The Central Drugs Standard Control Organization, which regulates the sale and distribution drugs in India, has reportedly found popular medication like Combiflam, a pain reliever, and D Cold Total, a cold medicine, to be substandard.
Comiflam is manufactured by Sanofi India while D Cold Total is made by Reckitt Benckiser Healthcare India. Combiflam and D Cold Total are pills commonly found most Indian households. For many people, these are the pills they resort to for a number of health problems like cough, cold, allergies and pain. These are also very easily available without a prescription at most chemists.
In a report, the organisation listed as substandard popular over-the-counter medicines such as D Cold Total, Combiflam, Cetrizine, Paracetamol, Pantoprazole, Ofloxaci and Lomotin. Combiflam, a painkiller manufactured by the Indian unit of French drugmaker Sanofi, had failed in similar tests last year as well. Several batches of Combiflam were withdrawn from the market after the regulator found the lots were substandard.
"It is important for companies to meet the standards set by the government for medicines to ensure that they are effective in treatment. When a drug is ingested it undergoes a complex metabolism in the body before it starts acting. This includes dissolving and absorption in the body's blood stream. The Central drugs Standard Control Organization has set standards for drug manufacture to maximize safety and efficacy of the drugs. Any deviation from the standard can compromise the therapy" said Dr Sonia Lal Gupta, Senior Neurologist at Metro Hospitals.
"Whether generic or brands, all pharmaceuticals need to follow guidelines to the tee. This is important especially with the new guidelines for prescription of medications coming out soon so the quality can be maintained at all levels", added Dr Sameer Gupta, Senior Cradiologist at MP Heart and Metro Hospital.
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The list features 60 common drugs which are all labelled "Not of Standard Quality"; the reason given in most cases is "Description and Particulate Matter" or "Disintegration" - which refers to time taken for the medicines to disintegrate or break down in the human body - an important parameter for routine assessment of pharmaceutical drugs.
This year’s list includes painkillers, medicines for anti-allergy, fever, cold, loose motion, constipation, as well as calcium and iron supplements, among others. A response from the various pharmaceuticals are awaited.
(With Inputs from Dr Sonia Lal Gupta, Senior Neurologist, Metro Hospital and Dr Sameer Gupta, Senior Cardiologist at MP Heart, New Delhi.)