Cover-38Th Report-H&FW

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

(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)

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 Reference very clearly along with plan of action to be executed. On the 8th October, 2008, revised report was furnished by DCGI which was, however, found to be another version of the earlier report. DCGI was, accordingly, advised by the Director General Health Services on the 17th November, 2008 to revisit the report again. Thereafter, DCGI furnished a revised report which stated that it was to be decided by the Directorate/Ministry as a policy decision as to which vaccines were to be produced and where and the same needed to be weighed/vetted in the light of the new facilities being planned at the upcoming Vaccine Park at Chengalpattu. It was also stated that the Committee was not equipped or competent to give the detailed micro-planning, financial requirements, pricing, architectural plans of buildings/infrastructure and specific manpower utilizations/requirements. The DGHS then furnished his comments on the revised report indicating the inadequacies in the report. The recommendations of the Expert Committee were approved by the Minister on the 17th February, 2009 and the decision was conveyed to the Institutes on the 12th March, 2009. Prior to this, in January, 2009, WHO advised that the new facility constructed by HSCC in CRI, Kasauli could be renovated for production of DPT vaccine and the work was being undertaken with the assistance of WHO. Similarly, facilities at PII, Coonoor were also reviewed by an Expert Team. As per the latest feedback received from the Ministry, a Core Group, under the Chairmanship of the former Health Secretary, has been set up in September, 2009 to review the reasons for suspension of manufacturing licenses of the three units and also review the roadmap for their revival to make them GMP compliant. 2.3 The above sequence of events since the suspension of manufacturing licenses of the three units in January, 2008 clearly establishes the fact that their revival is not envisaged by the Government in the near future. Rather every attempt has been made to create hurdles so as to ensure that the process of making them GMP compliant continues for long and manufacturing process of major vaccines of UIP at these age-old PSUs remains suspended. The Committee takes note of the fact that the Expert Committee headed by the Drug Controller General of India, the supreme authority for quality control of drugs in the country has expressed its inability at arriving at a decision about the status of the three units inspite of persistent efforts by the Ministry. The Committee wonders how the Director General Health Services who is directly under the control of the Ministry could simply negate the report of the Expert Committee. The Committee is not aware of the fate of the latest Committee (Javed Chaudhary Committee) set up by the Ministry. But, the fact remains that the time is running out for the three vaccine producing units. 2.4 What gives credence to Committee’s apprehensions is the background for setting up the Integrated Vaccine Complex at Chengalpattu (TN) and progress made so far. On a specific query, the Committee was informed that capability of HLL Lifecare Limited, a ‘Mini Ratna’ Public Sector Enterprise in implementing Healthcare projects, technology assimilation and expertise in vaccine business were the criteria for entrusting the company with the project. 3

The Committee is, however, surprised to note that the only expertise of HLL Lifecare Limited in vaccine business so far has been marketing of Hepatitis B and Typhoid vaccines from 2005, followed by recent entry into marketing for Rabies Vaccine (Human) and sourcing agent for Government of India for the import and supply of JE vaccines since 2006. Technology transfer discussions with Denmark, Korea and Belgium based Institutes and positioning of a project team are the technology assimilation credited to the company. 2.5 The Committee has also been informed that the first phase of the IVC project focusing on formulation facilities is expected to start in January, 2010 and to be completed in December, 2012. The second phase on bulk production units is expected to start in September, 2010 and to be completed in December, 2012. The Committee can, therefore, only conclude that at least for the next three years, supply of vaccines as per the requirements of the entire country will be met mainly by the private sector. Not only this, the quantum of manufacturing of UIP vaccines like DPT (100 million doses), TT (200 million doses), BCG (100 million doses), Measles (100 million doses), Hepatitis B (40 million doses) and Pentavalent combination vaccines (100 million doses) establishes the fact that the fate of the existing PSUs is sealed. 2.6 Committee’s worst fears are confirmed by the assessment about the three units given by the Ministry. According to the Ministry, what these units are going to produce is to be determined by a vaccine policy, yet to be formulated by the Government. Secretary, Health Research has been requested to organize a discussion with all concerned. Only thereafter, the policy on what the three units should manufacture for ensuring vaccine safety would be developed. It has also been pointed out that the three units, given their heritage status have inherent capacity constraints to undergo the requisite modernization. Consequently, their product mix can never be as dynamic as envisaged in the case of IVC. 2.7 The Committee is deeply disturbed by the conflicting signals emerging from the Government’s side on the status of the three existing vaccine- producing PSUs. On the one hand it is being emphasized time and again at different fora that Government is determined for the revival of the three units and every effort is being made to ensure their becoming GMP compliant, on the other hand it is also being categorically pointed out that their fate is to be decided by a vaccine policy yet to be formulated and they can never equate with the proposed ‘state of the art’ IVC project. 2.8 In the succeeding paragraphs an attempt has been made to analyse the progress made so far in the revival of the three PSUs.

