Drugmakers in Pakistan are suffering and parliament needs to implement on the proposed Drug Regulatory Authority (DRA) according to the Pakistan Pharmaceutical Manufacturers Association (PPMA).
PPMA chairman M Jawed Akhai made the comments at a press conference earlier this week according to a report in the PakTribune , telling attendees that drugmakers in being impacted by regulatory changes – including the 2011 decision to hand oversight of the health sector to provincial Governments.
“The pharmaceutical industry has been facing hardships after the 18th Amendment, which transferred the health sector from the federal to provincial governments. Although the ordinance for the DRA has been promulgated, the parliament has yet to make it an Act.”
The comments fit with what the PPMA told in-pharmatechnologist.com earlier this year when it said that the decision to dissolve the old DRA had “resulted in piling up of cases on licensing, registration, pricing, and contract manufacturing.”
Akhai also criticised Government price controls, which he said had not been revised since 2011. He said the out-of-date controls are creating shortages as manufacturers either stop producing certain medicines or opt to export drugs to countries where they can generate higher revenues.
“Just four companies are producing tuberculosis drugs because of the government's unreasonable price control strategy. Had the pricing methodology been fair, at least 40 companies would be manufacturing the same drug.”
Former PPMA chair Kaiser Waheed - who also spoke at the event - focused his criticism on import taxes, claiming that: “We [drugmakers] pay sales tax on 80% of the inputs we use in drugs. This reflects in our cost of manufacturing, and eventually in the market price that the consumer bears.”
Waheed called on the Government to abolish import and sales taxes for rug products and called for the introduction of free medical coverage for unemployed Pakistanis using existing federal government budgets.
The criticism chimes with comments made by the American Business Council (ABC) earlier this year when it warned that US drugmakers in Pakistan could face supply chain disruption as a result of the decision to give responsibility for allocating raw materials to regional governments.
In a letter the organisation said: “There is an urgent need to release quota for raw material of these products to avoid serious implication” adding that “unavailability of high-quality, safe and efficacious drugs will pave the way for counterfeiters, black marketers and spurious drug makers to flood the market.”