BRCC Fact Finding Mission in West Bengal

BRCC Fact Finding Mission in West Bengal Purpose: To gather the relevant information pertaining to some of the critical elements of this project, the fact finding visits are planned in each of the four project states 1 by CUTS and the respective state partner organisations. This involves meetings with the key stakeholders from the state which including government, regulatory authorities, academia, associations and other civil society organisations. The mission to West Bengal was held from 31 st to 5 th February 2012. Project team comprising of RSG, SCV and VB visited the state along with PN representing Calcutta Resource Centre (CRC) who are local partner organisation. Following is the brief account of the discussions held: Date: 01.02.12 Sulagna Datta, Community Development Medicinal Unit (CDMU) CDMU is principally working towards better distribution and access of medicines by poor and marginalised people They run a distribution network through NGOs/ CSOs in the districts and also test for spurious drugs if necessary She pointed out that the West Bengal Medical Sales Representatives Union (WBMSRU) will be helpful with regards to understanding the incentive structures of the distribution system and also the nexus that operate between different stakeholders She pointed out that counterfeit drugs are in the market. Many a time old/expired drugs are re-marketed by re-packaging or changing t he expiry stamp, which is never a printed one but just a stamp that can be removed She informed that a standard treatment guideline has been published by the department of Health & Family Welfare, GoWB but it is not binding She also said that she will talk to former Director of dug control Dr. Sajal Roy Choudhury and introduce the project idea to him, following which CUTS can approach him for further inputs Debal Ray, Chief Environment Officer, Department of Environment, GoWB Health care sector is a priority for the government from the environment impact point of view due to the recent spurt in the number of facilities that have come up in the state, especially around the Kolkata city. He shared instances when non-compliant (waste disposal, etc.) hospitals were penalised in the past by the Pollution Control Board. 1 GUJARAT, HIMACHAL PRADESH, ANDHRA PRADESH and WEST BENGAL have emerged as the four states. 1

This check carried out jointly by the WBPCB & Dept. of Health & Family Welfare, was for both private and government owned hospitals and they were equally taken to task where instances of lapses were observed. Presidency General (PG) Hospital was one of the prominent government owned hospitals that was penalised during this drive Pharma sector however is not so high on the priority as compared to the health care sector owing its low environment impact potential in West Bengal, he said. There aren t too many big manufacturing facilities in west Bengal he claimed. He also said that there haven t been many guidelines regarding the pharma sector in terms of environment impact as far as WB is concerned. There are guidelines for sponge iron and metallurgical facilities. EIAs are being done for new hospital projects. He particularly mentioned a TATA project- Cancer Hospital coming up in Rajarhat that claims to be putting in place environmental impact control facilities & practices that are unheard of in the state and that are 8 times as stringent of the usual practice in the state. He said that if CUTS wanted list of penalised units or such data, the best agency to contact will be West Bengal Pollution Control Board (WBPCB) since they are the principal implementing agencies for most of the rules & regulations with respect to environment impact management. When asked whether there has been any civil society/mass protest against adverse environmental impact of certain manufacturing/business practices, he cited that there was a case in Bankura where people have stopped industries from coming up/expanding due to ground water availability concerns. He also said that the department has received many complaints, concerns and voices against radiation hazards from cell phone towers. So much so that a new regulation is under process to look into this. The draft regulations almost ready. Sharmistha Kundu, West Bengal Pollution Control Board (WBPCB) WBPCB is a statutory authority entrusted to implement environmental laws and rules with in the state of West Bengal. The authority among others looks into prevention and control of pollution in water, air, noise, manufacture and storage of hazardous chemicals, bio-medical wastes etc, and other industrial pollution control measures On asking some specific issues related to the research questions, she responded that Pharmaceutical Industry is not very dominant in West Bengal. Many of the manufacturing unit produces formulations and not bulk drugs and therefore adverse environmental impacts are not a big concern to them. She also shared a list of pharma units in the state She mentioned that Bio Medical Waste Management is being dealt satisfactorily at the state level and is being handled by the private sector players who are in contract with the hospitals. However, their department keep on visiting randomly to various clinical 2

