Â
The Drug Regulatory Authority of Pakistan (DRAP) is a regulatory authority in Pakistan, responsible for ensuring that pharmaceuticals are safe and effective. As the SF issue in pharmaceuticals became increasingly apparent, the inadequacy of the health care system in Pakistan became more apparent as well.
Common Technical Document (CTD) of Drug Regulatory Authority of Pakistan
The Common Technical Document (CTD) is the format uses to submit applications for the registration of new medicines. It standardizes a document that intends to make the submission process as easy as possible. The Drug Regulatory Authority of Pakistan receives over 150 applications per month for authorization to market new or generic medicines. USAID supports the authority through its Promoting the Quality of Medicines program.
The CTD is a comprehensive document that includes international standards for manufacturer-submitted data. It includes information on quality, safety, and efficacy testing. These results report in different sections of the standardized CTD dossier. Drug companies require to report the results of these tests.
The CTD divides into 5 modules. Modules 2-5 are harmonised, while Module 1 is not. The first module is a regional or country-specific document, with requirements and numbering specific to each country. Modules two-five are standardized, and include information on quality, safety, and efficacy.
The CTD was recently adopt by additional countries around the world. This should have brought about greater harmonisation of requirements. However, many countries have chosen to make local adaptations to the CTD template, defeating the original goal of harmonisation. Additionally, the numbering structure and content of CTDs differ from country to country. This is problematic, since harmonisation requires uniformity among countries.
The CTD format is an internationally agreed-upon format for registration dossiers of medicines. It follows ICH guidelines to document the technical aspects of the medicine. The CTD also specifies the required documentation. For example, vaccine antigen master files are required by some countries but could be captured in other sections of the CTD.
Regulation of pharmaceuticals in Pakistan
Regulation of pharmaceuticals in Pakistan is a pressing issue for a country with a large pharmaceutical manufacturing industry and a large population with poor health indicators. To address this challenge, the government created an autonomous Drug Regulatory Authority (DRA) in 2012. The previous system did not provide adequate regulatory controls for the country’s pharmaceutical industry and was unable to protect the public health. The new system is more stringent and equipped to monitor the quality of pharmaceuticals. It will also take into account published data and separate myths from facts.
The regulatory authority is responsible for overseeing the manufacturing, pricing, and distribution of medicines. Its main task is to ensure that the quality of medicines is of a high enough standard. Its primary mission is to protect the interests of consumers. The agency is responsible for ensuring that medicines comply with international standards.
The Pakistani pharmaceutical industry is undergoing a period of fast transition and reforms are underway to create a more efficient regulatory framework. While a multidisciplinary, open, and evidence-based approach will be needed, it is evident that progress is being made. There are many challenges ahead, including the need to increase pharmaceutical exports.
The regulatory authorities in Pakistan are taking the necessary steps to ensure that medicines are safe and effective. This is a necessary step for public health and builds public trust. It also acts as a deterrent against falsified medicines and ensures that essential medicines are available in the market. In short, regulating pharmaceuticals is a crucial step for improving the country’s health care system.
The regulatory authority in Pakistan has begun implementing serialization and barcoding. It will also consider whether to allow individual companies to apply for exemptions. In addition, the authority will consider public comments before making decisions on implementing these initiatives. It has also published a compilation of public comments on the issue.
The draft resolution of the Ministry of Health is expected to provide guidelines for traceability and labeling of medicines. These regulations will phase in over the next two years and have an impact on the pharmaceutical industry. However, firm deadlines are still being work out. In early October, a national regulatory conference will hold to discuss upcoming regulations.
Lack of scientific data on medicine quality in Pakistan
In Pakistan, there are few scientific data about the quality of medicines. Published data are mostly case reports. They report repeated cases of substandard drugs that cause serious life-threatening conditions or even death. In addition, there are only three prevalence studies that provide analytical data. Two of them utilized compendial methods, while the third relied on case reports.
In Pakistan, the federal government manages the licensing, manufacturing, registration, and pricing of medicines, while provincial governments oversee distribution. However, international experts consider the decentralized regulatory system to be weak. The 18th amendment of the Pakistan Constitution delegated some drug regulatory powers to provincial governments, but this was later revoked by the Council of Common Interest. Another organization that is still under federal control is the Higher Education Commission.
Despite the large pharmaceutical industry in Pakistan, there are many problems associated with the quality of medicines in the country. For example, the health care system has not been fully effective in preventing drug-related deaths. The country has a large population, but the public expenditure on health is low. The country spent 45 US-Dollars per capita on health care in 2015 and 2016 – far below the WHO’s benchmark of 86 US-Dollars per capita. It has not been able to reach its target of six percent of GDP on health care for the past 10 years.
In addition, Pakistan’s pharmaceutical sector is understaffed and lacks scientific data on medicine quality. In 2018, the DTL (Department of Therapeutic Licensing) reported that only 3% of medicines were substandard and 0.2% of them were spurious. This is a worrying trend and one that warrants more study.
Pakistan has recently introduced the Punjab Provincial Quality Control Unit. This unit is responsible for collecting and disseminating information on failed samples of medicines. The province has also introduced Pharmacovigilance Officers and Clinical Pharmacists in health care facilities. It has also implemented a Medicines Surveillance System (MSS) – an online clinical and administrative reporting system. The aim of the system is to improve the quality of medicines and prevent harmful drug reactions.
The authors noted that in Pakistan, three public sector DTLs are certified under the 17,025 International Organization for Standardization (ISO) standard, but none of them has been prequalified by WHO. However, one private DTL, located in Karachi, had achieved WHO prequalification in 2014 but had voluntarily withdrawn after two years. Other public sector laboratories include the Punjab Drug Testing Laboratory and Research Centre, the Punjab Forensic Sciences Agency, and the Punjab Drug Testing Laboratory and Research Centre. Recently, the Punjab Drug Testing Laboratory and Research Centre has accredited as a WHO medicines quality control laboratory. It also has the ISO17025 certification.
Lack of capacity building in the field of modern approaches to combat SF medical products
The global lack of capacity building in the field of modern approaches in combating SF medical products is a concern for health care systems worldwide. This challenge compounds by the fact that SF medicines detract from the profitability and market share of branded drugs. This situation can damage the reputation of the brand and company, and patients may be less inclined to use branded medicines in the future. Furthermore, SF medicines devalue legitimate brands and may eventually push iconic brands out of business.
It estimates that one third of the world’s population does not have timely access to quality-assured medicines. This phenomenon costs the global economy US$ 31 billion per year. It jeopardizes patient safety, undermines public confidence in health systems, wastes resources, and contributes to antimicrobial resistance.
Substandard medicines result in the premature death and illness of millions of patients. The resulting health complications are often worse than not taking any medicine at all. These complications can avoid with the use of good quality medicines. By strengthening institutional frameworks and regulatory activities, governments can help reduce the impact of SF on the world’s health systems.
