A 54-year-old man who had tested Covid-19 positive on July 17 in Vadodara, and was in the Intensive Care Unit (ICU) of a private hospital, died on Friday after the family failed to get the Actemra (Tocilizumab), prescribed by the hospital. After the man died, the family got a call from an “agent” who claimed to have got a vial.
“We went from one chemist to another across Vadodara while our relatives tried in Ahmedabad, Rajkot, Surat, Anand and even in Mumbai. But not a single druggist had stocked the injection that is said to be life-saving for the critical Covid-19 patients. We do not know if the injection would have actually saved my father’s life, but since we could not get it, we will always have this question and guilt,” his son told The Indian Express.
Another Vadodara family, that had eight members under Covid-19 treatment in a hospital, was asked to procure five vials of Actemra for three of them who were critical. “We have managed to get three vials, but we need two more. We do not know when will it be available. We tried to seek help from the administration and many other people who could have helped. But everyone has expressed helplessness,” said a relative.
These are among the several critical Covid-19 patients in the state who are victims of what the Food and Drugs Control Administration (FDCA) calls “an artificial shortage” of Actemra (immunosuppressive drug) and Remdesivir (nucleotide analogue prodrug inhibiting viral RNA polymerases) — the two most sought after drugs for Covid-19 patients — created by those who could afford them.
Rackets involved in grey marketing of the two drugs were busted in Surat and Ahmedabad. Recently, a racket, involving a medical representative of Abbott Pharmaceuticals, was busted which allegedly sourced 209 Remdesivir injections from Bangladesh and sold 110 of them to patients in Surat and Ahmedabad at rates higher than the MRP. The first racket was busted earlier this month involving a pharma distributor in Surat who was illegally selling Tocilizumab injections for double the price.
While relatives are asked to procure one or two vials of Actemra and six of Remdesivir for each patient, it is Actemra –priced at about Rs 40,000 per injection –that has been the most difficult to procure.
HG Koshia, Commissioner of Food Safety, Food and Drugs Control Administration, said that FDCA is aware that the artificial shortage has been created due to rampant prescriptions and hoarding by those who can afford the drug.
“There is a huge tendency among people, especially in South Gujarat, who want to stock Tocilizumab injection fearing it may not be available in case of an emergency. I have received calls from acquaintances asking me to help procure the injections for them as a precaution. It is not an injection that should be administered outside the protocol prescribed by the ICMR. But private hospitals are prescribing it left, right and centre,”Koshia told The Indian Express.
He added that the state had received about 8,000 vials of the imported Tocilizumab since May.
Gujarat State Druggist and Chemist Association president Alpesh Patel has written to the Vadodara Municipal Corporation (VMC) and the state government, seeking action in the matter.
Alpesh says one private hospital in Vadodara prescribed 65 Actemra injections in a day. “It is obvious that not all those 65 patients are on ventilator support. There is bound to be a shortage because relatives want to go by the hospital advice and they run pillar to post to procure it,” Patel said.
On Friday, the Gujarat High Court, while hearing a civil application on the reported mismanagement of the injections, said there should be a centralised monitoring and supply system for the injections.
While Remdesivir is now manufactured in India by two pharmaceutical companies — Cipla under the brand name Cipremi and Hetero under the brand name Covifor — Actemra is imported by Cipla from its parent company Roche.
Dr Devesh Patel, Medical and Health Officer, VMC, says, “Every week, about 7,000-10,000 vials of Actemra are imported in the country and distributed to states depending on the need. The number of patients having prescription for the drug naturally outweighs the available vials. While the government-run hospitals in Vadodara are judiciously prescribing the drug, private hospitals are not. Tocilizumab is not even proven as life-saving. In our government-run hospitals, we are successfully treating many patients without these drugs.”
According to the National Clinical Management Guidelines of the Ministry of Health and Family Welfare, Tocilizumab “may be considered in patients with moderate disease with progressively increasing oxygen requirements and in mechanically ventilated patients not improving despite use of steroids.” The guidelines prescribe caution in case of presence of raised inflammatory markers and also lays down that the patients should “be carefully monitored post-Tocilizumab for secondary infections and neutropenia”.
Remdesivir is recommended under “Emergency Use Authorization” in patients with moderate disease, explicitly stating “those on oxygen”.
Dr. Aravind Badiger, Technical Director of BDR Pharmaceuticals International Pvt. Ltd., which is the sole manufacturer of Remdesivir (Cipremi) for Cipla in India, and has a factory in Daman, said, “Shortfall is definitely there. There is an effort going on to increase the number of sites in order to meet the requirements. Remdesivir is a Lyophilised Injection (Freeze Vacuum Dried), with a four-day cycle. With injections, there is a specific test called Sterility Test, which ensures that the injection is free from external contamination and so this takes 14 days for the entire manufacturing process to complete. Hence, the overall supply becomes atypically staggered.”
Since July, the company has supplied seven batches of Remdesivir (Cipremi) to Cipla. Each of the seven batches consisted 10200 vials, Badiger said.
Officer on Special Duty to Vadodara Vinod Rao said, “The state government has asked local authorities to keep check on private hospitals. We have also issued warnings to the hospitals here. These drugs cannot be prescribed unnecessarily as they can also harm the patient. We also conducted a video conference with heads of all empanelled private hospitals with expert intensivist Dr Atul Patel, who explained to the hospitals the need to judiciously use the two drugs”.