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February 6, 2015

Drug makers question effectiveness of regulations


February 6, 2015

LAHORE: Drugs makers on Thursday questioned effectiveness of regulations, saying the Drug Regulatory Authority of Pakistan has only 14 inspectors to monitor quality of nearly 80,000 medicines made by over 600 firms in the country.
“We are particularly concerned over the nontransparent procedures of price fixing,” said Amjad Ali Jawa, ex-chairman of Pakistan Pharmaceutical Manufacturers Association (PPMA), representing local companies. “The procedure is painstakingly slow.”
More than 1200 drugs have been awaiting price approval for the last 15 months, said Jawa.
“It is better to fix a leader price and allow all other manufacturers to market drugs not above the leader price,” he added. “This can spare the regulator from examining prices on case to case basis and it can then concentrate more on drugs quality.”
Shahab Rizvi, chairman of Pharma Bureau, comprising multinational pharmaceutical producers, said even a better alternative is to fix price of a medicine as mean of the rates of the same drug in India, Bangladesh and Sri Lanka having comparable social and living standards with Pakistan.
“The stubbornness of the regulator in not granting genuine increase in the prices of medicines has resulted in suspension of several life saving drugs in the country,” said Rizvi.
Citing an example of Thyroxin tablets for patients with malfunctioning thyroid gland, he said the licence to produce this medicine is available with both local and foreign companies. “However, there is an acute shortage of this drug in Pakistan because only we are producing it; although the current rates are not suitable,” he added.
“A 30 to 40 percent increase in prices of locally-made thyroxin tablets can make them abundantly available in the country,” said Rizivi. “It will also save money for patients who buy expensive smuggled medicines.”
Dr Khalid Javaid Chaudhry, ex-chairman of PPMA sees disparity in price determination.
“The prices

of a medicine – produced by both local and foreign firms – are found different,” said Dr Chaudhry. “Transparency will bring prices of medicines down in Pakistan in the long-run due to competition among 600 manufacturers.”
Arshad Saeed Khan, co-chairman of Pharma Bureau opposed a possible reduction in the prices of medicines.
“This will be tantamount to handing health sector over to importers and give a rise to spurious and substandard drugs,” warned Khan.
He said the Drug Regulatory Authority of Pakistan favoured a general increase of 94 percent in prices of drugs to offset the impact of inflation and escalating cost of production.

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