Despite dengue outbreak, Govt says no to French drug manufacturer

The government has decided not to rush for introduction of dengue drugs despite the recent outbreak of the epidemic. According to sources in the ministry, an MNC drug manufacturer has applied to Central Drugs Standard Control Organization (CDSO) for approval of dengue drug in 2015, when the deaths were all time high, but the drug regulator has expressed its reservations over introduction of the drug in haste. In 2015, there were 220 deaths due to dengue while 99,913 cases were reported.      

“As we have a robust mechanism to ensure the quality of drugs, such decisions can’t be taken in haste. We are accountable to over 100 billion citizens of the country. It’s true that a major drug manufacturing company – Sanofi – has submitted their application for approval of dengue drug, but we can’t compromise on quality issue whatever be the situation,” the official said.

“We are very much aware of the fact that drug has been in supply chain and has efficacy of 50-60 per cent. The drug has been tested on African strain and in India, the strain of dengue is Asian, on which the mentioned drug has not been tested. So, we have asked Sanofi to follow the quality guidelines as our crisis cannot be the opportunity for drug makers,” the official said.

Explaining about implications of ‘wrong’ drug on human life, the official said, “Once approved it would be included into mass immunisation programme and it wouldn’t be possible to withdraw the vaccine from that stage if the drug’s efficiency fails in middle of the programme. We have to introduce clinically tested drug only and the government made it cleared to other stakeholders and Sanofi too.”

Adding further, the official said, “Since clinical trial is a cumbersome process and lots of investment is required to complete the process, it might be the reason the drug maker is pushing for approval on the results of its successful vaccination reports on African strain.”

In contrary to the government’s stand, Sanofi has claimed that since its dengue vaccine – Sanofi Pasteur – is approved in 11 countries in Asia and Latin America, India should also approve it as the need for dengue prevention in the country is urgent. “Indian population at risk for this debilitating disease, for which there is no cure or treatment, deserves to have a choice to be protected against the disease with a well-tested vaccine proven effective against dengue,” said Jean-Pierre Baylet, who is country head of Sanofi Pasteur India, Sri Lanka and Nepal.

The highest fatality rate reported in India so far was during the 1996 outbreak. There were above 500 deaths and above 16,000 dengue cases were reported in that year. According to health ministry data, above 50,000 cases and 93 deaths have been reported in 2016, while in 2012, there were 242 deaths out of 50,222 cases reported.