Sabotaging Indigenous Production of Vaccines

By now it is well-recognised that government authorities who come under the influence of imperialism and big business do not hesitate to kill their own invaluable institutions. Several public sector institutions and organisations of great value have been destroyed in this way, with the willing participation of international organisations which too are, sadly, frequently under the sway of multinational companies and developed countries. This crime becomes all the more unpardonable when it takes place in the area of health, threate-ning the life of many people particularly children.

The health sector of developing countries like India functions in a situation of severe fund constraints. Even if the demands for significantly increasing the health budget are met, so immense is the task of providing satisfactory health care to all that we need maximum efforts to keep costs (particularly costs of medicines and equipment) low. The tendency of most drug companies to keep medicine prices high and fleece even poor countries is well-known. Therefore, self-reliance in the production of low-cost medicines and vaccines is extremely important for these countries. What is more, some critical areas and certain levels of production of medicines have to be retained in the public sector, so that the country is capable of meeting critical and emergency needs as well as retain the ability to keep the costs of essential medicines within reasonable limits.

However, what we have seen in recent times is the decline and decay of public sector units producing medicines while the private sector’s ability to charge high prices which have no relation to costs has never been so high. The number of medicines under price control has declined steadily. This did not happen suddenly and did not happen on its own—deliberate efforts were made by vested interests with the collusion of important people within the government to achieve this result.

It is in this framework that the decision of the government to cancel the licences of three vaccine-manufacturing public enterprises must be seen. Although this decision was taken in January 2008, the Opposition to this decision is now increasing with the emerging shortage of vaccines and the threat this poses to the health of people and particularly children. The three institutions affected by this decision are: the 103-year-old Central Research Institute (CRI), Kasauli; the 100-year-old Pasteur Institute of India (PII), Coonoor; and the 60-year-old BCG Vaccine Laboratory (BCGVL) in Chennai.

The All-India Drug Action Network (AIDAN), a national network of organisations that have been working on pharmaceutical policy issues, issued the following statement: “While there should be no compromise on the quality of medicines and vaccines produced, the cancellation of the licenses for the three vaccine-manufacturing public enterprises under the Ministry of Health and Family Welfare smacks of arbitrariness, and a planned attempt to kill these institutions and clear the way for private companies to operate in a segment which serves a critical national need—the production of vaccines for the large Expanded Program of Immunisation. Recent newspaper reports of alleged nexus between the Ministry of Health and Family Welfare and a private vaccine manufacturing company in blatant disregard of the public responsibilities of their role, use of coercion to effect closure of vaccine production units with a proven record of safety and quality, and the comments in the preliminary audit report of the Comptroller & Auditor General (CAG) point to an unprecedented disregard for public good.”

Responding to the government’s claim that these enterprises were ordered to suspend production for non-compliance with ‘good manufacturing practice’ (GMP), this statement by the AIDAN: asks “Since the public enterprises were under the Ministry of Health and Family Welfare, and had been requesting for assistance to upgrade their facilities since the past many years , what did the Minister of Health and Family Welfare do over the past four years to ensure their compliance with newer norms?”

Further this important statement by the AIDAN says: “The entire sequence of events over the past few years, with allegations of purchase of raw material for measles vaccines at inflated cost from private companies, providing them raw material from these three units at either free or at ridiculously low prices, and further agreeing to give 70 per cent of the profit from vaccine manufacturing to the private company needs an enquiry at the highest level.

“The harm to public health in India due to this malafide closure of public sector units is already being seen. many states are now facing dangerous shortages of vaccines like DPT and Tetanus toxoid, which were only to be expected. Shall the Minister assume the responsibility if any child dies of tetanus or diptheria? The All India Drug Action Network (AIDAN) calls on the Government to stop playing games with the health and lives of innocent children and with the pharmaceutical security of the nation, in its attempts to pave the way for private enterprise.”

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If we look at the past experience of how public health enterprises are destroyed to benefit big business, then generally the following pattern can be seen :

1. Suddenly develop new criteria and norms which will be difficult for public enterpries to satisfy under existing conditions. Rope in international ‘experts’ and institutions to push for these norms.

2. Use government’s powers to deny funds and facilities which would enable public enterprises to meet these norms.

3. Then use this as an excuse to take action against public health enterprises, all the time hiding behind so-called public health and quality concerns.

This is precisely the pattern behind the closure of the vaccines manufacturing facilities of these three units. Otherwise how can we explain the curious phenomenon of the government taking action against its own units while denying them funds and facilities to improve?

All this should be seen within the wider framework of how various vested interests have tried to dominate vaccine production and research to carve out markets and maximise profits. This is explained well in an editorial of the Indian Journal of Medical Research 127, January 2008 (written by Jocob M. Puliyal and Yennapu Madhavi.

“The methods used by economically well-off nations to gain control over economically poor countries by accessing their markets and creating demand for medical technologies/vaccines, irrespective of local needs, have been documented extensively. As a new product is being readied, research is published to highlight the number of deaths in the country caused due to the absence of that vaccine. The estimates are often outright exaggerations or reflect poor research design. The limitations of such models have been pointed out previously. The recent announcement by the National AIDS Control Organisation (NACO) that the prevalence of HIV/AIDS is only half of the earlier estimates is the first official admission of methodological fallacies. This comes close on the heels of an admission by authors based in Centres for Disease Control (CDC) Atlanta (authors who use a World Health Organisation (WHO) Geneva address, alternatively), that the model used to calculate hepatitis B mortality in India (which enabled them to inflate the figure 50-fold) was missing...

“In the face of bourgeoning and aggressive marketing of vaccines of doubtful utility, we have a widening demands-supply gap in Expanded Programme on Immunisation (EPI) vaccines. Over the last few decades, due to the decline of the public sector and the growing disinterest of the private sector, the number of firms supplying EPI vaccines has declined drastically both in India and abroad, prompting the UNICEF to express its serious concerns about the short supply of EPI vaccines. Private manufacturers prefer to sell them as ‘value-added cocktail vaccines’ at exorbitant prices in the open market, rather than supply to EPI. The universal tendency to combine EPI vaccines with non-EPI vaccines not only creates an artificial scarcity for affordable EPI vaccines, but also creates a backdoor method for the entry of expensive and perhaps unnecessary non-EPI vaccines into the universal immunisation programme, riding piggyback on the EPI vaccines.... Only a ban against combinations of EPI and non-EPI vaccines, and a stipulation that only those private manufacturers who supply EPI vaccines to the government will be allowed to sell them in any form in the open market will save the EPI as well as the consumers. Dire situations call for drastic action.... Within the emerging scenario where expensive vaccines swallow up the less expensive options, India could emerge as the ethical EPI vaccine supplier to the world.”

For India to be able to play such a noble role, we should first defeat the nefarious designs of those who seek to sabotage the indigenous production and R and D in the area of vaccines. A step in the right direction will be to re-start the production of vaccines in the three public enterprises by renewing their licencse for this purpose. As the AIDAN statement says, “Efforts must be made to ensure safe and steady supply of cost-effective vaccines and universal immunization of children. To ensure this, the robust functioning of public enterprises like CRI, Kasauli, PII, Coonoor, and BCGVL, Chennai are essential. We call on the Government to reverse with immediate effect its directives on the functioning of these enterprises and to ensure all assistance to make them compliant with newer norms.”