National consultation on consumer drug information in India: A situational analysis

A national consultation on ‘Consumer Drug Information in India: A Situational Analysis’ was organised by the Centre for Trade and Development (Centad) in collaboration with the Office of World Health Organisation (WHO) Representative to India in New Delhi on March 29, 2007.

The objectives of the consultation were:

• To share and discuss the findings of a background study carried out by Centad examining the current situation of consumer drug information in India.
• To critically examine the study and seek inputs for improvements.
• To hold an informed discussion on the current situation of consumer drug information in India.
• To deliberate on recommendations to address the problems identified on issues of consumer drug information.
• To formulate an action plan to implement the recommendations.
• To bring together various stakeholders involved with the subject, including medical professionals, pharmaceutical associations, pharmaceutical companies, civil society organisations working on health and consumer issues, WHO experts, and concerned ministries of the Government of India.

As a background to the consultation, Centad undertook a study analysing the current scenario regarding consumer drug information in India, and its nature and reach. This involved a survey on information being provided to consumers, channels through which this is being done and the actors responsible for providing the information.

The consultation was attended by various actors in the drugs and pharmaceuticals sectors including academicians, Government of India policymakers, medical representatives and practitioners, and civil society organisations.

The consultation featured three sessions:

• Session I: Presentation of approach paper.
• Session II: Experience-sharing by representatives from the government, civil society and pharmacy sectors.
• Session III: Panel discussion and open discussions on experiences, recommendations and formulating a plan of action.

Click here to view the consultation agenda. Click here to view the list of participants.

Session I: Presentation of approach paper

This session began after a welcome speech to participants and a round of introductions. The context and background of the study on consumer drug information was presented.

Centad then presented the paper ‘Consumer Drug Information: A Situational Analysis’. After the presentation, critical comments on the study were made by the panel members. This was followed by discussions and comments on the paper by the rest of the participants. Details of the study paper and comments and suggestions are described below.

The presentation discussed the following subjects:

• Need for and nature of consumer drug information.
• Law and policy regime.
• Survey of information gathered during the course of the study.
• Conclusions and recommendations.

The importance of providing information on drugs to consumers was discussed, and what the information should consist of. The essentials of information that must be provided to consumers were listed, as well as other types of information that may prove useful to consumers. The parameters of the manner in which this information should be communicated were also discussed. Click here to view detailed conclusions and recommendations made at the consultation.

At the outset, the importance of providing drug information to consumers was established -- to enable consumers to become more involved in informed decision-making and safeguard their right to health and right to information.

The essential components of drug information are:

• Whether or not the drug is a prescription drug.
• Details of its composition.
• Brand and generic names.
• Comparative lists of branded and generic drug prices.
• Dosage.
• Side-effects.
• Precautions and risks.
• Storage conditions.
• Approved indications and contraindications.
• Information on alternatives for prescribed drugs.
• Dietary requirements.

Other information that would be useful to consumers is whether a particular drug is a banned or hazardous drug, or its combination useless and irrational, and advice regarding traditional remedies.

The manner in which information is communicated is as important as the substance of the information. For information to be effective it must be accurate, reliable, accessible, user-friendly and provided at a basic and comprehensive level, depending on the consumer’s requirements.

The applicable law and policy regime in India, governing different aspects of consumer drug information, was also discussed. The analysis was presented in a critique of the shortcomings of various laws and policies. Gaps in law and policy were pointed out; it was concluded that they do not deal comprehensively or exclusively with the issue of consumer drug information. There is lack of clarity on the legal requirements for providing drug information to consumers.

The survey on drug information was discussed through an analysis of the information and material being provided by various categories of actors. These include government and quasi-government authorities, healthcare professionals, civil society and non-government organisations, pharmaceutical companies and other associations.

A broad analysis of the nature, content and form of the information was made.  

The issue of information required from a consumer perspective was also raised; whether or not the information currently being directed at consumers is indeed useful to them.

Following the discussion on the survey, broad conclusions and recommendations made in the study were presented. Click here to view conclusions and recommendations.

