Loopholes detected in framework: Drug regulatory authority
By Our Reporter
ISLAMABAD, Oct 16: A consumer rights organisation has pointed out sever loopholes in the framework of the proposed Drug Regulatory Authority (DRA) and has termed it an eyewash that will institutionalise the interests of pharmaceutical companies by further weakening government’s control on prices and quality of drugs.
DRA is supposed to be a smart, modern and paperless organisation. By creating new posts of grade 20-21, it will allow the bureaucracy to enjoy a long honeymoon of high salary packages at the expense of the taxpayers money, said Ayaz Kiani of the Network for Consumer Protection at a press conference here on Monday.
He said the authority promised no relief for consumers and seemed almost helpless in ensuring the quality and distribution of drugs.
Though Drug Regulatory Authority would still be primarily controlled by the federal government, its own control on maintaining quality and prices would further be weakened, he said while reading from a draft of the proposed authority.
He said the pharmaceutical industry would have permanent representation in the authority and they would determine the prices of their drugs by only providing a legal paper to the government that the prices of the same drugs are the same in other countries.
He said the authority was aimed at subsiding the growing public criticism over the inefficiency of the federal government to implement the Drug Act of 1976. “It is being used as a cover after the Supreme Court took a suo motu action recently and directed the health ministry to reform its regulations and mechanism for control of production and sale of drugs.”
He said the authority would not be able to regulate a burgeoning sector with over 400 manufacturers, 40,000 registered products and 60,000-plus sale outlets.
Mr Kiani said the authority proposed a 13-member team of policy board with nine members from the bureaucracy of health ministry, four experts and the federal minister. While the executive cadre will be hired from the market.
The authority would prove beneficial only to these high-ups, he added.
He said the framework divided the drugs into five categories and set up different rules for each category.
The first category included medicines that were listed in the World Health Organisation (WHO) list of essential drugs. The prices of these drugs would be controlled by DRA.
He said why was the government using the WHO list when the latter itself had advised its member countries to take the list as a guidance and prepare their own national essential drugs list. Pakistan has been preparing its own list and keeps reviewing it as well.
“Why would the DRA not be controlling the drugs included in the national list? More importantly, what does ‘control’ mean here,” he asked.
The second category is of non-essential drugs and the companies will be free to fix and raise their prices, he observed.
The act establishing the authority proposed the creation of a Drug Regulatory Authority fund that would receive grants and loans from the government and would also get various kinds of services fee from the industry, for example, drug registration fee, manufacturing licence fee, etc.
The framework also envisaged a Rs100 million annual budget for the organisation.
Though the authority would initially receive grants from the government, it had an objective of ultimately shifting its financial source completely to service fees or in other words to the industry.
