HomeHealthEvaluating the Role of Pakistan's Drug Regulatory Authority in Ensuring Public Safety

Evaluating the Role of Pakistan’s Drug Regulatory Authority in Ensuring Public Safety

Pakistan's Drug Regulatory Authority (DRAP) must adapt to pharmaceutical industry changes. Public safety should always be its first priority to prevent situations like the Avastin catastrophe.

Dozens of diabetes patients in Pakistan suffered vision loss after being given a contaminated drug, a provincial health official said Tuesday. Two men behind the supply of the drug, Avastin, have been arrested and 12 government inspectors suspended after an investigation found the medicine was packaged in an unhygienic environment, according to police and health authorities.

“As of now, the injection has severely affected the vision of 68 patients in Punjab,” said a spokesperson for the province’s health department, who declined to be named.

At least 12 people have reported complete blindness. “We will only be able to assess the true extent of harm done by the injection once the infections are completely treated,” the spokesperon added.

The Roche cancer medication Avastin was temporarily banned by Drug Regulatory Authority of Pakistan (DRAP) in September 2023 after 12 individuals had blindness as a result of the drug’s injection. According to the DRAP, Avastin injections were administered to the patients to treat diabetic retinopathy, a disorder that damages the blood vessels in the retina. In Pakistan, avastin is not authorized for the treatment of diabetic retinopathy. Avastin batches believed to have been involved in the incident are being recalled, according an order from the DRAP.

Roche has denounced the occurrence and said that it is assisting with the investigation by the authorities. The occurrence in Pakistan serves as a reminder of the value of pharmaceutical safety and the need for strict regulatory oversight of the pharmaceutical sector. It serves as a reminder of the risks involved with utilizing medications outside of their intended uses.

When a medicine is used for a function that the regulatory body has not authorized, this practice is known as off-label usage. Off-label usage isn’t always illegal or inappropriate, but it’s still necessary to be aware of the hazards. Only when extensive testing has shown the safety and efficacy of a drug for a certain purpose is it authorized for that use. There is less evidence to support a drug’s safety and effectiveness when it is used off-label.

When Avastin was used to treat eye problems, there have been instances of severe adverse effects, including vision loss. It is essential to remember that while these adverse effects are uncommon, they might happen.

Patients who are thinking about using a medication off-label should discuss the advantages and disadvantages with their doctor. Additionally, it’s critical to confirm that the doctor is licensed to prescribe the medication for the specified purpose. Public health is seriously impacted by the incidence in Pakistan. The Pakistani government must take action to punish the DRAP for its carelessness and to look into the businesses that were promoting and selling Avastin for the treatment of eye conditions. Before contemplating using a medicine off-label, patients should discuss the risks and benefits with their doctor and be informed of the dangers involved.

Avastin is not the only recent incident where the Drug Regulatory Authority of Pakistan (DRAP) has been careless in licensing medications, which has resulted in fatalities in the nation. Without doing enough testing, DRAP authorized the marketing of Panadol Cold and Flu in 2012. The medication contains a poisonous component called paracetamol, which, when used in excess, may have fatal negative effects. After being connected to multiple fatalities, the substance was subsequently outlawed.

Dolo-650, a medication that combines ibuprofen and paracetamol, was licensed for sale by DRAP in 2017. Ibuprofen, which may potentially have dangerous negative effects, including death if taken in excess, was discovered to be present in high concentrations in the medicine despite it not having been thoroughly evaluated. After being connected to multiple fatalities, the substance was subsequently outlawed.

DRAP authorized the commercialization of the nonsteroidal anti-inflammatory medication (NSAID) Novalgin in 2019. The medication was not thoroughly examined, and it was discovered to contain high concentrations of diclofenac, an NSAID that, when used in excess, may have catastrophic negative effects, including death. After being connected to multiple fatalities, the substance was subsequently outlawed.

These are only a few instances of how the DRAP’s carelessness in medication approval has resulted in fatalities in Pakistan. It is obvious that DRAP has to enhance its drug approval procedure in order to guarantee that Pakistan’s citizens have access to safe and efficient medications.

What steps can be taken to ensure that this doesn’t happen again? There are many actions that may be taken to stop the carelessness of DRAP from increasing the number of fatalities in Pakistan.

The medication approval procedure at DRAP has to be improved first. This entails evaluating new medications more thoroughly and ensuring that they are only licensed after being shown to be both safe and effective. DRAP also requires a mechanism in place to keep an eye on the security of medicines after they have been licensed and to respond swiftly if any issues are found.

Second, the Pakistani government must provide DRAP the tools it needs to carry out its mandate effectively. This involves ensuring that DRAP has enough resources and personnel. Additionally, the government must provide DRAP the right to take legal action against businesses that are discovered to be promoting or selling dangerous substances.

Third, the people of Pakistan must be made aware of the risks associated with consuming illegal pharmaceuticals and the need of sticking to those that have received DRAP approval. Before taking a medicine for a use for which it has not been authorized, people should discuss the risks and benefits with their doctor and be aware of the dangers of off-label drug usage.

Last but not least, the government of Pakistan must take stern notice of DRAP’s irresponsibility causing the number of fatalities in the nation to prevent such incidents in the future. It’s a wake-up call for all and sundry!

The views expressed in this article are the author’s own and do not necessarily reflect Coverpage’s editorial stance

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