Telangana High Court Grants Authorities Last Opportunity To Respond To Plea Against Misleading Advertisements Of ORS Substitute Products

The Telangana High Court on Wednesday gave authorities of the state and central government a last chance for filing their response in the PIL seeking action against "misleading, false and offensive "advertising of Oral Rehydration Solution (ORS) substitute products.

The division bench of Acting Chief Justice Abhinand Kumar Shavili and Justice N. Rajeshwar Rao said the writ petition was filed way back in 2022 but so far the respondents have not filed any counter.

"As there is urgency and also the products mentioned in the affidavit are affecting the health of the children, as a last indulgence, an opportunity is given to the respondents to file counter affidavit detailing their stand as to the grievance raised by the petitioner by the next date of hearing," it said, while listing the case for hearing on August 02.

The court was hearing a PIL filed by Dr. M. Sivaranjani Santosh, a leading paediatrician in Hyderabad, challenging the inaction on the part of the authorities in implementing regulations laid down by the Food and Safety Standards Authority of India (FSSAI) with regard to the advertisements of ORS substitute products, despite the petitioner making repeated representations before various authorities.

Advocate M.V Durga Prasad, representing the petitioner argued before the court that with the advent of monsoon, cases of stomach infections and diarrhoea are bound to skyrocket, warranting the immediate interference of the court.

Dr Santosh is a specialist in child wellness and over the years, she said, has seen the health of children worsen instead of improve due to the consumption of ORS substitutes that are being "falsely marketed as the real thing". 

"Unfortunately many big Pharma companies started advertising and selling ORS products without conforming to World Health Organization (WHO) formula with misleading statements, contrary to law. This resulted in grave misconception and misinformation among innocent consumers, with regard to WHO approved formula of ORS and is confusing the anxious parents of sick children. This has been directly affecting and deteriorating the health of children to a greater extent," she said in the PIL filed in 2022.

Dr. Sivranjani has argued that the altered version of ORS would fall within the meaning of ‘misbranded foods’, ‘substandard’ and ‘unsafe’ as per section 3(zf), 3(zz) and 3(zm) of the FSSAI Act. That section 18(f) of the FSSAI Act mandates that when there is a reasonable ground to believe that a certain drug may pose serious risk, appropriate steps should be taken to inform the general public of the risk.

"Some of these offending packs contain disclaimers/ precautions like, “Do not use during diarrhea” and “This is only a brand name or Trade mark and does not represent its true nature” in an obscure manner. The purpose of regulating the labelling and Packaging under law as above, is to protect the gullible public from such misleading representations. Hence, such obscure disclaimers on the pack or label, do not obviate the misleading effect nor extenuate the offence, when the packing and labelling is per se misleading the gullible consumers and hence, offending and incriminating," the plea reads.

Submitting that ORS is considered as "potentially the most important medical discovery of the 20th century" and is widely manufactured, distributed and sold throughout the world, the petitioner has alleged that many Pharma companies entered markets with their own ‘substitute’ products and branding, contrary to law and WHO standards.

"ORS as prescribed by 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 the misleading names ... with a plethora of flavoured and non-World Health Organisation standards, having sugar and salts in violation of WHO standards, due to which most parents buy and administer them to their children, falling for the misleading information, promotion labelling and names used by many brands. Thus, this illegal sale and use ends up in giving wrong formula to children when they already suffer with diarrhea or vomiting. It is pertinent to note that the high sugar content actually increases the osmolarity of the drink which makes it even more dehydrating and also increases the diarrhea, as a result of which, many children end up being hospitalized," the plea reads.

 Case Title: Dr. Sivaranjani Santosh vs. UOI

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