Delhi HC directs Pfizer to withdraw drug Medrol 6 months ahead of expiry

The Delhi High Court has asked pharma major Pfizer Ltd to withdraw imported stocks of its drug Medrol six months before the expiry period of 60 months prescribed under the rules, against the company's claim that the drug is effective beyond 61 months.

Pfizer's Medrol, which is used to treat a range of inflammatory, allergic and immune disorders, shows an expiry period of 61 months against the statutory 60 month period prescribed by pharma sector regulator Drug Controller General of India (DGCI).

Justice Rajiv Sahai Endlaw said the court issued the direction to bind Pfizer to its own statement before the court that it would withdraw stocks of the drug six months before date of expiry.

"This court by interim order in this petition having restrained DCGI (Drugs Controller General of India) from consequential action pursuant to impugned notice-cum-order of September 15, 2015 against the petitioner (Pfizer), it is deemed appropriate to bind the petitioner to its statement, of withdrawing the drugs from the market six months prior to their expiry, by directing the petitioner to withdraw all stocks of the drug Medrol with the date of expiry to which objection has been taken by the respondents, six months before the prescribed date of expiry, so that there is no possibility of the drug being consumed by anyone in the 61st month of its manufacture," the court said.

The order came on the company's plea challenging Drugs Controller General of India's (DCGI) September 2015 order rejecting Pfizer's representation to extend the expiry period of its medicine to 61 months and also refusing to allow continued sale of the concerned batches of Medrol.

As per DCGI regulations, the statutory period of life of medicines not specified under Schedule P of Drugs and Cosmetics Act should not exceed 60 months. Against this, Medrol's packaging shows an expiry period of 61 months.

Pfizer, on the other hand, had shown data indicating that Medrol was stable for 62 months. The pharma major had also said that since Medrol was a fast moving medicine, the possibility of it being in the market close to its expiry date is inequitable. The DCGI had rejected both these arguments.

The DCGI was of the view that Pfizer, which was non-compliant of statutory provisions, cannot also seek reliefs of extension of expiry period or permission for continued sale of batches concerned of Medrol.

The DCGI order of September 2015 had also pointed out that since Pfizer was found to be importing and marketing the product in violation of the Act and Rules, the Central Drugs Standard Control Organisation (CDSCO) may initiate legal proceedings against the company.