Report: Masood Anwar
Due to the criminal negligence of responsibility, the Drug Regulatory Authority of Pakistan (DRAP) has failed to effectively combat the spread of substandard and counterfeit medicines across the country. Tasked with regulating the pharmaceutical industry, DRAP’s negligence has led to a free-for-all, with any individual or organization able to market dangerous drugs as long as they keep the regulatory body’s interests satisfied.
To shield itself from any action or criticism, DRAP periodically issues call alerts regarding spurious and substandard drugs, these warning are often ineffective. They remain on record but rarely lead to significant action, such as removing harmful products from shelves or prosecuting the companies responsible. This negligence is putting the lives of Pakistani citizens at risk, with medicines frequently failing to meet required standards for safety and efficacy.
The companies involved in manufacturing substandard drugs include not just lesser-known pharmaceutical firms but also multinational giants like Sanofi, GSK, and Roche. DRAP regularly posts recall alerts on its website, naming substandard products, but its efforts to ensure these drugs are withdrawn from the market or to hold companies accountable remain insufficient.
If a well-known company like Sanofi Events is involved, the alert might state that batch number AD 482 of its Flagyl injection contains substandard ingredients, which could cause fever, cold, organ failure, and even death.
Similarly, the alert could indicate that a specific batch (such as one of the 35 batches) of Motival tablets manufactured by GSK has been reported as unfit for health in multiple cases and it is being voluntarily withdrawn by the company.
Or it could be an alert stating that Laroscorbine Injection is being fraudulently manufactured and sold in the market under the name of Roche Company, posing a serious threat to human life. Medicines in these three types of alerts are typically prescribed by doctors on a large scale for their patients.
Despite DRAP’s recall alerts, counterfeit and substandard medicines continue to be sold widely in thousands of medical stores nationwide. DRAP’s inability to track and remove these products from the market is underscored by alarming statistics.
In just one and a half months this year, 23 drugs from 20 different pharmaceutical companies both local and international were flagged as spurious or substandard. In contrast, DRAP issued 45 similar warnings in the previous year for 114 drugs.
These medicines include multivitamins, folic acid, painkillers, and other daily-use medications, which are commonly purchased by citizens from medical stores without a doctor’s prescription.
In response to inquiries by Karachi papers, DRAP was surprisingly reluctant to provide details on the outcome of its alerts, such as how many drugs were withdrawn from the market and how many were still in circulation.
The reality is that the drug company or DRAP can at most determine which batch of drug has been sold in which city or it can also be traced through which distributor it is offered to sale. Beyond that, there is no documented trail to identify which retailer is selling the drug within the city, nor any contact with them. Furthermore, DRAP lacks data on all medical stores across the country, through which warning can be issued to all these medical stores.
In the alert, DRAP does not even mention the specific city where the substandard and spurious batch number was distributed for sale. Currently, DRAP merely issues an alert, and the issue is often suppressed in exchange for a hefty bribe from the involved company.
The disturbing truth is that DRAP’s alerts are often ineffective, with some companies issuing voluntary recalls only when they are forced to do so. In more serious cases, DRAP simply announces the presence of spurious medicines without addressing the core issue.
The consequences of DRAP’s inaction are devastating. Patients continue to buy these dangerous drugs, which often worsen their conditions or, in some cases, lead to death.
In one case, a spurious vaccine for rabies, manufactured under the name BioMed Company, in the Indian city Ghaziabad, was found to be circulating in the market.
However, DRAP neither made any serious efforts to remove the spurious vaccine from the market nor took any action against its suppliers, resulting in the tragic death of a seven-year-old child in Unarpur, Jamshoro, Sindh.
The situation underscores a deep, systemic issue with the pharmaceutical regulation system in Pakistan. Until DRAP takes real, substantive action and is held accountable for its failings, the public will continue to be exposed to dangerous, substandard medications that put their lives in jeopardy.
