Though never quite able to keep criminals at bay, there has been a total breakdown of the drug regulatory system in the last two years. And there are no indications of improvements any time soon. Plans to set up the ethereal Drug Regulatory Authority of Pakistan (DRAP) have been taking rounds of parliamentary committees and bureaucracy comprising unabashedly of those having direct interest in the pharma industry. Indeed, there is a complete capture of the policy and regulatory development by the pharma industry.
Here is how Ralph Nader, father of the American consumer movement, explains this regulatory capture happens: “a kind of regular personnel interchange between agency and industry blurs what should be a sharp line between regulator and regulatee, and can compromise independent regulatory judgment. In short, the regulated industries are often in clear control of the regulatory process.” These words indeed characterise the cozy relationship between the regulator and the pharma industry in Pakistan.
Problems related to the safety and quality of drugs have existed in the modern age in many places around the world, in developing and developed countries alike. Some incidents have ended in tragedy, often with children and women as the victims. They are caused by the use of drugs containing toxic substances or impurities, drugs whose claims have not been verified, drugs with unknown and severe adverse reactions, substandard preparations, or outright fake and counterfeit drugs.
The difference between most other countries and Pakistan is that every time a major incident of medicine-related tragedy occurred, in other countries there would be an immediate introduction of effective regimes of drug regulation to ensure the safety, efficacy and quality of drugs, as well as the accuracy and appropriateness of the drug information available to the public. Over here we are unable to even set our priorities straight.
Regulation of drugs encompasses a variety of functions. Key functions include licensing, inspection of manufacturing facilities and distribution channels, product assessment and registration, adverse drug reaction monitoring, QC, control of drug promotion and advertising, and control of clinical drug trials. Each of these functions targets a different aspect of pharmaceutical activity. All of these functions must act in concert for effective consumer protection.
What we need is an agency which has competent and qualified professionals, especially those at the head, its jurisdiction encompasses all functions related to drug regulation, has full financial independence and authority in the command and control of these functions, as well as bearing the responsibility for their effectiveness. Of all these, the most important factor for the success indeed is who is charged to lead such an agency.
The current Commissioner of United States Food and Drug Administration (USFDA), a premier regulatory agency, is an experienced medical doctor and scientist who has been part of the Harvard Medical School, conducted research on neuroscience at Rockefeller University, studied neuron pharmacology at the National Institute of Mental Health and later focused on AIDS research as an Assistant Director of the National Institute of Allergy and Infectious Diseases. In 1994, she became one of the youngest persons ever elected to the Institute of Medicine. In 1997, at the request of the then President of USA, she accepted the position of assistant secretary for policy in the US Department of Health and Human Services (HHS).
The names being cited to head the DRA in Pakistan are by no means in the vicinity of such a profile and it is most likely that the industry is going to get somebody implanted at the critical position of the DRA head. There is an incredible lot of wrangling going between the powerful industry groups to snatch the position in favor of their candidate.
Reference: 1. Economic Regulation vs. Competition: Uncle Sam the Monopoly Man, Ralph Nader, Yale Law Journal 82, no. 5 (April 1973), 876.
2. Effective drug regulation: A multi-country study/ by Sauwakon Ratanawijitrasin, Eshetu Wondemagegnehu, WHO, 2002.
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