Drug regulation devolution: a threat to medicine quality? | Pakistan Today

Drug regulation devolution: a threat to medicine quality?

The devolution of drug regulation to provinces would affect the uniform quality of medicines in the country and reduce the high foreign exchange earned through the export of drugs, stakeholders told Pakistan Today.
Register in one province, sell in another: They said the devolution of drug regulation to provinces would “roll back” the quality assurance of drugs and “maturity” achieved in drug manufacturing since the promulgation of the Drug Regulation Act, 1976. “If a province does not register a drug over quality issues, the pharmaceutical company can get the same drug registered in another province and market and sell the same drug in the province where it was not registered and put an end to a uniform drug standard in the country. This is equivalent to putting the lives of millions at risk since there will be no uniform law to check the sale of sub-standard medicines,” they said.
How drugs are regulated: An expert on drug regulation said before 1976, there was no regulatory system for drugs, with only eight to 10 drug inspectors in the entire Punjab, while the drug testing laboratory was also not fully developed. With the promulgation of the drug act, a drug control section was set up in the Health Ministry, with drug controllers having PhDs in pharmacy serving there. The act also introduced the concepts of panel of experts and technical committees, while including different schedules in the act governed by standard operating procedures (SOPs) matching international standards. Also, the old drug manufacturing units were revalidated and re-inspected in light of the newly incorporated schedules and SOPs which introduced new concepts of quality assurance and revived the industry. “It is because of the improved standards over the years that Pakistan is exporting drugs to Sri Lanka, Middle East, Africa and other countries. Our export relations will be compromised by the devolution of drug regulation to provinces,” he added.
Drug policy and the developed world: A drug distributor, seeking anonymity, said considering the complexity of the issue, drug regulation is retained by the centre in the developed world including the United States (US) and the European Union. “The Food and Drug Administration (FDA) vests with the Centre in the US and is observed by all states within the US. The goods manufacturing practices (GMPs) evolved by the World Health Organisation over the years is implemented in letter and spirit by the FDA and the EU also follows the same recommendations, with drug regulation being a federal subject in the EU as well,” he said.
Ulterior motives: A pharmaceutical company owner said that the revenue generated by drug regulation is “peanuts” compared to the overall health budget and further alleged that the provincial regime has “ulterior” motives behind the act. “It is not sane to replace the maturity achieved over a period of 40 years. Experimenting is fine but to put human lives at stake is a risk not worth taking,” he added.
Government sources said the Punjab chief secretary had opposed the devolution of drug regulation to provinces in the first meeting of the Inter-Provincial Coordination Committee (IPCC) and proposed a national drug regulatory authority instead to ensure uniform drug standards across the country. “However, things took a different turn later and it became a political issue between the Punjab regime and the centre and hence the provincial government now wants to get all devolved subjects in letter and spirit, setting aside the logic presented by the chief secretary himself,” they added.

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