Delay in approval: Nicholas Piramal likely to drop chikungunya research

Nicholas Piramal India is likely to drop its plans to form a joint venture drug discovery research programme with the French pharmaceutical company, Laboratories Pierre Fabre, to develop a first-of-its-kind effective drug for chikungunya, prevalent in India, following the Central Drug Control Authority's delay in sanctioning the project.

"We will have to drop the drug research plans for chikungunya, since the Drug Controller General of India is yet to sanction the project. It is almost six months since we applied," said Swati Piramal, director - strategic alliances, NPIL.

Each of the new drugs entering the Indian market requires permission from the DCGI. She said the data on the existing drug from the French partner, translated from French, was provided to the regulator.

NPIL had announced that it would team up with the French company to develop a drug for the epidemic about six months ago, following the spread of the disease, mainly in southern India and Maharashtra in the last two years.

Currently, drugs are not available to effectively treat the disease and doctors in the country administer viral disease drugs such as paracetamol and other anti-biotics to check the infection.

Laboratories Pierre Fabre had developed effective drugs to prevent the outbreak of the disease in the Réunion Islands, a French colony, about two years ago and in some other tropical countries.

"The genetic pattern of the disease-causing germs in India are similar to those that caused the epidemic in the Réunion Islands. Therefore, we had signed an MoU to pursue the research," said Swati Piramal.

Chikungunya, a viral disease that spreads through the the Aedes Aegypti mosquito, causes severe joint pains, weakness, and stiffness of joints. Though not usually a life-threatening disease, Chikungunya often leads to arthritis.

Meanwhile, drug control officials said the delay in sanctioning the project was mainly due to the shortage of staff at the Central Drug Standard Control Organisation to process the applications. More than 2500 applications were currently pending approval, they said.