Years of hard-work by the government could go down the drain if the polio virus that has been deemed ‘eradicated’ raises its head again. A slip-up by one of the manufacturer suppliers of oral polio vaccine (OPV), Ghaziabad-based Bio-Med Pvt Ltd, has set alarm bells ringing.
But the Health Ministry insists there is no need to panic. “Our surveillance and regulatory systems are robust. We are alert and WHO is on board, all protocols are being followed. We will not allow polio myelitis to make a comeback,” said JP Nadda, Union Health Minister.
On September 27, the Drug Controller General of India (DCGI) issued a show-cause notice to the directors of Bio-Med to explain how the already eradicated type II polio virus strain had found its way, possibly through contamination, into the firm’s vaccine vials.
It also initiated criminal investigation against the company and its MD is behind bars, said Eswara Reddy, Drug Controller General of India. Bio-Med is allegedly in violation of the Centre’s instructions to completely destroy all traces of type II virus by April 25, 2016.
Official sources said that last month two children had been admitted in a Uttar Pradesh block with acute flaccid paralysis (AFP), a sudden onset of paralysis or weakness in limbs. Annually, 45,000 AFP cases are recorded in India.
One of the causes of AFP could be polio myelitis; however, that is not the case with these two children. The Union Health Ministry was alarmed, and a team including World Health Organisation officials analysed the stool samples of the children.
“Traces of type II polio virus were found. The children have recovered, though, and WHO has concluded that the AFP and type II are not connected. There is no reason for panic,” said a senior official.
Another official said: “However, we are worried as to how a vaccine strain that was pulled out of circulation in 2016 has found its way back into the system.” India had switched from a tri-valent vaccine (containing weak strains of type I, II and III polio virus) to a bi-valent one (containing weak strains of type I and III) two years ago. After the alarm raised by the AFP cases, officials picked up the deemed eradicated type II strain in the stool samples from sewage from UP and Maharashtra.
Later, samples traced back to Bio-Med were picked up and tested to realise that the type II virus has made a comeback. Up to 1.5 lakh vials had been manufactured; while two-thirds were administered to children, one-third have been withdrawn. “The offence of adulteration is non-bailable and attracts up to 10 years or even life time imprisonment,” Reddy said.
Speaking to BusinessLine Davinder Gill, CEO of Hilleman Labs, a non-profit vaccine research and manufacturing firm, said: “The credentials of the company are not good as it is not a WHO pre-qualified supplier. Risks are enormous for India due to this slip-up. The monumental work undertaken to eradicate polio by 25 lakh volunteers, in one stroke, has been placed in jeopardy due to the sloppiness and mismanagement of the company.” .
“The company probably did not destroy the vaccine even after instructions from the government. In the Democratic Republic of Congo, a similar incident had occurred in 2017,” he recalled. Experts say that quality checks at the procurement point could have nipped the problem in the bud. Official records show that in 2017 the DCGI inspected the Bio-Med facility in Ghaziabad twice.
Records also reveal that in March, Bio-Med was in the dock for poor quality of Peda Typh, a typhoid vaccine for children. The Central Drug Laboratory in Kasauli had declared it ‘Not of Standard Quality’ and all States were asked to keep a strict vigil on the movement of the product.