A market return track is needed for NDMA-related drugs

'Pincette regulation' needed by manufacturing lot number which impurities are detected

It is necessary to advance regulations to eradicate the stigma of 'NDMA is leaving the market'

The production and sales of Valsartan, Ranitidine, and Metformin have been discontinued due to the detection of NDMA (N-nitrosodimethylamine), a carcinogen, and prescriptions have been limited, and people's anxiety and the blow to the pharmaceutical industry are increasing.

 

In particular, while NDMA detected in Valsartan in the past was identified as a Chinese raw drug, NDMA in Ranitidine and Metformin are said to be 'fighting against invisible enemies' in the pharmaceutical industry without knowing the exact cause.

 

Therefore, the view of the pharmaceutical industry says that the government should not focus solely on the ban on the sale of impurity drugs, but should establish a regulatory measure to return the drugs that have been proven to be harmful to the market, so that NDMA detection can soon erase the stigma of permanent withdrawal from the market.

 

23 pharmaceutical companies with 31 items of Metformin diabetic drugs that were manufactured and discontinued on the 26th are busy with follow-up measures according to government announcements without prior notice.

 

Their worries are how to find the cause of NDMA detection beyond basic administrative measures, such as the recovery of distribution drugs, and how to seek survival measures for drugs that are prohibited for sale.

 

In particular, pharmaceutical companies with high impact are JW-Pharma and Hanall,, which prescription amount of ₩10 billion is banned.

 

Last year's prescription amount of Guardmet (100/1000mg,100/500mg, 100/850mg) by JW-Pharma was ₩9.7 billion.

 

Prescriptions amount of Glucodown OR (500, 750, 1000mg) by hanall was ₩ 8 billion over the same period.

 

With three consecutive NDMA detection bans occurring, pharmaceutical companies are sympathizing with the MFDS' prompt response, but are also urging them to make efforts to prepare for a resurgence of the bans.

 

The MFDS announced that suspension of manufacturing, sales and prescription for 31 items of Metformin would be discontinued, and the possibility of developing additional cancer was negligible.

 

Specifically, the MFDS estimates that the likelihood of developing additional cancer in patients taking the item is 0.21 out of 100,000, and said "the risk is very low." The ICH (International Drug Regulatory Organization) guidelines evaluate the level of negligibility in cases where there is less than one out of every 100,000 cancers.

 

In particular, the FDA estimated that the cause of the NDMA detection occurred in the manufacturing process of the drug rather than the raw drug.

 

Therefore, some of the pharmaceutical industry is arguing that there is a need to upgrade the regulation method of NDMA detection drugs compared to the existing ones.

 

It is to ask for regulations to be manufactured, sold, and prescribed again after the forbidden drugs meet the safety and risk criteria.

 

Currently, the MFDS analyzes the cause of NDMA detection and confirms that there is no need to reoccur in the manufacturing process, and then meets the three conditions for recovering the entire quantity of the problem in question, allowing it to be banned and re-released.

 

The time it takes to meet this condition is about 10 months in the past when comparing to the situation in Valsartan.

 

Even if the prescription is discontinued in the prescription market for only one month, the prescription drugs suffer the same level of damage as leaving the market.

 

The pharmaceutical industry claims that if it takes 10 months to re-release a prohibited drug, it is actually a fatal condition that cannot be returned to the market.

 

Accordingly, the pharmaceutical industry is not inadvertently manufacturing and selling the drug itself that exceeds the NDMA provisional management standard of the MFDS, but requires that 'Pincette regulation' in which the drug is applied only to the lot detected after the investigation of the items in question.

 

In this case, the pharmaceutical industry believes that not only can the pharmaceutical industry's NDMA povia be partially resolved, but also the fear of vague drug impurities in the public can be relieved.

 

An official from a pharmaceutical company in Korea said that it is necessary to consider not to ban or recover all NDMA-detected drugs, but to go through detailed inspections to ban sales of exceeding standards.

 

Ironically, the MFDS pointed out that it is distributing a press release saying that the hazard level is 0.21 per 100,000 people, which is negligible.

 

An official from domestic pharmaceutical company B explained that after confirming the impurity detection, all items to be produced and shipped after NDMA inspection have been shipped, and products with a lower than the standard value are released, but the lot number exceeding the standard is prohibited and sold, if that is difficult, the burden of pharmaceutical companies will be reduced by creating a procedural track that allows forbidden drugs to return to the market after meeting safety standards.

 

The official said, "The NDMA situation has continued with Valsartan, Ranitidine, and Metformin, and impurities have emerged from multi-drug drugs of various diseases.

 

Some of the drugs that have been taken this time have been below the standard in the pharmaceutical company's self-examination." "If we ban all sales at all times, the stigma of drug and drug companies will be repeated."