Cipla Drugs Recall Exposes India’s Weak Drug Safety Net. Is India’s Drug Approval System A Joke? How Indian Regulators Are Letting Pharmaceutical Giants Get Away With Murder

Cipla Producing Deadly Dose for Patients. Why has the DCGI failed to take stricter action against Cipla despite repeated quality control issues? Is Your Health Just a Price Tag?

The US Food and Drug Administration (FDA) recently recalled some asthma and bronchitis medication made by Cipla, a prominent Indian drug company. The affected batches, produced at Cipla’s Indore facility, had less medication than they should have. This raises concerns about the company’s quality control and potential patient health risks.

Cipla is recalling 59,244 packs of Ipratropium Bromide and Albuterol Sulfate Inhalation solution due to the risk of patients receiving less medication than indicated on the label. Deficiency can lead to suboptimal treatment and potentially life-threatening consequences for patients with asthma, chronic bronchitis, and emphysema.

The company received complaints about critical drug delivery failures impacting patient use. The company’s negligence in ensuring proper drug dosage and quality control measures is immediate action. The recall was initiated in response to the FDA’s warning letter, highlighting Cipla’s ongoing issues at its Pithampua facility. 

The US FDA has issued a warning letter to Cipla’s Pithampur facility, highlighting failures in addressing customer complaints, microbiological contamination, and establishing proper quality control procedures. Cipla has also faced issues with its Albuterol Sulfate inhalation aerosol, leading to recalls due to a container defect and product performance issues.

Cipla: A Repeat Offender 

In 2019, the US FDA inspected Cipla’s drug manufacturing facility in Goa and cited significant violations of current good manufacturing practice (CGMP) regulations. This led to a warning letter due to failures in cleaning, maintaining, and sanitising equipment and utensils.

Cipla received four show-cause notices for its drugs between 2018 and 2022. In August 2018, during an inspection, Cipla’s RC cough syrup failed to meet the standards. In July 2021, it got noticed twice for its Remdesivir medicine. It was found that in their Remdesivir medicines, the quantity of Remdesivir was insufficient. A cough syrup is not only given to adults but also to children older than six years.

Dangerous Indian Cough Syrups Kill Children Worldwide 

Look at this case from December 2022: 18 children lost their lives in Uzbekistan due to drinking substandard cough syrup. The following month, in January 2023, WHO linked the deaths of these children to two contaminated cough syrups: Ambronol Syrup and Dok1- Max Syrup.

Laboratory analysis revealed that these products contained high amounts of diethylene and ethylene glycol. Both these cough syrups were manufactured by a company in Uttar Pradesh,

Marion Biotech was distributed by Quramax Medical in Uzbekistan. But Uzbekistan was not the only case. Even in Gambia and Cameroon, children died due to contaminated cough syrups. Apart from Marion Biotech, two other Indian companies were involved.

Haryana-based Maiden Pharmaceuticals and Madhya Pradesh-based Riemann Labs.

In total, 141 children lost their lives, and Marion Biotech’s cough syrup was related to 68 of these deaths.

What was the Uzbekistani government’s response to this incident? 

Their Ministry of Health banned all the drugs that Quramax was importing.

In January 2023, their court cancelled the licence of Quramax Medical. It was decided that all remaining medicines imported by this company would be destroyed. The court sentenced 23 people to imprisonment for 2 to 20 years, to the people responsible for this. 

One of them was Raghvendra Pratap Singh, the Indian Executive Director of Quramax. He was sentenced to 20 years in jail. In India, there was an investigation by the Central Drug Standard Control Organisation. 22 samples of the cough syrup manufactured by this company were tested, and they were found to be adulterated. 

Weak Punishments and Lax Regulations 

Reuters reported that Marion Biotech was buying the ingredient propylene from a company named Maya Chemtech India. However, this company did not even have a licence to sell pharmaceutical-grade materials. It was given only an industrial-grade licence. The difference is that industrial-grade propylene glycol is toxic to humans. It is used in liquid detergents, paints, or coatings. 

