Registration of medicines: regressive policies of DRAP blamed for low drugs' export
Regressive policies of Drugs Regulatory Authority of Pakistan (DRAP) in granting registration and clearing backlog of more than 14,000 pending registration are creating hurdles in export, depriving the country of precious foreign exchange, industry sources told Business Recorder.
"Pakistan could have increased its pharmaceutical exports from $200 million to $1 billion by the end of 2015, had the proposed plan of the industry been materialised by the government," sources said. While the DRAP is contemplating to keep an unrealistic tight control over each and every drug made in Pakistan, industry experts said Indian authorities have realised their mistake and have retreated to free market in case of generic drugs after a judicial review.
According to former chairman Pakistan Pharmaceutical Manufactures Association (PPMA) Dr Kaiser Waheed, the DRAP is yet to come up with a pricing policy. He urged the authority to reconsider its approach on the pattern to Indian pricing policies. "We are given examples of Indian drug prices from both life saving and other segments but when the reasons of low prices are discussed they shy away from implementing the Indian policies, the most important being free market mechanism in non-life saving segment," industry sources said.
They further said that because of non-transparent practices in fixation of drug prices in Pakistan most of the quality drug producers have stopped manufacturing drugs that are not commercially-viable and this has badly impacted the pockets of poorer patients as the same drugs are smuggled and sold at double prices fixed by the drug regulator. The Indian pharmaceuticals market has features that make it unique. First, branded generics reign, making up for 70 to 80 percent of the retail market. Second, local manufacturers enjoy a dominant position driven by formulation and development capabilities as well as early investments. Third, price levels are low, impelled by excessive competition.
The government of India has announced policies to provide facilitating environment for the Indian pharmaceutical industry. These guidelines of the government of India are targeted at building a higher number of hospitals, boosting local access to healthcare, enhancing the quality of medical training, augmenting public expenditure on healthcare to 2-3 percent of GDP, up from the current level of 1 percent.
Experts said the industry in Pakistan is still tied up to submission of requests for revision in prices of thousands of drug formulation. The decision making in this industry is highly sluggish, as requests made years back are still awaiting approval. "The DRAP lacks the capacity and capability to take quick and prudent decisions on drug pricing and the government should link the prices of all drugs to the average price of similar medicines in the neighbouring countries ie India, Sri Lanka and Bangladesh till DRAP develop capabilities," an industry expert said.
It is pertinent to mention here that the experts from industry have projected the Indian pharmaceuticals market will grow to $55 billion by 2020 driven by a steady increase in affordability and a steep jump in market access. On the other hand, a completely different scenario is expected out of the Pakistani industry as according to experts the stalemate in drug pricing has effectively blocked the introduction of new molecules in Pakistan depriving the patients of the availability of modern and well researched medicines.
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