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File counter in ORS substitute products PIL plea: HC tells Centre, State

September 09, 2022 12:38 am | Updated 12:39 am IST - HYDERABAD

Telangana High Court on Thursday instructed the State and the Central governments to file counter affidavits in a PIL petition seeking action against officials failing to take act against companies indulging in marketing of Oral Rehydrated Solutions (ORS) substitute products with misleading and false advertisements.

A paediatrician, M. Sivaranjani Santosh, who filed the plea, requested the HC to instruct authorities concerned to prosecute manufacturers and vendors of ORS substitute products. The doctor said in her petition that inaction of the authorities in the matter is arbitrary and illegal. She stating that the Food Safety and Standards Authority of India (FSSAI) had already passed orders to check sale of substitute ORS products. However, the authorities did not take any steps to enforce that order, she contended.

According to the petitioner, ORS is a life saving drug. It is classified under Clause 27 of Schedule K of Drugs and Cosmetics Rules-1945. Researches suggested that use of ORS reduced deaths due to dehydration caused by diarrhea. As per World Health Organisation guidelines, ingredients of ORS include glucose, sodium chloride, potassium chloride and trisodium citrate.

However, certain pharma companies are manufacturing and selling certain products under the misleading names like Oral Rehydration Salt (ORSL), ORSL Plus, ORSL Rehydrate etc. These products contain sugar and salts in violation of WHO standards, the petitioner said.

The petitioner said that high sugar content actually increases osmopolarity of the drink and results in even more hydration of the patient and aggravation of diarrhea. ORS products should never be sweet, she stated. Such products are not in conformity with Clause 27 of Schedule K of Drugs Rules. Naturally, such product is deemed to be adulterated under the Drugs Act.

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