The Central Drugs Standard Control Organisation (CDSCO) has extended the deadline till October 31, 2020 for allowing import of drugs with residual shelf life less than 60% following representations from importers on delay in clearances at port offices due to shortage of staff in the wake of COVID-19 pandemic.
The CDSCO’s move has brought cheers to the drug industry which stated that this will ensure availability of drugs to patients in a timely manner. Earlier on April 17, 2020 CDSCO had granted importers permission to import medicines having residual shelf life under 60% on the condition that they give an undertaking that the drug would be consumed before the expiry date in the light of the pandemic situation.
The CDSCO’s move came after representations of industry associations that clearance of consignments at port offices has taken a hit due to COVID-19 outbreak and several drugs are losing their shelf life and getting below the threshold of 60 per cent.
As per Rule 31 of the Drugs and Cosmetics Rules, 1945, no drug shall be imported unless it complies with the standard of strength, quality and purity, provided that the licensing authority shall not allow the import of a drug with a less than 60 per cent residual shelf life as on the date of import.
However, in exceptional cases, the licensing authority may, for reasons to be recorded in writing, allow the import of any drug with a lesser shelf life, but before its expiry.
Welcoming the extension of deadline for importing medicines having residual shelf life under 60%, Sahil Munjal, vice chairman, Pharmexcil said, “This is much needed step taken by the CDSCO in the current situation of COVID-19 pandemic which led to disruption in freight movement causing delays in delivery of imported drugs.
There are lots of drugs stuck at the ports due to shortage of manpower and the lockdown situation in parts of the country and they are losing their shelf life. The patients need to have access to these medicines on time.”
Nipun Jain, chairman of Small and Medium Pharma Manufacturers Association (SMPMA) said, “This is a praiseworthy step taken by CDSCO for ensuring adequate availability of required drugs during this pandemic.”