India demands that Pfizer withdraw Medrol before patent expiry

Pfizer HQ

The Delhi High Court has told U.S. drugmaker Pfizer to withdraw its inflammatory and allergy drug Medrol from the Indian market half a year before its patent expiration date.

Justice Rajiv Sahai Endlaw issued the direction to Pfizer ($PFE), as it has been found to be noncompliant with new statutory provisions in the country and could not have the legal shelf life of its drug extended.

The court said: "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 order came in response to the company's plea challenging DCGI's September 2015 order rejecting Pfizer's wish to extend the expiry period of its medicine to 61 months.

In September of last year, a court order said that since Pfizer was found to be importing and marketing the product in violation of Indian rules, the Central Drugs Standard Control Organization (CDSCO) said it may also start legal proceedings against the company.

Pfizer says it has shown data that Medrol's price was stable for 62 months, but this was not considered by the authority.

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