III CENTRAL RESEARCH INSTITUTE, KASAULI 3.1 In its Thirty-Fourth Report, the Committee had voiced serious concern on the lack of vision and initiative on the part of the Ministry for revamping the existing structure of CRI, Kasauli, an age-old institution functioning as a subordinate office of the Ministry. In reply to the Committee’s observation, the Ministry in its ATN has stated that a proposal was approved in 1997-98 for creation of new facilities for manufacturing of Triple Vaccine at CRI, Kasauli for which M/s HSCC, Noida, a turnkey agency was selected with total allocation of Rs. 13.29 crores. However, the infrastructure created with the help of M/s HSCC, was found to be non-compliant with the GMP standards. Thereafter, another attempt was made for up gradation at CRI, Kasauli in 2002 with an approved outlay of’ Rs. 85 crores. However, the Ministry has not specified details about the progress made under this project. 3.2 The Committee had critically observed in its 34th Report that though two years had already passed by since M/s HSCC had expressed its inability to complete the structure in December, 2006, 4 the Ministry had displayed a laidback approach on such a serious issue by not initiating any substantive action against the agency for breach of agreement. As per the latest feedback received from the Ministry, it had been decided to issue a notice to M/s HSCC claiming damages for their breach of agreement, and the Central Vigilance Commission was also approached on 31st August, 2009 for tendering advice. Subsequently, the Ministry informed the Committee that the notice has been sent to M/s HSCC on 16th November, 2009. On being asked further by the Committee as to whether any response has been received from the Central Vigilance Commission in the matter, the Committee was apprised that the CVO of the Ministry had informed on 3rd November, 2009 that CVC had returned the records stating that comments/information of Ministry of Health and Family Welfare should be forwarded to it as per its new reporting format. The CVO of the Ministry has also advised that since the case pertained to professional impropriety rather than financial impropriety, the administrative division should process the case for taking administrative action against the officers as deemed fit. 3.3 The Committee observes that the reply of the Ministry regarding the action taken against M/s HSCC, Noida for its failure to build a GMP compliant structure at CRI, Kasauli is simply untenable. The Committee also raises serious doubts on the process of awarding the contract to M/s HSCC, Noida. The process of awarding contract for building a GMP complaint structure to an agency which did not have the technical competence to build such a unit itself speaks volumes of a faulty process of selection ab initio. The Committee observes that it seems that from 1997-98 until December, 2006 — the time when M/s HSCC, Noida expressed its inability in completing the project, monitoring as required was not done by the Ministry to assess the progress of work undertaken by the agency. 3.4 The Committee also finds that the action initiated by the Ministry against M/s HSCC, Noida has been perfunctory in nature. Instead of pursuing the matter vigorously, the Ministry has moved at a snail’s pace which is evident from the fact that action against the company has been initiated only after the matter was reported upon by the Committee in its 34th Report in February 2009, and thereafter also, it took the Ministry more than six months to reach a decision regarding referring the matter to CVC for advice and almost nine months to issue a notice to M/s HSCC. The reasons as to why the matter has remained pending from December, 2006 till date without any substantial action being initiated against the defaulter company simply escapes the Committee’s comprehension. The Committee also feels that the tardy pace of action taken so far clearly indicates dilatory tactic on the part of the Ministry. The Committee’s apprehensions in this regard get reinforced from the fact that the records pertaining to this case, which were forwarded to the CVC on 31st August, 2009, were not furnished in the prescribed new reporting format. The Committee is simply not ready to buy the argument that it took more than two months for the CVO of the Ministry to come to know that the communication from the Ministry to CVC was not forwarded as per the new reporting format. The Committee is constrained to call into question the seriousness of the Ministry to take stringent action against those who were responsible for this mix-up. The Committee, therefore, recommends that the Departmental Inquiry under progress may be completed within a strict time frame and action may be initiated against those responsible without further delay. The Committee would like the Ministry to provide a copy of the enquiry report as well as the follow-up action taken thereon. 3.5 The Committee takes note of the fact that the revised Schedule ‘M’, the Indian version of GMP norms of WHO was made effective for the existing units w.e.f. 30th June, 2005. Accordingly, during the inspection made by the drug authorities in 2001 and 2004, only partial compliance to NRA’s requirement was considered adequate. There were thus no specific recommendations by WHO for upgradation of these units at that time. It was only during the WHO-NRA assessment 5 in August, 2007, that all the three units were found to be non-compliant with GMP norms. In pursuance to September, 2007 directive of the Ministry, CRI, Kasauli submitted a proposal for construction of new GMP compliant facility for manufacturing of DPT Group of vaccines at an estimated cost of Rs.32 crores and constitution of a project Committee. The Committee has been informed that due to suspension of the license of institutes in January, 2008 and the constitution of an Expert Committee in April, 2008 on modalities of utilization of the institutes, the proposal could not be processed further. 3.6 The Committee had also drawn the attention of the Ministry to a response given in answer to Rajya Sabha Starred Question 34 on the 24th July, 2009, whereby renovation/upgradation project of the new GMP compliant building at CRI, Kasauli was expected to be completed by June, 2010. Feedback given by the Ministry in this regard is that the layout plan for DPT vaccine unit has been prepared with inputs from WHO and DCG(I) and approved for Rs.15 crore. There has been no response to the EOI issued by M/s HSCC. WHO has in the meanwhile forwarded names of three vendors having extensive experience in setting up GMP compliant vaccine manufacturing units. The Committee has not been made aware of any follow-up action initiated on the WHO suggestion. Instead HLL Lifecare Ltd., has been addressed on 16th November, 2009 to furnish their proposal for renovation of DPT facility at CRI, Kasauli. 3.7 The Committee takes serious objection to the state of affairs emerging after submission of a project proposal by CRI. The Committee wonders about the feasibility of the DPT unit at CRI becoming GMP compliant by June, 2010 as the process of selection of implementing agency is still continuing. Further, the rationale of inviting HLL Lifecare Ltd. for taking up the project by ignoring the names of experienced vendors suggested by WHO is also not known to the Committee. The Committee views with serious concern the involvement of HLL Lifecare Ltd., for Kasauli project when it is already set to start an ambitious Vaccine Park at Chengalpattu (TN). The Committee, accordingly, recommends that the approved layout plan for the DPT vaccine unit at CRI, Kasauli should be implemented in a transparent and time-bound manner. 3.8 The Committee in its Thirty-Foutth Report had pointed out the acute shortage of personnel especially in Group’ A’ and ‘B’ in CRI, Kasauli. As per the latest feedback received from the Ministry, out of 50 Group A posts, 27 posts were vacant. While out of 32 Group B posts, 10 remained vacant. Replying to a specific query made by the Committee on the reasons for the post of Director at CRI being filled up on deputation basis since 1997 and the reasons for reviewing the Recruitment Rules for the above posts, the Ministry informed that the posts of Director and Additional Director were CHS cadre posts and the Recruitment Rules limited the scope of filling up of the posts from CHS cadre officers only with PG degree/diploma in Bacteriology/ Microbiology. Since no CHS cadre officers were willing to join, they were de-cadred. After de- cadrement, the posts were filled up on deputation basis. The Ministry has also informed that the existing recruitment rules were reviewed by a Committee constituted by DGHS under the chairmanship of Special Director General (Public Health), with a view to widen the scope of recruitment of non-medical personnel and non-CHS cadre officers also so as to enable selection of proper incumbents having requisite speciality/cadre. The revised recruitment rules have been referred to Department of Personnel and Training for its consideration on 23rd November, 2009. The Committee was also given to understand that the requirement of manpower at the Institute in accordance with the GMP norms and the revival plan now required to be assessed. 3.9 The Committee is not happy with the status of duly sanctioned posts at CRI remaining vacant for so long leading to some posts getting lapsed. The fact that as many as 27 Group ‘A’ posts and 10 Group ‘B’ Non-Gazzetted Posts are still vacant at CRI requires the matter to be pursued vigorously and persistently. Not only this, action also needs to be 6 initiated without any delay for reassessment of requirement of manpower at CRI in accordance with the GMP norms and the revival plan.

