Import consignments delayed, DCGI eases norms

Strict action will be taken against importers if a product is found circulating in markets beyond its expiry date

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The Drugs Controller General India (DCGI) has relaxed norms to allow import of drugs with less than 60% of their shelf life amid the Covid-19 crisis as several import consignments were delayed because of movement restrictions. However, the relaxation has been offered only as a temporary measure for three months.

A circular from the Central Drugs Standard Organisation (CDSCO) stated: “In the light of present situation due to spread of Covid-19, ministry of health…has instructed to take various steps in order to ensure availability of sufficient quantity drugs in the domestic retails market besides ensuring that the product conform to the prescribed specification.

“One of the steps include issuing immediate approvals to applications…further relaxing the requirement of minimum 60% residual shelf life of all drugs including vaccines/biological products at the time of import temporarily, for three months until normal supply resumes.”

According to current regulations, no drug can be imported into India unless it complies with standards for strength, quality and purity, and has at least 60% residual shelf life on the date of import. However, the expiry regulations would be reviewed on a case-to-case basis, and some drugs or vaccines were allowed in exceptional circumstances.

Also read: DCGI to SDCs: Ensure availability of critical drugs

The revised regulation allows the import of drugs nearing expiry but with certain riders, such as the medicines cannot be stored and have to be consumed as soon as possible. Strict action will be taken against importers if a product is found circulating in markets beyond its expiry date.

A CDSCO official, requesting anonymity, said: “These are exceptional circumstances we are dealing with currently, and several industry people had made requests about relaxing the norms as their supplies were stuck at ports and losing shelf life because of the lockdown.

“They had asked for permission to bring these drugs in even though they were reaching closer to the expiry date.” The official added, “It has been made amply clear to importers that no drug or vaccine will be available in markets after their expiry date. That’s the condition.”

Suranjit Chatterjee, senior consultant (internal medicine) at Indraprastha Apollo Hospital, said, “As long as the medicine is not expired it is usually effective, and sometimes the medicine retains its efficacy even after the expiry date. However, as a rule of thumb, expired drugs must not be consumed.”