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PARLIAMENT OF INDIA RAJYA SABHA 38 DEPARTMENT-RELATED PARLIAMENTARY STANDING COMMITTEE ON HEALTH AND FAMILY WELFARE THIRTY-EIGHTH REPORT ON MAJOR ISSUES CONCERNING THE THREE VACCINE PRODUCING PSUs, NAMELY, THE CENTRAL RESEARCH INSTITUTE (CRI) KASAULI, THE PASTEUR INSTITUTE OF INDIA (PII), COONOOR, AND THE BCG VACCINE LABORATORY (BCGVL), CHENNAI (PRESENTED TO THE RAJYA SABHA ON 18TH DECEMBER, 2009) (LAID ON THE TABLE OF THE LOK SABHA ON 18TH DECEMBER, 2009) RAJYA SABHA SECRETARIAT NEW DELHI DECEMBER, 2009/AGRAHAYANA, 1931 (SAKA) Website : http://rajyasabha.nic.in E-mail : [email protected] PARLIAMENT OF INDIA RAJYA SABHA DEPARTMENT-RELATED PARLIAMENTARY STANDING COMMITTEE ON HEALTH AND FAMILY WELFARE THIRTY-EIGHTH REPORT ON MAJOR ISSUES CONCERNING THE THREE VACCINE PRODUCING PSUs, NAMELY, THE CENTRAL RESEARCH INSTITUTE (CRI) KASAULI, THE PASTEUR INSTITUTE OF INDIA (PII), COONOOR, AND THE BCG VACCINE LABORATORY (BCGVL), CHENNAI (PRESENTED TO THE RAJYA SABHA ON 18TH DECEMBER, 2009) (LAID ON THE TABLE OF THE LOK SABHA ON 18TH DECEMBER, 2009) RAJYA SABHA SECRETARIAT NEW DELHI DECEMBER, 2009/AGRAHAYANA, 1931 (SAKA) CONTENTS PAGES 1. COMPOSITION OF THE COMMITTEE ......................................................................................... (i)-(ii) 2. PREFACE .................................................................................................................................. (iii) 3. REPORT ................................................................................................................................... 1—12 4. OBSERVATIONS/RECOMMENDATIONS — AT A GLANCE ............................................................ 13—18 5. MINUTES ................................................................................................................................ 19—24 COMPOSITION OF THE COMMITTEE (2009-10) MEMBERS PRESENT 1. Shri Amar Singh — Chairman RAJYA SABHA 2. Shrimati Viplove Thakur 3. Dr. Radhakant Nayak 4. Shri Janardan Dwivedi 5. Shri Balbir Punj 6. Dr. Prabhakar Kore 7. Shrimati Brinda Karat 8. Shrimati Vasanthi Stanley 9. Dr. M.A.M. Ramaswamy 10. Dr. Anbumani Ramadoss LOK SABHA 11. Shri J.M. Aaron Rashid 12. Shri Ashok Argal 13. Shrimati Sarika Devendra Singh Baghel 14. Shri Vijay Bahuguna 15. Dr. Chinta Mohan 16. Shrimati Tabassum Hasan 17. Dr. Sanjay Jaiswal 18. Shri S.R. Jeyadurai 19. Dr. (Shrimati) Kruparani Killi 20. Shri N. Kristappa 21. Dr. Tarun Mandal 22. Shri Datta Meghe 23. Dr. Jyoti Mirdha 24. Shrimati Jayshreeben Patel 25. Shri R.K. Singh Patel 26. Shri M.K. Raghavan 27. Dr. Anup Kumar Saha 28. Shrimati Meena Singh 29. Dr. Arvind Kumar Sharma 30. Shri Pradeep Kumar Singh 31. Shri Ratan Singh (i) (ii) SECRETARIAT Shrimati Vandana Garg, Additional Secretary Shri R.B. Gupta, Director Shrimati Arpana Mendiratta, Joint Director Shri Dinesh Singh, Assistant Director PREFACE I, the Chairman of the Department-related Parliamentary Standing Committee on Health and Family Welfare, having been authorised by the Committee on its behalf, do hereby present this Thirty-Eighth Report of the Committee on ‘Major issues concerning the three vaccine-producing PSUs, namely, the Central Research Institute (CRI), Kasauli, the Pasteur Institute of India (PII), Coonoor and the BCG Vaccine Laboratory (BCGVL), Chennai.’ 2. The Committee after having done an extensive study of the ‘Functioning of the three vaccine-producing PSUs, namely, the Central Research Institute (CRI), Kasauli, the Pasteur Institute of India (PII), Coonoor and the BCG Vaccine Laboratory (BCGVL), Chennai’, had presented the Thirty-Fourth Report to the Parliament on 18th February, 2009. Thereafter, the Committee also considered the Action Taken Note on the Report received from the Department of Health and Family Welfare. While doing so, the Committee found that some important issues raised by the Committee were either not explained convincingly or further clarifications were required on those. It was, therefore, decided to present another report highlighting those major issues on which the Committee wishes to make further emphasis and obtain the Government's response. 