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First dengue vaccine gets approved in over 10 countries, but not in India yet

Business Today checked with the Drug Controller General of India (DCGI) and the Indian regulator's view is that the marketing approval to the vaccine has still not been granted in India because the regulator is keen to know the efficacy on the Indian population.

twitter-logo E Kumar Sharma   New Delhi     Last Updated: October 5, 2016  | 11:46 IST
First dengue vaccine gets approved in over 10 countries, but not in India yet

Sanofi Pasteur, the vaccines global business unit of Sanofi, on Tuesday, October 4, announced that its Dengvaxia dengue vaccine has now received its 11th marketing approval, four of which were granted from regulatory authorities recognised by the World Health Organization (WHO). To date the vaccine, it says, is approved in Mexico, Philippines, Brazil, El Salvador, Costa Rica, Paraguay, Guatemala, Peru, Indonesia, Thailand and Singapore.

It, however, does not say anything on the status on India. Business Today checked with the Drug Controller General of India (DCGI) and the Indian regulator's view is that the marketing approval to the vaccine has still not been granted in India because the regulator is keen to know the efficacy on the Indian population. However, since the company has sought a waiver on the need to conduct clinical trials in India, the matter is under scrutiny, according to the DCGI.

At the same time, if required, anybody can import a new drug or a vaccine based on a doctor's prescription under personal licence issued under the Drugs and Cosmetics Act.

While getting a vaccine may be an important element in dealing with a disease, experts caution that it has to be seen as only one of the elements in dealing with the ailment. They point out that for a country like India, larger issues of prevention are much more crucial and have long-term impact.

For instance, Manish Kakkar, Senior Public Health Specialist at Public Health Foundation of India (PHFI), says: "While having a vaccine may be a good thing, there is a danger of running into a false sense of security with it because often what happens is that once you get such kinds of intervention, people tend to shift focus to this running the risk of missing out on the bigger picture about the need for vector control."

He feels vector control and managing prevention in a manner that is far reaching in its impact is very important for India. Also, even if the vaccine is approved, the picture would be incomplete without a healthcare system that is geared up well to handle and administer it. Also, little is known on the likely pricing of such a vaccine in India.

The seriousness of the problem of dengue and other mosquito-borne viruses can hardly be emphasised

Read our earlier story on the issue here.

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