KARACHI: Some life-saving medicines have almost disappeared from the market, putting the lives of thousands of children at risk, it emerged on Sunday.

According to doctors, the drugs are used for the treatment of various genetic disorders, the most common among them is Congenital Adrenal Hyperplasia (CAH), a family of inherited disorders affecting the adrenal glands.

Speaking to Dawn, Dr Jamal Raza, a senior paediatric endocrinologist and the director of National Institute of Child Health (NICH), said that though availability of these drugs (hydrocortisone and fludrocortisone tablets) had always been a problem, they had almost disappeared from the market this time.

“We have repeatedly informed concerned government officials, including those representing the provincial health department, federal health ministry and the Drug Regulatory Authority of Pakistan (DRAP), about this issue. But it remains unresolved,” Dr Raza said, adding that the specific drugs were part of the WHO list of essential medicines.

Children born with CAH, Dr Raza said, faced high mortality risk in the country due to an acute shortage of relevant drugs and lack of awareness about the disease.

He explained the CAH resulted in adrenal glands’ failure to produce certain hormones responsible for managing the balance of potassium and sodium in body, regulating its metabolism, sugar level and blood pressure.

“They instead overproduce androgens (male hormones). The disease can result in serious illness, growth problem and gender identity disorders. If left untreated, it can lead to death. The drugs are required to be taken for life,” he said, adding that early diagnosis, proper treatment and care could help patients live a normal life.

According to NICH sources, over 400 children affected with CAH are registered at the institute, which offered these drugs free of cost to the patients.

Sharing the troubles families face in their search for the medicines, Shahid Ali, father of 12-year-old Zeenat, said: “My daughter was diagnosed with CAH in 2005. Since then, there have been many occasions when I couldn’t arrange medicines in time and her condition deteriorated.”

Employed as a clinic dispenser in Dadu, Ali travels to Karachi off and on to get medicines for his daughter. “When medicines are available, I get them either from the NICH or I have to buy it at a high price from a shop in Karachi, which is the only medical store in the province selling these medicines.”

As the life-saving medicines, the sources said, were not registered with DRAP, they were smuggled into the country. “Their price fluctuates according to their availability. When availability is scarce, patients have to pay 10 times more than their actual price and that, too, without confidence in their quality,” a doctor said, adding that these drugs were being manufactured in India.

The government, he noted, should direct DRAP to register these medicines at the earliest and issue licence to pharmaceutical companies to make sure their availability and uninterrupted supply.

Pharmaceutical companies, he believed, had shown no interest in manufacturing the drugs due to low profit margin involved in the business.

While DRAP chief executive officer was not available for comment, Qaiser Waheed representing the Pakistan Pharmaceutical Manufacturers’ Association (PPMA), said the medicines fell in the category of ‘orphan drugs’, which needed government support to make their production commercially viable.

“Internationally, orphan drugs are those which are intended to treat diseases that are so rare that companies are reluctant to develop them under usual market conditions. In such cases, states give special incentives to attract investment in their manufacturing.

“In our country, we are yet to define ‘orphan drugs’ though the government has set up a committee for this task,” he said.

In reply to another question, he said more than 300 drugs were on DRAP’s list of essential medicines out of which 15 faced an acute shortage in the country. “These medicines include drugs for common ailments such as flu and migraine as well as some neurological disorders. The government insistence to control their prices have made their production commercially not viable. Consequently, local companies have stopped their production but they are available in the black market at a very high price.”

The problem, he said, was quite old but got serious over the past few years. But there was little hue and cry over the issue maybe because their shortage affected only the less privileged as others could buy them even at a high price.

“The government wants the companies to ‘adopt’ the ‘orphan drugs’ but we can’t do that. It’s the state responsibility to provide relief to the common man,” he argued.

The sources said the federal government officials representing DRAP and the health ministry had held meetings with the PPMA in recent days but apparently no progress had been made on the issue.

Published in Dawn, August 21st, 2017