ISLAMABAD, Feb 8: As the Supreme Court directed the government to establish a Drug Regulatory Authority within 10 days, questions lingered about the ability of the proposed arm to ensure implementation of the laws.

Before the devolution of health to the provincial governments, the drugs wing of the defunct Health Ministry was monitoring and regulating the drug industry under the Drug Act 1976.

“The Drug Act defined the rules, which the companies were bound to follow,” said a senior official of the government. “No company could get a drug registered to manufacture, sell a drug, or obtain a licence for setting up a factory until it fulfilled the criteria laid down therein,” he added.

But even though the act had been described as comprehensive, its implementation was a major hurdle both in the open market and inside hospitals. This was even more evident with the Punjab Institute of Cardiology where over 100 people have died after taking an overdose of an anti-malarial drug, which was being distributed as a drug for cardiac issues.

“Drugs which are purchased by the government have to get a drug testing laboratory’s certificate before being made available by any hospital management to its patients in a hospital pharmacy,” said a senior defunct drug department official of the federal government.

He maintained that as per the government rules, drugs are not purchased by them (federal government) until a drug testing laboratory certificate is attached with every batch of medicine purchased by the government.

Details show that the four provincial governments have their own drug testing laboratories other than central drug testing laboratory in Karachi and the appellate laboratory in Islamabad at the National Institute of Health.

“The appellate laboratory after receiving the sample discovered that one of the ingredients in the drug was additional or more than its defined quantity, which the provincial drug laboratory must have overlooked and allowed the purchase of the medicines,” said a federal official requesting anonymity.

But even after the gross incompetence at the first level, none in the chain after them worked.The second check comes at the level of the hospital pharmacist who did not perform his duties well. Another federal government official told Dawn:

“According to government rules for hospitals, for every 50 beds there has to be one pharmacist who serves as the watchdog.

He checks all drugs coming to the hospital. In the case of PIC, we still don’t know anything about the role of the pharmacist in this drug scam.” Instead it is not cleared if PIC has a pharmacist or not.

Meanwhile, a local doctor on the request of anonymity added that even doctors play a vital role in the implementation of the drug act: “The hospital administration and even the attending doctors have to alert the authorities at the earliest whenever they start receiving complaints about adverse effects.” The point being that patients must have reported symptoms after they took the faulty medicine.

He added that at PIC, there had been no reports of the doctors voicing their concerns about the ineffectiveness of the drug to treat cardiac symptoms. “It’s quite baffling as to how none of the doctors could notice the changes in lab blood tests and not investigate further. The drop in the blood cell counts clearly did not happen overnight, it’s a slow process,” he opined.

However, according to a doctor at PIC, the drug was distributed on December 15, and they received their first complaint on January 10, but it was only in the last week of January that a full-blown investigation was launched. No official comment was available from the PIC, however.

Another doctor who works in a local government hospital said many drugs that do make it to clinics for free distributions are lighter formulations and have less efficacy: “It is possible that given that the drug was free, the doctors and the administration took for granted that it would not improve symptoms at the same pace as better and expensive formulations,” he said. But he too believes that doctors could have been more proactive and had taken the complaints of the victims more seriously as well as done proper follow ups.

“This case is not only about a case of a bad drug, it’s about the slacking on part of the clinicians as well,” he commented.

The federal government official hence feels that it was a long chain of failures that climaxed with the death of unsuspecting poor patients: “The quality check process was not followed at the pharmaceutical, the batches that arrived at PIC were not checked by the hospital pharmacist before distribution, the doctors did not bother to check on the reason why their patients were not improving and did not stop distribution of the drugs in the first week of January.”

He adds: “The quality of the drug testing was compromised or overlooked at every step and this needs to be further investigated.”

The official noted that laws are meant to be implemented and “if we can have a DRAP in a span of 10 days, stricter regulation and implementation of the drug act is needed to prevent a replay of PIC like scandals.” However, doctors at PIC were not available to comment since according to one official the matter is sub judice and they have no comments to offer for the tragic event.