The rift between the Drug Regulatory Authority of Pakistan (DRAP) and pharmaceutical companies has not only created acute shortage of various medicines but it is also hitting the country's pharmaceutical exports hard. A survey carried out byBusiness Recorder here on Tuesday and discussion with All Pakistan Pharmaceutical Association (PPMA) revealed that the confusion created by the Punjab government and the DRAP is directly hitting the poor masses.
According to druggists at Bohar Bazaar Rawalpindi, following the government's decision to link increase in medicine price with Consumers Price Index (which only allows up to 3 percent increase in drug prices per annum), a number of multinational drug manufactures have abandoned their operations in Pakistan, which has created shortage of a number of life-saving drugs.
According to traders, following drugs are facing shortage of supply in the market: (i) Neodipar tablets, which are used to treat high blood sugar levels that are caused by a type of diabetes mellitus or sugar diabetes called type 2-diabetes, (ii) Panadol baby & infant suspension, which provides effective temporary relief from pain and fever to children, (iii) Diagesic-P tablet, which is used for the treatment of mild to moderate pain of musculoskeletal origin, tension, anxiety, headaches and migraine, (iv) Xeroban tablets, which are used for prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery, (v) Betnovate-C cream, which is used for the treatment of inflamed skin conditions such as eczema, psoriasis and dermatitis, (vi) Amoxil 500ml injection, which is used to treat many types of infections caused by bacteria, such as ear infection, bladder infection, pneumonia, gonorrhea, and E coli or salmonella infection, (vii) Wymox 500ml injection, which is used to treat many different types of infection caused by bacteria, such as tonsillitis, bronchitis, pneumonia, gonorrhea, and infections of the ear, nose, throat, skin, or urinary tract, (viii) Lasix injection, which is used to help lose extra water in body, (ix) and avil injection, which is used for the treatment of allergic rhinitis, eye irritation, motion sickness, itchy and runny nose, sneezing and other conditions.
Traders said that a few month back, the entire range of anti-tuberculosis (TB) medicines from Ethambutol to Pyrazinamide were not available in the market following the government's directives that these medicines will be provided to patients from hospitals, and not from drug stores. Saleem Khan, a druggist said when the government decided to provide TB medicines to patients from hospitals after every 15 days, the drug producers started direct supply to hospitals and stopped supplying the medicines in the market.
"A TB patient is required to get medicine after every 15 days from hospitals but they have to come from far-flung areas for their treatment, which usually takes six months. As a result of the government's decision, poor patients face huge financial burden due to long travel for taking medicines from the government hospitals. Now the supply of these drugs has been restored which has provided a sigh of relief to the patients," Saleem said.
President PPMA Dr Kaiser Waheed talking to this correspondent said that the bureaucracy is allowing autonomous and independent functioning of the DRAP as per the provisions of the DRAP Act, 2012. He pointed out that companies associated with the pharmaceutical industry in the country should be allowed to function like other commercial entities as they are primarily meant to do business, instead of being charitable organisations.
He added that in Pakistan, prices of over 80 percent of the registered medicines have been frozen since 2001 and in 2013 the regulators themselves have conceded that the industry should be given an inflationary price adjustment of 94.24 percent. The cost of doing business has risen by over 100 percent during these 15 years of dormant prices. It is time to authorise an increase in drug prices so that companies can afford to manufacture those essential drugs.
The DRAP should either be placed under the control of Federal Ministry of Commerce or Council of Common Interests. This should be done because the Ministry of National Health Services, which at present is overseeing the Drug Regulatory Authority, has been unable to understand peculiar business needs of pharmaceutical companies being commercial entities. The Ministry of National Health Services is supposed to manage hospitals rather than regulating the DRAP, he added.
The biggest challenge faced by the industry has been frozen prices of pharmaceutical products since 2001 while drugs costs have gone up by more than 100 percent. The prices of inputs such as fuel, electricity, labour wages and raw materials have increased drastically, making the survival of the industry very difficult, the PPMA president said. Waheed said that there were 36 multinational companies working in Pakistan in the early 2000s but the number is now down to 22.
He said that at present the situation has worsen as most of the raw material is imported and any increase in dollar rates adversely affects the profitability of the local manufacturers.
According to Abu Zar, another top office-bearer of PPMA, Pakistan's pharmaceutical sector is simply unable to meet local demand and increase exports under the current regulatory regime, which is extremely oppressive. He said, "Pricing undoubtedly is the most burning issue with the DRAP. Contrary to DRAP, majority of developing countries regulate drug prices to safeguard the interest of the consumers, but their regulations are transparent. Neighbouring India and China liberalised their drug pricing, which has benefited domestic consumers and accelerated their exports.
India's exports are in excess of US 15 billion dollars per annum while Pakistan's exports have declined and are now approximately US 160 million dollars a year. If Pakistan aims to double its exports to Sri Lanka within a year as stated recently, it will need to review its drug pricing mechanism."
Zar while explaining the issue said that delays in approval of new molecules by DRAP, which often takes several years, is depriving patients of the benefits of the latest remedy.
"A cancer patient, for example, does not have the luxury of waiting for 3 to 4 years for a drug to come into Pakistani market. They need that drug right away. Poor policy and an inefficient regulatory structure are denying life-saving breakthrough technologies to patients in Pakistan," he mentioned.
He added that the pricing delay also happens when a company wants an adjustment due to the increase in cost of doing business. Thousands of price adjustment applications are still pending with the DRAP and at current speed, the regulator would take years to approve or reject the requests, since there is no set criterion and price determination varies on a case to case basis, he maintained.
He said that shortage of various medicines is directly linked to the federal government's failure to resolve this longstanding pricing issue. According to the PPMA leaders, the pharmaceutical companies keep informing the authorities about the hardships they have been facing for years due to the increase in input costs, pushing almost half the life-saving drugs into hardship category, while most of these drugs are priced between Rs 0.5 to Rs 3 a tablet, which DRAP terms unaffordable for patients.
It is irony that imported alternates, many of which come through grey channels, which are made available during periods of shortage are priced almost 10 to 15 times higher but DRAP neither tries to control the price of these drugs nor allows local manufacturers even a marginal price increase to keep these drugs viable, they complained.
These drugs are needed by millions of people in Pakistan every day because these diseases still exist in the country, therefore, the DRAP should take responsibility and give due price adjustment to local companies and ensure that needy patients get these drugs easily, they urged.
The PPMA officials said that companies have been requesting DRAP to consider these hardship cases in the best interests of the poor patients but DRAP is seemingly non-serious about the issue. When contacted, CEO DRAP Dr Aslam said the Authority has devised a uniform policy in consultation with all stakeholders over pricing mechanism of drugs. He added that the DRAP with the help of other relevant departments is taking stringent action against the sellers of smuggled, counterfeit and substandard drugs.
However, Aslam admitted that pharmaceutical exports of the country in past couple of years witnessed a decline but now the situation is improving as the government is providing a number of incentives to the industry, adding in coming years, the market will stabilise and exports will further increase.
Comments
Comments are closed for this article.