CDSCO extends consent to import drugs with less than 60 per cent residual shelf life by three months

The Central Drugs Standard Control Organisation (CDSCO) has given an extension of three months for the import of drugs with less than 60 per cent residual shelf life. The move is appreciated by the industry as well as regulators.

On April 17, 2020, the DCGI office had issued a letter stating that it has received the representations from industry associations’ informing that there are challenges in clearance at port offices due to COVID-19 outbreak and the shelf life of many products are dropping below the threshold of 60 per cent. Hence the CDSCO had allowed the import of drugs with less than 60 per cent residual shelf life. 

But, as per the issued circular, the permission to import these drugs was set to expire in July 2020. So, the industry had requested the authorities to extend this deadline. Understanding the situation caused by the COVID-19 pandemic in the country and need for uninterrupted supply of medicines in the country, the DCGI has heeded the request and allowed a three-month extension i.e. up to October 31, 2020, which has been appreciated by all the stakeholders.

Commenting on the DCGI’s decision, Manmohan Taneja, Assistant State Drugs Controller, FDA, Head Quarter, Haryana, Panchkula said, “There are so many drugs with expiry between three to five years as provided in the Schedule-P appended to Drugs and Cosmetics Rules, 1945. So, I see no harm in allowing the import of drugs or formulations with a residual shelf life lesser than 60 per cent until the pandemic continues.”

He added, “In such a crucial time, only a few months’ compromise in the shelf life of the drugs will not have any potential harm to importers/traders, pharma companies manufacturing these finished drug products and the end-users i.e. patients. Rather, the same would act as considerable relief to all of them as it will ensure availability of drugs, help continue businesses and save end-users’/ patients’ lives.”

Sahil Munjal, Vice Chairman, Pharmexcil and President-Operations, Ind-Swift highlighted, “Due to the outbreak of COVID-19 across the globe, many raw material manufacturers had a supply chain disruption issue, due to which, fresh material availability would have been a big concern for the industry.”

He continued, “Besides this, the industry is still struggling over the customs clearance issue, there is a huge backlog at different custom ports, which is again affecting the industry at large. The three-month extension for the import of drugs with less than 60 per cent residual shelf-life has given assurance to the industry and will ensure continuity in the supply of medicines.”

Praveen Khullar, President, Goa Pharmaceutical Manufacturers Association stated, “Under these adverse conditions caused by COVID-19, the extension of 60 per cent of remaining shelf-life would be useful for making imported formulations for patients and ensure availability of medicines.’

Pointing that there are several constraints in international travel and availability of courier services, he said that this decision by the DCGI is to ensure uninterrupted supply of medicines. 

Dr Sandhya Shenoy, Associate Vice President, FDC said, “Extending the deadline till October 31, 2020, is a noteworthy move from the CDSCO. It provides relief to manufacturers as well as patients by enabling timely access to medicines. There have been tremendous disruptions in the supply chain and delivery of imported drugs has seen considerable delays. In view of the rising fury of the pandemic, this uncertainty may continue for more time. Consignments will continue to remain stuck due to a plethora of issues related to manpower, logistics, restrictions on movement and many others. Hence, this is a welcome decision and industry needs to ensure that the drugs are utilised within the shelf life keeping patient safety in mind.”

Thus, it seems to be a move which will benefit both, the industry and the patients. The DCGI has also cited in its latest circular that the move is for the three months or till further order, whichever is earliest.