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Continued from Previous…… This series is based on a report compiled by Jilian Clare Cohen1, Monique Mrazek2, and Loraine Hawkins3 for World Bank.
Six decision points were identified where corruption could infiltrate. The first was manufacturing which was taken up in the last blog. Second is discussed below.
Decision Point Two: Registration and Market Authorization
1950s saw the great tragedy of a large number of limbless children born to women who were taking the drug, thalidomide. The drug was introduced as a sedative and became a popular prescription rapidly. Soon, reports of increase in limbless births started coming in but their relationship to thalidomide was not established immediately. By the time, the drug was withdrawn, number of defective births had mounted already. Even some patients kept taking what they had with them. Later, the parents of these children sued and were awarded huge compensations. Some of the children survived long into future with severe deformities and severe disabilities.
This human tragedy led to the need for a formal process for registration of drugs before marketing. The process of registration/market authorization is done by the national drug control agency, DRAP in case of Pakistan. DRAP is responsible for evaluation of the drug efficacy against specific diseases, safety, and possible side effects. For generic drugs, bioequivalence/bioavailability may also be required in some countries, but not yet in Pakistan. Drug regulating agencies also set standards for manufacturing, storage, and distribution. To further regulate Pharma business, Drug regulating agency requires that manufacturing and selling is done by relevant license holders only; the licenses are issued by the agency. Other areas of supply chain, use at the end consumer, and the gathering of information after the drug is sold on the market, are also controlled.
Drug registration/ market authorization has come a long way in the last decades. It is now an elaborate process which is time consuming and costly, both for the manufacturer/marketer and the regulator.
Drug registration must have a strong legal basis. In Pakistan, the governing law is Drug Act 1976 which is in force since its promulgation as law. It requires transparency in applying uniform application of defined standards. Transparency shall be possible if the agency is independent and empowered to do so. “In poorer countries where the capacity and effectiveness of the regulatory agency is dependenet on its financing from the fees it receives for the drugs it is meant to regulate, independence can be challenging, and it is particularly in such circumstances that independence of the regulatory staff, separation of functions and contact with manufacturers and transparency becomes even more important”.
Financing of drug regulating agency is an important yet neglected area in poorer countries. The formation of DRAP in Pakistan was done since the government wanted to offload its burden on exchequer. DRAP enhanced all fees immediately to make itself viable.
Apart from finance, the capability and capacity to ensure testing of applied drugs is the next challenge. We do not have any drug testing lab which has the resources and capability to test the drugs applied for registration. DRAP relies on the data submitted by the applicant company which also does not have capability to do sophisticated testing and long-term studies before registration. The applicant companies and DRAP rely on the data generated by the innovator company which may be available in the public domain.
“Various strategies can be used to lower the risk of corruption in the drug registration process. For example, it is important to ensure the uniform application of procedures and that all criteria are available publicly to minimize the risk of individual discretion. The regulatory authority must operate in an impartial way and justify its decisions clearly and openly. To facilitate this, all regulatory employees should be screened for any potential conflict of interest that could bias any decision making. Information on the drug registration process, its criteria and results should be published regularly and disseminated in local newspapers and on the internet. Disclosing on the website a register of all applications for registration and of all registered drugs (with dates) increases transparency. Overhauling the drug quality control system generally requires a multi-pronged approach led by strong political leadership to take reforms forward.
Drug quality control needs to go beyond the drug agency, as ongoing market surveillance is also vitally important to ensuring the integrity of the drug supply and identifying corruption. Implementing a market surveillance strategy that includes mechanisms to monitor the drug supply such as random batch testing and reporting streams to ensure feedback from health professionals and users to responsible authorities when problems are identified can be useful to ensuring the integrity of the drug supply.”
The situation in Pakistan has seen a favorable evolution over time. However, our drug registration system still suffers from a host of issues, which need addressing urgently and seriously.
To be Continued……
Disclaimer. Most pictures in these blogs are taken from Google Images which does not show anyone’s copyright claim. However, if any such claim is presented, we shall remove the image with suitable regrets.
- Jilian Clare Cohen – Toronto, Canada
- Monique Mrazek – Latin America
- Loraine Hawkins – London