While several patients and doctors have written to companies like Mumbai-based BDR Pharma to provide the drug on “compassionate grounds”, they have been unable to do so, in the absence of regulatory clearances. Sources told TOI that key legislators have now taken up the matter with the Union health minister.
Further, a grey market is said to be thriving with a hugely-marked up, generic remdesivir version from Bangladesh, whose authenticity and veracity is still to be proven.
Locally-manufactured remdesivir cannot be marketed as three companies — Cipla, Hetero and Jubilant are still awaiting marketing approval from the drug controller, while BDR Pharma’s application was not taken up possibly due to patent issue. This comes at a time when coronavirus cases have shot through the roof and India has become the third-highest country in terms of daily infections.
“We have been receiving multiple requests from patients and medical fraternity who are struggling to get vials (of the drug), but the company is not able to help them due to a pending marketing authorisation’’, Dharmesh Shah, chairman & managing director of BDR Pharmaceuticals told TOI.
Four companies –Cipla, Hetero, Mylan and Jubilant Lifesciences have signed voluntary licensing agreements with US-based Gilead.
TOI reviewed prescriptions of patients at major Mumbai-based hospitals –Breach Candy, Bhatia hospital, Nanavati and SRV, and spoke to doctors who confirmed it.
“We have been trying to procure remdesivir for our patients, but have not been able to do so. Some patients are also trying to get it on ‘compassionate’ ground, and are writing to the companies. Another drug, tocilizumab has been facing irregular supply. Both the drugs are potential therapies for critically-ill Covid-19 patients,” Dr Trupti Gilada physician, infectious diseases, Unison Medicare and Research Centre, who consults at Prince Aly Khan Hospital and Masina Hospital said.
Legislators and ministers including Maharashtra housing minister Jitendra Awhad said the non-availability of critical Covid-19 drugs in the state will be taken up with the Union government. BJP MP Gopal Shetty said he has written to the Union health minister to expedite approval of key drugs, and ensure their supply to patients.
Calls and messages to the drug regulator’s office on the query were not answered.
The second drug, Roche Pharma’s tocilizumab approved for use in rheumatoid arthritis, is imported and marketed by Mumbai-based Cipla, and has been facing supply issues.
“In the grey market, for 160mg of tocilizumab, the price being quoted is Rs 90,000 each vial, taking up the therapy cost to nearly Rs 3 lakh. Usually, 400 mg vial is used which is for around Rs 35,000 per vial, but that is out of stock,” a Mumbai-based doctor said.
When contacted, a company official said “Cipla has always stood for access to life-saving treatments. Given the surge in demand for this drug, we are working expeditiously to secure supplies.”
Recently, US-based company Gilead received regulatory approval for remdesvir in India, and will market the drug in July. Multiple global trials are evaluating the drug’s safety and efficacy for the treatment of Covid-19. Earlier, US Food and Drug Administration had granted remdesivir an emergency use authorization (EUA) for the treatment of hospitalised patients with severe infection.