Indiscriminate use led to bogus tocilizumab injections: FDCA

A racket selling spurious tocilizumab injections which are used in the treatment of COVID-19 was recently busted following raids in Surat and Ahmedabad.

Indiscriminate use of tocilizumab injections for COVID-19 treatment in Gujarat has led to a spurt in its demand, resulting in spurious drug manufacturers exploiting the situation, a senior official of the state’s Food and Drug Control Administration (FDCA) said on Sunday.

The patented drug is manufactured only by Switzerland-based Roche Pharma and marketed in India by Cipla, he said, adding that since May, as many as 6,400 tocilizumab injections have so far been imported in Gujarat.

A racket selling spurious tocilizumab injections which are used in the treatment of COVID-19 was recently busted following raids in Surat and Ahmedabad.

Sohel Ismael Tai, the racket”s alleged mastermind who ran a fake company called Genic Pharma in Surat, manufactured the spurious drug at his residence where raids by FDCA led to the seizure of filling machines, packaging materials and APIs (active pharmaceutical ingredients) worth Rs 8 lakh, FDCA Commissioner Hemant Koshia told reporters in Gandhinagar.

Tai supplied the medicine to agents who distributed it to various pharmacists, the officer said.

The FDCA has charged five persons under provisions of the Drugs and Cosmetics Act for manufacturing and selling spurious tocilizumab, he said, adding that the authority is in the process of filing a police complaint against them.

In the first week of May, the Gujarat government decided to procure tocilizumab injections and supply them to government hospitals for use on certain COVID-19 patients, after the medicine helped two patients recover at the Gandhinagar civil hospital, Koshia said.

“Only 20 injections were then available in Gujarat, which was procured by the state government. The company imported more injections after that…,” he said.

So far, since May, as many as 6,400 tocilizumab injections have been imported in Gujarat, out of which 50 per cent have been procured by the state government and 50 per cent are being sold in the open market, the official said.

“The medicine is used on specific cases of COVID-19 and does not have wide use. But after its inclusion in the treatment protocol for COVID-19 by the Indian Council of Medical Research (ICMR) on June 13, there has been a surge in the drug’s demand, causing a demand-supply imbalance and panic among the public,” he said.

“In Gujarat, when coronavirus cases started rising in Surat, people started using the injection indiscriminately, creating its demand. Relatives of the patients would go from one pharmacist to another in search of the injection that costs Rs 40,545 for a 400mg vial,” Koshia said.

Taking advantage of this demand-supply gap, some people tried to make spurious tocilizumab injections under a fake pharma company, called Genic Pharma, he said.

“An alert doctor sent a photo of a box of the fake tocilizumab injections on WhatsApp, after which our team started investigating. In two weeks, we busted the racket and charged four persons from Ahmedabad and one from Surat under provisions of the Drugs and Cosmetics Act. We will now file a police complaint against them,” the official said.

Tocilizumab is administered in certain critical COVID-19 cases where patients suffer from hyperimmune system response towards the infection that leads to multiple organ dysfunction.