Drugs: separating spurious and authentic claims

22 Jan, 2010

Speaking on the issue of spurious medicines in the National Assembly on Tuesday, Interior Minister Rehman Malik said that 40 to 50 percent medicines, including life-saving drugs for children, had been found to be spurious or substandard. According to a PML-N MNA, untested and unapproved imported medicines are freely available in the market.
The house passed a resolution, urging the government to take action against all those involved in the trade of such medicines. The issue of spurious drugs has been in the spotlight for quite some time. More recently, the Supreme Court took a suo motu notice of the matter in 2007, followed by the creation of a sub-committee of the Senate.
The problem, however, continues to persist. Early this month, the media reported a case of a drug-manufacturing firm which had allegedly supplied 300 million substandard Paracetamol tablets to the government's primary health programme. The only action taken against the firm was the suspension of its licence.
While the term 'merchants of death' is generally used for big arms producers and dealers, this is also applicable to those who manufacture or sell fake medicines, endangering the health and sometimes, the lives of unsuspecting patients. What is more, most of the victims happen to belong to the poorer sections of society.
Medicine outlets in upper class localities normally are careful, because the customers at such outlets have been found to be more conscious as they often check expiry dates and packings. In poor localities, however, people buy genuine or fake medicines obligingly while the illiterate have no way to even find out whether the drug has actually expired.
Sometimes, they can afford to buy only a few tablets, sold without any packing, with no guarantee of genuineness. This is particularly so in small towns, which cater to the rural population. Here those running drug shops can practically sell anything without fear of being challenged or checked.
As much larger margins are offered by the manufacturers of spurious drugs than those by suppliers of authentic drugs, there is always an incentive for unscrupulous traders to deal in such items. Besides endangering the health and lives of thousands of patients, the sale of fake drugs hurts the economy also, by contributing to the growth of a black economy.
Moreover, bonafide businesses suffer because of infringement on their legitimate profit-making prerogatives. The malaise starts from top in Islamabad, where decisions on new drugs are made along with large-scale purchases of medicines for state-run medical facilities.
There has been a continuing fear of unscrupulous firms corrupting politicians and officials in the search for contracts and licences for substandard medicines. On paper, there is a Central Licencing Board, a Drug Regulatory Board, and the Drug Appellate Board. Over the years, this entire system has proved to be ineffective.
Its major failure lies at the level of implementation. Among the reasons is that the same agencies are involved in policy-making and in regulatory and implementation roles. The situation is hardly any different in the provinces, where there are widespread complaints of lack of proper oversight on the part of the Quality Control Boards and provincial drug inspectors, mandated to ensure compliance with rules at the retail level and at the distribution chain to ensure quality.
Drug stores across the country continue to violate rules at will. Unless there is more vigilance by these bodies, things will remain unchanged. Among the problems that need to be addressed is the under-resourcing of regulatory bodies and weak mechanisms of accountability.
The speakers in the National Assembly underlined three issues: a serious lack of implementation of rules already on the statute book, the need to make the laws, governing the quality of drugs, more stringent and a more efficient disposal of cases against those who violate laws, an issue that Rehman Malik particularly underlined. As he put it, "The FIA seized raw material and drugs during various raids. But the culprits escape by the time investigation is completed and action initiated."
While the National Assembly has called on the government, through a resolution passed on Tuesday, to take measures to effectively deal with the menace, there is a need for the issue to be taken to a special parliamentary committee. It is a multifaceted issue, which requires a holistic approach. The recommendations should then be presented before the National Assembly for legislation.

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