3. The Committee held extensive discussion with the Secretary and other officers from the Department of Health and Family Welfare on the 26th October, 2009 to get a correct assessment about the revival of the three vaccine producing PSUs. 4. The Draft report, prepared on the basis of the feedback received from the Department and the discussions held with the Secretary and other officers from the Department, was considered and adopted by the Committee on the 17th December, 2009. AMAR SINGH NEW DELHI; Chairman, 17th,December, 2009 Department-related Parliamentary Agrahayana 26, 1931 (Saka) Standing Committee on Health and Family Welfare. (iii) 1 REPORT I INTRODUCTION 1.1 The Department-related Parliamentary Standing Committee on Health and Family Welfare had presented its Thirty-Fourth Report on the ‘functioning of the three vaccine producing PSUs, namely, the Central Research Institute (CRI), Kasauli, the Pasteur Institute of India (PII), Coonoor, and the BCG Vaccine Laboratory (BCGVL) Chennai’ to Parliament on the 18th February, 2009. This Report was based on an extensive study done by the Committee in the light of inputs received from all concerned and their objective analysis. The Committee had recommended revival of the three vaccine producing PSUs at the earliest. It took more than six months for the Ministry of Health and Family Welfare to furnish the Action Taken Note which was received in the last week of September, 2009. A scrutiny of the Action Taken Note, instead of indicating a significant progress, confirmed Committee’s apprehensions. Major part of the Action Taken Note seemed to display a lack of commitment on the Ministry’s part. The Committee strongly felt that presenting an Action Taken Report in the routine manner would serve no purpose as quite a few pertinent issues had remained unanswered. The Committee, accordingly, interacted with the Secretary, Health and Family Welfare at its meeting held on the 26th October, 2009. A detailed questionnaire covering all conceivable aspects was also forwarded to the Ministry by the Committee. 1.2 The Secretary, Health and Family Welfare during her presentation gave an overall idea about the present status of vaccine availability in the country. The Committee was given to understand that only four vaccines-BCG, DT, TT and DPT were being produced by the three PSUs. Out of that with the exception of BCG vaccine, 50 per cent requirement was being met from the private sector. It was also pointed out that against the total expenditure of Rs.200 crore for Universal Immunization Programme, contribution made by the three PSUs amounted to only Rs.90 crore, further reduced to Rs.30 to 40 crore taking into account Government funds being spent for their running. The Committee was, however, apprised that keeping in view its serious concerns, a three member Committee under the Chairmanship of Shri Javed Chaudhary, former Health Secretary had been set up on the 25th September, 2009 by the Ministry. This Committee was to give a report within three months on the reasons for suspension of manufacturing licenses of the three PSUs, the roadmap for their revival and their future role. 1.3 Based on the analysis of the Action Taken Note furnished by the Ministry, deposition of the Secretary and the response to its questionnaire, the Committee has the following observations/ recommendations on the most significant areas of concern. II REVIVAL OF VACCINE-PRODUCING PSUs 2.1 Committee’s attention has been drawn by the assurance given by the Ministry at many places in Action Taken Note about the revival of the three units. The Committee, however, finds that this assurance is subject to their becoming GMP compliant. The Committee had pointed out that manufacturing licenses of the three units should have been suspended for a specified period. And this period could have been utilized for removal of all the shortcomings in a time-bound manner under the overall supervision of the Ministry. The Committee had strong reservations on the suspension of manufacturing licenses till such time the deficiencies were rectified. The predominant element of ambiguity in the order of the Drug Controller General of India given in his capacity as the Central License Approving Authority on the 15th January, 2008 is borne out by the action taken by the Ministry so far. 2 2.2 It was decided in a meeting held on the 6th February, 2008 under the Chairmanship of Secretary, Health and Family Welfare to set up a Committee which was to visit the three units for study of infrastructure, facilities available/feasibility of conversion of existing labs into testing labs, and utilization of existing facilities for setting up a residential training facility and having some of the vaccines produced at the three units. An Expert Committee under the Chairmanship of DCGI could be set up on the 11th April, 2008, which submitted its report in September, 2008. In the meantime, the progress made in the setting up of Integrated Vaccine Complex and Medipark at Chengalpattu, Tamil Nadu was reviewed by the Minister for Health and Family Welfare. Project Managers had been appointed and tenders floated for detailed site survey and preparation of base maps. After discussing the report of the Expert Committee on the 18th September, 2009, DCGI was requested to revisit the report and address all the Terms of Reference of the Committee and indicate recommendations against each Term of