Over the past two weeks, the Food and Drug Control Administration (FDCA) in Gujarat has busted several alleged rackets, all originating from Surat, the present hotspot of Covid-19 infection, unearthing a black market of the injectable immunosuppressant drug, Tocilizumab, sold under the brand name, Actemra.
The first case filed was of conspiracy and criminal breach of trust. In the second, a case of attempted murder was registered when a spurious injection reached a patient in Ahmedabad and a doctor blew the whistle. Another racket was unearthed in Surat on Thursday where Tocilizumab was being sold at a higher price.
What do the alleged rackets flag?
High demand and short supply of Tocilizumab, distributed in India by Cipla under the brand name of Actemra and manufactured by Swiss firm Roche, has seen the Gujarat FDCA crack down on at least three incidences of blackmarketing and counterfeit sale in a span of nearly two weeks.
The FDCA busted a trail of blackmarketing in two instances where the drugs were being sold at a higher price, without bills. In one of the cases, 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 the second instance, the FDCA busted culprits selling a steroid and hormone mix as counterfeit for Tocilizumab, branded as Actemra.
What is the demand and availability of 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, on instruction of a high-powered committee headed by the Chief Minister, the state procured 20 injections, which were available among Gujarat stockists for Lupus patients.
In a report submitted before the Gujarat High Court on July 16, the state government said that since March 20 till date, it had placed orders for 4,597 injections from Cipla out of which 2,320 injections were delivered to the Gujarat Medical Services Corporation Ltd (GMSCL) for supply to government and semi-government hospitals. Out of this 2,243 injections were supplied to government and semi government hospitals and the remaining 77 were with GMSCL.
“Cipla assured GMSCL that there will be further supply of 100 to 150 injections within a week,” stated the report. Cipla is also supplying the drug to some private hospitals in the state —- four in Ahmedabad, one in Vadodara and one in Surat.
Koshiya clarified that he wo- uldn’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”.
What did 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 firstname.lastname@example.org, 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.
The Ahmedabad Municipal Corporation (AMC) has now decided to not simply rely on the GMSCL and state’s machinery for the drug and has taken a decision to procure the drug independently, to check black and grey marketing. The AMC will provide the drug to private hospitals and would seek replacement from them, either by replacing the drug or in monetary terms. The approval for usage will see a greater scrutiny. To avoid misuse, photographic proof and used vials should be submitted to the AMC.
Dr Deven Shah, MD and consultant physician based in Ahmedabad, who flagged the 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.” Shah adds that doctors and hospitals should always check for the bill.
What are the red flags to look out for?
Billed transactions, correct pricing at the time of sale and correct details on the box are three things 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, if the norms are completely adhered to by citizens, doctors and hospitals, such instances can 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 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 says 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 was of a pharma wholesaler in Surat selling each of these for Rs 57,000. In the latest racket, the drug was being sold for Rs 74,000.
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