Last week, the story that made the most noise was about the quality failure of many widely used medicines. The reason was the mention of commonly used drugs, including popular antacids, anti-influenza drugs, antibiotics and high blood pressure drugs in the monthly drug alert issued by the regulatory authority, the Central Drugs Standard Control Organization (CDSCO).
News18 was the first to report the matter after waiting for the responses of the drug manufacturers mentioned in the warning list issued by CDSCO, which is still available on their website.
After more than 24 hours, only two pharmaceutical companies have shared the requested comments, while the others either ignored or did not respond to the email. When the issue became more and more popular and started to be broadcast by other media, almost all the drug manufacturers issued statements saying that the drugs in question are fake and they do not produce them.
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On Sunday morning, the Indian Pharmaceutical Alliance (IPA) – a pharmaceutical lobby supported by India’s top drug manufacturers, some of whom are mentioned in the warning list – issued a press release expressing anger over the negative consequences of legitimate drug manufacturers in the production of fake drugs.
It said the lobby would work with the government to strengthen laws against counterfeit products to protect public health and India’s national image.
A PICTURE IN THE STORY
According to the August ‘Not of Standard Quality (NSQ)’ alert, issued by the country’s drug control body CDSCO, more than 50 drugs have been declared NSQ or substandard. NSQ warnings are the results of random sampling conducted by the federal drug authorities every month. The list includes the names of the best-selling medicines manufactured by the largest pharmaceutical companies in India.
Here are the lists.
HOW ARE DRUG WARNINGS ISSUED BY CDSCO?
Every month, state drug inspectors take samples from offline stores across India. These drugs are tested in government laboratories and their results are published on a government website.
Before publishing these results, CDSCO also sends these reports to manufacturers (pharmaceutical companies), instructing them to test product samples/control. Next, the pharmaceutical companies test their samples and send reports to CDSCO or state regulators.
Officials of top pharmaceutical companies told News18 that they respond to the government within 10-12 days with test reports. However, it does not guarantee that their name will be removed from the warning list.
“Even though we have given all the details of our investigation, our name is still appearing to people who do not pay. Ultimately, this tarnishes the brand’s reputation,” said an executive at a Mumbai-based pharmaceutical company, requesting anonymity.
THE BIGGEST CONCERN IS FALSE DRUGS
Although the story begins with the fact that the drugs produced by these large, reputable drug manufacturers fail quality tests, it turns out to be different. The real concern now is, no one knows who made those drugs and they are all fake.
Almost all of the drug manufacturers who were mentioned in the drug warning are now saying (in their official versions) that their investigation has shown that the drugs in question are not manufactured by them and are therefore fake. This means that the problem of “counterfeit or fake” drugs in the Indian market, is a very big problem that needs to be solved.
Unfortunately, for us, as consumers or patients in the end, the problem remains the same – we are still taking pills without knowing whether they are invisible, lethal or real pills.
Before writing the column, I spoke to many industry insiders who work with top pharmaceutical companies across India.
The chief executive of a top-selling painkiller company has described how they helped regulators uncover a counterfeit drug racket using their brand name.
“Our medicine is made with the same brand and packaging. They were selling a packet of drugs for just Rs 10 to the vendors. This agreement helped them both as there was no investment involved in making fake drugs and, the sellers were earning huge profit marks,” explained the official.
The company and the regulator, in this instance, worked hand in hand and were able to catch the makers near the border of Uttar Pradesh not just one brand of medicine, but many other popular, but fake brands.
Counterfeit or counterfeiting is not a new challenge in India. In 2019, the United States warned India about its growing problem of fake or fake drugs.
In its ‘Special Report 301’ on intellectual property protection and review of ‘notorious markets’ for piracy and fraud, the Office of the United States Trade Representative (USTR) blamed India for its growing counterfeit drug problem. The USTR report said that nearly 20 percent of all pharmaceutical goods sold in the Indian market are counterfeit.