IV BCG VACCINE LABORATORY, CHENNAI 4.1 The Committee had, in its Thirty-Fourthth Report, observed that as per the information furnished by the Ministry, the inspection report of the WHO-NRA inspecting team which had visited BCG VL, Chennai in August, 2007 had pointed out 55 major deficiencies. The Institute had, in its Status report, informed that out of the 55 deficiencies pointed out, 45 major deficiencies had already been rectified by it. The Committee had also been informed that as regards the remaining 10 deficiencies, corrective action had either been already initiated or justification for the existing position had been given by the Institute. Consequent to the WHO-NRA assessment in August, 2007, all the three units being non-compliant of GMP norms, they were advised in September, 2007 to formulate a plan of action and put up a detailed project report. Accordingly, BCGVL proposed renovation/upgradation of existing facilities for production of BCG vaccine at an estimated price of Rs.13 crores. However, it was not followed by submission of detailed proposal. 4.2 The Committee would like to point out that as per the status note of the Ministry, a proposal for upgradation/renovation of BCGVL, Chennai was submitted to the Drug Controller General of India on the 30th January, 2008. This was followed by a report of the Institute submitted to the Deputy Drugs Controller, South Zone on 26th February, 2008 and later on 20th March, 2008 to the Ministry of Health and Family Welfare about the rectification work that it had carried out in the Institute. Not only this, the Institute had preferred appeals twice, – once on 24th January, 2008 against DCGI’s decision to suspend its license, and again on 14th June, 2008 to the Ministry of Health and Family Welfare to revoke suspension of the license. However, the ATN did not mention as to what action was taken on the part of the Ministry to consider their case in the light of the rectifications carried out by the Institute. 4.3 On a specific query made in this regard, the Ministry has stated that BCG Vaccine Laboratory was inspected twice after August 2007 and it was observed that deficiencies were not complied till January 2008. Clarifying further on the issue of the proposal for up gradation/ renovation of BCGVL, Chennai, the Ministry has stated that the office of DCG (I) has furnished its observations/objections on the plan vide its letter dated 20th February, 2008. Attention of the Committee has also been drawn to the fact that while the Inspection Team had observed 70 deficiencies, the compliance statement of the then Director listed out only 55 deficiencies. 4.4 The Committee would like to note here that the Ministry had furnished the Inspection Report of the WHO-NRA team that had visited BCG VL in August 2007 along with the status note vide its O.M. dated 24th July, 2008 to the Committee for its consideration. The Committee would like to point out that the onus of furnishing vetted information to a Parliamentary Committee lies with the Ministry. The Committee finds it strange that the Ministry had not challenged the veracity of the report submitted by the Institute while forwarding the same to it. The Ministry continued to remain silent on this issue even in its Action Taken Note. It was only after a pointed query with regard to rectification of 45 deficiencies out of the 55 deficiencies pointed out by the WHO-NRA assessment team, that the Ministry has chosen to react. An attempt has been made by the Committee to make a comparative analysis of 55-deficiency and 70-deficiency Reports. The Committee has no hesitation in arriving at the conclusion that the so-called additional 15 deficiencies are duly reflected in the original report, the only difference being that some of the deficiencies are in the expanded form in the later report. The Committee is also not inclined to agree with the contention of the Ministry that the action taken information was not complete and did not indicate the manner of compliance/rectification of deficiencies. 7

4.5 The Committee takes note of the fact that as per the Expert Committee constituted in April, 2008, the existing facilities had inherent problems for renovation and vaccines can be manufactured only on the construction of new facilities. Feasibility of BCGVL becoming GMP compliant has become more difficult in the light of the latest report given by the Oversight Committee in October, 2009. Although, WHO GMP expert has been requested to prepare the preliminary layout plan for the Institute, there is no land available for the same. A proposal is, therefore, in the pipeline to shift the work of the Institute along with its personnel to the upcoming Vaccine Complex at Chengalpattu. The Committee strongly feels that a pre-conceived view about there being no possibility of BCGVL becoming GMP compliant is very dominant. The very fact that persistent efforts made by the Institute authorities to rectify the deficiencies pointed out in the WHO-NRA assessment report and succeeding in removing the majority of the same with the remaining ones being the responsibility of the Ministry have been of no avail, confirms Committee’s observations.

V PASTEUR INSTITUTE OF INDIA, COONOOR 5.1 The Committee notes that consequent to WHO-NRA assessment in August, 2007, PII, Coonoor was advised in September, 2007 to formulate a plan of action and put up a detailed project report. Accordingly, PII, Coonoor proposed renovation of existing facilities for TCARV and DPT at an estimated price of Rs.34 crores and construction of new facilities for DPT vaccine at an estimated price of Rs.120.93 crores. However, detailed proposal was not submitted by PII. This was followed by suspension of the license of the Institute in January, 2008 and constitution of an Expert Committee in April, 2008. 5.2 The Committee’s attention was drawn to the delay in the construction work on the new facility for production of TCARV with GMP compliant facility at PII. On a specific query in this regard, the Committee was informed that the lay-out plans for construction of Tissue Culture Anti Rabies Vaccine (TCARV) facility were finalized on 20th February, 2006, after which the drawings were prepared by HSCC (I) and submitted to the Coonoor Municipality during September, 2006, followed by the payment of fee for land development immediately after the assessment in October, 2006. Correspondence continued with the Coonoor Municipality during 2007 and 2008. In November, 2008, additional set of drawings as required by the Commissioner, Coonoor Municipality were prepared through the local engineer and submitted for approval for the construction of facility as per the layout plan without any deviation in the height limit. The matter was taken up with the Collector of Nilgiris District to grant approval to the construction of the manufacturing facility on 29th March, 2009 and again on 17th July, 2009. The Coonoor Municipality had forwarded the drawings to the Assistant Director of Town Planning, Coimbatore on 10th September, 2009 for examination and recommendations to the Hill Area Conservation Authority (HACA) for forwarding to the Department of Town and Country planning, Government of Tamil Nadu, Chennai for final approval. 5.3 In the meantime, the Oversight Committee comprising of WHO-GMP Expert, the DCGI and officials from the Ministry had visited the Institute on 14th and 15th of September 2009, and finalized the projects to be taken up by the Institute i.e., Diphtheria-Pertussis Block, Tetanus Block, Anti-sera, Animal Houses and Formulation and Filling Block including the TCARV. The conceptual layout plans of all the proposed buildings/blocks of PII, Coonoor were explained, discussed, modified and finalised by the Committee at its second meeting held on 21st October, 2009 at PII, Coonoor. 5.4 The Committee notes that the current layout plan is a revision of the one submitted earlier to the local authorities in terms of area (the total area of actual construction was 3958.00 Sq.mt. whereas in the new plan it is 5396.00 Sq.mt) the number of floors and the total working height 8 of the building (from three floors and 17.00 meter height in the earlier plan to four floors and 15.00 meter height in the new plan). Since the area of the structure was revised in the new plan, the plan for TCARV had to be re-submitted to the local authorities for approval. The estimated price for the TCARV project is Rs.50 crores and the tentative price of the entire project was placed at Rs.280 crores. 5.5 The Committee observes that till the 10th September, 2009 the issues surrounding the commencement of the construction work at PII, Coonoor were yet to be finalized even after three years, of the initial layout plans for the construction of TCARV facility being finalized on the 20th February 2006. Another disturbing fact which came to the notice of the Committee was that M/s HSCC (I), which had failed to build a GMP compliant structure at CRI, Kasauli after spending nearly 12 crores of public money, was involved by the Department to prepare the drawings of TCARV facility at PII, Coonoor. The Committee fails to understand as to how the services of an agency which expressed its inability to construct a GMP compliant structure in another Institute could be retained by the Ministry in the case of a second unit again. The Ministry has informed that the layout plan was originally submitted to the local body i.e. Coonoor Municipality during September, 2006. In November, 2008 another set of drawings was submitted for approval for the construction of the facility. Subsequently, the Oversight Committee visited the Institute in September, 2009 and the conceptual layout plans of all proposed buildings/blocks of PII were modified and finalized by it in October, 2009. Thereafter, the revised layout plan was again resubmitted to the local authorities for approval. The Committee is constrained to observe that a gap of almost three and a half years between the submission of the first layout plan and the last revised layout plan not only reflects poorly on the decision making process in the Ministry but also shows a lack of urgency on the part of the Ministry for reasons best known to it, in addressing this vital issue in a proactive manner. The Committee apprehends that given the pace with which the approval of the previous plan had progressed, a similar situation may arise for the revised plan. The Committee, therefore, suggests that the Ministry should, henceforth, leave no stone unturned to expedite the approval of the revised plan so that it is not inordinately delayed.

