Questionnaire for Pharmaceutical Firms

Transcription

1 Questionnaire for Pharmaceutical Firms [To be answered by respondents at three levels in the Pharma firm: (i) Proprietor; (ii) Officer in Processing Division & (iii) Officer in Marketing Division] Name(s) of Research Investigator(s) Name of Pharma Firm (OPTIONAL) Name(s) and Title(s) of Respondent(s) (OPTIONAL) Date, Time and Venue of Meeting Section A: Environment 1. When was your firm incorporated? 2. Can you please provide information about the following aspects of your firm: (i) No of employees (ii) Annual turnover (in INR) (iii) Main products (iv) Size: Large Medium.Small 3. Are you aware of Good Manufacturing Practices (GMP) norms set under the Schedule M of the Drugs & Cosmetics Act, 1940? 4. If response to Qs 3 is Yes, can you state benefits that might have accrued to the company? a. Quality of products b. Goodwill of firm c. Increase in sale d. International recognition e. Others (Please specify) 1

2 5. What elements of Good Manufacturing Practices (GMP) has your firm adopted? a) Disposal of sewage & wastes in conformity with requirement of SPCB b) Standard operating procedures for sampling, inspecting and testing of raw materials c) Verification of environmental procedures d) Filling products in powder form exercised with special care so as to avoid contamination of environment e) Filter installed to retain dust and protect the local environment f) All of these 6. How would you rate the compliance (in %age) of the different segments of the pharma sector with GMP requirements in the state? (i) Large: (ii) Medium: (iii) Small: 7. What difficulties do firms face in being GMP compliant? a) Rules and regulations are too tough to follow b) Government is not supportive c) Lack of awareness among firms/association d) Financial constraints e) Others (please provide details here: ) f) No difficulty 8. How can the following entities help in this regard: (i) State Government/Central Government a) Providing financial support b) Keeping firms interest in mind while formulating the regulation c) Conducting awareness programme for firms regarding GMP d) All of the above (ii) Pharmaceutical Association a) Providing financial support to small firms for adopting GMP technology b) Having regular interaction with government authorities to discuss problems faced by firms 2

3 c) Keeping firms updated on recent developments related to technology, policies, regulation. d) All of the above 9. What support did your firm get from the State/ Central Government that might have helped in the process of establishment of the firm?, support was received (provide details here: ) ne c) Can t Say 10. Do you agree that some of the pharma firms which do not follow GMP guidelines are more likely to create environmental hazards? 11. On the basis of your experience in the sector, how would you rank (on a scale of 1 to 10 1 ) the contribution of the Pharma industry to the following environmental impacts in the state? i. Air Pollution ii. Water Pollution iii. Land Pollution iv. Hazardous Waste v. Health problems in the community vi. Occupational Health problems vii. Others (please provide details here: ) 12. What steps has your firm initiated on its own to bring environmental concerns on the list of priority issues of pharmaceutical firms? a) Including it in boardroom discussions b) Raising the issue with the association c) Interacting with other firms d) Engaging with the Government/State Pollution Control Board, Any other (please provide details here: ) e) Don t know 1 1 corresponding to lowest level of impact, and 10 to the highest level 3

4 13. What steps have you taken to mitigate/minimize negative/adverse impacts in the communities located near the plant? 14. Are you aware of some firm which has faced any regulatory action taken by the SPCB on account of environmental impacts of your firm? 15. Do you think such action from SPCB is justifiable -why -why 16. What impact these actions could have on firm s business? a) Monetary loss b) Action taken by government c) Bad reputation d) Others 17. Does your firm also outsource the manufacturing of pharmaceuticals? 18. If yes, what measures are taken to ensure that the contract manufacturer complies with environmental regulations? a) Before entering into any contract, it is made sure that the firm is following all environmental concern and is GMP compliant b) Firms are encouraged to follow environment related regulation and GMP guidelines c) Others 19. Based on your experience (your firm s and the sector s), what would be those three ways in which you think a firm like yours can improve on its environmental impacts. What role should the association and government play in each of them? S.No. Improvements Role of Association Role of Govt

5 In the final analysis, do you believe these issues are better solved in the long run on the basis of: a) Consistent and better informed government regulations b) Strict enforcement of regulations c) Self-regulation d) Any Other 21. Do you think the implementation of regulatory laws should be done differently depending on the nature of the unit (Formulation, Bulk) and size of firms (Large and SMEs)? 22. Do you have a dedicated Environmental Management department in your firm? 23. If yes, can you provide some details regarding: (i) Number of staff (ii) Annual expenditure (iii) Environmental Policy 24. Is there any environmental infrastructure in place to reduce the negative environmental impacts of your firm? 25. What assistance did your firm receive from the government (State/Central) in this process? a) Monetary help b) Information related to technical requirements c) Others (Please provide details here: ) d) No assistance received 5

