— Despite action by DRAP, availability of adulterated drug Avastin remains largely unaddressed
LAHORE: The interim Punjab government has thus far been unable to provide sufficient information regarding the production, quantity, and distribution of the injections linked to patients losing their eyesight. In the meanwhile, the number of vision loss cases in Punjab has surged to over 70.
According to the caretaker Health Minister of Punjab, Dr. Javed Akram, people were not affected by the side effects of this injection, but rather due to the use of counterfeit injections. The primary issue lies in the misuse of these injections.
Dr. Akram explained that the genuine problem with these sixteen-milliliter injections is their limited shelf life after being taken out of their protective seal. Addressing recent events in Punjab, Dr. Javed revealed that a private hospital in Lahore administered Avastin injections to several eye disease patients using separate syringes at different times, resulting in many patients losing their eyesight.
He also mentioned that the injection solution was tampered with to increase its volume, contributing to the adverse effects. These adulterated vaccines were produced by an unregistered fake company, a criminal offense according to the Drug Regulatory Authority of Pakistan (DRAP).
Dr. Javed Akram disclosed that these fake injections were being manufactured illegally within a private hospital in Lahore, specifically located at Thokar Niaz Baig area. Certain rooms in the private hospital were converted by a dispenser or doctor to illicitly produce this injection that is not safe for use.
Dr. Javed Akram emphasized, “We took immediate action on Saturday morning, removing the entire stock of this injection from the market and promptly banning its usage to prevent further harm.”
Additionally, three individuals have been apprehended in connection with this illicit operation, and legal proceedings have been initiated against them. However, on one hand, Dr. Akram is discussing the punishment for the three accused individuals, while on the other hand, the Department of Health Care has only named two people, Naveed and Bilal, in the FIR.
Moreover, Dr. Akram explained that a comprehensive investigation is underway to determine the scope of the distribution network for these counterfeit injections. Simultaneously, stringent measures have been taken to immediately cease the sale of Avastin in the market, prioritizing public safety.
Licensing issues
Sources within the Department of Primary and Secondary Health Care Punjab informed this scribe that the license issued for this injection by the Department did not grant authorization for dispensing of Avastin injections.
According to sources, this license, numbered ‘05-352-0065-96873P’, only permits the dispensing of skin items and tablets. Dispensing Avastin injections requires a separate license from DRAP.
Furthermore, no legal action has been taken against the individual holding the license issued by the healthcare department. The responsibility for the illegal action falls upon the qualified individual listed on the license, Asim Khalid, who has not yet been charged. The FIR only names Bilal and Naveed as accused parties.
As per the Drug Regulatory Authority of Pakistan (DRAP), the Avastin injection sold in Pakistan by M/S Genius Advanced Pharmaceutical Services is both fake and unregistered. Drug Regulatory Expert Noor Mehr stated that these counterfeit injections have been circulating in the market for years, priced at just Rs 12,000.
In Pakistan, the Roche Company’s Avastin injection is sold for 80,000 to 1 lakh rupees. In contrast, its price in Europe is approximately 1900 Euros (around six lakh rupees), and in India, it costs approximately one lakh rupees in local currency.
However, as per media reports, the initial investigation has uncovered chronic issues in the repackaging (compounding) and distribution of the Avastin drug, as well as the maintenance of the cold chain, leading to a disease outbreak in Punjab.
Official data indicates that the contaminated drug has severely affected the vision of 68 patients in the province since the scandal came to light. Among these patients, 25 cases were reported in Lahore, 19 in Multan, five in Bahawalpur, and four each in Kasur, Rahim Yar Khan, Sadiqabad, and Khanewal, with an additional three patients reported in Mian Channu.
There are reports of more cases emerging across the province, and health authorities are assessing them to include them in official records.
Swiss pharmaceutical company Roche stated that its Avastin drug was approved in over 130 countries, including the United States, for treating various types of cancer. However, it strongly condemned the criminal act of counterfeiting in Pakistan and emphasized its cooperation with authorities to protect patients from counterfeit drugs.
In Pakistan, the vision loss associated with Avastin has been attributed by authorities to contamination from a third-party supplier. The regulator clarified that Avastin had been used off-label in the cases in question, meaning it was used outside its approved indications to treat diabetes-related eye conditions.
Avastin, a cancer drug, is used at lower doses as an alternative to the eye drug Lucentis in many countries to treat certain conditions that cause blindness. Roche emphasized that Avastin is not approved for eye use and warned of the health risks posed by counterfeit medicines, as their contents may be ineffective and potentially harmful.
Punjab’s deputy drug controller, Alam Sher, who filed a police complaint against the distributors, explained that some companies purchase Avastin and repackage it in smaller doses to make it more affordable for patients.
‘High-profile’ victims
The revelation came to public attention when Chaudhry Manzoor, a prominent leader of the Pakistan People’s Party, shared on social media the distressing experience of his brother, who was adversely affected by this injection.
Chaudhary Manzoor reported that his diabetic brother had complained of eye pain and was taken to a hospital in Kasur. At the hospital, he received an injection called Avastin, which is administered into the eye. Subsequently, his brother began experiencing pain in his eyes.
Late at night, his brother expressed that the pain had become unbearable. However, when he woke up the next morning, he had lost his eyesight.
Manzoor added, “We promptly transported him to Lahore, where, upon examination by a doctor, it was revealed that the injection was likely responsible for his vision loss.”
He further stated that they sought a second opinion from another doctor at a different private hospital in Lahore, who informed them that around 250 to 300 patients had been affected by this injection. Additionally, twelve more affected patients arrived during their visit.
