Published in The News International on March 06, 2012:
Currently, there is just one drug quality testing laboratory in each province but most are either inoperative or lack infrastructure, equipment, or qualified competent and experienced staff. It is critical that the government invests as well as attracts investments in this area.
An appropriately structured arrangement can have public-private resonance, offering a commercially viable investment opportunity. A sustainable system can also be developed which serves a public goal by ensuring quality of medicines.
This is also a time for a deeper policy review of the problem of substandard medicines. Pakistan today ‘boasts’ of 709 pharmaceutical units but none of them are FDA-certified. A large number of manufacturing units have been set up on shoe-string budgets and are quality deficient from the outset.
Many experts are of the opinion that the deterioration in the pharmaceutical manufacturing standards, amongst other things, is the result of the former MoH’s irrational policy – also currently in effect – of linking licensing of products to having one’s own manufacturing facility. This forces every new supplier entering the market to set up their own manufacturing facility to get into the business.
In some cases, these units are name plate operations. Many never have the volumes/capacity utilization required to achieve CGMP standards. While they put in place brick and mortar, other critical ingredients are lacking – professionals with competency, robust and validated systems and periodic audit. Most units are unable to undertake the requisite investments in manufacturing equipment and infrastructure to upgrade themselves to international levels.
As a result, substandard units have burgeoned, over time. These systemic limitations have also been recognised by some factions within the local industry itself, as was evidenced by the resignation of the PPMA (Pakistan Pharmaceutical Manufacturers’ Association) acting chief, as reported in newspapers on Feb 17.
The policy of lumping together “manufacturing license” and “commercial supplier’s license” is in deviation from the Drug Act (1976) Rules, which envisage a tolling policy allowing companies to have their products manufactured at any licensed manufacturers’ premises. Use of tolling can create an incentive for manufacturers to raise their standards and processes for both manufacturing and also quality control to international levels.
The existing policy should be reviewed in light of the recent debacle. The government must lay down minimum standards for manufacturing units with WHO’s help and should stipulate a timeline for their achievement. It is in the interest of the industry to support such standards and open themselves to licences’ review, rather than resist them as was indicated in a PPMA statement, quoted in newspapers on Feb 18.
In terms of the way forward there is also the imperative to revise the Drug Act – the fourth point. The Act’s weak enforcement is the subject of much debate, but it is not fully appreciated that the law has exploitable covenants, particularly in relation to “warranty of sale”. Traditional medicines prescribed by 130,000 practitioners remain outside the law’s purview.
A draft bill on traditional medicines has been in the parliamentary review pipeline for the last 10 years without action, for no apparent valid reason. These weaknesses have opened an avenue for collusion across the entire layer of provincial drug regulation relating to distribution, pharmacy sales and storage and have encouraged back street production of counterfeit – issues outside of the scope of today’s comment.
Lastly, it must be appreciated that much would depend on the capacity and effectiveness of the new DRA. Most of the tasks outlined above and many others would fall within its remit. The DRA must be appropriately resourced as a starting point. The government has been collecting a 1 percent tax on gross income from all pharmaceutical manufacturers since the early 70s with a view to channelling funds towards a ‘research fund’. Since the latter has not materialised fully, these billions could be used as an initial input to resource DRA’s institutional building effort in these times of severe financial hardship in Pakistan.
The DRA’s governance structure should be carefully established. It would be critical to learn from past mistakes in establishing independent regulatory authorities, where controls still rest with the government and where under-resourcing and lack of appropriate accountability frameworks create space for collusion, inefficiencies and commandeering by vested interest groups.
Meticulous transparency is needed in this respect. The EMA’s recent initiative is an example of such transparency – from March 1, 2012 the EMA will start to publish information on applications for centralised marketing authorisation for human medicines that it has received for evaluation.
One of the key responsibilities of a government is to protect its citizens, and if the present government does not step up to make radical changes it will be blamed when more tragedies inevitably occur. The new DRA is a window of opportunity – by establishing it the government has taken the right first step but much more needs to be done quickly!
The writer is the founding president of the NGO think tank Heartfile. Email: email@example.com