Daybreak - How Indian women’s go-to drug, Meftal Spas, became a victim of its own popularity

Episode Date: February 7, 2024

It wont be a stretch to say that the Meftal Spas is life-changing for those who suffer from dysmenorrhea. The medicine which is a combination mefenamic acid and dicyclomine was launched more than 40 years ago by Blue Cross Labs, an Indian pharma company. Meftal Spas enjoys the lion’s share of the market at nearly 90%.But at the end of November last year, the Indian Pharmacopoeia Commission (IPC), an autonomous body under the Ministry of Health and Family Welfare, issued a  drug safety alert  on mefenamic acid—one of the two main components of Meftal Spas.Soon after, many regular users started avoiding the medicine and some hospitals even stopped prescribing it. In fact, pharmacies saw a marked drop in Meftal Spas sales .But media reports were misleading. While the advisory was about mefenamic acid, many media houses reported that the advisory was about Meftal Spas. And that is not all, many health professionals are questioning the govt advisory itself.Tune in.Daybreak is produced from the newsroom of The Ken, India's first subscriber-only business news platform. Subscribe for more exclusive, deeply-reported, and analytical business stories

Hi, this is Rohan Dharma Kumar. If you've heard any of the Ken's podcasts, you've probably heard me, my interruptions, my analogies, and my contrarian takes on most topics. And you might rightly be wondering why am I interrupting this episode too. It's for a special announcement. For the last few months, I and Sita Raman Ganeshan, my colleague and the Ken's deputy editor, have been working on an ambitious new podcast. It's called Intermission.

We want to tell the secret sauce stories of India's greatest companies. Stories of how they were born, how they fought to survive, how they build their organizations and culture, how they manage to innovate and thrive over decades, and most importantly, how they're poised today. To do that, Sita and I have been reading books, poring over reports, going through financial statements, digging up archives, and talking to dozens of people. And if that wasn't enough, we also decided to throw in video into the mix. Yes, you heard that right. Intermission has also had to find its footing in the world of multi-camera shoots in professional studios, laborious editing, and extensive post-production.

Sita and I are still reeling from the intensity of our first studio recording. Intermission launches on March 23rd. To get an alert as soon as we release our first episode, please follow intermission on Spotify and Apple Podcasts or subscribe to the Ken's YouTube channel. You can find all of the links at the ken.com slash I am. With that, back to your episode. You heard of dysmenoria? It is the medical term used to describe the cramps that women get before or during their period every month.

And if you know dysmenoria, then you must be familiar with the cramps. meftal spas. It won't be a stretch to say that the tablet is life-changing for those who suffer from dysmenoria. The medicine, which is a combination of mephanamic acid and dichyclamine, was launched more than 40 years ago by Blue Cross Labs, an Indian pharmaceutical company. Now, of course, there are many manufacturers who sell the mephanamic acid and dicyclamine combination, but it is Blue Cross's meftal spas that has the large, share of the market, nearly 90%. To give you a sense of just how widely it is used, in 2021, nearly 500 crore tablets of mafal spas were sold across the country. That is more than

than double of dolo, the most common paracetamol medication used to treat fever and all kinds of aches and pains. But at the end of November last year, the Indian Pharmacopia Commission, or IPC, an autonomous body under the Ministry of Health and Family Welfare issued a drug safety alert on mephanemic acid, one of the two main components of meftal spas. Next thing you know, many regular users were avoiding the medicine. Some hospitals even stopped prescribing it. In fact, pharmacies across the country saw meftal spas sales draw. But here's the thing.

Media reports were misleading. While the advisory was about mephanamic acid, many media houses, probably because they thought, oh, mephanamic acid, meftal spas, same thing, they reported that the advisory was about meftal spas. And that is not all. Many health professionals are questioning the government advisory itself and they have valid concerns. Welcome to Daybreak, a business podcast from the Ken. I'm your host, Nickda Sharma, and I don't chase the new cycle. Instead, thrice a week on Mondays, Wednesdays and Fridays, I will come to you with one business story that is worth understanding and worth your time. Today is Wednesday, the 7th of February.

