Senior Congress leader Anand Sharma on Friday hit out at the Centre over the deaths of children in the Gambia allegedly due to the consumption of cough syrups manufactured by an Indian firm and asked the government to fix accountability.
The World Health Organisation (WHO) on Wednesday warned that four "contaminated" and "substandard" cough syrups allegedly produced by Maiden Pharmaceuticals Limited based in Haryana's Sonepat could be the reason for the deaths in the West African nation.
India's drug regulator Drugs Controller General of India (DCGI) has already initiated a probe and sought further details from the WHO.
In a statement on the issue, former commerce and industry minister Anand Sharma said the deaths of dozens of children in the Gambia "due to consumption of Cough syrup made by an Indian company Maiden Pharmaceuticals has shocked the world".
"This is a monumental tragedy that raises serious concerns as conveyed by WHO and also questions which, must be answered. The bland statements from the Health Ministry and Central Drugs Standard Control Organisation (CDSCO) are devoid of sensitivity and empathy and do not register the seriousness of the issue and its adverse fallout," Sharma said.
Noting that over the decades, the Indian pharmaceutical industry has assiduously built a reputation and global acceptability, Sharma said the arrival of Indian generics brought down the cost of life-saving medicines and made them available at affordable costs in Africa and developing countries across continents.
That saved millions of lives and earned India recognition as the "Pharmacy of the world", he said.
"That unsettled the vested interests entrenched Pharma multinationals. I consider it imperative to recall the formation of a Global Alliance of US and European Pharma lobby and launch of an orchestrated campaign against counterfeit medicines targeting Africa to discredit India-produced medicines and Generic drugs in 2010-11," he said.
"The campaign was effectively countered by India. Indian missions were activated and personally engaged with African ministers and senior officials who travelled to Africa and other developing countries. It was a hard-fought battle that India won," the Congress leader said.
India has a firm legal framework and regulatory mechanism on safety, quality and standard of manufacturing, he noted.
No drug that fails the test of safety can be marketed let be alone exported, he added.
Sharma said the "casual statements" of the government authorities and Drugs regulator that these syrups are not sold in India and are exported only to Gambia are not reassuring that the gravity has registered.
"This is unacceptable and needs an urgent course correction," he asserted.
"No drug can be exported without the Certificate of Pharma Products (COPP). How syrups adulterated with Diethylene glycol and Ethlyne glycol were given export permits? This incident is a wake-up call. India must revisit the regulatory framework to ensure national uniformity for certification, licensing, marketing and export," he said.
The tragedy in Gambia must not be allowed to cast a shadow on the reputation of the Indian pharma industry or provide an opportunity to entrenched global pharma lobbies to exploit this, Sharma said.
"I urge the Government to take Urgent and deterrent action and fix accountability," he said.
The Union Health Ministry had said the exact "one-to-one causal relation of death" has neither been provided by the UN health agency nor the details of labels and products been shared by it with the Central Drugs Standard Control Organisation (CDSCO), enabling it to confirm the identity or source of the manufacturing of the products.
