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Drug rules or control freak

November 18, 2012

Low costs, weak laws and inadequate enforcement and penalties have made India an attractive destination for the tests, human rights groups say. – File photo courtesy Creative Commons
The pharmaceutical sector has shown progressive growth. The local industry has expanded phenomenally with growth rate as high as 28 per cent per annum. Last year, it grew by 10 per cent. – File photo courtesy Creative Commons

THE drug business is likely to pull itself up as the government moves to put in place the regulatory framework that lapsed mid last year pushing the high growth sector in a state of virtual disarray.

The desperate private sector that endured the stress wished that the government could make up for its short sightedness by creating a more vibrant regulatory system/set up that may respond to demands of modern day business. It, however, felt that the government lacked sense of urgency and was inclined to revert to its old non- professional lethargic ways, high on controls and low on efficiency.

Officials claimed that the seven-member independent policy board will be constituted and meet within next week while the autonomous (Drug Authority of Pakistan) Drap will become fully functional within three months. The board will be expanded over time by inducting eight new members to attain its strength of 13. It will include representatives of provincial health ministries, experts, and civil society representatives.

The federal health ministry ceased to exist in May 2011, following the devolution under 18th Amendment, leaving a highly controlled sector without a regulator in the country. It cost the sector dearly — as it needs authentication at every step of the trade from registration of new medicines to pricing to import and export.

President Zardari last week signed the Drug Regulatory Bill 2012 into an Act to complete the legal obligation for setting up of a federal body to regulate the manufacture and trade of medicines and devices.

The authority, with much wider scope, is being projected to be more business-friendly, efficient and apt to address the regulatory demands of the drug business on modern lines.

“What our request failed to achieve, a human disaster did. It took the death of 100 patients in Lahore in the medicine scam at a government hospital to activate the issue of drug sector regulation seriously. It is good that the government has responded to the tragedy though it would have been better if it had acted more responsibly to avoid the occurrence of such sad incidents in the first place”, an embittered local druggist commented.

Arshad Farooq Fahim, the interim CEO of Drap, talking to Dawn over telephone from Islamabad, dismissed the apprehensions regarding the government and the body in formation.

“Yes, an unintentional mistake was made when the federal ministry of health was disbanded and the subject of health was transferred to provinces that lacked capacity and the framework to look after pharmaceuticals. On realisation, all four provincial assemblies passed resolutions to authorise the federal government to deal with the sector at the federal level and thus Drap happened.

“Now we have a clear mandate and a roadmap with deadlines to complete our part of the deal in a record time. However, it is not an easy task as it involves a lot of homework on rules and regulations and establishment of directorates to encompass all aspects of medicine business”, he explained.

Fahim found the fears of the private sector about the replication of archaic, politicised, corrupt regulatory structure of the past misplaced.

“A body is likely to be transparent, efficient and independent if it is manned by professionals appointed on merit and sustains itself independent of the government. Drap hopefully will fulfill both these prerequisites. The post of the CEO will be filled on merit through open competition. We will place an advertisement in newspapers for the post soon.

“As for financial independence, we hope to generate enough funds through our operations to sustain the authority without government doles. Besides, we have already received approval from the ministry of finance to allow transfer of the account of the Research and Development Fund to the authority”, he said.

The leaders of local and multinational drug manufacturers closely monitoring developments were cautious in their response.

Generally they supported the establishment of Drap but raised some issues that they found worrisome. They tried to veil their mistrust of the PPP-led government but repeated their assertion that Drap needs to be headed by professionals and not a political appointee.

“The taste of pudding is in the eating. The announcement of Drap is good but not sufficient. We hope that the government matches the business expectations, but if we go by their track record we have every reason to be unnerved. The political leaders do not understand the intricacies of business and the bureaucrats are control freaks. We are keeping our fingers crossed”, a leading drug manufacturer said.

“Why has the private sector not been given representation in the body formed to regulate them? We have not been allowed to sit even as an observer in the policy board”, argued Qaisar Waheed a former president of Pakistan Pharmaceutical Manufacturers Association.

The CEO of Drap defended the government’s position. “We need to be guided by national and not commercial interest. Our objective is to ensure that patients get quality medicine at affordable rates. We have taken input from the private sector at every stage. If given a seat in the policy board, industry representatives can block any move that they perceive against their commercial interest.

“Besides, there are conflicts amongst different segments: between local and multinationals, importers and exporters, chemists and hospitals, etc. It could paralyse the body”, he said.

The executives of multinationals focused more on positives. Asif Jooma, President of Pharma Bureau, a representative body of multinational drug companies acknowledged that Drap is in line with the aspirations of his community.

“The biggest challenge is to have a right composition of efficient professionals in the regulatory body. Much would also depend on the degree of autonomy that the authority gets to enjoy”.

Jooma favoured high registration fee that, he felt, would discourage irresponsible people from entering the arena of pharmaceutical business where quality and standards can only be compromised at human cost.

Tariq Wajid, a former president of Pharma Bureau, hoped that Drap will notify the exact time of processing of different categories of applications by drug manufacturers.

The pharmaceutical sector has shown progressive growth. The local industry has expanded phenomenally with growth rate as high as 28 per cent per annum. Last year, it grew by 10 per cent.

According to industry data, Pakistan exports drugs to 60 countries. The sector employs four million people and meets 90 per cent of the country’s drug requirements.

Out of 400 pharma units, 70 per cent are national and the rest are multinational companies.