establishments in the state and issue warning to those who are not undertaking it properly. If the establishment does not improve its practices even after the official warnings the board serve them legal notices to comply with the minimum standards. Around 10-12 notices were issued in the year 2011 On asking some specific issue of irresponsible conduct in health and pharma sector which has a bearing on environment, she highlighted that the issue of timely and efficient disposal of expired medicines is an environmental concern which is getting huge with the growing number of pharma players in the market. In our country, medicines worth millions of rupees well past their expiry dates remain in the distribution system as the players in the supply chain do not have the knowledge or the resources to dispose them off. Date: 02.0212 Dipankar Bhattacharya, Confederation of Indian Industry, West Bengal Chapter CII has a eastern regional health sub-committee where there are around 35 members out of which 17-18 are the CEOs and owners of the major hospitals in Kolkata There is an association of the hospital owners called Association of Hospitals of Eastern India (AHEI). He gave some contact coordinates for the association (Rahul: 9831872039, coordinator) and asked us to get in touch with the President of AHEI, P. Tondon. He also mentioned HOSMAC but could not give coordinates for it. He mentioned that CII helps in bringing the industry and government on a platform and also encourages take up of good practices. However the more important aspect of the health sub-committee is to promote business for the members He mentioned hospitals like Apollo, Peerless, Medica Superspeciality, R. N. Tagore as those that are ahead of the rest in good practices. He claimed that these hospitals are having certain self regulations in place. He also added that AMRI was also counted amongst the forerunners, but the recent fire mishap has tarnished its image and there is a lot of skepticism among hospital groups/owners regarding the regulatory environment. They also may not be high on transparency under such circumstances, he opined. He however clearly mentioned that he/cii will not be able to extend much support to the study unless there are directions from their Delhi headquarters/ National Health Sub-committee. He suggested that CUTS approach the Delhi office with the requirements and also mention the takeaways for CII in the process to facilitate matters. As suggested by Sameer, he said that CII may arrange some event with the hospital owners to help in the study once there is approval from the Delhi office. Sameer got in touch with AHEI and wrote a mail to the secretary who said that she will get back later 3

Dr. Krishnangshu Roy, Director, Calcutta School of Tropical Medicine He mentioned the regulatory areas for healthcare and pharmaceuticals overlap in many places Ethical marketing of drugs, WHO lays down the code of conduct for pharma marketing. The Department of Health & Family Welfare has come out with a Standard Treatment Guideline last year. He said that the pharma companies have built in mechanisms in their marketing practices to influence doctors. Recently there is a trend of influencing the quacks in the vast rural regions of the state to induce prescribing of their drugs. In the name of organising educational seminars for these people they promote their own drugs. The quacks are also more easily influenced than doctors. He also mentioned that in addition to the already well known nexus between chemist shops-doctors, pathological labs-doctors, nexus also exist between doctors and hospitals wherein the more the number of patients the doctor gets admitted to the inpatient departments from the OPD, higher is the cut money he gets. This is more prevalent with senior doctors since patients don t question their suggestions of getting admitted. Junior doctors also get influenced through such malpractices of their seniors. He said it ay be a good idea to have medical/practical ethics as part of the MBBS curriculum He mentioned flouting of norms is much more prevalent in the districts when compared to Kolkata where the media glare and higher awareness levels of consumers. He pointed out that the number of drug inspectors under the Drug Control department also needs to be looked into. The bane of self medication is also something that helps in promoting unethical and problematic practices in pharma trade. The team flagged that CUTS is contemplating having a reference group for the project and requested him to be part of the same. Shashangka Dev, DISHA, CSO working on bio-medical and other toxic waste management issues. Very few big hospitals (100 beds or more)( in the districts. They mostly are in and around Kolkata. There is no official classification of the sizes (big/medium/small) of hospitals by the government/regulator Usually around 200-250 gms of bio-medical waste is generated every day per bed. Segregation of waste is an issues and it is not being done properly, resulting in some hazardous elements ending up in municipal dump sites. 4

