Earlier this month, the Government promised to lend more support to the local pharma sector after reforming its “inactive” Drug Regulatory Authority and establishing the Ministry of National Regulations and Services.
At the time new body’s Federal Minister Firdaus Ashiq Awan said the multinational pharma firms currently operating within Pakistan play a big role in supporting the industry and the quality of medicine provided there, but that there is potential – and a need – for more foreign drugmakers to get involved.
Speaking at a dinner held by Pakistan’s Pharma Bureau, she also pledged the new ministry would make operating in the region more “transparent” and hence more attractive to international producers. She said the country now hopes the regulatory body means a more even playing field for all payers.
However the PPMA (Pakistan Pharmaceutical Manufacturer’s Association) voiced its concerns to in-PharmaTechnologist.com, saying the plan is fundamentally flawed because there is no room in the drug manufacturing market for newcomers.
A spokesperson for the trade organisation said: “The local pharma industry has been mushrooming for the last decade, leaving little space for the addition of foreign manufacturers.”
PPMA added that local producers already established may not take kindly to Ashiq Awan’s plight, saying: “The domestic pharma industry would not accept losing their share of the market. The medicines not produced locally will have more scope.”
But the association was not entirely negative about the ideas of the new ministry, adding that the “odd plant” could still enter the sector, providing their products are either in big demand or are “innovative”.
Establishing a centralised regulatory authority
Despite apprehensions about the push for foreign investments, PPMA welcomed the harmonisation of regulations in the country that were put in place partly to attract the firms.
The spokesperson said the devolvement of the Federal Health Ministry last June led to a fragmented industry because control got shifted to the provinces.
“The Drug Regulatory Authority also became in active,” PPMA said. “This resulted in piling up of cases on licensing, registration, pricing, and contract manufacturing.”
The organisation told us all hopes now rest on going back to the old times, once again using a central Drugs Regulation Agency to tackle the issues.
When asked if the move could be a response to the US FDA’s (Food and Drug Administration) recent User Fee Reauthorisation Bill – which requires inspection of all pharma plants that wish to supply the States with meds – PPMA replied: “This could be one factor, but Government understands that only the quality medicines will have acceptance at home and abroad.”
The raw problem
Other concerns about the Governments new pledges have focused around raw material woes for the area.
Plans to devolve the ministries also created a legal backlog for raw material allocation, the Government claimed in April, and the American Business Council (ABC) warned US drug manufacturers to brace themselves for a hit.
However speaking at the Pharma Bureau dinner, chairman Asif Jooma remarked that there was still no provision for the problems in the aligned Ministry’s plans.
Daily Times Pakistan reported that he said: “The list included in the budget document did not capture the main raw materials for which exorbitant protection has been accorded to a couple of companies, in some cases, for over 20 years,” before urging Ashiq Awan to re-evaluate the situation.