The detection of 446 spurious drugs in the last five years has been a significant challenge for the Drug Regulatory Authority of Pakistan (Drap) because of the resulting fall in trust, the authority’s credibility and the efficacy of medicines at the national and international level.

However, Drap has argued that this case was not an exception to Pakistan and that it is routine for spurious drugs to be discovered around the globe.

According to National Assembly documents, Drap has collected more than 200,000 samples from medical stores and healthcare facilities in the last five years and found 446 medicines to be spurious. These documents were submitted in response to a question raised by PML-N legislator Azhar Qayyum Nahra, who has asked the Ministry of National Health Services (NHS) for the total number of spurious drugs that the public has been made aware of by Drap and their names in the last five years.

The reply stated that 229,453 samples were tested at federal and provincial drug testing laboratories overall. In 2015, Drap collected 40,291 samples of which 202 were spurious. In 2016, 96 out of 43,705 were found to be spurious, while in 2017, 59,611 samples were collected and the labs declared 84 spurious.

A total of 44,146 samples were collected in 2018 of which 41 were determined to be spurious and 24 out of 41,700 samples collected in 2019 were found to be spurious.

The documents claimed that upon receiving the reports from the Central Drugs Testing Laboratory, Drap issued recall alerts to its field offices, provincial health departments and the manufacturers to initiate the recall process for these drugs.

The medicines found to be spurious or substandard in 2019 mentioned by Drap included Chlorpheniramine syrup and Galtran tablets. In 2018, Cardol tablets, Quinozef 250 milligram tablets, Magnett-DS suspension, Amropyron injections (for veterinarians only), Zerodol tablets and Samodryl Expectorant were found to be spurious or substandard. In 2015, Amcof cough syrup was found to be spurious.

Dr Waseem Khawaja from the Pakistan Institute of Medical Sciences (Pims) told Dawn that taking medicines with low potency can have adverse effects for patients.

“Let’s say a diabetic patient takes medicine as advised by a doctor but the medicine has less potency; his sugar level will remain high and other organs will suffer as a result. The case of cancer medicines and other diseases is similar,” he said.

There can be side effects if patients do not get medicines according to their requirements, he said.

“That is why we prefer to prescribe medicines from credible companies as they ensure that the potency level is not disturbed,” he added.

Drap CEO Dr Asim Rauf said it was not unusual for medicines to be found to be spurious.

“Lets say a medicine or specific raw material has to be at least 90pc of the medicine but it is found to be 89pc; the medicine would be declared spurious according to international standards,” he said.

“It has to be understood that there can be many reasons for getting less percentage of certain chemical compositions as no company does it deliberately because their reputation is at stake. Moreover, there are a number of checks nowadays due to which it is next to impossible for spurious drugs to be sold without detection,” he said.

Dr Rauf said that in Pakistan, the potency level of medicines has dropped at different stages because medicines have to be stored at room temperature but end up being stored outside pharmacies and warehouses.

“We experience severe summer every year so the potency of medicines is disturbed if they are placed in direct sunlight. However, some blunders or mistakes can be made at the time of manufacturing. So whenever it is confirmed that the potency of medicines is disturbed we investigate it at all points i.e. at the company, wholesalers and medical stores,” he said.

“In any case, if it is confirmed that the medicine has low potency, the manufacturer is directed to recall the medicine,” he said, adding that it was rare for companies to include low-potency medicines deliberately because it could lead their licences to be cancelled.

When asked why a number of patients complain that local medicines do not bring them the same relief that imported versions do, Dr Rauf attributed this to psychological reasons and the formulation of medicines.

“A number of patients get relief because their brain starts telling them that they will get the relief as they have taken the imported medicine, in this case the whole body starts working to overcome the problem. The second reason is that some medicines, due to formulation, are quickly absorbed in the body and people get immediate relief,” he said.

He said Drap has begun benchmarking pharmaceutical units to check if they are following current good manufacturing practices (CGMP).

“We were working on it for a long time and called intentional trainers to train 25 drug inspectors in Pakistan. Two training sessions were held in Islamabad and Lahore and after that exams were also held to make sure that the inspectors perform well in the field,” he said.

When asked how CGMP would work, Dr Rauf said that after completion of inspection, according to the new criteria, companies will be divided into categories.

Using the classifications, Drap will know which companies are in the lower category and need frequent visits or may even be closed, he said.

Published in Dawn, February 16th, 2020