Supply of anti-rabies vaccine set to receive a shot in the arm

At a time when India is reeling under an acute shortage of anti-rabies vaccines, Chiron Behring's facility in Gujarat, which was acquired by Bharat Biotech, is looking to start supply of 1.5 crore doses in the country over a period of three months. Chiron Behring announced this in New Delhi on Wednesday.

“We are making additional investments in the Ankleshwar vaccine facility, up to $10 million, to spruce up production capacities and raise production to 1.5 crore anti-rabies doses annually. We will see the shortages reduce in three months, hopefully,” Krishna Ella, Chairman and Managing Director, Bharat Biotech, told BusinessLine.

India is estimated to need 3.5 crore doses of anti-rabies vaccines annually. Sources in the Health Ministry, however, said that over the last year, with manufacturers such as Indian Immunologicals Ltd (IIL), Zydus Cadila and Serum Institute of India (SII) focussing on exports, domestic supply had taken a beating.

On November 7, for instance, the National Pharmaceutical Pricing Authority (NPPA) wrote to all five manufacturers of anti-rabies vaccines, IIL, Zydus Cadila, Bharat Biotech, SII, and Sun Pharmaceuticals, to find a way to address the vaccine shortages after Goa raised an alarm. BusinessLine has accessed a copy of the communication.

Alarming numbers

In 2018, the Health Ministry reported 110 rabies patients, all of whom died, according to latest data available in the National Health Profile 2019. Rabies is the only communicable disease with a case fatality rate of 100 per cent, which means that all those who get infected by it will die, if vaccination is not taken in time. Also, there is a gross under-reporting of deaths, as it is estimated that 20,800 rabies-related deaths occur in India alone, and only a fraction of them are recorded. Poor surveillance and data-keeping, coupled with a lack of vaccines, has lead to the deaths.

Owing to faulty procurement practices by the states, the Health Ministry has now written to all the states to specify their estimated need as far as stocking the vaccine goes. “Earlier, the states were purchasing from companies on rate contract, and did not specifying the quantities they required in advance. It was difficult for us to supply huge quantities in a short time, as we needed between 30 to 45 days for bulk production, another 45 days for internal testing, and 45 additional days for testing at Kasauli’s Central Drug Lab. We are manufacturing between 30,000 to 50,000 vials per batch, which goes through this process and it is continual,” explained a Bharat Biotech official, who did not wish to be quoted.

The official also said that Chiron Behring Vaccines’ Ankleshwar facility had become inoperable since 2017. It was acquired by Bharat Biotech from GlaxoSmithKline in March 2019 and commercial operations restarted in May 2019.

According to the latest World Health Organization (WHO) guidelines, a person bitten by a stray dog needs not more than three anti-rabies vaccine doses taken in under a week.

WHO estimates that 59,000 deaths occur annually due to rabies on account of a lack of vaccination. According to a ministry source, the newly launched vaccine ChiroRab will be sold to states at ₹253 per dose. NPPA has put a price ceiling on anti-rabies vaccines at ₹334 per dose.

Poor surveillance of rabid animals

While India reports hundreds of deaths due to rabies, in the US, on the contrary, there are not more than one or two reported rabies deaths every year, Charles Ruprecht, retired Chief of the Rabies Programme at the US-based Centers for Disease Control and Prevention told BusinessLine.

“This is because of a strong culture of surveillance and reporting of stray animal bites that began in late 19th and 20th century. There are at least 130 laboratories in the US that diagnose rabid animals and submit their reports in a timely manner so the human bite victims receive immunisation. Nearly one lakh suspected rabid animals, the highest in the world, are euthanized in the US each year for better surveillance,” Ruprecht said.

“In India, doctors don’t report the stray animals. The question is who will catch the stray animal. The surveillance is poor,” said a senior official from Bharat Biotech.