The Delhi High Court has ordered global drug major Pfizer to withdraw its anti-inflammatory drug Medrol six months before the expiry date. The Delhi High Court has also allowed the Central Drugs Standard Control Organization (CDSCO) to initiate legal proceedings against the company after it was found to be violating rules.
The drug is used to treat inflammatory, allergic and immune disorders.
Justice Rajiv Sahai Endlaw issued the orders to Pfizer, directing it to withdraw stocks of the drug six months before the expiry date, the Press Trust of India reported.
"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 Delhi High Court said.
Pfizer had earlier filed a plea challenging the DCGIs' order, which made it mandatory for the drug company to keep the shelf life only for 60 months. The DCGI rejected Pfizer's' representation of extending the expiry date to 61 months and also asked it to stop the sale of those batches of Medrol that were available in market and exceeded the date of 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 Delhi High Court said, according to the PTI.
According to the Drugs and Cosmetics rules, the statutory expiry date of medicines not specified under Schedule P of the Act should not exceed 60 months whereas Medrol's packaging shows a recommended period of usage of 61 months.
The DCGI said that since Pfizer violated the statutory provisions, it cannot seek the relief of extension of expiry date or continue selling the concerned batches of Medrol.
Pfizer, on the other hand, said that the studies showed that Medrol was stable for 62 months, which was ignored by the drug controller.