Ensuring quality medicinal products
To control and regulate medicinal products in the country, the 81st session of the National Assembly passed the Medicines Act in 2003.
The following year, the Drug Regulatory Authority (DRA) was established as per Chapter III of the Act with three staff. The authority was under the umbrella of health ministry until 2008.
DRA currently has 30 staff including drug inspectors.
Drug controller with DRA, Kinga Jamphel, said the authority regulates medicinal products to make it fit for consumption in terms of quality, safety and efficacy for the consumers. The regulatory authority regulates human and veterinary medicines.
He said medicines are different from other goods as patients or consumers and even healthcare professionals are not equipped to make independent assessments of the quality, safety or efficacy of their medicines. Medicinal products so, he said, should be regulated.
“Desperate patients may buy ineffective or even toxic medicines and there could be a misuse of medicines such as antibiotics which can have serious implications for individual and public health,” he said. “Usual perceptions may not help in making judgements about medicines.”
He said lack of a regulatory authority will create room for irrational consumption and prescription of medicinal products, and sale of substandard, counterfeit and harmful medicines.
Formulating policy briefs and promoting effective laws for the regulation of the medicinal products, developing standard operating procedures, guidelines and standards; enforcing the regulations for sale, manufacture and storage of medicinal products; and conducting public advocacies and awareness programmes are some of its key strategies.
The authority also monitors the competency and skills of personnel involved in the import, storage, manufacture and sale of the medicinal products, and conduct research on pertinent issues related to the products.
Kinga Jamphel said the authority aims to make quality and safe medicinal products available in private and public health facilities, have minimal incidences of adverse events from medicinal products, have positive feedback from the clients in terms of delivery of services and have no complaints related to corruption.
Officiating chief regulatory officer with DRA’s Post Marketing Control Division, Pelden Chejor, said with a handful of drug inspectors with the authority, the coverage of inspection and monitoring of premises is less.
The Inspection Division has three regulatory officers and five drug inspectors.
“Most of the people are not aware of the existence of DRA and its mandates,” Pelden Chejor said.
Human and animal health centres, retail pharmacies, wholesellers, ports of entry and any premises or individuals suspected of illegal sale and distribution of medicinal products are areas that need to be inspected.
Besides ensuring that medicines are sold by the right person (competent person) from authorized premises, the drug inspectors take the sample of the suspected defective product for testing and seize or embargo the unauthorized medicines.
Promoting availability of wide range of registered medicines in the private pharmacies, lack of awareness on safety and quality of medicines which is evident from more number of people getting into self-medication, lack of education and awareness on antimicrobial resistance resulting in people buying antibiotics easily from across the borders are some of the challenges the authority faces.
“People still buy medicines from the cross-border areas, unauthorized premises and dealers not registered with the DRA,” he said.
Lack of technical expertise for medical devices regulation is also one of the drawbacks.
Pelden Chejor said it is difficult to monitor and control the advertisement and promotion of herbal medicines including cosmetics with steroids and antibiotics in the social media platforms like Facebook.
Kinga Jamphel said the authority will regulate and monitor the sale of cosmetics online gradually. “We will initially start with creating awareness and then discouraging people from using the products not fit for use and sensitizing on the risk of using such products claiming various benefits.”
Officiating chief regulatory officer with the Inspection Division, Kunzang Dorji, said the regulatory authority create awareness to the public on the safety issues of consuming medicines bought online.
“Those involved in advertising or promoting medicinal products online are informed not to do so without the approval of the DRA,” Kunzang Dorji said. “The media houses, both visual and audio are also requested and informed not to advertise any medicinal products saying it has multiple health benefits without the authority’s approval.”
Kunzang Dorji said cosmetics are currently not regulated by the DRA. “However, we caution the general public through notifications about the adverse effects of cosmetics containing steroids and antibiotics.”
Currently, only a few medical devices related to blood and blood products are regulated. The DRA plans to develop strategies to regulate medical devices, cosmetics and related products.
“We also plan to institute mechanisms to counteract and regulate e-pharmacy practices or online sale of medicines and improve mechanisms to regulate products with health benefit claims like health supplements,” he said.
While the authority will continue its effort to raise awareness on medicines safety and regulation to the public through different mechanisms, it will improve collaboration with other law enforcement agencies to ensure better compliance to regulations through their interventions as the DRA cannot reach every part of the country.
People can follow Drug Regulatory Authority on their Facebook page for latest updates on medicines and regulation on medicines.
The Authority reports to the Bhutan Medicines Board for policy directives. The Drug Technical Advisory Committee (DTAC) and Blood Technical Advisory Committee (BTAC) provide the technical advice to the Authority.
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