ISLAMABAD: More than 60 medicines categorised by the World Health Organisation as ‘essential medicines’ are not available in the Pakistani market or are in short supply because of pricing issues, delays in approval to buy controlled raw material or international alerts to stop using the drugs.

Pharmaceutical manufacturers have also said that some of the medicines are not available because it is not viable for them to produce them at the prices determined by the Drug Regulatory Authority of Pakistan (Drap).

Drap has said that a Committee on Availability of Essential and Short Medicines (CAESM) has been formed to ensure that medicines are available. Stakeholders such as the Pharma Bureau and the Pakistan Pharmaceutical Manufacturers Association (PPMA) are members.

Pakistan is bound to implement the list of more than 350 essential medicines prepared by the WHO. This list was first prepared in 1994, and has been revised many times over the years. However, many of the medicines on this list are not available in the market.

Pricing issues, delays in approval for controlled substances among reasons behind shortage

Mohammad Saleem, who lives in Islamabad, told Dawn his father was taking Kayexalate, which is used to treat high levels of potassium in the blood, and Hydroxyurea, used for sickle-cell disease, chronic myelogenous leukaemia, cervical cancer and other illnesses, but both these drugs are no longer available.

He said he has had to ask someone to send the medicines from abroad because he could not compromise on his father’s health. Mr Saleem is just one of many people in this situation.

Drap has even written to pharmaceutical associations asking them to ensure more than 60 drugs are available in the market.

According to documents that the PPMA sent to Drap, in most cases it has become impossible to manufacture these drugs. Other medicines have disappeared because of apathy on the part of Drap.

Acetazolamide, which is used to treat glaucoma, epilepsy, altitude sickness and periodic paralysis, is not available in the market because Drap decided to increase its price in February 2019 but did not notify it.

Documents show that Phenobarbitone, used to prevent seizures, is not available because of the lack of quota items, which cannot be sold without government approval. The PPMA has also suggested that other companies should be registered to make Hydroxyurea available.

Pricing issues have also led to the unavailability of atropine injections, which are administered to lower mucus secretions and keep heartbeats normal before anaesthesia, as well as medicarpine, eye drops used for glaucoma.

A Drap official, who asked not to be named, said that there was an effort in the past to push companies to manufacture medicines even if they were not viable to produce.

“We used to tell companies that manufacture more than one medicine that if they make billions selling other medicines they should continue selling non-viable medicines because it would only reduce their profit and patients would not face problems,” he said.

“However, the overall profit of pharmaceutical companies has reduced over the years because of which they prefer to stop manufacturing. The owners of pharmaceutical companies have become more professional business owners and they do not care about patients.

“On the other hand, we used to have very competent and credible individuals in health departments who were able to push companies to continue production. During the last two decades we have observed that health officials developed their stakes in the pharmaceutical industry, due to which they were not able to push the industry, which is very powerful,” he said.

Pharmacy owner Saeed Ahmed told Dawn that a number of medicines are unavailable in the market.

“Companies provide medicines to hospitals, which then provide them directly to patients at the rate of their choosing, and the medicines remain unavailable in the market. In some cases, the demand for medicines is so low that no company wants to manufacture them due to the fear of expiration. Less production increases the prices, so mostly imported drugs are sold,” he said.

Pharma Bureau Executive Director Ayesha Tammy Haq told Dawn that the Ministry of National Health Services (NHS) sent a list of 18 medicines claiming they were not available.

She said: “We have informed that many products on the list are available in the market. One product on the list is an infant formula and not an essential medicine. With regard to the rest, some products were discontinued several years ago and Drap was informed.”

“The manufacturing of some products have been stymied by restrictions on contract manufacturing and, as per the law, until those restrictions are removed the products cannot be manufactured,” she added.

Ms Haq said some products, such as the rabies vaccine, were not available because of the ban on imports from India.

“The matter has been resolved and those products are now being made available. Others have been rendered unviable to manufacture and are in hardship [meaning they cannot be manufactured without an increase in prices].

“The hardship issue was addressed but it has been 11 months and the new prices have not yet been approved. Once the minutes, which have been pending approval since February last year, are approved manufacturing will restart,” she said.

“With regard to psychotropic and other drugs containing controlled substances, delays in allocating and releasing the quotas lead to delays in manufacturing the same and results in shortages. In addition, there is a worldwide shortage of anti-venom vaccines,” she said.

Former PPMA chairman Hamid Raza, who is currently a member of the association’s central executive committee, said that the NHS ministry had indicated more than 60 medicines that are not available in the market.

“We have held four CAESM meetings and every molecule has been discussed in detail. Salts of some medicines have become abandoned or obsolete because better medicines have arrived in the market. On the other hand, doctors have stopped prescribing some medicines due to which their demand has been reduced,” he said.

“The prices of a number of medicines were fixed when $1 was Rs40, and the prices are almost the same when $1 is more than Rs150. Even nowadays the prices of some tablets are in paisas, rather than in rupees. We are here to do business. How can we manufacture medicines that are being sold at rates many times lower than the manufacturing cost,” he said.

Mr Raza said a number of medicines are prepared using controlled substances, and according to policy companies have to inform the government after consuming 70pc of their stock.

“Although we inform the government just after consuming 70pc of the stock, it takes months to get the permit from the government. Then it takes months to import those controlled substances. The demand for some medicines is very low. We have suggested establishing a helpline so people can get information on where medicines are available,” he said.

Drap CEO Dr Asim Rauf said the CAESM meets regularly to ensure the availability of medicines.

“Three types of medicines remain in short supply; some are placed under the narcotics quota and permits are issued to purchase raw material. Sometimes, international alerts are generated that medicines can be hazardous so the sale of those medicines is stopped immediately.

“Sometimes pharmaceutical companies claim they cannot manufacture medicines because they are not viable. Moreover, there is such a variety of medicines that some remain short in the market,” he said.

“Sometimes medicines by other brands are available but patients insist they will remain loyal to their brand. We have introduced a system in which a statutory regulatory order is issued to allow patients or hospitals to import medicines. Despite all the difficulties, we have been working to ensure medicines are available in the market,” he said.

Published in Dawn, January 13th, 2020