There is no regulatory framework for pharmaceutical industry in the country to stop catastrophe of the like which has hit Lahore. Experts have expressed serious concern over this situation and demanded of the government to establish a single centralised Drug Regulatory Authority (DRA) in the country on top priority basis.
"The entire pharma industry is extremely uneasy over the lack of clarity in the absence of a regulatory framework in the country," according to Dr Farid Khan, an expert on the pharmaceutical industry and former CEO and former VP Pharmacy Council of Pakistan. He told Business Recorder that the government should devise a regulatory framework that could ensure availability of quality medicines for the consumers. "Since the registration-related issues, especially the quality testing, were of centralised nature across the globe, the same ought to remain with the central government," he said.
Contending that regulatory framework was a federal subject world-wide, he said that DRA could only reap better results when it is formed and that too mindfully at the federal level and if there are independent experts on its Board. "The world is going towards more cautious and centralised approach towards drugs regulations," Dr Farid said.
He said that the government announced to devolve the country's drug regulations to the provinces in July 2011 under the 18th Amendment despite the fact that none of the four federating units possessed the capability as well as capacity to formulate these highly important regulations.
Another expert of medicine manufacturing industry requesting anonymity said that reestablishment of required infrastructure in the provinces would be wastage of the resources developed by the federal government over the past many years. He questioned the ability of the proposed provincial DRAs to rearrange human resource while having a weaker capacity thus creating new risks for adverse ramifications for the patients.
He also expressed concern over the price differential to be established in the provinces that would lead to potential shortages of drugs. "Constitutionally guaranteed inter-provincial trade cannot restrict movement and sale of drugs in other provinces and the independence of price fixation will result in differences in the price of a particular brand in different provinces." Additionally lack of a central quality board and monitoring authority could lead to varying quality and efficacy to drugs leading to a tragedy similar to that being experienced in the Punjab at present.
In absence of a central authority on intellectual property rights, the provinces are likely to register different categories of drugs having the same brand with potentially fatal consequences. While discussing different regulatory models, he mentioned that regulation is moving from national to regional models in regions such as GCC countries, ASEAN, EU and Latin America. Global trends aim at standardisation and building centers of excellence for fast track registration to enhance patient interest, he said.
Industry sources said that at present, expertise gaps exist for even one centralised DRA, staffing six set ups to an acceptable level of capability will be impossible and that weak capacity in any province will affect the health of entire country. The replication and duplication of work in establishing and operating of a complete infrastructure in each province would be wastage of the resources as the federal government had already invested billions of rupees to develop such infrastructure over the past many years.
Regarding the technical issues arising from devolution, they said that absence of uniform standards would lead to proliferation of poor quality of drugs. They warned that post devolution, all effective control will be lost as regulating the 60,000 drug products and their quality in each province is practically impossible. "With lesser control, provinces could register different categories of drugs with the same brand name with potentially fatal consequences," one of the sources said adding that the differences in legal requirements in the provinces will also create confusions.
They said that the federal government should realise the situation and the provinces should urgently agree for establishment of a centralised independent regulatory authority that has jurisdiction over the whole of Pakistan. The legal formalities need to be initiated and completed immediately.
They suggested that the DRA should be staffed by technical experts and professionals. The chairman of the organisation may rotate amongst the provinces, however, strict adherence to selection/ recruitment criteria needs to be observed along with complete independence of the proposed DRA. "Aspects related to trade within the provinces can continue to remain with the provinces," they said.
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