ISLAMABAD: The Drug Regulatory Authority of Pakistan (DRAP) has failed to take action against drug warehouses violating storage rules in Sindh.
According to an official letter sent to DRAP, the People’s Primary Healthcare Initiative (PPHI) department has stored drugs across Sindh in extensively high temperatures.
The Karachi drugs inspector informed federal authorities, including DRAP, the Federal Health Ministry and others that the temperature at most of the department’s warehouses in Sindh was between 40 to 56 degree Celsius.
“The citizens of Sindh are compelled to consume drugs that have already been exposed to the extreme temperatures. These drugs are not only taken orally, but some of them are also administered directly into the blood,” Drugs Inspector Obaid Ali said.
Talking to Daily Times, DRAP officials said that no action had been taken against such violations so far.
Requesting anonymity, a DRAP official said that when drugs were kept in inappropriate temperatures, they could become unfit for human consumption.
“The PPHI warehouses are used for the storage and distribution of drugs of dozens of pharmaceutical companies. It is very regretful that that the companies themselves do not have adequate arrangements to keep the drugs in better warehouses,” he said.
In 2007, the Sindh government had established the PPHI to provide healthcare facilities to the citizens, especially in remote and rural areas of the province. Now it is being run under a public-private partnership with the help of some registered pharmaceutical companies. The drug inspector further informed the authorities that throughout Sindh, it has been reported that regulatory standards were not adhered to when it came to storing drugs.
“At most such warehouses, air conditioning and electricity backup generators have either not been installed at all or are non-functional. The whole province experiences high temperature during summer,” he added.
Moreover, he said that the drugs in category A and B required temperatures between 2 to 08 degree centigrade temperature. “However, such drugs were found stored in such warehouses in Sindh,” the drug inspector said.
He claimed that temperature control and humidity played a key role in maintain critical quality attributes of drug products. “Extreme temperatures have the potential to alter a drug’s performance characteristics. On the other hand, exposure of degraded drugs to patients could have adverse effects,” he said.
He also said that after exposure to unsuitable temperatures, it was not possible to detect any deterioration in drugs through chemical or microbiological testing.
A Health Ministry official said that DRAP was responsible for implementing rules to ensure that drugs were stored at the right temperatures.
“The drug companies should also comply with rules as it is the matter of people’s health,” he said.
He quoted the example of the ice cream companies, stating that these companies had provided refrigerators to every shopkeeper/distributer for maintaining the required temperature. “Because they do not want to spoil their products,” the official said.
Drug Inspector Obaid Ali also told the authorities about the failure of the Sindh government to regulate such practices. “The government has not taken any action to ensure that the PPHI followed rules regarding storage and distribution,” he said.
He regretted that the pharmaceutical companies/distribution channels had also failed to fulfill their responsibility in order to ensure supply of their drug products under controlled conditions to the patients.
When Daily Times contacted Aslam Afghani, the DRAP chief executive officer, he confirmed the violations. “After receiving the observations made by our drug inspector, we have written to the Sindh government to take action to rectify the situation,” he said.
To a question, Afghani said that there was no provision in DRAP regulations to interfere in provincial matters. “It is the provincial domain. Only, the Sindh government can take any action over this. Our department can only give suggestions or recommendations to provincial authorities for action,” he said.
Published in Daily Times, August 5th 2017.