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Participants from agencies like BNCA, BAFRA and RRCO participated in the workshop
Participants from agencies like BNCA, BAFRA and RRCO participated in the workshop

DRA calls for collaboration among regulatory and law enforcement agencies

A couple of years ago, a man working with an embassy abroad visited a lam and received herbal pills (rib) that were said to cure epilepsy and migraine. The man stopped taking medicines from hospital and took the rib for two months until he suffered from facial palsy.

Following a serious side effect, the man was referred to a hospital in Geneva for further treatment and investigation. It was found in his hair that there is high lead content in his body. Later, when the authority tested the pill, it was found that the pill was coated with some paint that contains a high amount of lead.

A regulatory officer with Drug Regulatory Authority’s (DRA) Post Marketing Control Division, Jigme Tenzin shared this incident in Paro at a collaboration workshop the authority had organised among regulatory and enforcement agencies.

He said that in general, people have the conception that herbal pills are pills of god and that it heals a different kind of diseases or disorders.

Jigme Tenzin said there is a need to control the distribution of herbal pills because they do not fulfill the good manufacturing practices requirements nor is there a well established clinical or research data.

“There is a risk of misleading people with falsely claimed health benefits,” he said. “ With no good manufacturing practice compliances during the manufacturing process, the product may contain harmful or toxic substances which may render injury to the health.”

More than 15 participants from Bhutan Agriculture and Food Regulatory Authority (BAFRA), Regional Revenue and Customs office (RRCO), Bhutan Narcotic Control Authority (BNCA), Royal Bhutan Police, Department of Immigration and Airport officials, and Bhutan Post participated in the workshop.

Drug controller with DRA, Kinga Jamphel, said there are several regulatory agencies in the country and many are not clear on the function of the agencies. “People think that DRA and BNCA have the same function, which is not correct,” he said.

He said the authority ensures that any medicinal products that are coming into the country are safe and are of quality medicinal products. “The Authority also promotes the availability of medicines.”

The workshop, he said, is expected to strengthen coordination and collaboration with the other law enforcement agencies and sensitise the participants on the DRA and importance of medicine regulation.

According to the Medicines Act, 2003, medicinal products include all substances intended for internal or external use of human beings or animals and intended to be used in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals.

Kinga Jamphel said it’s important to regulate medicines because unlike other goods, patients or consumers and even healthcare professionals are unable to judge its quality or fitness for use. “They are not equipped to make an independent assessment of the quality, safety or efficacy of their medicines.”

Preventing entry of counterfeit, fake or substandard pharmaceutical products; disease burden based treatment; ensuring that medicines are manufactured in compliance to current good manufacturing practices and international standards, and prevention of drug resistance among the public are some of the reasons for regulating medicines.

However in terms of herbal pulls, lack of information on illegal practices, cultural barrier, uncontrolled advertisement or prescribing and less awareness among the population on the risk associated with its use are some of the challenges for the authority. “This system is practised based on traditional or indigenous or local knowledge,” he said. “It is not rampant but we keep sensitising as a preventative measure.”

Jigme Tenzin pointed out that it is important that people are aware of the risk associated with herbal pills. “Help us by reporting if there are any premises or personnel dispensing ribs and such products to the public so that we can investigate and test what the pill actually contains.”

Some of the other recommendations the participants made are that DRA explore strategies to counteract e-pharmacy, the authority and BAFRA to collaborate on trainings related to health supplements, to depute a drug inspector at the airport to regulate the influx of medicinal products in the country and initiate more advocacy programmes related to risks associated with the use of herbal pills.

Participants from BNCA, BAFRA and RRCO among others also shared their agencies’ mandates at the workshop.

Dechen Tshomo | Paro

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