ISLAMABAD: The Pakistan Young Pharmacists Association (PYPA) and the Pakistan Drug Lawyers Forum (PDLF) alleged at a joint press conference on Thursday that the dengue vaccine had been registered in Pakistan despite a ban imposed by the World Health Organisation (WHO).

PYPA representative Mohammad Usman told the press that the vaccine was registered in the Philippines in September 2017 and was donated by the WHO for up to 730,000 children.

“However, severe reactions to the vaccine were reported, due to which not only did the WHO immediatly collect all the vaccines, but also imposed a ban on it. Investigation is being done on how the manufacturer launched the vaccine without market surveillance,” he said.

Mr Usman explained that vaccines are prepared using dead viruses or by eliminating their ability to reproduce, but this did not mean a vaccine could be prepared for every disease, and so the registration of vaccines is a very sensitive issue.

“Despite the ban imposed by the WHO, the Drug Regulatory Authority of Pakistan (Drap) not only included the registration of the dengue vaccine as an agenda item in its meeting on 29 Dec, 2017, but after the meeting, Drap officers gave interviews that the vaccine had been registered,” he said.

He said they had contacted Drap and told them the decision would become a matter of embarrassment for the country at the international level, but Drap had defended the decision to register the vaccine. “They were insisting because, we have learnt, commission of Rs500 million was received for the registration of the vaccine,” he claimed.

He said the matter was discussed at the international level, due to which three days after registering the vaccine, Drap claimed it would not allow the manufacturer to market the vaccine until April 2018, by which time the WHO would have issued its guidelines for the vaccine.

Mr Usman drew a parallel between this situation and the matter of contaminated baby formula that he said was banned in France but continued to be sold in Pakistan until it was discussed in the international media. “Because of such decisions, no one at the international level trusts medicines manufactured in Pakistan,” he said.

Mr Usman also alleged that Drap was supporting the increase in drug prices and, according to the consumer price index released by the State Bank, the prices of drugs had increased by 15.68pc in October 2017.

“Two years ago, the government of Punjab asked Drap to ban hormones that are given to cattle to increase milk production, but Drap imposed the ban in a soft way, which provided the company with an opportunity to seek a stay order from the court,” he said.

PDLF President Noor Mahar said medicines’ records had been deliberately misplaced, and companies had now been asked to provide their records, which would allow them to submit records with significantly higher prices.

“Currently Bangladesh has progressed a lot and it has seven factories recognised by United States Food and Drug Administration (USFDA) but in Pakistan there is not a single USFDA-approved factory, which shows that Drap has been doing nothing.

“Our exports of drugs were $220m during the PPP govt but now they are reduced to $120m. Our imports have been increased from $409m to $690m. On the other hand India has been exporting drugs worth $30 billion annually,” he said.

Drap responds

In an official statement released by the authority in response to Thursday’s press conference, Drap called the claims an attempt to halt regulatory reforms and improvements enforced by the authority.

It said drug prices had risen by 2.08pc to 2.9pc per the pricing policy. The statement also said no records were missing, and that Drap’s decision to initiate the digitisation of its decades-old manual records was disturbing miscreants.

After news from the Philippines regarding adverse effects of the dengue vaccine in the routine immunisation programme, the Drap registration board reviewed recent WHO recommendations and decided to adopt the latest WHO guidelines for the administration of the dengue vaccine under strict medical supervision, as it is not banned in any part of the world.

The statement said the prices of the vaccine would be determined after WHO guidelines have been received. It said Drap also banned the sale of the contaminated baby formula as soon as it learnt of the issue.

Published in Dawn, January 5th, 2018