E-DRUG: Vaccine production in developing countries (2)
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AIDAN press release re cancellation of vaccine manufacturing units
All India Drug Action Network (AIDAN)
(http://aidanindia.org/)
Towards a people oriented, rational, drug policy!
June 2, 2008 Press Release: AIDAN/080602/ 01
Cancellation of vaccine-manufacturing public enterprises licenses:
AIDAN calls for a rethink
The All India Drug Action Network (AIDAN) is a national network of organizations that have been working on pharmaceutical policy issues since the early eighties. Reacting to the news of cancellation of licenses of three vaccine-manufacturing public enterprises, namely 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) has 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 Immunization. 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)1 point to an unprecedented disregard for public good.
The Minister of Health and Family Welfare, Dr. Anbumani Ramadoss has said that the enterprises were ordered to suspend production for non-compliance with good manufacturing practice (GMP). This gives rise to many issues:
1) 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 4 years to ensure their compliance with newer norms? While the Government is planning to spend Rupees 3000 to Rupees 5000 billion to develop the upcoming vaccine and medical park in Chengalpattu which will become operational in 2012, why were these three enterprises which were engaged in vaccine production since decades not provided with the Rupees 500-600 billion they required? Who will supply vaccines in the interim, and at what cost?
2) The closure of vaccine production in these units comes at a time, when the demand-supply in vaccines for Indias Expanded Program for Immunization (EPI) is widening, private companies are pushing expensive cocktails of the EPI vaccines with other vaccines in the market, and coverage of immunization against these crucial vaccine preventable diseases is declining2. The closure of production of these vaccine producing units will have enormous implications for the cost and access to these vaccines in the future.
3) While the Ministry has acted with alacrity and closed down production in public sector units, it has dragged its feet in matters where private pharmaceutical companies are involved, even if the issues are of crucial concern to people and public health. A few instances of these are:-
a. Action is curiously lacking in the matter of regulation of drug quality with only 17 testing laboratories in the entire country, and only 7 which can be termed fully functional, as per the Mashelkar report in 2005.
b. Action is also curiously lacking against private companies which continue to manufacture hundreds of formulations which the Drug Controller General has admitted in Court as lacking his approval and are therefore illegal.
c. Action is curiously lacking in the matter of hazardous drugs like Nimesulide, which are freely promoted in India for use in children, while it is banned for use below 12 years in the European Union and not available in USA, Canada, Australia or even in neighbouring Sri Lanka.
d. The Health Ministry also does not seem concerned with the low availability of essential medicines in public health facilities3 or the increasing unaffordability of drugs in India.
e. The Health Ministry is not known to have taken any stand or action when competitive
medicine brands are sold at an entirely inexplicable 1000% price difference or where drugs are provided to the retailer at even 5-10% of their retail price, or where any attempt at regulating the retail prices are vociferously challenged by the pharmaceutical companies.
Even if by a curious anomaly, the pharmaceutical policy is formulated by the Ministry of
Chemicals, has the Ministry of Health and Family Welfare ever articulated these concerns, which are creating misery for millions?
In this context, 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 3 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 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. The falling rates of immunization are a blot on the functioning of the Government, especially the Ministry of Health and Family Welfare and the state health departments. 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.
Addresses for Correspondence:
Dr. Mira Shiva, A-60, Hauz Khas, New Delhi. India, Tel: +91 (0)11-26855010, +91 (0)9810582028. Email: mirashiva@yahoo.com
Dr. Gopal Dabade, 57, Tejaswinagar, Dharwad 580002. India, Tel: +91 (0)836-2461722, +91 (0)9448862270. Email: drdabade@gmail.com
Mr. S.Srinivasan, LOCOST (Low Cost Standard Therapeutics), Tel: +91 (0)265-2340223/2333438. Email: sahajbrc@youtele.com
Dr. Anurag Bhargava, Jan Swasthya Sahyog, Bilaspur, Tel: +91 (0)7752-270751, Email: abhar786@yahoo.com
References:-
1)
the heedless decision by the Ministry/Drugs Controller, without ascertaining all the factors, is not acceptable to audit. BCG Vaccine Lab is not a private company; it is a 100 per cent Government of India department. If there is any deficiency in modernisation of building as per norms of WHO or system change in quality control, the Government should use all its force and concentration so that the unit is revitalised.
2) The immunization coverage of children among 1 year olds in India for 3 doses of DTP has come down from 70% in 1990 to 55% in 2006. In contrast, the global figures indicated an increase from 75 to 79% for the same period. These figures were released by World Health Organisation (WHO) in its latest publication World Health Statistics 2008. The Third National Family Health Survey (NFHS-3) had earlier shown that the
percentage of children between 1 and 2 years who had received all recommended vaccines had also come down from 61% to 58% in urban areas between the period of NFHS-2 (1998-99) and NFHS-3 (2005-06).
3) In a study done in 6 states and published in the May 2007 issue of the Indian Journal of Medical Research, the availability of essential medicines varied from 0% to 30%.
Dr Gopal Dabade,
57, Tejaswinagar,
Dharwad 580 002
Tel 0836-2461722
Cell (0)9448862270
www.jagruti.org
www.aidanindia.org
www.daf-k.cjb.net
Dr Gopal Dabade <dabadedr@yahoo.com>