VI PROCUREMENT PRICE OF VACCINES 6.1 The Committee had, in its Thirty-Fourth Report, commented on a very pertinent issue regarding the procurement price of the vaccines. The Committee had observed that CRI, Kasauli, BCG VL, Chennai and PII, Coonoor are in the public sector and therefore, vaccines were available to the people at cheap prices, and the price of the vaccines could go up in future once their manufacturing goes into the private hands. 6.2 In reply, the Ministry in its ATN has informed that the three PSUs were supplying vaccine to the UIP as captive units, on no profit and no loss basis equal to their capacity without going through the tendering process from 2006-07 onwards. After the suspension of their manufacturing licenses for non-compliance of GMP norms, UIP vaccine procurement is being carried out from other PSUs as well as indigenous private sectors to meet the present requirements on the basis of competitive rates after inviting tenders. 6.3 On the issue of rising prices of vaccine the Secretary, Department of Health and Family Welfare had, informed during the course of her deposition before the Committee that although the private sector had quoted higher prices for the vaccines, the Government had negotiated at a relatively fair price. On being asked to provide full details of PSUs/ private firm-wise and quantum of vaccine supplied by them during 2007-08 and 2008-09, the Department has furnished the requisite details. A close scrutiny of the feedback received from the Ministry as indicated below 9 confirms the Committee’s apprehension regarding the increase in prices of vaccines after the closure of the three PSUs :

Vaccine Procurement Price BCG Years 2004-05 2005-06 2006-07 2007-08 2008-09 2009-10 Rate (per vial of 10 doses in Rs.) 20.00 13.00 13.00 – – Vaccine Institutes – – – 13.00 17.50 27.85 (SII) Other Public/ 13.50 Private Sector DPT Years 2004-05 2005-06 2006-07 2007-08 2008-09 2009-10 Rate (per vial of 10 doses in 14.37 11.8 11.80 11.80 – – Rs.) 12.15(BE), 13.00 13.00 13.50 13.40(II 23.59 (IIL and Vaccine 12.51(HBP L, BE), 23.49 Institutes CL). 14.37(se (Shantha) Other Public/ 15.20(SII) rum), Private Sector 16.88(BE)

D T Years 2004-05 2005-06 2006-07 2007-08 2008-09 2009-10 Rate (per vial of 10 doses in Rs.) 7.49 8.10 9.60 9.60 – Vaccine Institutes 7.49 7.49 9.14 12.00(IIL), – Other Public/ 13.85 Private Sector (BE)

T T Years 2004-05 2005-06 2006-07 2007-08 2008-09 2009-10 Rate (per vial of 10 doses in Rs.) 6.10 6.20 6.20 6.20 – – Vaccine Institutes 6.10 6.66 6.20 – 8.40 17.69(IIL, BE Other Public/ (IIL), and SII) Private Sector 11.85 (BE)

6.4 The Committee observes that from the year 2004-05 onwards the prices of the four vaccines namely BCG, DPT, DT and TT remained stable untill 2007-08. However, in the year 2008-09, and especially in 2009-10, the prices of vaccines have nearly doubled with the price of BCG rising from Rs.13.00 per vial of 10 doses in 2007-08 to Rs.17.50 in 2008-09 and to Rs.27.85 in 2009-10. Similarly, in the case of DPT vaccine which was earlier procured from the other public/private sector units at the rate of Rs.13.50 per vial of 10 doses to Rs.13.40 for the quantities procured from Indian Immunological Limited (IIL), Rs.14.37 from Serum Institute of India (SII), Pune and Rs.16.88 from Biological E. (BE) Ltd., Hyderabad during 2008-09. While, in 2009-10 the price per vial of 10 doses for DPT rose to 10

Rs.23.59 for supplies procured from IIL and BE, and Rs.23.49 from Shanta. Similarly, the price of the DT vaccine rose from Rs.9.14 per vial of 10 doses in 2007-08 to Rs. 12.00 (IIL) and Rs.13.85 (BE) for the quantities procured for the year 2008-09. For TT vaccine, the price per vial of 10 doses was Rs.6.20 in 2007-08 which rose to Rs.8.40 (IIL) and Rs.11.85 (BE) for the quantities procured for the year 2008-09 which again shot up to Rs.17.69 for the quantities procured from IIL, BE and SII for the year 2009-10. 6.5 The Committee observes that within two years of the closure of the three PSUs, the competitive prices of vaccines have shot up to more than double the figures. The Committee notes that with the rising prices of vaccines, the expenditure incurred in the implementation of the Universal Immunization Programme in the country would surely add to the burden of the Public Exchequer and the very objective of providing highly essential drugs like vaccines to the targeted population at affordable prices would stand defeated. Thus it is beyond doubt that the Ministry’s argument that the vaccines have been procured at relatively fair prices is not factually correct. It is also evident that after the closure of the captive units, the challenge to the private sector to provide vaccines at competitive prices has been nullified. Hence, the prices of vaccines have been spiraling upwards. The Committee has been given to understand that the Integrated Vaccine Complex at Chengalpattu, Tamil Nadu would be completed by the year 2012 and until then the vaccines required under UIP would be procured through the process of tendering as has been continuing since the last two years. The Committee apprehends that given the present trend of price rise, the prices of vaccine may rise manifold in the coming years which would hit hard the general public as well as the Government Exchequer. The Committee, therefore, observes, even at the cost of repetition, that for stabilizing the prices of vaccines, there may be no other alternative than revoking the suspension of the manufacturing license of the three vaccine Institutes to enable them to start production forthwith.

