People's Democracy

CPI(M) Demands Protection Of

Public Sector Vaccine Units

Health Minister Responds Positively

In reply to a letter of CPI(M) MP and Polit Bureau member Brinda Karat regarding stoppage of production in three public sector vaccine units Dr Anbumani Ramdoss, minister for health said that ministry of health & family welfare has initiated steps to establish a state of the art vaccine manufacturing facility in public sector and during this transitory phase, requirement of vaccine for our immunisation programme would be met through our domestic supplier following due procurement process.

Below we publish text of the both the letters:

Brinda Karat�s letter

to Dr Anbumani Ramadoss

on April 10, 2008

Dear Dr Anbumani Ramadoss,

I am writing to you in connection with the reported decision of the health ministry to stop production in three public sector vaccine units following the suspension of their licenses to produce vaccines by the DGGI. The grounds are that these units do not meet the WHO standards of GMP (Good Manufacturing Process). Safety and efficacy of vaccines produced are critical for public health and more so when the country�s basic immunisation programme for millions of infants and children use vaccines produced in these units. Measures to upgrade the manufacturing processes of these units are therefore extremely important and no compromise should be made on this score. At the same time it is equally important to note that the quality, potency and safety of the vaccines produced and supplied by the PSUs has never been in question.

These units have been producing 60-70 per cent of the immunisation requirements of the country at low cost. Their closure will leave the field open to corporate pharma companies and MNCs to supply the vaccines required for the national immunisation programme and the public health system. Surely this is not in the national interest. The units have trained manpower, and have developed indigenous R and D capability that should be the core of any public health programme. It is therefore inexplicable why the health ministry instead of upgrading these units in a time bound framework should take a decision to close them down. Has any feasibility study been done by any experts before taking such a decision? It is reported that the upgradation of the Coonoor Institute had already begun at a cost of Rs 30 crore and that another Rs 20 crore is required to complete the process; the Kasauli institute will reportedly require another Rs 30 crore. The financial implications are therefore not substantial. Moreover the units have enough land to permit further expansion.

It is reported that as an alternative the ministry has planned to start a vaccine park in Tamilnadu entrusted to HLL at an initial cost of Rs 150 crore. Does HLL have the necessary expertise in vaccine production and what is the timeframe for it to produce the vaccines? In the interim will private companies be supplying the vaccine? When there are already vaccine producing units in the public sector with the necessary expertise what is the logic behind such a decision? Is the ministry planning to set up new public sector units in this park or is the intention to encourage private sector companies to take over the entire vaccine production in the country to supply public health programme? If so the cost of the exchequer will be extremely high apart from dealing a death blow to the model of self-reliance being pursued by the PSUs who have been functioning to decades.

It is worth looking at the experience of other third world and developing countries who have been at the receiving end of the profit-making agendas of corporate pharmas precisely because their health programmes became dependant on the private sector.

I would request you to reconsider this decision. Upgradation of the PSUs is in the national interest and will further strengthen the immunisation programme.

MINISTER�S

REPLY ON

May 16, 2008

Dear Brinda Karat ji,

Please refer to your letter No. BK/2008/1166 dated April 10, 2008 regarding stoppage of production of vaccine at three public sector vaccine institutes following suspension of their licenses for non-compliances of WHO standards of GMP and for considering upgradation of these institutes.

In this connection I would like to share with you certain developments as under.

• WHO has a Scheme of assessing National Regulatory Authority (NRA) assessment in order to monitor the quality of vaccines supplied globally to various UN agencies and for exports. India went through this evaluation for the first time in the year 2001, next in 2004 and lastly in August 2007.

• Prior to the last assessment, a partial compliance of the requirements used to be accepted. The NRA assessment was cleared in the years 2001 and 2004 by partial compliance only. But in July 2007 the benchmarks for the evaluation were tightened and partial compliance was no more acceptable for recognition.

• In the last inspection of these units and NRA review in August, 2007, the WHO inspection team observed that NRA had not been able to ensure compliance as far as GMP requirements are concerned. Based on this the license of these Vaccine Institutes were suspended.

• It would be pertinent to mention here that we have a dearth of testing facility and its is our plan to expand this facility at the Institute. As you are fully aware that our testing facilities of BCG Lab Chennai, PII Coonoor, CDL Kasauli, are already functioning with constraint and it is proposed to expand these facilities further and provide requisite training to the employees for this purpose. The Institutes are, therefore, proposed to be re-structured accordingly. An expert team has been constituted which will examine the facilities of these Institutes for further restructuring.

• Ministry of health and family welfare has initiated steps to establish a state of the art vaccine manufacturing facility in public sector and during this transitory phase, requirement of vaccine for our immunisation programme would be met by our domestic supplier following due procurement process. After the restructuring of the existing vaccine manufacturing Institute and commissioning of the new manufacturing facility, departmental/public sector units would be in position to supply major requirements for our immunisation programme.

I appreciate your deep concern about these Institutes. I assure you that my ministry will make all endeavours to protect the interest of the institutes and of the government as well.

(INN)