A major portion go the waste is being salvaged by unauthorised agents mostly engaged in spurious recycling trade Hospitals are many a time declaring lesser number of beds to the Central Treatment Facility (operated mostly by Ramky in West Bengal) so that the charges for collection and destroying of waste are less. Almost 70% of the bug/major hospitals are tagged with Ramky central treatment facility for bio-medical waste. Small hospitals/nursing homes are flouting norms, though missionary or NGO run hospitals are trying to live up to the standards. The gaps in conformation to rules are many a time due to lack of knowledge/awareness amongst this particular section of hospitals. The accreditation bodies/licensing authorities are not giving priority to bio-waste management status or existing facilities of an institution while providing accreditation/license. However the health department of GoWB took early initiative to regulate the sphere of bio-medical waste management He mentioned CMRI (Alipore) as one of the errant institutions in terms of flouting of regulations and mentioned it was taken to task by WBPCB Forensic and pathological labs are violating norms to a very large extent and more so in the districts. On the issues of self regulation and good practices, he mentioned Institute of Child Health, (Park Circus) and Bellevue Clinic as good examples. He said that good institutions organise capacity building events and refresher trainings for their staff to promote good practices and stay ahead of the competition. He mentioned a few organisations like Sheesh (S 24 Pgs), Welfare Associations in Jalpaiguri & Siliguri, as CSOs that may be tapped during the survey He gave contact coordinates of a few media people who have been working on related issues. He mentioned one instance of adverse environmental impact from pharma manufacturers in Dankuni, but couldn t provide any details He promised to provide more coordinates in future and was requested to be part of the RG 03.02.12 Tulsi Chakraborty, President, Indian Pharmaceutical Association (IPA) West Bengal Chapter Indian regulators have lifted regulations in toto from the US/UK without giving due consideration to the vast difference that exist between the political economy and other circumstances of these nations and India This is creating non-tariff barriers for small manufacturers 5

Regulators are unable to defend the practice of having two different standards for drug manufacturers and hence there is increasing pressure for conforming to world standards for all manufacturers, a feat he claimed to be impossible for small & medium players. He said that big manufacturers like Ranbaxy are running entirely separate facilities when manufacturing for the world market and outsourcing manufacture of drugs for the domestic market to subsidiaries/small & medium players He was critical of the efforts from the government to promote collective facilities for small & medium players saying the infrastructure provided is hardly sufficient and since the standards worldwide change very frequently it is only a very high-cost futuristic facility that can ensure a reasonably long run for the manufacturers. To put in place such facilities is very much out of bounds for small players. He mentioned that several drug manufacturing facilities are on offer for sale without any takers, mostly due to this fast obsolesce rate of manufacturing infrastructure. He mentioned that a majority of the medium & small players are dumping their effluent into common/municipal drains which is a gross violation of regulations. In absence of a proper monitoring regime and also the prohibitive cost of putting in place appropriate facilities these players are not thinking much ion the lines of conforming. He mentioned Dabur India s drug manufacturing facility as one of the good facilities that can be explored to identify good practices. He also mentioned that to conform to world standards, drugs need to have impurities in certain specific percentages. When the manufacturers are asking the authority to supply such trace impurities they are not able to provide them One more issue that makes Indian drug manufacturing industry lag behind is that the proportion of resources apportioned to R&D. he said that while the US/UK counterparts are having a 15-16% share of the outlay, in India it is as low as 2%. He mentioned that it may be good to talk to IDMA Vice President Dipnath Roychoudhury and shared his contacts. He was requested to be a part of the RG. Pradyut Kumar Basu, Deputy Director, State Drug Control Department IDMA guidelines are followed by most pharma manufacturers There is a gap in the regulation in terms of no specifications regarding the time line and process for transport of drugs. The regulations do not mention how the drug is to transported and how long it can be stocked at the distribution end/godown. This is causing unethical practices to creep in 6

and since the drugs are at times stored with other products, it also run the risk of contamination He shared that the Expiry Date logic is not full proof and a structured rationale as to why a certain expiry is 5/3/4 years is questionable. He further added that the phrama manufacturers also promote short expiry limits so as to be able to push new batches. In this direction he m\cited a SLEP study done in the US which found that 95% of the drugs stored for 15 years in an army storage facility were fully functional. He said that the Drug Control department has authority to issue certificates to chemists and inspect the drugs being sold in the market which it does through its drug inspectors. Theer have been instances when licenses were confiscated/ suspended on investigation after complaints form different entities. He said a list of such complaints received is available with the Drug Control Office and may be accesses with permission from the Director. He however suggested that CUTS should approach the Principal Secretary, Department of Heath & Family Welfare for a blanket permission in the form of an order for all relevant departments to extend cooperation to CUTS 7