LAHORE - The devolution of drug regulations has resulted in serious financial implications as it has increased the input cost of drug manufacturing manifold.
While the world is going towards more cautious and centralised approach towards regulation of drugs to ensure uniform and top quality medicines for consumers, the government has decentralised regulation of drugs to provincial level without going into pros and cons of this decision, sources in pharma industry said. It is to be noted that the drug regulation was decentralised to provincial level from July 1, 2011 through 18th amendment although none of the four provinces had developed capacity to undertake this highly important regulation.
According to pharma industry experts, prior to this, the provincial governments oversaw the storage, distribution and transportation of drugs, besides ensuring that the retail and wholesale rates and quality of medicines were according to those approved by the federal government regulating agency. They said that federal government while having an oversight over clinical research and development, regulated the main aspects of drugs including registration of new molecules and fixation of their prices, manufacturing of the medicines under globally practiced manufacturing and quality standards. The regulatory body also provided protection to patents and trademarks besides regulating import and export of medicines and their raw materials.
They said that expertise gap did exist even when centralised drug regulating agency was working. They wonder how six provincial DRAs would be able to arrange human resources needed for this purpose. Moreover, they apprehended that weak capacity in any of the six devolved DRAs would have adverse health implications for entire country.
Experts also expressed their grave concern that absence of uniform standards may lead to widespread marketing of substandard drugs and constitutionally guaranteed inter provincial trade would ensure free movement of drugs from one province to the other.
They said that independence in price fixation would mean the rate of each drug would differ from the other province. This would be exploited at retail level and the patients would end up paying the highest price.
They pointed out that adherence to good manufacturing practices is critical for making drugs of standard quality. They said that Pakistan has recently entered drug export market that can be jeopardised because of the absence of centralised drug regulatory authority. Some experts warned that it would be beyond the capacity of the provinces to regulate 0.6 million products and their quality which would encourage marketing of spurious and substandard drugs.
“With no central control of intellectual property, provinces can register different categories of drugs with the same brand name with potentially fatal consequences,” they said, adding that differences in the label requirements in the provinces will create confusion.
They said that the coordination with international agencies like World Health Organisation (WHO) will be compromised in the absence of a central agency, as the provincial DRAs are still not operational.
The experts revealed that the drug regulation in all developed economies like United States and Canada is centralised while in the European Union it is regionalised where all 26 member countries follow same regulation.
They said that India also tried devolved drug regulatory agencies but soon reverted back to centralised agency.