SHC seeks report on action taken against pharma company for making substandard antibiotic

The Sindh High Court has directed the additional secretary health and the Drug Regulatory Authority Pakistan (Drap) to submit a progress report on whether or not the authority was taking action against a pharmaceutical company for manufacturing a substandard antibiotic drug.

The directive came at a hearing of a petition against supplies of a substandard antibiotic drug to the Civil Hospital Karachi (CHK).

Petitioner Mehmood Akhtar Naqvi submitted that the Civil Hospital had ordered 95,000 bottles of Cefixime suspension, which was provided to the hospital by the supplier from a pharmaceutical company, Baxter. He submitted that the company, however, supplied a substandard medicine and it could not be used.

He said the medical superintendent of the CHK and an inspector from the Drug Regulatory Authority had written letters to the pharmaceutical company, complaining about the substandard drugs; however, no action had been taken against the manufacturer for making such substandard drugs.

He submitted that the supply and use of substandard drugs put patients’ lives at risk. He requested the court to order an end to the supply of substandard drugs, besides taking action against those found to be involved in it.

The additional secretary health filed comments mentioning that the provincial drug inspector had picked up samples of three batches of bottles supplied to the hospital for providing them to the provincial drug testing laboratory for tests and the stock available at the Civil Hospital was sealed accordingly.

He submitted that the provincial inspector distributed test reports of all three batches -- XM-330, XM-340 and XM-341 -- which were declared substandard by a government analyst.

The secretary health submitted that the drug inspector referred the case to the provincial quality control board on March 6, 2020, for taking further action against Ms. Baxter pharmaceuticals and its distributor Ms.

Hospital solution for having manufactured, stocked, exhibited for sale, and sold Ximbact suspension 100 mg/5ml batches XM330, XM-340 and XM-341 for a decision. He informed the court that legal action against the manufacture and distributor would be taken a per decisions of the provincial quality control board.

A high court division bench headed by Justice Mohammad Ali Mazhar observed that nothing had been placed on record as whether or not Drap had taken any action against the pharmaceutical company. The court directed the provincial quality control authority board to examine the matter and decide a line of action against the manufacturer of the drug at the next hearing.

It issued notices to the additional secretary health and Drap to submit a progress report on whether or not they were taking action against the pharmaceutical company for manufacturing the substandard drug and adjourned the hearing till March 31.