The acting chief of the Pakistan Pharmaceutical Manufacturers Association has resigned from the organization in outrage over a drug scandal that has cost more than 130 lives. And consultant Robert Walsh, who went to Pakistan twice last year to survey its pharmaceutical industry, says he understands why Tariq Ikram stepped down.
Walsh, whose Samsara Biopharma Consulting does business development and due diligence for international biotech pharmaceutical companies, said his visit confirmed the problems over which Ikram is frustrated.
In a comment left on the blog Pharmalot about the situation, Walsh said, "[b]iotech drugs are barely regulated, especially the interferons, as HepC is rampant there. As a result, you have 'biosimilars' on the market from companies I never heard of, and other Pakistani companies importing bulk material from God-Knows-Where to formulate and vial locally."
In a telephone interveiw with FiercePharmaManufacturing, Walsh pointed out Pakistan's population is north of 180 million, so there is huge demand for drugs. Oversight has been pushed back to the province level, and many provinces are ill-prepared to maintain good manufacturing practices.
"Some big provinces may be able to do regulation well--or not. In other areas like Peshawar, not only is regulation of the pharmaceutical industry a causal concept, they are g__ d___ dangerous to be in," Walsh said.
He said the issue seem particularly challenging in the import and manufacturing of biosimilars. Walsh said he had three companies press him on how they could get safe materials from China.
The resignation of Ikram as acting director of the PPMA, which his family helped found 25 years ago, appeared to be in frustration over how efforts by the organization to get the government to form a national Drug Regulatory Authority have played out. He also withdrew his company, Opal Laboratories, from the organization. The PPMA was urging federal oversight after a steady stream of patients died in recent weeks and hundreds got sick following treatments at the Punjab Institute of Cardiology. The institute had given them drugs received as a donation that reportedly tested with a high quantity of an anti-malarial chemical.
Ikram was to present a statement from the PPMA at a press conference, but he indicated his input had not been included. Later, in his own statement to the International Herald Tribune, Ikram said that even as the pharma manufacturing industry has grown tremendously, politics and corruption have kept bad players from being weeded out.
Statistics Ikram provided included:
- Between 1988 and 2011, the health ministry issued 580 drug manufacturer licenses. It had issued only three manufacturing licences for pharmaceutical firms per year--126 in total--between 1947 and 1988.
- Manufacturing facilities have grown to 709 in 2011 from 129 in 1988, a 450% increase.
- The number of provincial drug inspectors grew to 263 in 2011 from 91 in 2008, a 189% increase, which he said was insufficient to enforce GMPs.
He also complained of government interference in efforts to police facilities making substandard drugs.
Even though the situation in Pakistan appears chaotic from the outside, Walsh has some favorable impressions, particularly after making trips throughout the country and meeting with drug companies there.
“I went expecting India but in spite of the security problems, it is a very orderly society,” he said. “I met people who were quite capable of setting up manufacturing.”