tainted ophthalmic drug that risked users’ eyesight has exposed the quality control protocols and potential medical negligence.

Avastin injections are administered to prevent blindness among diabetic patients. Up to 80 patients in various districts of the Punjab have however ended up losing their eyesight from the very same treatment. The data with regard to affected patients has been uploaded on the official portal/ dashboard.

“Most of the patients required minor surgeries, treatment for infection or mere washing of their eyes. However, the exact extent of damage to their eyesight will be determined after the infection treatment,” says Dr Jamal Nasir, the caretaker Punjab minister for primary and secondary healthcare. “More than 90 per cent of the patients were given Avastin injection in one eye. God forbid if the vision is lost, the other eye is intact,” he says.

Avastin injection (bevacizumab), available in 100mg/ 4ml packs in the market, is meant primarily for cancer patients. However, it is also effective in small quantities in preventing blindness among diabetes patients. The diabetes patients require only a 1.25mg/ 0.05ml dose, one pack is used to make up to 80 doses by refilling in small vials or syringes.

The drug, in this case, was supplied from Lahore to Multan, Rahim Yar Khan and Sadiqabad via courier services offered by passenger bus businesses and bike ride apps.

Ophthalmologists recommend that Avastin injection be stored at 2 to 8 degrees Celsius and administered to the patient within six hours of refilling. However, the injections were dispatched in unsafe conditions and the desired cold chain was not maintained.

A 10-member high-powered committee, comprising two minister as co-conveners, the additional chief secretary, the law secretary, the special secretary (development), for primary and secondary health, the KEMU vice chancellor, the SHEMED additional secretary (Technical), Dr Asad Aslam and the director general (Drugs) was named initially to investigating the circumstances to ascertain the cause of severe drug reaction, fix responsibility and plug the loopholes to prevent such unfortunate incidents in the future.

Later, five additional members, including the Punjab Quality Control Board secretary, a representative of the Punjab Healthcare Commission, Prof Dr Sidra Saleem, a professor of microbiology, Prof Dr Muhammad Moin, a professor of ophthalmology and Prof Dr Allah Rakha, a professor of forensic medicine, were co-opted to assist the probe.

“The committee does not include a retina specialist despite being assigned to evaluate the current clinical practice regarding the use of Avastin injection through intravitreal route of administration,” a senior health official pointed out, speaking to The News on Sunday on condition of anonymity. Instead, he said, two ophthalmologists and a general surgeon had been included.

The committee restricted the off-label use for the ophthalmic condition of diabetic patients and sent samples to the Drug Testing Laboratory to examine the quality and safety of the medicine and submit a report within two weeks.

In the meantime, an analysis of drug reactions, based on reports of six affected patients, identified contamination during refilling and/ or drug transportation. On the face of it, the report suggests that the chances of contamination in original drug products manufactured/ imported by multinational pharmaceutical companies are minimal. A definite determination shall however be made by the DTL.

Earlier, experts had feared losing an important drug for the patients. A lot now seems to depend on DTL findings.

“If the original product, manufactured/ imported by a multinational pharmaceutical company, is found contaminated it will be a huge disaster,” says Dr Jamal Nasir. He says a pack worth Rs 28,000 currently is administered to 80 patients. If the original product is found contaminated, the cost treatment for all patients will be huge.

The Punjab government has so far arrested two people, Bilal Rasheed and Asim Khalid, working the local pharmaceutical company, on charges of unauthorised re-filling and unsafe transportation. The raids are also being carried out to apprehend a third suspect, Anwar from Multan. A fourth potential accomplice, Naveed, has been put on the exit-control list (ECL). Cases have been registered against the suspects under various sections of the Drug Act 1976.

The local business has been sealed and all materials seized. The PHC has also sent notice to a private hospital in Lahore where refilling allegedly took place.

Acting on the committee’s recommendation, the Health Department has suspended more than 20 drug inspectors, drug controllers and deputy drug controllers posted in various districts of the Punjab under the PEEDA Act, 2006, on account of inefficiency.

Some of the industry stakeholders have accused the committee of bias. Pakistan Pharmacists’ Association-Punjab president Furqan Hashmi has described the suspension of drug inspectors as victimization and an attempt to shield the real culprits.

Caretaker Minister for Specialised Healthcare and Medical Education Prof Dr Javed Akram has said that good clinical practices were apparently not observed during the use of the injection. “It is necessary to obtain the patient’s consent in the local language. This wasn’t ensured,” he says. He has also said all those responsible will be brought to justice.

Meanwhile, the committee has so far suspended more than 20 drug inspectors/ controllers, but none of the eye surgeons.

A Benevolent Trust, run by an NGO to combat blindness in Pakistan, was allegedly selling Avastin injections to non-Zakat deserving patients, instead of asking the patients to buy the drug vials for ophthalmic use from Shaukat Khanum Hospital.

Avastin injections caused blindness among several patients in the United States in 2011 and many patients lost eyesight in India due to unsafe use of the same drug. It warrants separate packaging for cancer use and eye treatment of diabetic patients by the manufacturing/ importing pharmaceutical company or enforcement of strict repackaging/ sale of ophthalmic doses by a licensed/ authorised dealers.

The writer is an investigative journalist associated with The News International. An EWC and GIJN fellow, he also contributes to various international media outlets. His X handle: @AmerMalik3