VII SHORTAGE OF VACCINES 7.1 Asked to comment on the shortfall of 11.22 crore doses of UIP vaccines in the year 2008-09 and 17 crore doses in the year 2009-10 as admitted by the Ministry itself in reply to an RTI application, the Ministry in a written reply has tried to explain away the shortage by stating that the actual requirement of vaccines for any particular year for which procurement order is placed during the year may be more or less than the projected requirement shown by the states as the actual requirement depends on a number of factors such as balance reported by States/GMSDs as on 1st April of that year, pipeline supplies of previous year etc. The Department has further stated that no shortage is anticipated during the year 2009-10. 7.2 The Committee is not inclined to agree with the explanation given by the Ministry about the actual requirement and the projected requirement of vaccines under UIP. The Committee wonders as to how the Ministry could deny the information submitted by it under RTI. Fact of the matter is that somewhere something is gravely wrong. Either the categorical information given under RTI supplemented by the fact that requirement details of some states were yet to be received is wrong or the subsequent clarification given by the Ministry is misleading. Either way, position seems to be very disturbing. Besides that, requirements projected being not judiciously made or non-utilization of available vaccines in a year cannot be considered an ideal situation. The Committee, accordingly, recommends that necessary steps may be taken for assessment of actual requirements of vaccines by different states followed by monitoring of their timely utilization. The Committee would also like to point out that inspite of overall coverage of states under UIP being satisfactory, very low coverage in some of the crucial states is a cause of serious concern. Committee’s attention has been drawn by the below 50 per cent coverage of vaccines under UIP in Delhi 11 in 2008-09, showing a downward trend when compared with 2007-08 figures. When this is the state of affairs in the capital city of the country, factual position in respect of other states is likely to be different from what is shown on paper.

VIII EFFICACY OF PSU-VACCINES VIS-A-VIS WHO NORMS 8.1 The Committee, in its Thirty-Fourth Report, had noted that until the inspections were carried out, the Institutes had been meeting the vaccine requirement for the entire country without reports of any adverse effects from the use of such vaccines. The Drug Controller General of India, during his deposition before the Committee, also admitted that no such complaint against the three vaccine producing units had been received so far. Response received from the Ministry to a subsequent query has been that no compilation of data with respect to the complaints received about the effectiveness of the vaccines produced by the three units during the last five years has been maintained. 8.2 On being pointed out by the Committee that since there has not been a single complaint about the safety of the vaccines produced by the three PSUs, why can’t the Department immediately start their production at these PSUs, in view of the shortage of the vaccines for Universal Immunization Programme to the tune of Rs.11.22 crore doses vis-a-vis the requirement of Rs.75.63 crore doses in the year 2008-09 and Rs.17 crore doses in the year 2009-10 as revealed by the Ministry in reply to an RTI application, the Secretary replied that India is a big exporter of vaccines and exports Rs.1600 crore worth of vaccines to almost 150 countries. If the National Regulatory Authority, who is Drug Controller General of India, adopts dual standard of imposing certain GMP norms on private sector but having completely non-compliant public sector, he would stand being derecognized by the World Health Organisation (WHO) which is the main agency for getting the country’s exports to the other countries. It was for this reason that the suspension of the manufacturing licenses of the three PSUs were not revoked. 8.3 The Committee notes that despite the Secretary’s admission before the Committee on 26th October, 2009 that “there is no evidence to show that the vaccines produced by the three PSUs were unsafe for the children” the Ministry has not taken any concrete steps towards resuming production of vaccines at the three PSUs. The Committee would like to make it abundantly clear that neither will it compromise on safe vaccines nor is it against GMP compliance, innovations or building competencies for new technology. However, it cannot remain a mute spectator to a situation where in the name of exports, GMP compliance and new technology, the entire vaccine market is handed over to the private sector and an impending shortage of vaccines is allowed to loom large over the Universal Immunization Programme. It is in this context that the Committee is of the considered view that revoking of the manufacturing licenses of the three PSUs should not wait for the submission of the Javed Chowdhary Committee Report. 8.4 The Committee, therefore, recommends that while the Ministry continues its exercise towards making the three vaccines Institutes GMP compliant, it should immediately revoke suspension of the manufacturing licenses of the PSUs to enable them to resume production of the vaccines produced by them earlier so that the flow of adequate supply of the vaccines at affordable prices for the UIP is maintained uninterrupted.

IX INTRODUCTION OF NEW VACCINES 9.1 During the course of her deposition before the Committee, the Secretary, Health and Family Welfare, pointed out that a new vaccine- Pentavalent vaccine-which can provide a child protection from three vaccines covered under DPT vaccine and also Hepatitis B and Hemophilus Influenzae type B (Hib) is proposed to be introduced under UIP. For that, required processes, competencies, 12 skills and infrastructure needed to be built up. The Committee notes that one of the vaccines proposed to be produced by the Integrated Vaccine Complex is Pentavalent Vaccine (100 million doses). 9.2 On a specific query regarding the effectiveness of the Pentavalent vaccine specially in the context of Indian population, the Committee was informed that the Sub-Committee on Hib and Pneumococcal of the National Technical Advisory Group on Immunization (NTAGI) had recommended, in April, 2008, for introduction of the same. The reason being that there was significant evidence of relatively high Hib disease burden in the country to warrant early introduction of Bib vaccine into the UIP. 9.3 The Committee notes that the price of Pentavalent Vaccine is about Rs.100 per dose whereas the price inclusive of CST/VAT @ 4% in the case of DPT vaccine is Rs.2.45 and for Hepatitis B Rs.4.96 per dose. The Committee has also been given to understand that Hib vaccine is available for Rs.300-400 per dose in the market. The Committee finds that now a review is being undertaken in view of high price and concerns for relevance of Pentavalent vaccine. The Secretary, Health Research has, accordingly, been requested to organize a discussion with paediatricians and experts. Only, thereafter, the policy on Pentavalent vaccine would be developed. The Committee is constrained to observe that the decision of NTAGI for introduction of Pentavalent vaccine was not based on any scientific assessment of its requirement in the country. 9.4 The Committee is happy to note that ultimately the Ministry has realized the essential need for going for an objective assessment in co-ordination with all concerned before arriving at a final decision on a vital issue relating to the health of our children, the future of the country. 13