Maya Chemtech, in its defence, said it didn’t know that another company used their Propylene Glycol to make Cough Syrups. But why did Marion Biotech do this? The then-head of operations of this company, Tuhin Bhattacharya,

They confessed to Reuters that the company was exporting these cough syrups for more than ten years. And in those ten years, they had never tested their Propylene glycol. The Pharmaceutical Export Promotion Council of India suspended Marion Biotech’s registration certificate in December 2022.

The authorities of Uttar Pradesh cancelled the manufacturing licence of this company in March 2023, and 3 employees were arrested. An FIR was lodged against two directors of this company, Sachin Jain and Jaya Jain. But then comes a twist in our story. UP police officer Vijay Kumar says that these three employees were later released on bail. In April 2023, Allahabad High Court issued an order related to Sachin Jain and Jaya Jain. “Unless there is a conviction against them, police cannot arrest them.”

In October 2023, it was reported that this company was allowed again to reopen its factory. It was found that the Uttar Pradesh government had issued an order regarding this on 14th September. The order states that the company cannot manufacture any propylene glycol products. But is allowed to manufacture and sell all other products.

The Nationwide Threat of Substandard Drugs

This is not a standalone case, either. There’s a similar story about another company. In September 2023, in Udhampur district of J&K, around 12 children were reported dead. Some of them were only two months old. Some were one year old, and some were two years old. They died because they drank cough syrup, which had a high amount of diethylene glycol. Digital Vision Pharma Company made this cough syrup. When it was tested, it was found that they were using industrial-grade ingredients in their medicines, too. 

Despite the death of so many children, it took three years to file a charge sheet in this case. And according to this case, even though it’s been four years since the incident, no one was found guilty. But before this incident, this Digital Vision Pharma Company was given several warnings. The drug regulators of Maharashtra and Gujarat had issued at least 16 warnings to the company. 

Another example is this: In December 2023, the Central Drug Standard Control Organisation tested the samples of different cough syrups. It was found that 54 pharma companies had failed the export quality tests for the cough syrups. For years, our country has had the reputation of being the Pharmacy of the World. But first, those three companies brought down this reputation and then when the samples of cough syrups from these 54 companies were analysed, what impact would it have on the country’s reputation?

Since our government cares about the country and its people, they must have taken some action. They must have tried to make quality control stricter. They must have passed laws to improve the quality of medicines.

But no, What kind of laws did the government pass?

The outcome was a bill to ease penalties for low-quality drugs passed in Parliament. The government wants that if a company made drugs of low quality, then the penalty imposed on it should be lower. Jan Vishwas Bill decriminalises minor offences committed by companies. Public health activist Dinesh Thakur said that it is wrong and that such crimes should not be decriminalised. But the most problematic thing was that the government amended Section 27D of the Drugs and Cosmetics Act. 

If a company fails to pass the lab test earlier, they could have been sentenced to 1-2 years of imprisonment. But now, an out-of-court compromise is enough. They can pay to eliminate the matter, like buying the electoral bonds.

Remdesivir Scandal

Even During the second wave of Covid in India, working at Uttar Pradesh’s Chiranjeevi Hospital anesthesiologist Jitendra Pal got a call from the nursing staff. Over the call, he was told about stranger symptoms in 2 patients. They were shivering with high fever, and suddenly, their blood oxygen level dropped. Both patients were given the first shot of the antiviral medication Remdesivir. And only an hour later, this was the reaction. Shockingly, this was not the only incident. A few days ago, as Jitendra Pal had seen, the same thing happened to 4 patients of Lifeline Hospital. After investigation, it was found that in both these hospitals, the same batch of shots was given to the patients. 

Batch V100167 It was manufactured by a company in Gujarat, Zydus Cadila. This medicine was procured from the company by the UP government. But as soon as doctors noticed the adverse reactions among patients, Doctors stopped using this batch of the medicine. The doctors informed the families they would use another medicine for Covid patients. Once they stopped using this medicine, patients’ conditions improved, But similar stories were playing out in many other hospitals in Uttar Pradesh. 