After the presentation Session I panel members offered their comments, criticisms and suggestions on the study. Some of these include:

• There should be greater emphasis on connections between the pharmaceuticals industry and doctors. This affects the medication being given to patients, as information from the industry is often biased.
• The study needs to include the consumer perspective and focus on the actual consumer, or patient, rather than the other stakeholders. It was also recommended that the consumers should be surveyed. The impact of material directed at consumers should be assessed.
• Other categories, such as doctors and pharmacists, should be included as consumers.
• The study needs to be more critical of the government.
• The study should survey write-ups in newspapers and advertisements given in publications that are often misleading.
• The survey should determine the quality and sort of information being given out. In an assessment of quality, there should be clear parameters for evaluating material.
• The material should be checked to see how updated it is and how many times it has been revised. There should also be an analysis of the actors providing the material, in terms of why a particular material was produced.
• The study should mention the efforts of actors in various states.
• Best practices in other countries should be reviewed.
• There should be a focus on the role of pharmacists in providing information on drugs.

Session II: Sharing of experiences

This session incorporated five presentations where experiences were shared by the panel members, who were representatives of civil society organisations working with health and consumer issues, pharmacy councils, medical professionals, AIDS patient groups, etc.

A representative from an AIDS patient organisation presented a booklet, published by the organisation for HIV/AIDS patients on ARV (antiretroviral) treatment, which should improve communication between patients and doctors.

In another presentation, examples were given of the type and format in which information should be provided to consumers. The need for a prescription guidance service for patients was pointed out. Also, that information should be provided not only to consumers but to doctors and health activists as well.

A pharmacist from a state Drug Information Centre (DIC) discussed the experiences of the DIC with patient queries, efforts at educating patients about treatment options, and guidance on prescriptions.

A representative from a consumer organisation spoke about the need for technical education at consumer organisations and efforts being made to educate consumers on drug issues.

In a presentation by a representative from an organisation that provides information to pharmacists and answers their queries, the type of data being provided (such as data on brands and drug prices) by the organisation was discussed. It was noted that community pharmacists are one of the best sources of information for patients and that by providing information to pharmacists, patients too were being educated. It was also pointed out that there is no official list of Over The Counter (OTC) drugs in India.

Session III: Discussions on experiences and recommendations, and formulating a plan of action

Open discussion by participants

In the open discussion in this session, participants discussed specific issues and recommendations for all actors engaged in providing drug information to consumers. The recommendations made to the Ministry of Consumer Affairs by a taskforce (2004), which worked on examining drugs and pharmaceutical devices from a consumer perspective, were discussed.

On the issue of drug prices, the taskforce recommended that as attempts to control prices through regulatory mechanisms had failed, competitive pressures should be used.

There is a need for greater regulation of traditional medicines such as ayurvedic and unani drugs.

The taskforce also recommended that the resources of the Drug Controller General of India (DCGI) and state authorities for drug-testing should be augmented.

The need to set up a website with information for consumers on identical drugs and their manufacturers was stressed.

Another recommendation of the taskforce was that the current package leaflet should be replaced by a patient package insert.

In discussions on the issue of patient package inserts by participants at the national consultation, it was stated that the provision of information can never be harmful and that the fear that patients self-medicate when they are provided information is misplaced.

It was suggested that drug manufacturers submit the text of patient package inserts themselves; this would prove beneficial to them too as it would allow them to safeguard their interests.

The importance of the role of information in lowering drug prices was reiterated; it was noted that the reason why market forces have failed to do this is because the consumer does not have the requisite information. Once consumers have the information they will demand the prescription of cheaper and generic drugs.

Discussion by panel members            

In this session, the initiatives taken by various organisations and authorities dealing with health and consumer issues were discussed. The application and workings of the Consumer Protection Act were studied. It was stated that the Act applies to drug commodities as well, and that it gives certain rights to consumers. Even where the manufacture of a particular drug has been licensed under law, if consumers of the drug have problems with it they can seek redressal under the Act.

Initiatives taken by the World Health Organisation (WHO) were also discussed in this session. These include the development of norms and guidelines, finding gaps in the available information and determining how to fill them, building databases of information, disseminating information, supporting the Karnataka State Pharmacy Council in the development of drug information centres in north India, etc.

The types of inputs that the WHO could provide include norm-setting, helping build databases, looking at prescription audits, pushing for changes in legislation, and identifying areas where information is unavailable.

Issues discussed in detail included drug package inserts and the role of pharmacists in providing information.

