How pharma companies sell fruit juice in the name of ORS in India

Hyderabad: One-third of the total deaths of children under five years of age in India are caused by diarrhea, vomiting, and dehydration.

If a child suffers diarrhea, doctors prescribe ORS. But what kind of ORS (oral rehydration solutions) are you giving your child?

Not many know that there are many pharmaceutical companies misleading consumers with fruit juices labeled as ORS. These solutions are not authorized by the World Health Organization (WHO).

Dr. M Sivaranjani Santosh, a leading pediatrician in Hyderabad, filed PIL in Telangana High Court in September 2022 seeking action against officials failing to take action against companies indulging in the marketing of Oral Rehydrated Solutions (ORS) substitute products with misleading, false, and offensive advertising.

She challenged the authorities in implementing regulations laid down by the Food Safety Standards Authority of India (FSSAI) about the advertisements of ORS substitute products.

The doctor has seen the health of many children worsening instead of improving due to the consumption of ORS substitutes that are being falsely marketed.

After months of fighting by the doctor, the Chief Justice of Telangana High Court on Thursday asked FSSAI and the Drug Controller General of India to respond to the PIL on misleading labels of fruit juices labeled as ORS. They were asked to file a counter affidavit detailing their stand in the court by August 14; otherwise, the court would pass an order on the issue.

Two weeks before, the court gave the state and central government a last chance to file their response in the PIL. According to the court, there is urgency and the products mentioned in the affidavit are affecting the health of the children.

Dr Sivaranjani has also written to actor Sonu Sood who is endorsing Rebalanz Vitors of Dr Reddy’s Laboratories Ltd requesting to remove ORS from the label.

What does WHO recommend?

As per World Health Organization guidelines, ingredients of ORS include glucose, sodium chloride, potassium chloride, and trisodium citrate.

WHO recommended formula ORS has 13.5 grams of glucose per liter (1.35 grams of glucose per 100ml). Total osmolarity 245 milli osmoles per liter.

Extra sugar/glucose than this, will pull out water into the gut, and worsen diarrhea and dehydration.

"When children or adults have diarrhea, it is a must to give ORS formula as recommended by WHO. Illegal sale and use of ORS substitute products end up in giving wrong formula to children when they already suffer from diarrhea or vomiting. The high sugar in the juices will pull out water from the body into the gut and worsen diarrhea. As a result, many children end up being hospitalized. People are deceived by the prominent labels," said Dr Sivaranjani speaking to News Meter.

She urged parents to read the complete information on the ORS tetra packs before buying the ORS.

Ingredients of misleading ORS

Many pharma companies are seen misleading the public with products like ORSL Plus, ORSL Rehydrate, Stay Fit ORS FIT, and Rebalanz Vitors. They are not ORS but fruit juice. They are selling ORS products without confirming to WHO formula with misleading statements.

According to her plea, ORS as per the drug rules does not permit any sugars or flavours. However, certain pharma companies including the unofficial respondents are manufacturing and selling certain products under misleading names, with a plethora of flavoured and non-WHO standards, having sugar and salts in violation of WHO.

"They are not an ORS but a ready-to-use fruit beverage, which got a license from FSSAI. These contain a Sugar content of 120 grams per liter (12 grams per 100ml) and 68 grams per liter (6.8 grams per 100ml), while the WHO recommendation is for only 13.5 grams per liter/1.35 grams per 100ml. WHO recommendation is for only 13.5 grams per liter/1.35 grams per 100ml," said Dr. Sivaranjani.

According to the doctor, Pharmacies sell fruit drinks as ORS. Some care to read the formula, while many are illiterates who blindly purchase whatever is given by the pharmacy.

Dr. Sivaranjani has argued that the altered version of ORS would fall within the meaning of ‘misbranded foods’, ‘substandard’, and ‘unsafe’ as per Section 3(b) of Food Safety and standards Act.

After multiple representations from doctors and activists, FSSAI has issued a directive on the April 8 under section 16(5), where it was clearly mentioned that drinks without approval from the DCGI cannot use 'ORS' on their labels under sections 23 and 24 of FSS act 2006 and that the companies are punishable under FSS act sections 52 and 53,if the companies continue with selling MISBRANDED drinks.