Proposal by Department of Pharmaceuticals says Vitamin C is found in a variety of food products and is not a critical medicine that needs drug price regulation.
New Delhi: The government may soon qualify Vitamin C tablets as a food supplement instead of an essential medicine, a move that will free the pills of price control.
The tablets are currently regulated by drug watchdog National Pharmaceutical Pricing Authority under the list of essential medicines. If the Department of Pharmaceuticals’ proposal for reclassification goes through, its manufacture and sale will be overseen by food regulator Food Safety and Standards Authority of India (FSSAI).
Found in a variety of fruits and vegetables like oranges and potatoes, Vitamin C, in the right dosage, is known to help protect cells, maintain healthy skin, blood vessels, bones and cartilage, and ease wound healing. It also helps absorb iron, whose deficiency can lead to anaemia.
Human bodies do not produce Vitamin C, which means it has to be taken through foods rich in it or via supplements.
Price control on Vitamin C tablets has kept its prices as low as Rs 5 for 10 pills, a fact that has been blamed for the recent shortage in its supply.
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The Department of Pharmaceuticals’ proposal, a source said, is driven by the fact that “Vitamin C can be found in a variety of food products and is not a critical medicine that needs drug price regulation”.
“Our intention is not to over-regulate drugs,” a senior official in the Department of Pharmaceuticals, which falls under the Ministry of Chemicals and Fertilizers, told ThePrint.
“In the past, the prices of the raw material of APIs (active pharmaceutical ingredients, the central component of a drug) had jumped significantly, due to which several companies stopped producing the drug, which caused the shortage of Vitamin C pills in the market,” the official added.
“We plan to remove Vitamin C from the portfolio of regulated, essential medicines as it not a drug but a food supplement,” the official said. “We will go ahead with the plan after consulting medical experts.”
Field experts ThePrint approached for comment described the proposal as a welcome move.
“Vitamin C was used to treat scurvy (Vitamin C deficiency),” said Dr K.K. Aggarwal, a cardiologist and former president of the Indian Medical Association (IMA). “However, now the disease is quite rare. During cough and cold, instead of prescribing Vitamin C, we prescribe fruits and fruit juices, which have an abundant quantity of this vitamin. Vitamin C can easily be termed a food supplement instead of medicine.”
Dr Satish Koul, a senior consultant for internal medicine at Narayana Superspeciality Hospital, Gurgaon, said he had “always treated Vitamin C as a supplement and hardly as a medicine”.
“It can be prescribed to patients suffering from cancer, cardiovascular diseases or orthopaedic problems in a dose ranging from 100 mg to 300 mg,” he said. “However, it’s not a treatment, and a supplementary therapy that may not require tablets but only Vitamin C-rich foods.”
“Like Vitamin C, products like charcoal, oxygen and condoms are regulated under drug and medical device pricing (mechanisms),” said D.G. Shah, secretary general of the Indian Pharmaceutical Alliance, the biggest pharma lobby of domestic drugmakers, including Cipla, Lupin and Sun Pharma.
“Moving Vitamin C to the bouquet of food supplements is a wise decision as it is no more treated as medicine.”
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Shortage of Vitamin C due to price control
The basic ingredient in the tablets, sodium ascorbate, is sourced from China, but its prices have jumped by over 50 per cent in the past year amid a crackdown on polluting factories in India’s eastern neighbour.
“Pharma companies were not allowed to increase the prices of drugs when the price of raw materials increased,” B.R. Sikri, the vice-president of the Bulk Drug Manufacturers of India, told ThePrint.
“Hurt by the price rise, several companies had discontinued the production of the drug for a brief interval,” he added. “These firms have continued manufacturing Vitamin C only to maintain the brand equity, otherwise these tablets are sold for Rs 10 for 10 tablets and are not viable for production under stringent price controls.”
Over the past several months, chemists have reported a shortage in the supply of Vitamin C tablets.
New Delhi Medicos, near RML Hospital in Delhi’s Connaught Place, confirmed the shortage of the popular chewable Vitamin C tablets Limcee and Celin over the past few months.
Another pharmacist, Family Chemist in West Delhi near Ganga Ram Hospital, also confirmed the shortage of these brands.
Mails written to Abbott Healthcare Pvt Ltd, which manufactures Limcee, and Glaxo SmithKline Pharmaceuticals, makers of Celin, did not elicit any response.
The NPPA has now written to drug inspectors across India to look into the complaints of shortage.
“We were informed by some group of chemists in Goa about the shortage of Vitamin C and, based on the complaint, we have alerted drug inspectors across states to check the shortages,” said a senior official from the NPPA.
Vit C is a very important anti-oxidant and in a year or two it will be a major part of treatment for brain ischemic stroke, heart attack and neonatal encephalopathy. It should be easily and cheaply available under price control. Dr Gohil
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