6 26. Did the association provide any assistance? 27. Why did you think it to be necessary to have this department? a) To tackle environmental issues more effectively b) It helps to keep regular track of all changes in environment related policies, regulation, etc. c) It works as a channel between firm and government agencies. d) Not sure/can t Say 28. Do you know what constitutes Corporate Social Responsibility (CSR)? Yes No 29. Do you have a CSR policy in place in your organization? Yes No 30. If yes, why did you think it was necessary? a) It was felt by the proprietor/governing body of the company b) Government regulations, etc. c) Helps firm/ industry to maintain a good image d) Earn trust/goodwill of the community/society e) Any other (Please provide details here: ) 31. Have you heard about the National Voluntary Guidelines on Social, Environmental and Economic Responsibilities of Business (NVGs)? 32. Where did you hear about them (NVGs)? a) Through government agencies b) Through Association c) Through media d) Others 33. What are your impressions about its substantive part, and operationalisation? 6

7 a) It will create more clarity on Social, Environmental and Economic Responsibilities of Business b) It will push firms/industry to fulfill their responsibilities towards society better c) It will increase awareness a d) Will create further ambiguity among firms. e) Will make no impact f) Others (Please provide details here: ) Section B: Marketing & Distribution 34. What are the strategies adopted by your firm for marketing and distribution of drugs? a) Visiting doctors (through MRs) b) Visiting chemists (through MRs) c) Visiting Hospitals (through MRs) d) Professional middlemen, exporters e) Print and electronic media f) All of the above 35. How many Medical Representatives (MRs) are employed with your firm. 36. How many doctors in a month are visited by MRs working with your firm 37. How are these doctors chosen. a) Area of specialization b) Experience of the doctor c) Popularity of the doctor d) Which institution he is associated with e) Other means (please provide details here: ) 38. Has your firm sponsored events (meeting, workshop, seminar, etc.) for the doctors? 39. If yes, how many do you generally do in a year If no, why not a) Firm do not have such policy b) These are unethical practices c) Other reasons (Please specify here: ) 7

8 41. What benefits do you expect to get from such events? a) Spread information about our products b) Raise sales targets c) Create pressure on Doctors and hospitals d) As part of Continued Medical Education (CME) e) Others 42. Do doctors ask for any kind of gifts from MRs when the MR visits doctors/hospitals? 43. What is your opinion about this? Do you think this is bad conduct from the part of doctors to ask for gifts? (Why?) (Why?) 44. Are you aware of Code of Medical Ethics Regulations, Medical Council of India formulated by Medical Council of India (MCI) in the year 2002? a. Yes b. No 45. Have you taken any initiative to comply with this regulation? (please explain) 46. Are there any specific problems created by chemists and wholesalers/stockist (or their associations) which have direct bearing upon Marketing and Distribution of the pharmaceutical companies? a. Yes b. No 47. If yes, what steps have been taken (at the firm level/association level) to deal with this kind of issue? a) Meetings with chemists and wholesalers association b) Approaching government agencies to resolve the problem c) Others d) NA 48. From your experience of the sector, how would you think the expenditures towards gifts, incentives, etc. are booked by Pharma firms? (a) Promotion 8

9 (b) Marketing (c) Advertisement (d) CME (e) Other heads? 49. What would you consider are the main reasons (for firms to indulge in such behavior to push their products into the market? a) To maximise profit/bottomline b) To gain new markets/more customers (could me more relevant in case of large/medium Cos.) c) It is a usual practice among the firms d) To survive in the sector (could me more relevant in case of small firms) e) Other(Please provide details here: ) 50. Are you aware of the UCPMP (Uniform Code for Pharmaceutical Marketing Practices)? ( ( 51. If yes, are you in favor of it in its present form or you wanted some amendments? ( it is fine in its present form (, we want some amendment to be made in it (what...) 52. What is the structure of the remuneration being paid to the MRs of your firms: (a) Fixed (b) Based on sales target only (c) Fixed + based on target (percentage of the target achieved) (d) Any other 53. If the answer to above is (b) or (c) Have you ever felt worried that focus on sales target to assess performance would result in unhealthy interaction with providers (doctors, hospitals, etc.)? 54. Would you be willing to fix the remuneration part for MRs working with your company? (Provide reasons to support your choice) 9

10 55. Does your organisation acknowledge that there are certain ethical concerns relating to the Incentive Structure 2 associated with the interplays among different actors involved with marketing and distribution chain of drugs. a. Yes b. No 56. Has this issue been discussed in association meetings? a. If yes (what were the results?) b. If no (Any possible reasons?) 57. Have you or your association taken any step to discuss this issue with any government agency or has any government agency raised the matter with you? a. Yes (Details) b. No 2 Players involved in marketing and distribution of drugs often provide various types of Incentives to actors at the next level of the supply chain 10