How repurposed Covid-19 drug tocilizumab came to be at the centre of a fraud in Gujarat

What do the two alleged rackets flag?

High demand and short supply of the immunosuppressive drug tocilizumab, distributed in India by Cipla under the brand name of Actemra and manufactured by Swiss firm Roche, has seen the Gujarat FDCA crackdown on at least two incidences of blackmarketing and counterfeit sale in a span of less than two weeks.

Earlier this month, the FDCA had busted a trail of blackmarketing, where the drugs were being sold at a higher price, and without bills. The trail ran from a wholesaler in Surat through a stockist in Surat, to a pharma agency in Ahmedabad and to a pharmacist at the Ahmedabad Civil Hospital. In a second instance, the FDCA also busted culprits selling a steroid and hormone mix as counterfeit for tocilizumab, branded as Actemra.

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What is the demand and availability for tocilizumab in Gujarat?

FDCA commissioner Hemant Koshiya says that in the first week of May, a doctor at the Ahmedabad Civil Hospital used it experimentally. By the second week of May, upon the instruction of the high powered committee headed by the Chief Minister, the state procured 20 injections, which were available among Gujarat stockists for Lupus patients.

Until July second week, the state has procured approximately 6,000 of these injections, of which more than 3,000 were kept with the government and a little less than the remaining 50 per cent stock was distributed to stockists and private hospitals, said Koshiya. He clarified that he wouldn’t say “there is a shortage, but yes, it is in limited supply because there is a single manufacturer and the whole world wants it”.

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What did the state government do to regulate this demand?

In Surat, the district administration formed a committee of three doctors to regulate the supply of the drug. Private hospitals seeking an Actemra injection have to mail an application to covid19.inj@gmail.com, with details of prescription, investigation report, and case papers of the patient. The committee will check the documents and find out how much of the injection is required, and send the proposal to the medical superintendent.

At the user end, Dr Deven Shah, MD and consultant physician based in Ahmedabad, who flagged authorities on the fake Actemra, says, “The state government in a very short time has put a good system in place where it mandates a prescription, Aadhaar card of the patient and Aadhaar card of the relative to be submitted to the authenticated stockists.”

However, a loophole here is that an Aadhaar card copy can be easily availed of any party, who may not be the purported user, but Shah hopes that this will be worked out eventually. Shah adds that doctors and hospitals should always check for the bill. “Say the state has supplied 500 of this injection and then sees 550 instances of the drug administered, the state can then trace that the 50 either came from the black or the grey market.”

What are the red flags to look out for?

Dr Shah says that with a “huge demand and less supply,” an estimated two-hour process of procurement, and the panic of patients’ relatives may have led to black-marketing, hoarding, and counterfeiting of the drug. However, there are checks and balances in place, and if completely adhered to by citizens, doctors and hospitals, such instances will be detected.

“It is the citizen’s responsibility to purchase the drug through the proper channel. It is also important for doctors to always check for the bill. The hospital is also responsible to convey to the state government on administering this drug,” says Shah.

Shah emphasises that any pharmacy selling the drug legally, will always provide a bill. Koshiya adds that the drug price too is an indicator — it should not cost the retail buyer more than Rs 40,545 for a 40 mg vial. The first case made out by the FDCA had a pharma wholesaler based in Surat selling each of these for Rs 57,000.