SOME REASONS WHICH MAKE DRUGS FAIL TESTS
Industry officials say the drug storage methods followed by federal drug inspectors are not always up to standard. They do not test the samples immediately after collecting them and therefore, they are not sure how these drugs are stored, ultimately, affecting the quality of the sample tested.
“For example, the inspector picked up a sample from a seller and kept it in his bag and continued to select samples from shops in the area. The medicine continues to be exposed to heat or sunlight, which eventually leads to the spoilage of the sample,” said an official associated with a Hyderabad-based drug manufacturer.
Also, industry officials say the time when the sample is taken and when the sample is tested varies. “Sometimes, regulators send information about our medicines, two to three months after collecting samples. If so, how can we be sure that they keep the samples in the required condition.”
Another reason that came up repeatedly in my conversation with the pharmaceutical industry was the creation of local groups that buy from third-party manufacturers and sell directly to doctors.
There is a growing trend where retired executives of several companies join hands and buy drugs from third-party manufacturers. These officials start the business on the basis that they know many doctors in the area and can sell these medicines directly to them.
“These companies can obtain licenses to sell medicines, but they do not have a strong infrastructure that can ensure the safe storage and supply of these medicines. In the end, if the drug does not work, it is the company that is most blamed,” a veteran of the industry told News18.
WHAT SHOULD THE ADMINISTRATOR DO?
CDSCO should change the way it works, using an approach similar to that of the US FDA, rather than just posting the results on its website.
As CDSCO has been working hard to solve the problem of substandard drugs being manufactured and exported, it should also start hunting the counterfeit market operating within the Indian market.
Also, when CDSCO informs drug makers of those NSQ results, they should ask the company to stop selling to the particular group in question and submit a report of their internal analysis. Both CDSCO and drug makers should conduct a joint analysis and return to supply chain monitoring. The regulator must dig deeper to understand if the drug is produced by the company, how the drug moved down the market (trace chain) and if not, how it was injected into the market.
Also, while issuing the warning, CDSCO should mention that “only this cluster” is available for NSQ and not all clusters.
One of the most important procedures is to ask the company to recall a questionable batch as such batches continue to freeze in the market making the whole exercise useless.
Also, it is the regulator’s responsibility to educate the public about possible actions while issuing warnings and managing panic.
They must state cautionary advice, similar to the US FDA, that the public should contact their health care providers for clarification or alternatives.
WRONG DRUGS CAN LEAD TO SERIOUS PROBLEMS: HEALTH EXPERTS
More than half a dozen health experts told News18 that access to quality medicines in the Indian market is a matter of concern for both doctors and patients.
Ultimately, it means that we are exposing fake medicines or medicines of compromised quality. Therefore, patients will not recover over time and therefore have to be treated for longer or have to take more doses to control their disease.
Also, it will make our bodies resistant to pathogens such as bacteria, fungi and viruses – leading to resistance to bacteria – which means that medicines will stop working when we get sick. Therefore, it puts us at risk of contracting serious diseases and even death.
One sample interview with Dr Anirvan Karmakar, senior consultant, intensive care unit, Narayana Hospital, Howrah, who believes that “failure of drug quality is a major threat to treatment outcomes”.
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If these drugs fail to meet quality standards, patients may experience ineffective treatment, prolonged illness, or dangerous side effects.
Karmakar believes that this especially affects vulnerable people, such as the elderly, people with chronic conditions, and those with compromised immune systems, as they rely heavily on conventional and effective medications to maintain their health.
“For these patients, even a slight decrease in the quality of drugs can lead to serious complications, problems in disease management, and, in some cases, hospitalization.”
He pointed out that drug failures often destroy patients’ trust in the health system, making it difficult for doctors to ensure that they comply with the rules. “Physicians, too, need to remain vigilant and consider alternative therapies when drug quality concerns arise, ensuring that patient safety and effective treatment remain a priority.”
In short, it is time for the regulatory agency to strengthen its oversight and for pharmaceutical companies to respect strict manufacturing standards.