Skip to content Skip to sidebar Skip to footer

The urgency of the Drug and Food Control Bill

good manufacturing practices

DISCUSSION It is anticipated that the draft law (RUU) on drug and food control and the independence of the food and drug supervisory agency (BPOM) will soon be finished. This is due to the fact that kidney failure brought on by the substances ethylene glycol (EG) and diethylene glycol (DEG) claimed the lives of about 199 children not long ago.

In July 2016, at least 37 healthcare facilities were involved in instances of distribution of children's DPT/HIB vaccines that were distributed fraudulently, according to digital footprints. 14 prestigious hospitals are included.

Numerous people who contracted food poisoning from processed foods based on liquid nitrogen were well-known to kids as Chiki Ngebul up until the most recent time. Due to a string of incidents, the general public is now more aware of the need to improve a thorough system of food and drug regulation. This will increase public confidence in their level of protection against potentially harmful products.

According to pharmacologist and clinical pharmacy specialist Keri Lestari of Padjadjaran University in Bandung, the challenge for the drug and food supervisory authority is to be divided into two parts, namely safety and independence factors that must run concurrently with the same objective. A protracted, convoluted bureaucratic procedure that even costs a significant sum of money shouldn't be used to complicate the challenge of presenting a safe product.

Approximately 90% of the nation's total drug volume is produced by the country's pharmaceutical industry, which also produces a variety of other medical products like tablets, syrups, injections, capsules, and inhalations. Less than 2% of all drugs in circulation were contaminated, compared to the approximately 5% contamination rate of the various syrup drugs that had been in circulation.

Other syrup drugs, on the other hand, are safe to consume in greater than 94 percent of cases. On the one hand, they must conform to international standards, but on the other, they must deal with domestic service demands that occasionally call for discretion under certain circumstances.

For instance, he said, "flexibility in licensing herbal medicines that have proven effective through empirical evidence because they have been used for a long time in the community, so there is no need for subchronic toxicity tests which are expensive and take a long time to process.". Also read: Children's futures are built on the foundation of mental health.

Additionally, Keri continued, the stigma associated with the complexity of the bureaucratic system used to deal with BPOM needs to be removed through improved public relations. The issuance of permits, for instance, could be sped up and made easier by providing education about how to comply with the necessary procedural requirements.

The presence of a supporting ecosystem that satisfies stakeholder expectations is another requirement for BPOM in order to achieve this independence. As a result of the fact that it must still coordinate with other institutions, the BPOM may not currently be meeting stakeholder expectations, he suggested.

Penny K. Lukito, the head of BPOM, expressed his concern regarding the limited power of law enforcement. One of them relates to the disclosure of instances of unlawful food distribution involving online networks, where the Indonesian Ministry of Communication and Information (Kemkominfo) is the competent authority.

"It appears that we are powerless when using the internet. only be taken down, one killed, and 1,000 more grown.

Sanctions are applied when BPOM and Kominfo coordinate, the official said. All types of law enforcement in Indonesia that deal with food and drug products frequently result in suspended sentences for offenders.

It is a long way from the 10 year prison term specified by Article 196 of the Health Law. It is governed by the provisions on good manufacturing practices (GMP), Good Drug Distribution Methods (CDOB), and good service practices in the process of monitoring drug and food products until they reach consumers.

It's unlikely that anything will go wrong. But according to Law No.

36/2009 concerning Health only regulates Supervisors who are tasked with overseeing everything related to resources in the health sector and health efforts; it is unclear whether Supervisors in the fields of medicine and food in functional positions like GMP inspector, CDOB inspector, food inspector, food safety instructor, and evaluator are also covered by this regulation. The Drug and Food Control Bill is anticipated to strengthen BPOM's position in carrying out its responsibilities, one of which is to oversee the distribution of drugs and food based on a strong legal umbrella in order to establish an image as a protector of the public.

(R-3).

The Drug and Food Control Bill is anticipated to strengthen BPOM's position in carrying out its responsibilities, one of which is to oversee the distribution of drugs and food based on a strong legal umbrella in order to establish an image as a protector of the public.

Post a Comment for "The urgency of the Drug and Food Control Bill"