Folic acid unavailable in market for 6 months

LAHORE
Folic acid, an essential drug given the status of an orphan drug, has been missing from the market for over six months due to row over its pricing between the manufacturers and Drug Regulatory Authority of Pakistan (DRAP).
The Folic Acid (a type of B vitamin), an essential drug for treatment of anemia disorder, and especially administered to pregnant women for proper growth of the baby, could not be made available in the market for over six months now, as DRAP authorities have failed to prioritise the matter and resolve the row with the manufacturers through developing a mutually-agreeable pricing mechanism.
It is learnt that DRAP has declared more than 40 drugs including Folic Acid that are unavailable in the market as “Orphan Drugs”, which are defined as ‘essential drugs to the extent of a national need besides their commercial aspect’. The other medicines in short supply in the market are categorised in “Hardship Case”, which include the types of medicines with issues of their commercial viability.
A random survey of the medical stores and chain pharmacies in the City revealed that Folic Acid, in a bottled packing of 100 tablets (5mg) at maximum retail price (MRP) of Rs 30, was not available for the customers, whereas the black-marketeering of the medicine was going on at certain drug outlets at a price of Rs 200 to 250. Besides, an imported brand of Folic Acid (800 mg) in a packing of 20 tablets is available at a price of Rs 400.
Furthermore, there are certain smuggled (so-called imported) brands of Folic Acid available in the market at higher prices, but carry doubts about their status of expiry, efficacy, substandard or even fake, for these brands were not routed through legal channels before reaching the shelves.
Nisar Ch, a representative of wholesale traders from Lohari Medicine Market, has confirmed shortage of Folic Acid during the last six months mainly due to non-production of the drug by manufacturing companies owing to their less margin of profit. He, however, rejected the allegation of hoarding of medicine by wholesalers to earn exorbitant profits through black-marketing.
The manufacturing companies have lost interest in manufacturing of Folic Acid due to less or no profit owing to low MRP of Rs 30 per bottle against high input cost.
“The companies even suffer loss in production of Folic Acid due to low retail price against production cost including raw material, manufacturing, packing and supply in the market,” said a representative of a local pharmaceutical company. The medical experts termed it a shame that DRAP authorities remain unmoved all this period of over six months and didn’t show any seriousness to resolve the issue of price and therefore deprived the patients of vital vitamin involved in saving lives of the patients. The DRAP has been continuously failing to ensure proper production of Folic Acid during the last six months or so to ensure availability of this essential drug on medical stores in sufficient quantity in order to meet the demand of the patients.
Prof Dr Irshad Hussain, Professor of Medicine at King Edward Medical University/Mayo Hospital, Lahore, revealed extreme shortage of Folic Acid, which was prescribed to patients of anemia (loss of blood) as well as for treatment of loose motions in certain cases. Besides, he said, Folic Acid was also prescribed in cells maturation arrest in marrow.
Folic Acid helps the body produce and maintain new cells, and also helps prevent changes to DNA that may lead to cancer. “The Folic Acid in combination with iron was available in the market, but it is not as effective as simple Folic Acid,” he added.
Prof Dr Yasmin Rashid, former Professor of Gynaecology at KEMU/Mayo Hospital, Lahore, confirmed unavailability of Folic Acid in the market, saying that it was a cheap but extremely vital medicine administered during first trimester of pregnancy, which prevents neural tube defects (birth defects of the brain, spine, or spinal cord) and helps in proper growth of the baby.
A pharmacist also claimed that the deficiency of Folic Acid is also considered one of the reasons in abortions. Besides, if a pregnant woman becomes anemic due to deficiency of Folic Acid then newborn is likely to suffer from anemia through genetic transmission of the disease.
When contacted, Chief Drug Controller, Punjab, Dr Zakaur Rehman said that shortage of Folic Acid due to reduction in production of this medicine due to vanishing difference between cost of production and sale of medicine in the retail market. He, however, claimed that locally-manufactured Folic Acid in a packaging of 1,000 tablets was available in the markets, which implied that the customer was forced to buy excess medicine than original requirement after paying 10 times higher price.
He informed that DRAP’s blanket order had barred the manufacturers from increasing price of any medicine before June 2016, which discouraged the pharmaceutical companies to produce Folic Acid in the absence of commercial interest in its production.
“This is the reason some of other low-priced drugs like Thyroxin, Ventolin Respiratory Solution, etc., disappeared from the shelves every now and then,” he added. When asked why it is not allowed to increase price of this vital drug, he said that Punjab’s drug control authority only dealt with storage, distribution and sale of medicines, while the registration and pricing of drugs was in the purview of DRAP.
Talking to The News, DRAP, Islamabad, CEO Dr Muhammad Aslam Afghani, who has a doctorate in pharmacy, said that two committees Orphan Drugs and Hardship Cases to quickly dispose of the cases after freezing the commercial purposes to ensure availability of Folic Acid and all essential medicines in the market. “Setting aside the bar on increasing price before June 2016, we may have to ‘allow increase of price in case of orphan drugs’ to ensure availability of essential drugs in the market,” he said.
However he failed to give a satisfactory answer to justify a prolonged delay of over six months to take such a decision to ensure availability of Folic Acid in the market, giving the logic that the DRAP feared criticism of price increase in percentage i.e. 100 to 300 per cent increase in price, whereas actually it would have been a small increase from Rs 30 to Rs 60-90.
However, according to experts, this inordinate delay in fixing of this issue reflects badly as DRAP authorities have completely ignored ramifications of this negligence in provision of a vital medicine on the health of patients especially the pregnant women and newborns during the last six months.