The Delhi High Court has directed Pfizer Ltd. to withdraw stocks of the drug Medrol already on sale six months before the specified expiry date.

The drug, which is imported, is used to treat a variety of ailments, including allergies and inflammations.

The direction comes as a follow-up of a series of court procedures, in which the Drug Controller General of India (DCGI) had ordered recall of Medrol, and the pharmaceutical major appealing against this order.

As per the DGCI’s rules, medications under Schedule P should not have an expiry date beyond 60 months from the date of manufacture, whereas the imported stocks of Medrol, which falls into the above category, show an expiry date of 61 months.

The DCGI had rejected Pfizer’s plea to relax the 60-month stipulation, on the basis of evidence that the medication stayed stable for around 62 months, and also the contention that Medrol was a fast-moving drug, and hence there was little chance of it being sold past the expiry date. Pfizer challenged the withdrawal order.

The High Court ordered that the stocks of Medrol should be withdrawn six months before the printed expiry date on the packaging to ensure that there is no chance of the medicine being consumed beyond the expiry date.


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