CDSCO allows import of COVID-19 drugs with less than 60 per cent shelf life and instructs pharma industry associations to share drug availability stock report

▴ The Central Drugs Standard Control Organisation (CDSCO)
The import of such drugs may be permitted after taking an undertaking from the importers by the port officers of CDSCO that the drug will be utilised or consumed before the expiry date and no part of it will be available for sale and distribution after its expiry

The Central Drugs Standard Control Organisation (CDSCO) allows the import of drugs with less than 60 per cent residual shelf life on the condition that importers give an undertaking that the drug would be utilised or consumed before the expiry date.
The Ministry of Health and Family Welfare (MoH&FW), also issued a letter to all the State and Union Territories Drugs controllers instructing them to take various measures in order to ensure availability of sufficient quantities of drugs in the domestic retail markets besides ensuring the products conform to the prescribed specifications.
“In the light of the present situation due to the COVID-19 outbreak, the health ministry has instructed to take various steps in order to ensure availability of a sufficient quantity of drugs in the domestic retail market, besides ensuring that the product conforms to be of the prescribed specification. One of the steps is issuing immediate approvals to applications for registration, manufacture and import of pharma,” said the Drug Controller General of India (DCGI).
“Further, we have received a representation from the industry association that there are challenges in the clearance at port offices due to the COVID-19 outbreak and many products are losing their shelf life and getting below the threshold of 60 per cent,” he added in the circular.
Dr Hemant Koshia, Commissioner, Food and Drugs, Control Administration (FDCA) Gujarat, said, ” Yesterday, we got an instruction from the centre to provide available medicines in the state. I have already instructed my team to gather the data on a priority basis and in the next two to three days, we will be able to provide the exact data to the authority.”
Mahesh Doshi, President, Indian Drugs Manufacturers’ Association (IDMA) said, “We have asked our member companies to furnish the details of the requested category of medicines on an SOS basis. We are trying to submit the data from our end to the State FDA authority by early next week.”
The government also stressed to a point to have effective communication and interaction with manufacturers / stakeholders and ensuring that retailers/wholesalers continue to adhere to normal ordering patterns and avoid stockpiling of medications.
A source from the development indicated that the government is taking all the required measures in order to ensure the drug availability in the market for next three months.

Tags : #CDSCO #Medicine #Drugs #Import #COVID-19 #Expiry

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