Jhansi Maharani Lakshmi Bai Medical College, Meerut’s Lala Lajpat Rai Memorial Medical College, and Varanasi’s Ashirvad and Apex Hospital, between 7th and 9th May, Dr. Anuj Kumar, who worked in another hospital, reported the same thing. Five patients who had purchased Remdesivir from this company of the V100156 batch suddenly developed a fever and started having breathing problems. Dr Anuj Kumar reported that although the symptoms of COVID were similar, it was easy to identify that the patients were having problems due to the medicines.

After a few days, similar news was also coming from other states. Rajasthan, Maharashtra, Gujarat, Bihar. Patients were getting sicker after taking Remdesivir. These medicines were from similar batches. V100153, 156, 166, 167, 170, or L100148. In all of these cases, the manufacturer was the same. Cadila. Government-owned procurement companies bought these medicines. Many hospitals raised concerns over this, but state regulators in Uttar Pradesh, Rajasthan, Maharashtra, and Gujarat did not do much.

A Pattern of Regulatory Neglect

Only Bihar’s regulators raised a red flag. They tested the medicines of this company’s V100167 batch, and it was found that these medicines contained bacterial endotoxins. Compounds that can cause fever in humans and can cause septic shock if taken in excess.

When this came to light, a case was filed against this company in Patna’s civil court. However, the manufacturing unit of this company was located in Gujarat. And it was Gujarat FDCA’s responsibility to check whether the medicines of this company were meeting the quality standards. 

They had granted the license to this company to manufacture these medicines. When these reports started pouring in that some of their medicines were of sub-standard quality, Bihar’s regulator informed the Gujarat FDCA, too. And it was their responsibility to test these batches. However, they did not conduct any testing. The Joint Commissioner of Gujarat’s Regulatory Lab said that the batches of these medicines never reached their lab for testing. The Gujarat FDCA Commissioner was repeatedly asked why their department didn’t test the medication.

But there were no answers. As per the Drugs and Cosmetics law, every remaining bottle of this medicine should have been recalled. However, there is no proof that the Gujarat FDCA recalled those medicines. When Cadila’s spokesperson was asked about these reports, they denied these allegations.

But now, there’s another shocking twist in this story.

Six months before this happened, In November 2020, WHO, the World Health Organisation, said we should not use Remdesivir. WHO studied over 14,000 people across more than 450 hospitals in 35 countries. The study found that Remdesivir is not effective against Covid. Even so, not only did our government approve Remdesivir, but it also talked about increasing its production.

Are these regulatory bodies fulfilling their mandate, or are they merely bureaucratic entities consuming resources without effectively regulating the industry?

In India, the responsibility for overseeing Cipla’s drug manufacturing quality checks lies with the Drugs Controller General of India (DCGI). However, the recent revelations of lapses in quality control at Cipla’s facilities raise serious concerns about the DCGI’s performance in fulfilling its duty as a regulator of pharmaceutical standards. The DCGI’s underperformance in ensuring the authenticity and safety of medicines manufactured by Cipla reflects a significant failure to uphold regulatory standards and protect public health.

The DCGI’s negligence in conducting thorough inspections and enforcing stringent quality checks has allowed issues of adulteration and substandard quality to continue within Cipla’s operations. This failure to proactively monitor and address manufacturing deficiencies has compromised the integrity of the pharmaceutical supply chain, putting patients at risk. The DCGI’s lack of swift and decisive action in holding Cipla accountable for quality control breaches undervalues a systemic breakdown in regulatory blunder.

The Urgent Need for Change

The DCGI has been slow to act on Cipla’s repeated quality problems, raising doubts about its commitment to pharmaceutical standards. This delay in addressing issues shows a severe failure to protect consumers’ well-being. The DCGI’s lack of action in ensuring good manufacturing practices and enforcing rules highlights a significant flaw in regulatory enforcement that needs fixing immediately.

The DCGI must be more active in inspecting, enforcing quality controls, and holding companies like Cipla accountable. It needs to show a solid commitment to maintaining high standards and protecting public health by quickly addressing any manufacturing issues and strictly following regulations. If it fails to do so, it will undermine trust in the pharmaceutical industry and risk the safety and effectiveness of essential medications for patients in the whole country.