Promotion of Sugary Drinks? ORSL Stall at Pedicon Conference Leads to Controversy

Hyderabad: The recently held annual conference of the Indian Academy of Pediatrics (IAP) led to a controversy after the event included an exhibition stall for ORSL, which is popularly known as an alternative to Oral Rehydration Solution (ORS). 

Due to this, the association received criticism from Hyderabad-based paediatrician Dr. Sivaranjani Santosh, who, over the years, has been endeavouring to make the public aware that ORSL cannot be considered an alternative for ORS as it contains a huge amount of added sugar.

Dr. Santosh previously wrote to the Central Drugs Standard Control Organisation (CDSCO) and the Food Safety and Standards Authority of India (FSSAI) in this regard and has already filed a Public Interest Litigation (PIL) before the Telangana High Court.

Speaking to Medical Dialogues, Dr. Sivaranjani explained that ORSL, which is an energy drink, contains added sugar- around 10 times the recommended amount by the World Health Organisation (WHO).

While the pharmacies sell the ORSL as ORS for higher profit, these drinks, in reality, can worsen diarrhoea among children.

Is ORSL an Alernative for ORS? 

Specifying the differences between ORS and ORSL, Dr. Santosh said, "Oral Rehydration Solution (ORS) is a drug, which has saved millions of lives all over the world. The third leading cause of death among children in the under 5 age group in India is Diarrhea and the first and foremost mode of treatment for diarrhoea is to rehydrate. The best solution recommended by WHO and every paediatric academy is the low osmolar ORS. WHO has recommended that the ORS has a total osmolarity of 245 milliosmoles per litre (mOsm/L) and they have a particular formula for it. The amount of glucose in the WHO-recommended ORS is exactly enough to take the sodium in the ORS into the body."

"If the WHO-recommended low osmolar ORS has 1.35 gm glucose per 100 ml of solution, the ORSL by Johnson and Johnson company has around 11 gms of added sugar, which is around 9 times more than the WHO-recommended amount. What does this extra sugar do? It pulls water into the gut and worsens the diarrhoea," she added.

Dr. Santosh further explained that all the actual WHO-recommended ORS brands like Electral, Walyte, Electrobion etc. get permission from CDSCO, give it a brand name, and mention the WHO-recommended formula on the label.

"These are the ones we are supposed to give to children when they have diarrhoea. But these are kept somewhere in the corner, and this ORSL, which has almost 9 times the sugar, is kept prominently in all the pharmacies. So, when someone goes to a pharmacy and asks for ORS, it is the ORSL that is handed out to them," Dr. Santosh mentioned, further explaining that when parents give this to the children, the diarrhoea can worsen and the added sugar can worsen diabetes-related complications in diabetics as well.

Fight against ORSL and Misleading Label: 

Dr. Santosh informed that when they objected to ORSL being sold as a drug in the pharmacies and as an alternative for ORS, the company added a small disclaimer behind it, advising not to use during diarrhoea.

"But nobody reads the disclaimer and the ORSL is dominating the market," added Dr. Santosh, further pointing out that while drinks like Frooti or Maaza are not sold in a medical shop, the ORSL (which has similar sugar percentage in the drink as Frooti or Maaza) is available in the pharmacies. She also informed that when a plea in this regard was filed before the Delhi High Court by the parent of an affected child, the Court asked the FSSAI to look into the matter. However, after that nothing happened.

Dr. Santosh started raising awareness about this back a few years ago. She started writing to the CDSCO in 2021 and later the CDSCO had directed her to FSSAI. 

"I wrote to FSSAI and Central Health Ministry, which asked FSSAI to look into it. Finally, on 8th April, 2022, an order was issued by FSSAI saying misleading labels should never be allowed. So, we were very happy that this label would go away because this was misleading. While people wanted to give ORS to their children, they were actually giving ORSL. But what happened we don't know but in July they changed their order. Now, these people can sell their drink by adding a disclaimer. There is a disclaimer saying that this is not an ORS, this is an energy drink. After that, their marketing strategy changed as well," said Dr. Santosh.

ORSL is now sold as an "electrolyte drink" that "helps restore energy and hydration". However, Dr. Santosh opined that the drink cannot be promoted as a drink for rehydration when it worsens diarrhoea and can harm people with diabetes.

"Influencers are being asked to promote it as a drink to correct silent dehydration, the term which we have never come across when we studied medicine," she added.

"Disclaimers do not protect dubious labels. They can't have misleading labels. There are millions of people who don't even know how to read the labels for disclaimers. They don't understand the meaning," she said. Dr. Santosh has filed a PIL in September 2022 asking that ORS' should not be used in the labels of high-sugar drinks/any drink that does not conform to the WHO-recommended formula ORS and that these high-sugar drinks should not be sold in pharmacies and in school. The plea is pending before the Telangana High Court.

Why is IAP Endorsing ORSL? 

Questioning the role of IAP in this whole scenario, Dr. Santosh said, "I have also written to the local IAP heads as well as Central IAP heads saying that at least we should not endorse it in our conferences. This is ridiculous! This is harming the children of our country. 

However, Dr. Santosh, who was formerly an executive board member of IAP Twin Cities Branch informed that one of the secretaries of the association said that it was ultimately the "parents' choice". 

This year also, some of the IAP members reached out to the National Pedicon organizer and despite assuring that they would not endorse ORSL, they went ahead and put an ORSL stall, she informed, adding that this was disappointing from a "body that is supposed to work for the health of the children, which is supposed to protect the health of the children in the country... So much hypocrisy!"

When asked how she planned to pursue her battle to raise awareness in this regard, she informed Medical Dialogues that she plans to follow up with the PIL, in which already All India Endocrine Society and Women Paediatricians' Forum have impleaded themselves.

"Young Pediatricians from the IAP also expressed their support. We will pursue the PIL and I will write to IAP again and mention that what they have done is morally wrong and they should be the ones who should be raising awareness instead," she added.

Also Read: ORS or not ORS? PIL seeks prohibition of JnJ ORSL brand questioning its composition

Plea before Delhi HC: 

Medical Dialogues had earlier reported that a PIL was filed before the Delhi High Court alleging that Johnson and Johnson (JnJ) has been deceptively selling ORSL drinks as ORS health formula. The plea sought to restrain the sale and distribution of its 'ORSL' product, claiming that whereas on the face of it the product is indicative of Oral Rehydration Salts (ORS), its composition does not use the requisite ORS formula.

The petition submitted by a JNU Assistant Professor, had raised the question of why, if a drink is merely a fruit juice-based drink or a non-carbonated water-based beverage, it is made, distributed, marketed, or sold under the term ORSL, which is likely to confuse an average customer as a prescribed ORS.

In the plea, it was highlighted that 'ORS' is a drug classified as Class 27 of Schedule K of the Drugs and Cosmetics Rules 1945, and is used to treat diarrhoea with a solution containing sodium 75 mmol/L and glucose 75 mmol/L, with an osmolarity of 245 mmol/L.

However, the plea had alleged that while the name ORSL apparently was indicative of ORS, "None of the beverages being sold under the name ORSL use the composition of the new ORS formulation as prescribed by WHO."

Consequently, the HC bench had directed the Food Safety and Standards Authority of India (FSSAI) and Delhi government to decide the representation in accordance with the law, rules, regulations and government policy applicable to the case and disposed of the petition.

Also Read: JnJ ORSL Matter: Delhi HC asks FSSAI, Delhi Govt to decide