In the wake of rampant cases of blackmarketing of life-saving essential medicines for COVID-19 treatment like tocilizumab, the Maharashtra Food and Drug Administration (FDA) has increased inspections and recently did a record 2,164 inspections between the period of July 14, 2020 and August 03, 2020.
The state regulator has till date booked 16 culprits selling life-saving essential COVID-19 medicines at overcharged rates.
During a recent joint raid, Maharashtra FDA and Bandra Police laid a trap and caught a resident of Kashipur, Uttarakhand who was found selling tocilizumab at an exorbitant price of Rs.1 lakh per vial which has the MRP of Rs. 40,000. Total 15 vials of tocilizumab were seized from him. In preliminary investigation, it was revealed that he brought these injections from Delhi market.
Joint raids were conducted in different pockets of Mumbai and Thane in which senior FDA officials posed as decoy customers.
This is the fifth raid in a row. State drug regulator conducted four raids over a period of 14 days earlier in joint operations with police as the black marketing had involvement of unscrupulous traders who were selling drugs without any drug license. These black marketers had links with company officials and marketing representatives of reputed companies. The Maharashtra booked offenders for illegal sale of COVID-19 drugs for violating Essential Commodities (EC) Act, Drugs and Cosmetics (D&C) Act and Drug Price Control Order -2013 (DPCO-2013)
With the state registering over 7,000 new cases of COVID-19 daily, there’s been growing demand for emergency use authorized medicines like remdesivir and tocilizumab, which have been effective in many serious cases of the infection. However, this has led to a shortage of these drugs in the market as well as overcharging through illegal channels. State FDA has asked citizens to file complaints about overcharging on its helpline 1800222365.
State FDA minister Rajendra Shingne said the government plans to publish the price and availability of the drugs online for transparency. These drugs have been given emergency use authorization by the Drugs Controller General of India (DCGI) for critically ill or lab suspected COVID-19 patients. Maharashtra FDA caught five people red-handed selling remdesivir injection at Rs. 25,000 (the Cipla’s branded injection Cipremi (remdesivir) MRP is Rs. 4,000) and tocilizumab sold under Actemra by Cipla in India which has MRP of Rs. 40,545 was unethically sold at Rs. 80,000 much higher than market retail prices without license in violation of different sections of the Indian Penal Code (IPC), DPCO-2013, EC Act and D&C Rules.
Maharashtra FDA started the massive drive to curb black marketing following an action plan chalked under the guidance of Dr. Rajendra Shingane, Maharashtra FDA Minister, Rajendra Yadravkar, Minister of State, Maharashtra FDA in consultation with Maharashtra FDA Vigilance Commissioner Sunil Bharadwaj.
The state drug regulator has appealed to the patients to contact toll free number of Maharashtra FDA 1800 222 365/022-26592362 if drugs are being sold at a higher rate than the printed rate or MRP.
Tocilizumab manufactured by Roche Pharma and marketed by Mumbai-based Cipla is today being used on COVID-19 patients who suffer from extreme immune system response towards the infection, called cytokine storm, leading to multi organ failure and eventually death.
Tocilizumab in certain trial studies has shown to slow down the cytokine response in COVID-19 patients by modulating a protein called IL6. Union health ministry has separately approved a few hospitals in India to start multi-centre trial of this drug for critical patients of COVID-19.
Roche recently announced that the phase III COVACTA study of Actemra/RoActemra (tocilizumab) did not meet its primary endpoint of improved clinical status in hospitalised adult patients with severe COVID-19 associated pneumonia.
In addition, the key secondary endpoints, which included the difference in patient mortality at week four, were not met; however, there was a positive trend in time to hospital discharge in patients treated with Actemra/RoActemra. The COVACTA study did not identify any new safety signals for Actemra/RoActemra. Further analysis of the trial results is needed to fully understand the data. The results will be submitted for publication in a peer-reviewed journal, Roche in a release stated.