OBSERVATIONS/RECOMMENDATIONS — AT A GLANCE

II REVIVAL OF VACCINE-PRODUCING PSUs The above sequence of events since the suspension of manufacturing licenses of the three units in January, 2008 clearly establishes the fact that their revival is not envisaged by the Government in the near future. Rather every attempt has been made to create hurdles so as to ensure that the process of making them GMP compliant continues for long and manufacturing process of major vaccines of UIP at these age-old PSUs remains suspended. The Committee takes note of the fact that the Expert Committee headed by the Drug Controller General of India, the supreme authority for quality control of drugs in the country has expressed its inability at arriving at a decision about the status of the three units inspite of persistent efforts by the Ministry. The Committee wonders how the Director General Health Services who is directly under the control of the Ministry could simply negate the report of the Expert Committee. The Committee is not aware of the fate of the latest Committee (Javed Chaudhary Committee) set up by the Ministry. But, the fact remains that the time is running out for the three vaccine producing units. (Para 2.3) What gives credence to Committee’s apprehensions is the background for setting up the Integrated Vaccine Complex at Chengalpattu (TN) and progress made so far. On a specific query, the Committee was informed that capability of HLL Lifecare Limited, a ‘Mini Ratna’ Public Sector Enterprise in implementing Healthcare projects, technology assimilation and expertise in vaccine business were the criteria for entrusting the company with the project. The Committee is, however, surprised to note that the only expertise of HLL Lifecare Limited in vaccine business so far has been marketing of Hepatitis B and Typhoid vaccines from 2005, followed by recent entry into marketing for Rabies Vaccine (Human) and sourcing agent for Government of India for the import and supply of JE vaccines since 2006. Technology transfer discussions with Denmark, Korea and Belgium based Institutes and positioning of a project team are the technology assimilation credited to the company. (Para 2.4) The Committee has also been informed that the first phase of the IVC project focusing on formulation facilities is expected to start in January, 2010 and to be completed in December, 2012. The second phase on bulk production units is expected to start in September, 2010 and to be completed in December, 2012. The Committee can, therefore, only conclude that at least for the next three years, supply of vaccines as per the requirements of the entire country will be met mainly by the private sector. Not only this, the quantum of manufacturing of VIP vaccines like DPT (100 million doses), TT ( 200 million doses), BCG (100 million doses), Measles (100 million doses), Hepatitis B (40 million doses) and Pentavalent combination vaccines (100 million doses) establishes the fact that the fate of the existing PSUs is sealed. (Para 2.5) The Committee’s worst fears are confirmed by the assessment about the three units given by the Ministry. According to the Ministry, what these units are going to produce is to be determined by a vaccine policy, yet to be formulated by the Government. Secretary, Health Research has been requested to organize a discussion with all concerned. Only thereafter, the policy on what the three units should manufacture for ensuring vaccine safety would be developed. It has also been pointed out that the three units, given their

13 14 heritage status have inherent capacity constraints to undergo the requisite modernization. Consequently, their product mix can never be as dynamic as envisaged in the case of IVC. (Para 2.6) The Committee is deeply disturbed by the conflicting signals emerging from the Government’s side on the status of the three existing vaccine- producing PSUs. On the one hand it is being emphasized time and again at different fora that Government is determined for the revival of the three units and every effort is being made to ensure their becoming GMP compliant, on the other hand it is also being categorically pointed out that their fate is to be decided by a vaccine policy yet to be formulated and they can never equate with the proposed ‘state of the art’ IVC project. (Para 2.7)

III CENTRAL RESEARCH INSTITUTE, KASAULI The Committee observes that the reply of the Ministry regarding the action taken against M/s HSCC, Noida for its failure to build a GMP compliant structure at CRI, Kasauli is simply untenable. The Committee also raises serious doubts on the process of awarding the contract to M/s HSCC, Noida. The process of awarding contract for building a GMP complaint structure to an agency which did not have the technical competence to build such a unit itself speaks volumes of a faulty process of selection ab initio. The Committee observes that it seems that from 1997-98 until December, 2006 — the time when M/s HSCC, Noida expressed its inability in completing the project, monitoring as required was not done by the Ministry to assess the progress of work undertaken by the agency. (Para 3.3) The Committee also finds that the action initiated by the Ministry against M/s HSCC, Noida has been perfunctory in nature. Instead of pursuing the matter vigorously, the Ministry has moved at a snail’s pace which is evident from the fact that action against the company has been initiated only after the matter was reported upon by the Committee in its 34th Report in February 2009, and thereafter also, it took the Ministry more than six months to reach a decision regarding referring the matter to CVC for advice and almost nine months to issue a notice to M/s HSCC. The reasons as to why the matter has remained pending from December, 2006 till date without any substantial action being initiated against the defaulter company simply escapes the Committee’s comprehension. The Committee also feels that the tardy pace of action taken so far clearly indicates dilatory tactic on the part of the Ministry. The Committee’s apprehensions in this regard get reinforced from the fact that the records pertaining to this case, which were forwarded to the CVC on 31st August, 2009, were not furnished in the prescribed new reporting format. The Committee is simply not ready to buy the argument that it took more than two months for the CVO of the Ministry to come to know that the communication from the Ministry to CVC was not forwarded as per the new reporting format. The Committee is constrained to call into question the seriousness of the Ministry to take stringent action against those who were responsible for this mix-up. The Committee, therefore, recommends that the Departmental Inquiry under progress may be completed within a strict time frame and action may be initiated against those responsible without further delay. The Committee would like the Ministry to provide a copy of the enquiry report as well as the follow-up action taken thereon. (Para 3.4) The Committee takes serious objection to the state of affairs emerging after submission of a project proposal by CRI. The Committee wonders about the feasibility of the DPT unit at CRI becoming GMP compliant by June, 2010 as the process of selection of implementing agency is still continuing. Further, the rationale of inviting HLL Lifecare Ltd. for taking up the project by ignoring the names of experienced vendors suggested by WHO 15 is also not known to the Committee. The Committee views with serious concern the involvement of HLL Lifecare Ltd., for Kasauli project when it is already set to start an ambitious Vaccine Park at Chengalpattu (TN). The Committee, accordingly, recommends that the approved layout plan for the DPT vaccine unit at CRI, Kasauli should be implemented in a transparent and time-bound manner. (Para 3.7) The Committee is not happy with the status of duly sanctioned posts at CRI remaining vacant for so long leading to some posts getting lapsed. The fact that as many as 27 Group ‘A’ posts and 10 Group ‘B’ Non-Gazzetted Posts are still vacant at CRI requires the matter to be pursued vigorously and’ persistently. Not only this, action also needs to be initiated without any delay for reassessment of requirement of manpower at CRI in accordance with the GMP norms and the revival plan. (Para 3.9)

IV BCG VACCINE LABORATORY, CHENNAI The Committee would like to point out that as per the status note of the Ministry, a proposal for upgradation/renovation of BCGVL, Chennai was submitted to the Drug Controller General of India on the 30th January, 2008. This was followed by a report of the Institute submitted to the Deputy Drugs Controller, South Zone on 26th February, 2008 and later on 20th March, 2008 to the Ministry of Health and Family Welfare about the rectification work that it had carried out in the Institute. Not only this, the Institute had preferred appeals twice, - once on 24th January, 2008 against DCGI’s decision to suspend its license, and again on 14th June, 2008 to the Ministry of Health and Family Welfare to revoke suspension of the license. However, the ATN did not mention as to what action was taken on the part of the Ministry to consider their case in the light of the rectifications carried out by the Institute. (Para 4.2) The Committee would like to note here that the Ministry had furnished the Inspection Report of the WHO-NRA team that had visited BCGVL in August, 2007 along with the status note vide its O.M. dated 24th July 2008 to the Committee for its consideration. The Committee would like to point out that the onus of furnishing vetted information to a Parliamentary Committee lies with the Ministry. The Committee finds it strange that the Ministry had not challenged the veracity of the report submitted by the Institute while forwarding the same to it. The Ministry continued to remain silent on this issue even in its Action Taken Note. It was only after a pointed query with regard to rectification of 45 deficiencies out of the 55 deficiencies pointed out by the WHO-NRA assessment team, that the Ministry has chosen to react. An attempt has been made by the Committee to make a comparative analysis of 55-deficiency and 70-deficiency Reports. The Committee has no hesitation in arriving at the conclusion that the so-called additional 15 deficiencies are duly reflected in the original report, the only difference being that some of the deficiencies are in the expanded form in the later report. The Committee is also not inclined to agree with the contention of the Ministry that the action taken information was not complete and did not indicate the manner of compliance/rectification of deficiencies. (Para 4.4) The Committee takes note of the fact that as per the Expert Committee constituted in April, 2008, the existing facilities had inherent problems for renovation and vaccines can be manufactured only on the construction of new facilities. Feasibility of BCGVL becoming GMP compliant has become more difficult in the light of the latest report given by the Oversight Committee in October, 2009. Although, WHO GMP expert has been requested to prepare the preliminary layout plan for the Institute, there is no land available for the same. A proposal is, therefore, in the pipeline to shift the work of the Institute along with 16 its personnel to the upcoming Vaccine Complex at Chengalpattu. The Committee strongly feels that a pre-conceived view about there being no possibility of BCGVL becoming GMP compliant is very dominant. The very fact that persistent efforts made by the Institute authorities to rectify the deficiencies pointed out in the WHO-NRA assessment report and succeeding in removing the majority of the same with the remaining ones being the responsibility of the Ministry have been of no avail, confirms Committee’s observations. (Para 4.5)