On the issue of package inserts, it was pointed out that package inserts should not be made too non-technical and simple as there could then be legal problems. The industry believes information should be provided in medical language so that it is precise.

It was also stressed that patients cannot rely solely on package inserts; the doctor’s advice must always be taken as there could be conditions specific to a particular patient.

Problems relating to the type and format of information to be provided in package inserts were also discussed. It was noted that information like price comparisons and facts about the disease could not be provided by the producer, as he would be able to give information only on the product.

The problem with providing information in local languages is that once the product leaves the factory it ends up all over the country; the manufacturer cannot monitor its distribution.

One speaker spoke of the important but under-utilised role of community pharmacists in providing consumers with information. The need to provide cost-effective and reliable information to pharmacists was highlighted.

Conclusion

In the course of the presentations and discussions at the consultation, it emerged that the drug information being provided to consumers is scattered and from a variety of sources. It also differs in terms of both quality and reach.

Overall, the quality of information available, including that from the government, is poor. Though there are a number of legislations and policy provisions that cover different aspects of consumer drug information, there is the need for greater clarity and a more comprehensive approach.

The Centad study reiterates the need for coordination and cooperation among the various stakeholders. Click here to view details of conclusions and recommendations reached at the consultation. 

Conclusions and recommendations in the Centad study

Conclusions

Some broad conclusions drawn from the survey on materials and law and policy frameworks are:

• The availability of consumer drug information in India is very limited, particularly in terms of quantity.
• There is no single dedicated actor concentrating only on consumer drug information.
• The multiplicity of actors makes it possible for the range and reach of information to be as broad as possible, thereby reaching out to a large number of consumers. At the same time, efforts differ in their standards and content. The consumer may, in some cases, be unable to decide which source of information is the best.
• There is no level of consistency with respect to the information supplied.
• Information directed at consumers is largely aimed at awareness-creation about preventive strategies and is not very technical.
• Most technical information on drugs is directed at medical professionals and not at consumers.
• In most cases, the information is not given in a user-friendly manner. It is usually neither comprehensive nor brief, and is not presented in a manner that is understood by laypersons and also has all the information on the drug and treatment.
• There is particular lack of information about drug prices, for which there is no comprehensive database. Only some actors engaged in providing consumer drug information provide information on prices. In the course of this study there was found to be no information on clinical trials, which is another neglected area.
• Though efforts have been made by a number of organisations to provide comprehensive information to consumers in a simple manner, this is usually done through the publication of books, booklets or CDs or in formats that are not normally accessed by the common consumer.
• Although considerable information is available in journals and academic papers, particularly on issues of rational drug use, such sources of information are not accessed by laypersons. Though there may be the chance that the information percolates down to the layperson from technical people accessing the information, the common consumer cannot access the information directly. These are therefore secondary and indirect sources of information.
• Information is sometimes provided both in English and the local language, though, for some sources of information, such as labels on medicines and the Internet, the information is primarily in English. Another limitation is that information provided in local languages is usually basic, not very comprehensive, and too technical.
• Information is provided mostly on allopathic drugs. There is limited information on traditional medicines, medical technologies and equipment, and diagnostics.

Recommendations

Recommendations made in the study were categorised into those for immediate implementation, those for consideration at a broader level, and recommendations for various categories of actors.

Recommendations that need to be immediately implemented to address the pressing issues of consumer drug information availability are:

• There should be bigger packs of medicines, leaflets and printed material. This should be made compulsory for all drug companies, and should be regularly reviewed. Also, the print on medicine labels should be larger.
• There should be a team of pharmacologists, clinical professionals and consumers reviewing all information and material provided by pharmaceutical companies. Drug companies should be compulsorily made to use part of their profits to provide drug information to consumers.
• Information on the prices of drugs and comparisons between the prices of various branded and generic versions of the drug should be more readily available to consumers.
• Detailed information on drugs should be disseminated in a simple, easy-to-understand manner.
• Dissemination of information should also be carried out in local languages.
• A forum should be set up where the actors involved in disseminating information can meet and deliberate on common steps to take the movement for advocating rational drug use forward, particularly regarding consumer drug information.
• Consumers should be encouraged to be more proactive in seeking information on drugs. Patients are usually more proactive about obtaining information on how to treat medical conditions that require continuous or lifelong monitoring, such as diabetes. In such situations, patients are more demanding about information on the drugs and treatment required, including such details as drug prices.