“Afterward, I took to social media and posted a tweet informing others about my brother’s experience to raise awareness and prevent further harm. Following my tweet, the administration became aware of the issue and contacted me, requesting that we bring my brother to Mayo Hospital immediately.” Manzoor explained.
According to him, “Dr. Asad Aslam, the CEO of Mayo Hospital Lahore, promptly performed surgery on my brother. We were informed that his vision had been lost within a few hours due to the injection, necessitating an urgent eye operation.”
He concluded by saying, “My brother’s eye patch has not yet been removed, so we are uncertain if he has regained his sight following the surgery.”
DRAP in action
The Drug Regulatory Authority of Pakistan (DRAP) initiated a crackdown against medicine distributors on Monday, responding to the increasing cases of vision loss attributed to the use of substandard injections in Punjab.
Initially, it was reported that more than 40 diabetes patients in Punjab had experienced vision issues, prompting the provincial caretaker government to impose a two-week ban on the sale and usage of Avastin for ophthalmology-related treatments. However, the number of affected individuals has since risen to over 70.
Following the reports of these cases, DRAP imposed a nationwide ban on the use of these injections in hospitals, pharmacies, and by patients. DRAP officials emphasized that no hospitals, laboratories, or pharmacies in Pakistan have a license to repack these injections.
They revealed that both registered and unregistered injections were available in the market. The officials also advised people and hospitals not to use imported injections until quality check results were obtained.
Earlier, DRAP and provincial drug authorities conducted raids on the offices of medicine distributors, recovering 110 vials. These vials were sent to a drug testing laboratory in Lahore for examination.
According to recent information, out of the 70 affected patients, 10 are from Multan, one is from Bahawalpur, and three are receiving treatment at Nishtar Hospital in Jhang. Additionally, cases have been reported in Lahore, Multan, Rahim Yar Khan, Sadiqabad, and Faisalabad.
In a notification released by the interim Punjab government, 11 drug inspectors have been arrested for selling injections procured from illegal, unregistered companies. The notification stated that three drug inspectors from Lahore, two from Bahawalpur and Rahim Yar Khan, and one each from Jhang, Sadiqabad, Kasur, Bahawalnagar, and Khanewal have been suspended.
A day earlier, the Punjab government imposed a two-week ban on the sale and usage of Avastin for ophthalmology-related treatments. Punjab caretaker Chief Minister Mohsin Naqvi also announced that free medical treatment would be provided to patients affected by substandard eye injections.
He pledged to take immediate, strict action against drug inspectors responsible for the availability of non-sterile injections, pending an inquiry. The CM also stated that the government would establish a high-powered inquiry team to expedite the investigation, and the police were instructed to ensure the arrest of those found responsible for the incidents.
However, the government has not provided any statistics or information regarding the production and distribution of these injections, including their quantity and sources.
Health department sources have revealed that not only are these injections a concern, but there is also a significant presence of counterfeit medicines other than Avastin in the market, posing life-threatening risks. What is particularly alarming is that top authorities are unable to estimate the quantity of these drugs, including the mentioned injections, that are still circulating in the market.
One of the primary reasons for this issue is the lack of strict monitoring of the entire process by the staff appointed by DRAP and the District Administration.
Now, due to increased pressure from higher authorities on DRAP and the health department, only the formalities of conducting raids are being carried out.
The science of Avastin
Dr. Nasir Chaudhry, an ophthalmologist, explained that this injection contains anti-cancer agents primarily employed in the treatment of cancer patients.
Furthermore, it is also employed in managing ‘retinopathy,’ a condition commonly diagnosed in diabetic patients.
According to Dr. Nasir Chaudhry, ‘retinopathy’ occurs when elevated sugar levels in patients lead to the leakage of delicate blood vessels within the eyes, resulting in damage. Subsequently, new, fragile blood vessels form in the eyes. This injection is administered to halt this entire process in such patients.
He additionally clarified that ‘this injection is administered multiple times to patients and is readily available at a low cost in Pakistan, used by all doctors and hospitals.’
He also emphasized that ‘prior to administering this injection, a thorough assessment of the patient’s medical history is conducted. This helps determine whether the patient is a suitable candidate for the injection, as individuals with heart or stroke conditions may experience side effects. Therefore, it necessitates careful consideration.
Diabetes endemic in Pakistan
Considering the increasing number of diabetic patients in Pakistan, the presence of such fake medicines in the market is nothing short of a concern.
According to data from the International Diabetes Federation (IDF), the prevalence of diabetes in Pakistan has rapidly increased over the past years due to lifestyle and dietary habits of the common people. Pakistan has a population of over 220 million people, and the adult population is about 124 million, and around 33 million of them have some form of diabetes.
This means that about 27 percent of adult citizens of Pakistan are suffering from this disease, which means at least every fourth adult citizen of Pakistan has been affected by this disease. The International Diabetes Federation reported that this disease killed more than 40,000 Pakistanis in 2021, and internationally, Pakistan ranks third after China and India in terms of the number of diabetes patients. The prevalence of diabetes in Pakistan has been increasing over the past decade, and it is a major public health concern in the country.
It is pertinent to mention here that individuals in America and India have also suffered from the effects of this injection. In the United States, 21 people were infected in 2011, with many experiencing blindness. The American Federal Drug Authority initially registered this injection for cancer treatment, but many American doctors also used it to address eye diseases. Similarly, in India, in 2016, five people lost their eyesight due to Avastin injections.
