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INDIA TODAY
    CURRENT ISSUE OCTOBER 10, 2005
 
   CONTROVERSY: VACCINES
 
Prestige Pinpricks

Manufacturers wrangle over who first indigenously produced an important four-in-one combination vaccine in the country.
 
It is at best a tenuous claim that those tapping science and technology make in the scramble to be first-off-the-block with an indigenous product. In the race for one such coveted label, well-known vaccine manufacturers Serum Institute of India (SII), Pune, and Shantha Biotechnics, Hyderabad, have locked themselves in an unseemly row. The question is: who made the first indigenous four-in-one combination vaccine to protect children against life threatening infections-diptheria, pertussis (whooping cough), tetanus and hepatitis-B?

"We are proud to be the first Indian company to indigenously develop all components of this combination vaccine," claims Shantha Biotechnics Managing Director K.I. Varaprasad Reddy, who launched Shantetra in mid-August. "This is the outcome of our concentrated efforts in developing a new generation vaccine that combines a high degree of safety and strong immunogenicity."

    SECOND TO NONE
DR CYRUS POONAWALLA,
MD, SERUM INSTITUTE OF INDIA

"We got the release for the vaccine a month before Shantha Biotechnics."

K.I.VARAPRASAD REDDY,
MD, SHANTHA BIOTECHNICS

"We are the first Indian company to indigenously develop all components of the combination vaccine."

SII, the country's leading vaccine manufacturer, contests Reddy's claim. "It is factually incorrect to say they were the first to do so," says its Managing Director Cyrus Poonawalla. "On July 18, the National Quality Control Laboratory, Kasauli, issued the release of the vaccine to the Serum Institute whereas the release of commercial production to Shantha Biotechnics was done a month later on August 19 for the same vaccine." He explains that the SII vaccine, Q-Vac, was launched earlier, on August 3.

Reddy, however, questions SII's claims of launching an entirely indigenous combination vaccination. He points out that the technology for the hepatitis-B component of the SII vaccine was taken from a German company, Rhein Biotech, which in turn had acquired it from Transgene Biotech, another Hyderabad-headquartered company. Moreover, GSK and Chiron are two MNCs that are already manufacturing and selling the tetravalent vaccine in India.

However, both Shantetra and Q-Vac have not only reduced costs but also made vaccination less painful for children as they now have to suffer only three pricks with the combination vaccine instead of the earlier six. SII has priced Q-Vac at Rs 50 per dose which is less than a fourth of the cost of the MNC offering priced at Rs 225.

Competition among vaccine makers is intense and it is estimated that the domestic market for the four-in-one combination vaccine alone will be about 150 million doses if it comes under the government's Expanded Programme on Immunisation. Globally, the phenomenon of combination vaccines is catching on. Further, the decline in the share of vaccine production by developed countries is contributing to the rapid growth of the Indian vaccine industry. Indian companies are cashing in on this opportunity. SII is working with heat-stable vaccines, which are more suitable for countries with tropical climates. In all, there are 22 companies and the Rs 1,000 crore vaccine industry is growing at the rate of 15 per cent a year.

The Union Government is also mulling setting up an apex body for vaccine production to help the companies achieve better efficiency. Industry insiders say that instead of making tendentious claims, manufacturers should work jointly and effectively if India is to become a vaccine manufacturing hub, capable of developing new vaccines.

-By Amarnath K. Menon

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OCTOBER 10, 2005
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