Other recommendations to be implemented include:

• There should be a single, comprehensive source of information that can be readily accessed by the consumer. This could be provided by the government as a source of verified and authentic information.
• Comprehensive regulations and guidelines should be developed and their implementation ensured, governing all possible sources of consumer information and the actors providing the information. This involves setting up guidelines for providing consumer drug information that act as a common standard for all those involved in dispensing such information. It also involves examining current law and policy in greater detail.
• Coordination among the various actors is necessary so that a common approach may be developed with respect to the standards and guidelines to be evolved.
• There should be an authority to assess the information being provided. The assessment should be done in a manner that involves the inputs and efforts of different actors including NGOs.
• Guidelines and checks must be evolved for information provided online.
• There should be a range of journals and websites to cater to different levels of understanding among various sections of the public.
• Current efforts at providing consumer drug information must be continued, as also efforts at providing information to medical practitioners.
• There should be a focus on subjects where there is greater lack of information, such as traditional medicine.
• Further analysis is required to determine current obstacles in the development of comprehensive consumer drug information. This includes determining what prevents the government from setting up a centralised information database and what can be done to address this.
• As patients consider doctors their primary and most trusted source of information, doctors must provide them at least basic and comprehensible information, according to the standards prescribed for the provision of drug information to consumers.
• It is important to keep in mind similar recommendations regarding sources of information for doctors.

The study also mentions certain issues to be considered as future research questions and areas for examination:

• Issues of consumer drug information must be understood from the demand side as well. This means that the information expected and demanded by consumers and organisations representing and protecting consumer interests must be understood. The provision of consumer drug information can be effective only if it meets the needs of consumers.
• Considering the level and type of information available to consumers at present, the major legal, ethical and other reasons behind the current state of play need to be identified.
• There is a need to link research done on the marketing and drug-promotion strategies pursued by the pharmaceutical industry with mechanisms for the provision of consumer drug information and the quality of the information.
• Doctors and other medical professionals should be asked their views on the promotional activities being pursued by pharmaceutical companies, and how this impacts them.
• Advertisements should be studied in greater detail as they are a direct and predominant source of information for consumers. The issue of monitoring drug advertisements also needs to be examined as, for certain diseases and medical conditions, advertisements are prohibited. The level of actual compliance with the law should be assessed. Instances of false and misleading advertisements must also be determined; the issue of how such advertisements can be prevented and monitored must be considered.
  

Recommendations made in the course of the consultation

Apart from the recommendations, important issues for consideration were highlighted at the consultation. These are provided below according to the topics they broadly relate to.

Recommendations on type and form of information required

• There is a need for greater information, particularly on prices and brands. Catalogues with this information should be readily available.
• A brand name registry should be created.
• Consumer information on medical technology and devices needs to be examined in greater detail. A large portion of out-of-pocket expenditure is on testing and medical technology and devices. There is also an absence of regulation on technology.
• There is a need to create awareness about clinical trial registration.

Recommendations on effective communication of information

• The media should be used to disseminate information to laypersons.

Recommendations concerning the government

• There must be a focus on the government’s responsibility to take action. There is need for greater regulation in this area and for the enforcement of such regulation.
• The government should set up a registry to which any information published on consumer drug information is sent. This should be put up on a website.
• The government should frame requirements for registering clinical trials in India.
• The government should establish drug information centres in hospitals catering to healthcare professionals and patients.
• There is a need to determine a final authority that decides what information is to be passed on to the public and who should provide the information.
• More stringent licensing conditions are required in the manufacturing and quality control of drugs.
• A drug price system should be institutionalised.
• Drug information centres should network and carry out need assessments, instead of being prescriptive. Need assessments should be conducted throughout the country.
• Regulatory capacity should be increased in terms of personnel.
• Alternative mechanisms to regulation should be examined.
• Regulatory structures should be publicly examined.
• The drug policy must include a component on rational use of drugs. There is a need to assess how medicines are being sold, prescribed and used.
• Amendments to legislations are needed.

