influencing Business
Responsibility in the 2 sectors in the State
 Weak Regulatory Regime, more importantly the implementation thereof, to
address the issue of unethical business practices in the face of intense
competition.
 Stringent norms under GMP difficult for SME Pharmaceutical units –
Counter Competitive.
 Lack of an appropriate HR policy for MRs.
 Lack of proactiveness and mandate among Business Associations to promote
responsible business behaviour by their members.
 Government’s role was opined to be inadequate by many of the sectoral
associations.
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Evidence suggesting violation of ‘Business
Responsibility’ in the pharmaceutical sector
 Majority of pharmaceutical surveyed units don’t have
dedicated environment management department.
 Pharmaceutical firms are mostly not willing to fix salaries of
Medical representatives
 Low awareness on UCPMP, NVGs, etc. among
pharmaceutical units
 20 out of 50 pharmaceutical companies surveyed sponsor events
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like meeting, workshop, seminar etc for doctors.
 Medical Representatives (MR) said that gifts are given to doctors
though they may not ask for it
 Though many of the MRs were not forthcoming, some did agree
that there is a nexus between doctors and pharmaceutical firms.
Communities’ Voice
 Out of the 6 communities surveyed only 2 complained about
environmental problems.
 They experience health related problems like headache,
vomiting and the bad smell causes discomfort.
 Water bodies in the locality are also polluted.
 Weak monitoring and implementation and violation of
guidelines by pharmaceutical firms lead to such problems.
 The community members fight these issues jointly through local
club.
 Opined that industry should be located in special industrial
zone.
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Evidence suggesting violation of ‘Business Responsibility’ in
the private healthcare sector
On Regulations:
 Around 75% of the hospitals follow code of Optimal Healthcare
 Other guidelines like those on prescriptions, RUD, etc. are not so
religiously followed.
 Low awareness on UCPMP, NVGs, etc. among Hospitals
 Bigger hospitals seem slightly better off than medium and small hospitals
in this respect
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Prescription Analysis
 Auditable Prescription: 305
 Total number of complete prescription: 14
 Prescription not auditable: 22 (8 were illegible)
 Number of Drugs per prescription: 2.9
 Rational Prescription: 1.96 %
 Irrational Prescription: 98.03 %
 Prescription containing antibiotic: 26.55 %
 Prescription containing Analgesics: 27.54 %
 Average Costs per prescription per day: INR 55.00
 Most irrationally prescribed drugs were:
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(a) Antibiotics (b)NSAIDs (Non-Steroidal Anti-Inflammatory Drugs)
(c) PPI (Proton pump inhibitors, gastric acid reduction) (d) H2 Blockers
(gastroesophageal reflux disease) (e) Vitamins (f) Antipsychotics
(g)Antihistaminics (allergies)
 No banned drugs were prescribed
Corporate Social Responsibility
 17% of the Pharma firms and 73% of the Hospitals have CSR
policy.
 The reasons for having CSR activities has mostly to do with
goodwill and image. Though hospitals seem to more inclined
towards CSR as integral part of their business than
Pharmaceuticals.
 Perception about business responsibility/CSR is mostly limited to
charitable initiatives like medical camps, free treatment for the poor,
etc.
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Recommendations
 Creating incentives for recognising and adopting business responsibility as
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part of the core business activity and taking penal actions for violation.
Pharmaceutical Industry being a very important part of healthcare system
needs proper surveillance of the Govt. specially the work conditions and
job security of the MRs as these are the determinants of unethical
practices.
Detailed audit of the CME expenses of the pharmaceutical firms and audit
of the income-expense of the service providers.
Multi-stakeholder dialogues on important issues and specific guidelines to
make policy making more participatory leading to higher ownership.
Govt. can weigh down the cost of environmental externalities caused by
smaller firms if the GMP norms are relaxed for them vis-à-vis the
increasing retail price of medicines produced by the bigger firms and
reconsider separate GMP norms for the smaller companies.
