Indian government should not bypass safety norms in clinical drug trials and testing to give expedient advantage to pharmaceutical companies and risk innocent lives
A global public health emergency has been declared by the World Health Organisation (WHO) on the outbreak of mosquito borne virus Zika. The Indian government too has sounded the alarm on February 2. The virus gets its name from Zika forest in Uganda where it was first found in rhesus monkeys. It is transmitted by the Aedes mosquito which is also responsible for Chikungunya and dengue. The outbreak commenced in Brazil in May 2015 and nearly 1.5 million people are reported to have been affected. The virus is responsible for some serious congenital malformation.
Though a causal link has not yet been established, as of January 23, 4180 newborns had been reported in Brazil with microcephaly — where newborn babies have abnormally small heads. Cases of Guillain-Barre syndrome — a condition in which the immune system attacks the nervous system have also been reported. WHO estimates that there could be up to 4 million cases of Zika in Americas in the next year. The fears of rapid spread of virus through Americas has forced governments to issue travel advisories. This outbreak is reminiscent of Ebola virus in West Africa which killed about 11,000 people in 2014. What makes diagnosis more difficult is that the symptoms of Zika are very similar to dengue and there is no known cure available in the market at present.
An Indian firm, Bharat Biotech announced a breakthrough in developing the first Zika vaccine on February 3. The vaccine is at an advanced stage of development. Krishna Ella, the Chairman and Managing Director of the company hopes that the Indian government will move quickly to give approval for trials because of the pandemic situation. The Aedes mosquito is widely found in India and there is every reason to be apprehensive. In addition to rigorous mosquito control measures, there is an urgency attached to introduce the drug into the market. The export potential can be very encouraging, both from building goodwill as well as profit for the company.
As a norm, drug development policies are quite stringent about testing and safety. The clinical trials takes three phases of development before being approved. Regulatory approval is granted only after completion of pre-clinical studies which normally takes five months. Earlier, the company had bypassed phase 2 for Ebola vaccine trials, which is its justification to speed up the process. This phase is testing of drug on patients to assess efficacy and safety. To side step this again will be setting a dangerous precedent. Just because a previous risk taking was a success is no convincing reason to bypass safety norms. The company needs to be questioned whether it is a mere coincidence of the outbreak and development of vaccine. As the outbreak is not yet reported in India, the ministry of health should issue instructions for necessary preventive measures. The government should ask Bharat Biotech to produce the drug after due testing process. We cannot afford to put innocent lives at risk.
Guru Aiyar is a Research Scholar at Takshashila Institution and tweets @guruaiyar
Featured Image: Antibiotics by Michael Mortensen, licensed from creativecommons.org