Recommendations related to healthcare professionals

• Doctors/healthcare-providers should be held primarily responsible for providing accurate and comprehensive information to consumers in a manner that is easily understood.
• The Indian Medical Association, Medical Council of India, etc, should be approached to bring out a code of conduct for information dissemination to patients. Healthcare professionals should be sensitised.
• Healthcare professionals must ensure that they refer to updated information. There is the need for updated national and state formularies, and for a Prescriber’s Journal of India. Continuing medical education of healthcare professionals must be ensured through updated sources of information.
• Prescriptions should be made out using generic names.
• People specialising in pharmacogenics should also be recognised, apart from doctors and pharmacists.
• Irrational combinations of drugs need to be weeded out.

Recommendations related to pharmaceutical companies

• Production of irrational drug combinations must be stopped.
• The marketing strategies used by pharmaceutical companies to promote their products among the medical fraternity must be examined.
• The issue of outsourcing drug manufacturing must be addressed in order to determine how quality control needs to be done.

Recommendations for civil society

• There is a need for coordination among civil society organisations.
• The RTI (Right to Information) Act must be used to obtain information, particularly on irrational drugs.
• There should be greater sharing of information between civil society organisations.
  

List of participants

1. Dr M R Dave (CEO, Consumer Education and Research Centre Ahmedabad)
2. Dr P K Lakshmi (Karnataka State Pharmacy Council, Bangalore)
3. Kannamma Raman (Association for Consumer Actions on Safety and Health, Mumbai)
4. Padma Prakash (E-Social Sciences, Mumbai)
5. Dr Rekha V Ganachari (Bangalore)
6. Dr Prakash C Rao (Bangalore)
7. Amitava Guha (Federation of Medical & Sales Representatives’ Associations of India, Kolkata)
8. Professor G P Mohanta (Department of Pharmacy, Annamalai University, Annamalai Nagar)
9. Dr Raj Vaidya (Indian Pharmaceutical Association -- Community Pharmacy Division, Goa)
10. Rajan R Gandhi (Safety Action Group, New Delhi)
11. S Swarna Latha (Research Scholar, Centre for International Legal Studies, JNU)
12. D Jameel Zamir (International Planned Parenthood Federation, South Asia Regional Office, New Delhi)
13. Dr Mira Shiva (All-India Drug Action Network, New Delhi)
14. Dr Shilpa Modi (Modinagar, UP)
15. Rukmini Pillai (Torchbearers, New Delhi)
16. Dr Abhijit Sangma (Christian Medical Association of India, Delhi)
17. Dr M M Mittal (Medguideindiacom, Delhi)
18. Dr Nandlal Jotwani (Global Harmony, New Delhi)
19. Anagha Khot (World Health Organisation, New Delhi)
20. Loon Gangte (Delhi Network of Positive People, New Delhi)
21. Dr C Sathyamala (Council for Social Development, New Delhi)
22. Arun Kumar (Consumer Coordination Council, Noida)
23. G Mahesh (AIDS Healthcare Foundation)
24. Terri Ford (AIDS Healthcare Foundation)
25. Reji K Joseph (Research Scholar, JNU)
26. Deepu M (Research Scholar, JNU)
27. Vinod Bhanu (Centre for Legislative Research and Advocacy, New Delhi)
28. Gajanan Wakankar (Indian Drug Manufacturers’ Association)
29. Sandhya Venkateswaran (CARE India)
30. S Srinivasan (Low Cost Standard Therapeutics, Baroda)
31. Leena Menghaney (Medicins Sans Frontiers, New Delhi)
32. Meghendra Banerjee (World Health Organisation)
33. Dr P Tiwari (National Institute of Pharmaceutical Education and Research, Mohali)
34. Ashwini Kumar (Pharma Solutions)
35. Kasim (Pharma Solutions)
36. Yatin Gupta (Yamuna Chemist)
37. Kajal Bhardwaj (Lawyers’ Collective HIV/AIDS Unit)
38. Dr Usha Gupta (Delhi Society for Promotion of Rational Use of Drugs, Delhi)
39. Bejon Misra (Consumer VOICE, Delhi)
40. Shubha Maudgal (Cancer Patients Aid Association)
41. Amit Sengupta (All-India Peoples Science Network/Jan Swasthya Abhiyan, Delhi)

Centad thanks  S Swarnalatha from JNU, New Delhi for her substantial contribution in preparing this report.