Dr. Kruti Adidam, who is pursuing an MS in gynecology from Bangalore's Védehi Institute of Medical Sciences, told my colleague the Ken reporter Shivani Varma, and I'm quoting, it is the best drug out there to treat menstrual cramps. She has been prescribing meftal spas to her patients for over two years. Medical doctor and health educator Tania Narendra, popularly known as Dr. Couturist on social media, said that it is the presence of dichyclamine which stops spasms that makes meftal spas different from other standard drugs with mephanamic acid. All the pharmacists that the Ken spoke to said that meftal spas is the most and sometimes

the only drugs sold and prescribed by doctors for menstrual cramps. Other alternatives, which on average have half the sales of meftal spas each, include Drotin M, ibuprofen and cyclopam. Liver disease specialist Syriac Abbe Phillips, who is popularly known as the liver doctor, rubbish the advisory in a post and called meftal spas one of the most safest drugs available out there. But many regular users of meftal spas have stopped using the medicine. in after media reports of the advisory. Take 27-year-old Nehan Perven from Delhi, for example.

She told my colleague Shivani that she'd been using Meftal for the last couple of years, but now she stopped using it and has chosen to bear the pain instead. In fact, a person familiar with the matter told the Ken that a major chain of private hospitals has recalled Meftal spas and has stopped prescribing it to patients. So what exactly was the advisory and why do health care? professionals think that it was a false alarm. Stay tuned to find out. The IPC issued a drug safety alert about mephanamic acid saying that it triggers an

adverse drug reaction or ADR called Dress Syndrome, which affects your internal organs. Now, just so you know, mephanemic acid has been used around the world for over 60 years. Many doctors say that these side effects that the IPC alerted against are extremely rare. Some of them even said that they haven't seen severe ADRs during their practice and that reactions to the drug depended on individual patients. They also pointed towards overuse of meftal spas. Dr. Tanya and Narendra, for example, said that the news was blown out of proportion and that there hasn't been a single case of dress syndrome reported in India due to mefonymic acid.

Which is why the IPC advisory has raised many questions. among industry insiders. They questioned the criteria, the data used, and the transparency of the government ministry in issuing safety alerts. So we went to a former IPC executive to understand the process behind such alerts. They told us that the Pharmacal Vigilance Program of India by IPC maintains and develops a database of all suspected severe adverse drug reactions or ADRs to medicines. There are over 650 ADR monitoring centers, including medical colleges and hospitals, both government and private.

These monitoring centers send reports of ADRs to IPC. Once the reports are received, they are processed by physicians, pharmacists, etc. Then a signal is generated after which a drug safety alert is issued. But in the case of Meftal Spass, apart from the drug name and ADR, the IPCC is issued, advisory did not provide other important pieces of information like total number of ADRs reported their origin and severity of the reaction. We asked the IPC about it and they responded by saying and I'm quoting, the pharmacovigilance program of India has received individual case safety reports for mephanemic acid associated dress syndrome from its AMCs or monitoring centers

across the country. End quote. But they did not specify. the locations and the total number of cases. So, unfortunately, being the most popular drug with mephanemic acid, it was meftal spas that had to bear the brunt of the advisory. The former IPC executive told the Ken that the whole thing was completely media generated. They pointed to how a common person would not understand what mephanamic acid is. So many reports just used the meftal spas name to make the general public aware. And that is how Meftal Spaz became a victim of its own popularity.

So what we need now is for the IPC to be more specific and detailed in its advisories and tell us critical information related to a safety alert. Otherwise, other popular important medicines like Combeflam and Croissant may suffer the same fate as that of Meftal Spass. Daybreak is produced from the Newsroom of the Ken, India's first subscriber-focused business news platform. What you're listening to is just a small sample of our subscriber-only offerings. A full subscription unlocks daily long-form feature stories,

newsletters, subscriber-only apps and podcast extras. Head to the ken.com and click on the red subscribe button on the top of the website. I am Snigda Sharma, your host, and today's episode was edited by my colleague Rajiv Sien.