Thursday, October 18, 2012

Drug Regulatory Authority of Pakistan Bill, 2012 by the National Assembly

THE eventual, unanimous passage of the Drug Regulatory Authority of Pakistan Bill, 2012 by the National Assembly on Tuesday is a step in the right direction. The consensus achieved underscores the ability of this set of lawmakers to come together for a common cause. It vindicates the feeling that, with a little more purpose, this House could have had an even more productive record than it has shown overall. On Tuesday, the not so minor step of removing the single word `only` was agreed to by all parties.

`...[N]o person shall be appointed as the CEO or director of the authority unless he is a citizen of Pakistan only`, read the original draft. The MQM sought the deletion of `only` from the line, opening up the way for Pakistanis with dual nationality to hold the posts. This was in sync with the position of most parties in the National Assembly.

The need for regulating this sphere has in recent times been highlighted by unfortunate deaths resulting from the consumption of spurious or low-quality drugs and by scandals surrounding the granting of quotasfor substances used in the manufacture of medicines. Even without these high-profile incidents, the greed of pharmaceutical companies is well known, as is the fact that other makers and suppliers of fake, substandard drugs have remained a threat to public health. Governments have failed to take due action and, in return, have exposed themselvesto allegations of not just apathy but collusion with such unscrupulous manufacturers and suppliers.

Whatever mechanism the country had for controlling the sector was made largely ineffective by the transfer of the subject of health to the provinces under the 18th Amendment, and reminders were sent to the legislators that they needed to move fast and decisively on this.

The bill, which now needs a nod from the Senate to become law, raises genuine hope about regulation of the drug sector. One of the drug authority`s vital tasks would be to streamline the interprovincial trade of drugs.

The authority will also help define the federal government`s response and role in relation to obligations and commitments with international organisations. Not least, it will help develop ethical criteria on drug promotion, marketing and advertising, and on the rational use of drugs, on research and development.

The authority `shall undertake measures to ensure self-sufficiency ... to create a conducive environment for manufacture, import and promotion of export`.

This is not an easy agenda but the Drug Regulatory Authority bill is an expression of intent to allow experts to oversee the sector. So long as the emphasis is on merit, so long as the authority is free of politics and is willing to improve its working while learning through experience, success can be achieved.    

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