A drug dearth in store?

LAHORE: While hurdles in the availability of items i.e., personal protective equipment, medicines, etc, needed for COVID-19 management, are being removed expeditiously; however, another crisis is in the making as authorities are dragging feet on notifying numerous essential drugs and new molecules’ prices, duly approved in February 2019.

Patients other than novel coronavirus victims are already facing numerous issues to consult their physicians after pandemic lockdown. Their woes have been multiplied because the country is facing shortage of numerous lifesaving drugs because the federal cabinet gave its consent to the increase in prices recommended by Drug Regulatory Authority of Pakistan (DRAP) after a delay of over 14 months. The ball is now back in DRAP’s court that has yet to issue the required notification in this regard. The notification has to be issued by the chief analyst of DRAP, but this post that fell vacant on March 13, 2020 has only recently been filled. The new Chief Analyst has not yet notified the price increase.

This delay has almost suspended the supply of streptokinase required by the heart patients. It has put the life of millions of heart patients at risk. The anti-rabies vaccine is not available in many hospitals. This vaccine is the only cure for dog bite. If a rabies infected dog bites any human being, he would not survive if not vaccine with rabies vaccine within a 7-10 days after bite. Pakistan yearly needs 1.5 million rabies vaccines every year.

The approved list also includes medicines used in dialysis. Failure to undergo dialysis for a month or so could be fatal for many patients with kidney malfunction. It also includes vaccine for hepatitis. There are around 40 million hepatitis patients in the country. The approved list also includes insulin so vital for diabetes patients, tetanus injections and meningitis vaccine.

It may be mentioned that DRAP’s price control committee approves prices of new and existing medicines after a long proceeding. The prices are enhanced or fixed to ensure their commercial viability. When producing drugs are not commercially viable the manufacturers stop producing them and importers quit imports. This causes severe shortage of those drugs.

This is what is happening in Pakistan; this time mainly due to the procedural delays.

This points out to a glaring flaw in the drug regulation mechanism. Nowhere is the world the health issues particularly relating to the medicines are treated as casually as in Pakistan. These delays might create a bigger health crisis in Pakistan than Covid-19. There should be some timeline during which a request for any price change, asked by the manufacturers, is finalised.

Earlier only DRAP was authorised to notify the new prices of drugs. Only in this regime its was deemed necessary that the drug prices approved by DRAP should also be endorsed by the federal cabinet. Experts say it would have been prudent that the DRAP experts that approved the new prices brief the cabinet on reasons for enhancement.

On few drugs where the cabinet was not satisfied should have been temporarily removed from the list and rest approved. The DRAP official be called in the next meeting to satisfy the cabinet, which should give its final decision. In this case the price approval agenda was placed before cabinet several times and was pended on objection of one or two cabinet members for over a year. After the matter was highlighted in media it was finally approved.

Past practice was that the DRAP pricing committee, after approving the prices, would issue the notification directly without going through cabinet approval; but the approval for biological drugs was notified by the authority’s chief analyst. In this case all the price increases were of biological drugs and absence of chief analyst caused further delay.

We have seen in the current pandemic that Pakistan was among the least prepared countries in the world to handle the crisis. The government of Pakistan did a commendable job to gear itself up in a short time to somewhat handle it through new procurements and establishing dedicated facilities for COVID-19 patients. However, neglecting other health issues is also unjustifiable.

Why do we wait for a crisis to develop out of proportion before we react? We should streamline our health system on permanent basis instead of waking up when it’s a bit too late.