V PASTEUR INSTITUTE OF INDIA, COONOOR The Committee observes that till the 10th September, 2009 the issues surrounding the commencement of the construction work at PII, Coonoor were yet to be finalized even after three years, of the initial layout plans for the construction of TCARV facility being finalized on the 20th February 2006. Another disturbing fact which came to the notice of the Committee was that M/s HSCC (I), which had failed to build a GMP compliant structure at CRI, Kasauli after spending nearly 12 crores of public money, was involved by the Department to prepare the drawings of TCARV facility at PII, Coonoor. The Committee fails to understand as to how the services of an agency which expressed its inability to construct a GMP compliant structure in another Institute could be retained by the Ministry in the case of a second unit again. The Ministry has informed that the layout plan was originally submitted to the local body i.e. Coonoor Municipality during September, 2006. In November, 2008 another set of drawings was submitted for approval for the construction of the facility. Subsequently, the Oversight Committee visited the Institute in September, 2009 and the conceptual layout plans of all proposed buildings/blocks of PII were modified and finalized by it in October, 2009. Thereafter, the revised layout plan was again resubmitted to the local authorities for approval. The Committee is constrained to observe that a gap of almost three and a half years between the submission of the first layout plan and the last revised layout plan not only reflects poorly on the decision making process in the Ministry but also shows a lack of urgency on the part of the Ministry for reasons best known to it, in addressing this vital issue in a proactive manner. The Committee apprehends that given the pace with which the approval of the previous plan had progressed, a similar situation may arise for the revised plan. The Committee, therefore, suggests that the Ministry should, henceforth, leave no stone unturned to expedite the approval of the revised plan so that it is not inordinately delayed. (Para 5.5)

VI PROCUREMENT PRICE OF VACCINES The Committee observes that from the year 2004-05 onwards the prices of the four vaccines namely BCG, DPT, DT and TT remained stable untill 2007-08. However, in the year 2008-09, and especially in 2009-10, the prices of vaccines have nearly doubled with the price of BCG rising from Rs.13.00 per vial of 10 doses in 2007-08 to Rs.17.50 in 2008-09 and to Rs.27.85 in 2009-10. Similarly, in the case of DPT vaccine which was earlier procured from the other public/private sector units at the rate of Rs.13.50 per vial of 10 doses to Rs.13.40 for the quantities procured from Indian Immunological Limited (IIL), Rs.14.37 from Serum Institute of India (SII), Pune and Rs.16.88 from Biological E. (BE) Ltd., Hyderabad during 2008-09. While, in 2009-10 the price per vial of 10 doses for DPT rose to Rs.23.59 for supplies procured from IIL and BE, and Rs.23.49 from Shanta. Similarly, the price of the DT vaccine rose from Rs.9.14 per vial of 10 doses in 2007-08 to Rs.12.00 (IIL) and Rs.13.85 (BE) for the quantities procured for the year 2008-09. For TT vaccine, the price per vial of 10 doses was Rs.6.20 in 2007-08 which rose to Rs.8.40 (IIL) and Rs.11.85 (BE) for the quantities procured for the year 2008-09 which again shot up to Rs.17.69 for the quantities procured from IIL, BE and SII for the year 2009-10. (Para 6.4) 17

The Committee observes that within two years of the closure of the three PSUs, the competitive prices of vaccines have shot up to more than double the figures. The Committee notes that with the rising prices of vaccines, the expenditure incurred in the implementation of the Universal Immunization Programme in the country would surely add to the burden of the Public Exchequer and the very objective of providing highly essential drugs like vaccines to the targeted population at affordable prices would stand defeated. Thus it is beyond doubt that the Ministry’s argument that the vaccines have been procured at relatively fair prices is not factually correct. It is also evident that after the closure of the captive units, the challenge to the private sector to provide vaccines at competitive prices has been nullified. Hence, the prices of vaccines have been spiraling upwards. The Committee has been given to understand that the Integrated Vaccine Complex at Chengalpattu, Tamil Nadu would be completed by the year 2012 and until then the vaccines required under UIP would be procured through the process of tendering as has been continuing since the last two years. The Committee apprehends that given the present trend of price rise, the prices of vaccine may rise manifold in the coming years which would hit hard the general public as well as the Government Exchequer. The Committee, therefore, observes, even at the cost of repetition, that for stabilizing the prices of vaccines, there may be no other alternative than revoking the suspension of the manufacturing license of the three vaccine Institutes to enable them to start production forthwith. (Para 6.5)

VII SHORTAGE OF VACCINES The Committee is not inclined to agree with the explanation given by the Ministry about the actual requirement and the projected requirement of vaccines under UIP. The Committee wonders as to how the Ministry could deny the information submitted by it under RTI. Fact of the matter is that somewhere something is gravely wrong. Either the categorical information given under RTI supplemented by the fact that requirement details of some states were yet to be received is wrong or the subsequent clarification given by the Ministry is misleading. Either way, position seems to be very disturbing. Besides that, requirements projected being not judiciously made or non-utilization of available vaccines in a year cannot be considered an ideal situation. The Committee, accordingly, recommends that necessary steps may be taken for assessment of actual requirements of vaccines by different states followed by monitoring of their timely utilization. The Committee would also like to point out that inspite of overall coverage of states under UIP being satisfactory, very low coverage in some of the crucial states is a cause of serious concern. Committee’s attention has been drawn by the below 50 per cent coverage of vaccines under UIP in Delhi in 2008-09, showing a downward trend when compared with 2007-08 figures. When this is the state of affairs in the capital city of the country, factual position in respect of other States is likely to be different from what is shown on paper. (Para 7.2)

