expresspharmaJuly 08, 2020
Tag: CDSCO , Remdesivir , DCGI
The Central Drugs Standard Control Organisation (CDSCO) has requested the Drug Controllers of all States and the Union Territories Drug Controllers to take immediate measures for prevention of black marketing of remdesivir injections in the country. The move comes after reports of illegal marketing of the drug started doing rounds.
In fact, the letter issued by Dr VG Somani, Drug Controller General (India) (DCGI) to all Drug Controllers stated that the office has received a letter from LocalCircles, independent community engagement and social media platform, through the Ministry of Health and Family Welfare (MoHFW), raising concerns regarding black marketing and overpricing of remdesivir by certain unscrupulous persons.
In a letter written to high-level government authorities, Sachin Taparia, Chairman CEO, LocalCircles stated that over the last 72 hours, it received many posts and comments from citizens across India about black marketing of remedisivir. The letter also pointed out that the MRP of remedisivir marketed by Hetero Healthcare is Rs 5400 but consumers have reported that it is being sold at a price of anywhere ranging between Rs 15,000 to Rs 60,000. Reportedly, various medical shops have been telling buyers that the medicine is in short supply but can be made available if they are ready to pay a premium.
The letter also highlighted that as per a survey conducted by LocalCircles which received 8329 responses, 93 per cent consumers from 233 districts of India said that the legal metrology and drug inspectors should be directed to take immediate action against black marketing of the remedisivir. It also suggested that the NPPA and DCGI must ensure that Hetero Labs provides patient-level traceability on a daily basis for every sold unit.
Speaking on the situation, Manmohan Taneja, Assistant State Drugs Controller, FDA, Head Quarter, Haryana, Panchkula informed, “So far we have not received such complaints in our state, however, our officers are keeping a strict vigil and offenders will be dealt with an iron hand. We have already issued circulars to all concerned C&F distributors. They have been asked to submit sale and stock statements every day without fail. Field officers have also been directed to verify them daily and send the report to headquarters on or before 5 pm.”
Rajiv Singhal, General Secretary, AIOCD, said, “Today, we had a discussion with higher authorities in the CDSCO and assured them that the ongoing unethical marketing practices related to remedisivir are not being carried out by our members. However, we have also committed to them that if we find any of our members’ involvement in it, strict action will be taken against them.”
Reportedly, pharma companies involved in manufacturing and marketing of remedisivir injections too are in the process of preparing a stringent process to avoid such circumstances in the future.
Last month, the DCGI approved ‘restricted emergency use’ of remedisivir injections for the treatment of patients with severe COVID-19 infection.
The DCGI letter also informed that remedisivir formulation of the innovator was approved on June 1, 2020, for import and marketing of the drug in the country. However, the importer is yet to import the drug. Subsequently, the CDSCO has granted permission to Cipla, Hetero and Mylan Laboratories to manufacture and market the drug.
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