There is a shortage of life-saving drugs in the United States!, India's second largest pharmaceutical manufacturer explodes in Ananapali | India | Help

The latest report from the US Food and Drug Administration shows that inspectors found "deficiencies" in the cleaning and storage controls of production equipment at Alabindo Pharmaceuticals Limited's factory located in Ananapali, eastern India, during a visit last month.

For example, drug sampling tools are not cleaned and maintained, and these tools are used to produce certain active pharmaceutical ingredients, which are the core raw materials for manufacturing drugs.

The report states that the factory laboratory has also failed to establish scientifically reasonable and appropriate standards to ensure that drugs meet appropriate characteristics, quality, and purity standards. It is reported that during the inspection of the warehouse, auditors also found that the raw materials were stored in overheated and humid conditions. According to the company's information, the factory mainly produces raw materials for cardiovascular and antifungal treatments.

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Alabindu Pharmaceutical Co., Ltd. is the second largest pharmaceutical manufacturer in India, headquartered in the pharmaceutical center of Hyderabad. It was founded in 1986 and mainly produced semi synthetic penicillin at that time. Since then, the company has continuously expanded its scale and become an enterprise exporting drugs to more than 150 countries and regions, with an annual revenue of about 3 billion US dollars, of which 90% comes from the international market, and currently about 15% of sales come from raw materials.

After being exposed by foreign media and "reported" by the FDA, the company did not respond. However, in a statement in May, Alabido Pharmaceuticals confirmed that the FDA recorded "procedural" observations after inspecting its factory in Ananapali in May. Although the company did not provide detailed information on the observation results, it stated that efforts are being made to address these issues and will respond to the FDA.

This is not the first time the company has been warned by the FDA. In January 2022, its Durtabad factory located in central southern India received a warning letter, which was one of the strictest enforcement measures by the FDA. In the letter, the FDA stated that the factory produced adulterated raw materials, and repeated failures "indicated insufficient supervision and control of drug production by executive management.".

Last month, Subolamanian, Chief Financial Officer of Alabindu Pharmaceutical Co., Ltd., stated in a conference call with industry analysts that the company is working to "clear" warning letters.

The FDA has the right to inspect pharmaceutical companies that produce FDA regulated products at any time and record their opinions on a form called "483". Simply put, if there are no issues, it is in the NAI state, which is "zero defect"; If there is a problem, it is in VAI status. If the response to the 483 form is not timely or accepted, it will result in a warning letter being sent, and this status is called OAI. If the FDA does not agree with the relevant response content, it will issue an import warning and refuse the entry of the pharmaceutical company's products.

It is worth mentioning that the warning letter can be seen on the FDA's official website, and the global reputation of the relevant pharmaceutical companies will also decline. If other countries' health departments see such warning letters, most of them will also include the products of the relevant companies in the prohibited import list.

This year, the FDA conducted rapid inspections on over 1000 foreign pharmaceutical factories, with Indian pharmaceutical factories becoming the hardest hit areas.

India's $50 billion pharmaceutical industry is known as the "world pharmaceutical industry", but it has been rigorously scrutinized after scandals involving dozens of children dying from fake cough syrup in the Gambia and Uzbekistan.

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The problem with Indian factories has spread to the United States, and FDA inspection reports indicate that the shortage situation may worsen, adding pressure to the White House working group formed to address supply chain quality issues.

In fact, a test result by the FDA in India directly led to the United States experiencing the most severe shortage of cancer drugs in years.

According to FDA data, Indian pharmaceutical company Intas is a private company that produces over 100 approved generic drugs in the United States and has three production facilities in Ahmedabad, India.

In November 2022, the FDA discovered a large number of torn documents related to drug quality during inspections, indicating that the factory had made serious mistakes and raising doubts about the safety and efficacy of its drugs from the US side. Subsequently, one of the factories was closed. According to data, the company supplies about half of cisplatin to the United States. After the incident, TAS shut down the production of cisplatin and other drugs at the factory, and the already produced cancer drugs need to undergo intensive testing to ensure their safety. But a few months later, problems began to emerge, and the United States began to face shortages of chemotherapy drugs cisplatin and carboplatin. Cisplatin is a broad-spectrum anti-tumor drug suitable for lung cancer, testicular cancer, ovarian cancer, cervical cancer, etc.

After the shortage of cisplatin injections, the FDA began global drug search. According to the Qilu Pharmaceuticals website, "In March this year, Qilu Pharmaceuticals received an urgent email from the FDA stating that there was a shortage of cisplatin injection in the US market. Qilu Pharmaceuticals, which exports more than 20 formulation products to the US and has the highest sales volume in nearly half of its products, was given priority to inquire whether it can supply them. Qilu Pharmaceuticals quickly completed the preparation of documents, translation, and application of plans. Subsequently, the FDA initiated a rapid approval process and approved the export of Qilu Pharmaceuticals' cisplatin injection to the US on May 23. While ensuring domestic product supply, Qilu Pharmaceuticals achieved rapid shipment of exported products to the US."

However, the FDA's re examination of Intas still did not yield satisfactory results. In an inspection conducted in May this year, the FDA found that employees of the company were manipulating data so that the injection could pass through visual inspection of particulate matter. Employees handwritten diagonal markings on the initially recorded dataset that did not meet US particle standards and recorded new data that had just reached an acceptable level.

The FDA inspection report states that "since at least 2021, this pattern of repeated changes and/or manipulation of visual inspection records has been observed, involving multiple visual inspectors and supervisors." The company's quality department used "defective records to release a batch of drugs to the US market.".

The inspectors also stated that the evidence they found suggests that the staff of Intas ignored the investigation results of over 1000 "spore forming organisms" over the past three years, which may include dangerous bacteria in sterile areas, including some areas of the factory that produces tumor drugs.

The FDA also stated that TASS has not yet verified the accuracy of its quality testing methods for 112 generic drugs approved by the FDA.