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[e-drug] Vaccine production in developing countries (2)

E-DRUG: Vaccine production in developing countries (2)

AIDAN press release re cancellation of vaccine manufacturing units
All India Drug Action Network (AIDAN)
  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 India?s 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 
  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
  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
Dr Gopal Dabade <dabadedr@yahoo.com>

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