Gunjan Organisation for Community Development

Goal: To stimulate better business to achieve sustainable development objectives in India Objectives:  Motivate firms to adopt ‘responsible’ corporate conduct.  Evolve a policy discourse between business community and policymakers to facilitate a policy environment that promotes business development in a sustainable manner.  Address the regulatory and operational constraints faced by businesses in India.

 Pharmaceutical Sector  Private Healthcare Sector

A. Environment RESEARCH PROBLEM:  What is the level of adverse environmental impact (especially in terms of pollution) from Pharmaceutical companies in the state?  Why have the available regulatory safeguards not worked in places where impacts were found to be significant?  What should be done to make these regulations work, so that there are no such adverse environmental impacts in future?

B. Marketing & Distribution RESEARCH PROBLEM:  What is the current status of incentives (cuts/commissions) provided by Pharmaceutical companies to Doctors and Chemists in the state?  What impact does it have on ‘Rational Use of Drugs’?  Why have these incentives continued to be provided by the companies, in spite of regulatory safeguards being in place?  What can be done to ensure that companies undertake their marketing activities keeping in view the principle of ‘Rational Use of Drugs ’

A. Environment RESEARCH PROBLEM:  What is the current status of bio-medical waste management practices being followed by hospitals and diagnostic service providers in the state? If the situation is problematic, why is it so – in spite of regulatory safeguards?  How can the situation be corrected?  What have been the steps taken up by the hospital associations/industry bodies to deal with the problem?  What are the good practices?  What are the drivers of good practices and how can these be scaled up or replicated?

B. Marketing & Distribution RESEARCH PROBLEM:  How prevalent is the act of ‘cuts/commissions to doctors (individuals/in hospitals)’ among diagnostic service providers in the state?  Why have these cuts/commissions to doctors existed in spite of regulatory safeguards in place?  How to combat the situation? What have been the efforts of hospital associations and other such collectives to deal with the problem? What are the regulatory barriers, if any?

Firms:  Pharmaceutical firms  Private health care hospitals Sectoral Associations:  Pharma association  Private hospital Association  MR association  Chemist Association  State level business chambers Regulators/Government Agencies:  Government healthcare machinery  State Pollution Control Board  Municipal corporations Other:  Consumers  Communities

 Fact finding visit was undertaken and on the basis of that institutions were identified to seek support in research activities.  Primary advocacy was done during the inception meeting in which representatives of stake holders were explained about the research goals, objectives and process.  Research study is being conducted in three phases: First phase: Questionnaires were filled with  Pharma firms  Private hospitals  prescription audit Second phase: Questionnaires were filled with  Pharma associations  Medical Rep associations  Chemist associations  BMW agency  Hospital associations Third phase:  State level government agencies like food and drug controller, SPCB, Environment, Health and family welfare

 All the production units are following GMP and they think that GMP ensures quality products that give goodwill to the firms and facilitate in getting Govt. Contracts.  All the large industries, 56% medium scale and 36% small scale industries have dedicated Environmental Management department.  Most of the small and medium scale industries (77%) don’t have CSR policies while around 70% large industries have CSR policy in place.  None of the firms is aware about the National Voluntary Guidelines on Social Environmental and Economic Responsibilities of Business (NVGs).

 Around 83% large and medium scale firms sponsors events (meeting, workshop, seminar, etc.) for the doctors.  Though asking whether doctors ask for gift most of the organisations said no but talking informally they said this is part of the business.  Asking about the Code of Medical Ethics Regulations, Medical Council of India formulated by Medical Council of India (MCI) around 66% are not aware about it.

 Hospital association has been initiated with the objective to create a forum for the members to discuss technical and administrative issues and to protect the rights riteria c and update the knowledge.  Currently Private Hospital Association of district Shimla (……) has a base of members and any set up run by the allopathic doctor can be the member of the association.

 Criteria to be a member of hospital association is not well defined and only criteria which has come up during discussions that any Hospital managed by allopathic doctors can be the member of the association.  No guidelines have been developed so far for the member hospitals to ensure responsible conduct from their part.  Clinical establishment act formulated by GoI and state government was discussed during the last meetings.

 The Clinical Establishment (Registration and Regulation) Act 2010, which will be implemented soon in the state, is likely to make life difficult for private practitioners here as the state has already given ascent for its implementation.  Private practitioners thinks that  Act had been framed keeping in mind corporate hospitals and health insurance schemes at the cost of poor patients and doctors doing private practice.  Act prescribed minimum standards for up to 10 bed clinics and hospitals. If the minimum standards for buildings, equipments and trained manpower as prescribed in the Act were implemented, the cost of running 10 bed hospitals would go up to about Rs 3.5 lakh per month.  The Act also prohibits examination, diagnosis and treatment of patients at unregistered places which will restrict free medical camps, eye camps or first aid posts, especially in rural areas.  Even home deliveries would be illegal.  Heavy penalties proposed in the Act. As it says registration of a medical establishment can be cancelled if convicted under the Act and there is no provision for revocation of cancellation.

 Patient’s satisfaction record is being maintained by the hospitals, but it was not very clear to the surveyors, how this was being done [‘Bell’ story]  Members of the association are not aware about the National Voluntary Guidelines on Social, Environment and Economic Responsibilities of Business  There is no interaction with any of the entities except IMA in last one year.  Doctors and nurses are working on hybrid model (Salary + per case payment)

 Doctors agree that the idea of standard treatment code will set the framework of treatment.  None is aware about Uniform code for pharmaceutical Marketing Practices(UCPMP)  No policy or guidelines have been developed for the members to ensure rational use of drugs.  No prescription audit is envisaged so far but preliminary discussion has been initiated for the same.

 Association has not taken action against any member so far.  No response was given to identify the factors which have contributed to the emergence of unethical behaviour in private health care.  Association never tried to bring together different stakeholders (chemist, pharma industries etc.) to discuss health care related issues like standard procedure protocols, rational use of drugs and incentive structures.

 Association is aware about BMW rules 1998 and think there is scope for improvement as it is not being managed professionally and need capacity building of BMW agencies.  Irregular services by the agency creates a lot of problems.  Encouraging Private agencies might resolve the challenges faced for the disposal of the bio- waste.

 Association is not aware on National Voluntary Guidelines on Social, Environmental and Economic Responsibilities of Business that have recently been issued by the Ministry of Corporate Affairs, Government of India.  Association interact with State Pollution Control board as and when any issue comes otherwise send reports timely to the board.

 Incentives by Pharma firms and Weak regulatory framework/institutions dealing with marketing and distribution factors have contributed to the present “incentive regime "in the pharmaceutical industry  No mechanisms within the association to monitor the marketing strategy has been developed so far.  Marketing spurious medicines, Neglecting the licensing requirements and Regulatory adherence are to be considered as major misconduct.

 Association is aware of Code of Medical Ethics Regulations, 2002 formulated by Medical Council of India (MCI) and is satisfied with its present form but not aware of the UCPMP (Uniform Code for Pharmaceutical Marketing Practices).  As far as level of awareness among the member firms about regulation and regulatory authorities related to pharmaceutical industry is concerned, only few of the bigger firms keep themselves aware of regulations pertaining to pharmaceutical industry.

 Sectoral associations in both pharma and health care is a weak link in the state.  There is lack of information about relevant regulation among the players of both the sectors.  State Pollution Control Board has played a proactive role in the state.