VIII EFFICACY OF PSU-VACCINES VIS-A-VIS WHO NORMS The Committee notes that despite the Secretary’s admission before the Committee on 26th October, 2009 that “there is no evidence to show that the vaccines produced by the three PSUs were unsafe for the children” the Ministry has not taken any concrete steps towards resuming production of vaccines at the three PSUs. The Committee would like to make it abundantly clear that neither will it compromise on safe vaccines nor is it against GMP compliance, innovations or building competencies for new technology. However, it cannot remain a mute spectator to a situation where in the name of exports, GMP compliance and new technology, the entire vaccine market is handed over to the private sector and an impending shortage of vaccines is allowed to loom large over the Universal 18

Immunization Programme. It is in this context that the Committee is of the considered view that revoking of the manufacturing licenses of the three PSUs should not wait for the submission of the Javed Chowdhary Committee Report. (Para 8.3) The Committee, therefore, recommends that while the Ministry continues its exercise towards making the three vaccines Institutes GMP compliant, it should immediately revoke suspension of the manufacturing licenses of the PSUs to enable them to resume production of the vaccines produced by them earlier so that the flow of adequate supply of the vaccines at affordable prices for the UIP is maintained uninterrupted. (Para 8.4)

IX INTRODUCTION OF NEW VACCINES The Committee notes that the price of Pentavalent Vaccine is about Rs.100 per dose whereas the price inclusive of CST/VAT @ 4% in the case of DPT vaccine is Rs.2.45 and for Hepatitis B Rs.4.96 per dose. The Committee has also been given to understand that Hib vaccine is available for Rs.300-400 per dose in the market. The Committee finds that now a review is being undertaken in view of high price and concerns for relevance of Pentavalent vaccine. The Secretary, Health Research has, accordingly, been requested to organize a discussion with paediatricians and experts. Only, thereafter, the policy on Pentavalent vaccine would be developed. The Committee is constrained to observe that the decision of NTAGI for Introduction of Pentavalent vaccine was not based on any scientific assessment of its requirement in the country. (Para 9.3) The Committee is happy to note that ultimately the Ministry has realized the essential need for going for an objective assessment in co-ordination with all concerned before arriving at a final decision on a vital issue relating to the health of our children, the future of the country. (Para 9.4) 19

MINUTES 20 21

II SECOND MEETING (2009-10)

The Committee met at 3.00 P.M. on Monday, the 26th October, 2009 in Committee Room ‘B’, Ground Floor, Parliament House Annexe, New Delhi. MEMBERS PRESENT

RAJYA SABHA 1. Shri Amar Singh — Chairman 2. Shrimati Viplove Thakur 3. Dr. Radhakant Nayak 4. Shri Janardan Dwivedi 5. Shrimati Brinda Karat 6. Shrimati Vasanthi Stanley LOK SABHA 7. Shri Ashok Argal 8. Shrimati Sarika Devendra Singh Baghel 9. Shri Vijay Bahuguna 10. Dr. Sanjay Jaiswal 11. Shri S.R. Jeyadurai 12. Dr. (Shrimati) Kruparani Killi 13. Shri N. Kristappa 14. Dr. Tarun MandaI 15. Shri Datta Meghe 16. Dr. Jyoti Mirdha 17. Shri R.K. Singh Patel 18. Shri M.K. Raghavan 19. Dr. Anup Kumar Saha 20. Shrimati Meena Singh 21. Shri Ratan Singh SECRETARIAT Shrimati Vandana Garg, Additional Secretary Shri R. B. Gupta, Director Shrimati Arpana Mendiratta, Joint Director Shri Dinesh Singh, Assistant Director

21 22

WITNESSES Representatives of Department of Health and Family Welfare

1. Ms. K. Sujatha Rao, Secretary 2. Shri V. Venkatachalam, Additional Secretary 3. Mrs. Shakuntala Gamlin, Joint Secretary 4. Dr. Surinder Singh, Drug Controller General (India) 2. * * *

3. The Committee then heard the Secretary and other senior officers of the Ministry of Health and Family Welfare on the Action Taken Note (ATN) furnished by the Department of Health and Family Welfare on the Thirty-Fourth Report of the Committee on “Functioning of the three vaccine producing PSUs, namely, the Central Research Institute (CRI), Kasauli, Himachal Pradesh; the Pasteur Institute of India (PII), Coonoor, Tamil Nadu and the BCG Vaccine Laboratory (BCGVL), Chennai, Tamil Nadu”. 4. During the course of the evidence, Members sought clarifications on a number of issues like the rationale behind suspension of licenses of the three vaccine producing PSUs despite no adverse reports about their safety and efficacy; the reasons behind the Department's failure to take timely corrective action on the recommendations made by the WHO – National Regulatory Authority (NRA) in their first two inspections in 2001 and 2004; the updated status of the efforts towards making the above PSUs Current Good Manufacturing Practices (cGMP) compliant; status of availability of vaccines during the current year and other allied aspects. The Secretary replied to some of the queries raised by the Members during the course of the meeting and assured to furnish written replies to all the queries raised during the deliberation. 5. * * *

6. A verbatim record of the meeting was kept.

7. The Committee then adjourned at 4.34 P.M.

*** Relates to other matters. 23

V FIFTH MEETING (2009-10)

The Committee met at 5.00 P.M. on Thursday, the 17th December, 2009 in Room No. 67, First Floor, Parliament House, New Delhi.

MEMBERS PRESENT

RAJYA SABHA 1. Shri Amar Singh — Chairman 2. Shrimati Viplove Thakur 3. Dr. Radhakant Nayak 4. Shri Janardan Dwivedi 5. Shrimati Brinda Karat 6. Shrimati Vasanthi Stanley LOK SABHA 7. Shrimati Sarika Devendra Singh Baghel 8. Dr. Chinta Mohan 9. Dr. Sanjay Jaiswal 10. Dr.(Shrimati) Kruparani Killi 11. Dr. Tarun MandaI 12. Dr. Jyoti Mirdha 13. Shrimati Jayshreeben Patel 14. Shri R.K. Singh Patel 15. Shri M.K. Raghavan 16. Shri Ratan Singh SECRETARIAT Shrimati Vandana Garg, Additional Secretary Shri R. B. Gupta, Director Shrimati Arpana Mendiratta, Joint Director Shri Dinesh Singh, Assistant Director

2. At the outset, the Chairman welcomed Members to the meeting and briefed them about the agenda of the meeting. The Committee then considered the draft 38th Report on the ‘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’. After some discussion, the Committee adopted the Report with certain minor changes.

23 24

3. The Committee, thereafter, decided that the Report may be presented to the Rajya Sabha and laid on the Table of the Lok Sabha on Friday, the 18th December, 2009. The Committee authorized the Chairman of the Committee and in his absence Shrimati Brinda Karat to present the Report in Rajya Sabha, and, Dr. Jyoti Mirdha, and in her absence Dr. Tarun MandaI to lay the Report on the Table of the Lok Sabha.

4. * * *

5. The Committee then adjourned at 5.45 P.M.

*** Relates to other matters. Printed at : Bengal Offset Works, 335, Khajoor Road, Karol Bagh, New Delhi-110005.