Court Asks Pfizer To Withdraw Drug 6 Months Before Expiry

New Delhi: The Delhi High Court has asked pharmaceuticals major Pfizer Ltd to withdraw stocks of its already imported drug Medrol, used to treat a wide range of inflammatory, allergic and immune disorders, six months before the expiry period of 60 months prescribed under the rules.

Justice Rajiv Sahai Endlaw issued the direction to bind Pfizer to its statement before the court that it will 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...," the court said.

"...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," it added.

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, statutory period of life of medicines not specified under Schedule P of Drugs and Cosmetics Act and its rules should not exceed 60 months while Medrol's packaging shows an expiry period of 61 months.

The authority was of the view that since the company was found to be non-compliant of statutory provisions, it cannot, thereafter, seek the reliefs of extension of expiry period or permission for continued sale of batches concerned of Medrol.

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

According to Pfizer, it had shown data indicating that Medrol was stable for 62 months, but this was not considered by the authority.

The pharma major had also said Medrol was a fast moving medicine and therefore, the possibility of it being in the market close to its expiry date is inequitable, but this too was rejected by DCGI.