Capacity building of private sector/industry on voluntary guidelines –
charting a sector specific roadmap to this end
Recommendations
 Higher involvement of Civil Society Organisations towards monitoring
ethical & environmental concerns, spread awareness, demystifying
technical & jargonised guidelines, rules for common consumers, redressal
of grievances etc. to ensure higher transparency.
 Associations to more actively engage to help make the private sector more
responsible and make them aware about the rules and regulations-inclusion
of business responsibility clauses in the mandate of associations and
periodic assessment with support/facilitation from Ministry of Corporate
Affairs
 Compliance through better self-regulation, capacity building, better
communication amongst all stakeholders and greater transparency by
encouraging higher consumer understanding and participation.
 To realise that strong corporate governance and responsible business
conduct brings better transparency and better credit rating, goodwill etc.
which in turn help them gain financially as well.
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THANK YOU
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Awareness Level of Guidelines
100%
90%
80%
70%
21
27
31
60%
45
No
50%
Yes
40%
30%
20%
19
21
9
10%
5
0%
Med Ethics MCI
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NVG
UCPMP
CSR
Awareness among Pharma Companies on Selected Regulations and Guidelines
• Do you have any dedicated Environmental management department in your
firm?
• Do you have any infrastructure in place to reduce negative environmental
effects?
• Do you think that implementation of regulatory laws should be done differently
depending on the size and nature of the unit?
Environment Management
84%
Have dedicated Env. Mgmt. Dept.
Have Infra to Reduce Pollution
Rules must vary on Size & Nature
88%
55%
25%
10%
8%
Yes
15
20%
No
2%
2%
No Response
Perception of Pharmaceutical companies about implication of salary structure on
Ethical behaviour and areas of ethical concern
Salary of MRs vs Ethical Concern vs Initiatives
Yes
51%
37%
37%
No
No Response
45%
39%
33% 33% 33%
18%
12%
63%
55%
6%
Willing to Fix salary Target Based Salary
creates ethical
concern
Incentive vs Ethics
33%
4%
Discussed in Assoc.
Discuss with Govt.
Areas of Ethical Concern
Yes
39%
No
No Response
51%
45%
41%
31%
27%
16%
16
Sponsor Events?
Ask for Gifts?
24%
25%
Problems by Chemists/Stockists
Problem Areas as opined by Medical Representatives
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
14
11
4
26
29
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Sponsor events
NEXUS-Doctors+Pharma
Co
25
14
Doctors ask for Gift
Gifts given to doctors
No/Others
17
Yes
18
Code Of Optimal Healthcare - Private Hospitals
Don’t Follow
24%
Follow
76%
Guidelines & Quality Checking
100%
80%
60%
40%
20%
0%
10
12
13
15
8
No Comments
23
15
20
No
RUD Guidelines
Guidelines on
prescriptions
Mechanism to ascertain
compliance
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Compliance with selected Guidelines by Private Hospitals
Yes
Awareness on Guidelines
100%
90%
7
80%
18
20
70%
60%
Unaware
50%
40%
Aware
39
30%
21
22
UCPMP
NVG
20%
10%
0%
Code- Med. Ethics ,MCI
Awareness among Private Hospitals on Selected Regulations and Guidelines
20
Awareness on various Guidelines and Regulation
among different Category of Private Hospitals
94%
BIG
MEDIUM
SMALL
76%
53%
70%
53% 52%
30%
14%
Have inhouse guidelines
prescription
21
20%
Awareness on NVG
Awareness on guidelines
issued by MCI
Pharmaceutical- Have CSR policy?
Hospitals- Have CSR policy?
17%
27%
Yes
No
73%
Yes
No
83%
Hospitals of different size
BIG
MEDIUM
SMALL
100%
52%
Have CSR Policy
22
50%
Reasons for doing CSR- Pharmaceuticals
32%
32%
26%
11%
Felt by the proprietor
Govt regulations
Helps maintaining good Earn goodwill of the
image
society
Reasons for Doing CSR- Hospitals
65%
47%
29%
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BIG
43% 40%
20%
Increases Goodwill
MEDIUM
30%
24%
10%
We understand our CSR is an integral part
Social Responsibility
of business
SMALL
18%
10%
Others
0%

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