Chennai: After re-looking into the ban of fixed-dose combination drugs, the Supreme Court is to ban around 344 combination drugs that include cough syrups, painkillers and flu medicines like Phensedyl, Saridon, Vicks Action 500, Dart, Corex and D’Cold Total very soon.
Officials at state chemists and druggists association are expected to receive the final notification in the coming week, said the officials.
Though the issue the regulation and ban of fixed dose combination drugs was already raised and the High Court had ordered the ban in 2016, pharma companies approached the apex court for relief.
Later, the drug advisory body reviewed the issue and recommended the ban of medications, after which the Supreme Court is likely to impose the ban of sale, manufacture and distribution of these drugs very soon.
Various over-the-counter drugs are in the list that has been recommended by Drug Technical Advisory Board to be banned. The 344 combinations including those of paracetamol, phenylephrine and caffeine; chlorpheniramine maleate, codeine syrup and paracetamol, propyphenazone and caffeine might have more than 5,000 products and will have a huge impact on the medical hub and market.
Fixed dose combination drugs are a combination of two or more drugs in a single dosage form and are The Food and Drug Admin istration, USA defines a combination product as ‘a product composed of any combination of a drug and a device or a biological product and a device or a drug and a biological product or a drug, device, and a biological product’.
The apex body said that FDCs are likely to be banned, as they are claimed to be unsafe and irrational. As per the Food and Drug Administration, combination drug is a product composed of any combination of a drug and a device or a biological product and a device or a drug and a biological product or a drug, device, and a biological product.
Pharmaco logists say that rational drugs in the combination should act by specific mechanisms without possessing the supra-additive toxicity of the ingredients. However, in case of FDCs, the toxicity of the ingredients is alleged to be unsafe for human intake. The single formulations are safe to use, while the FDCs can lead to damage to other organs. Several drugs that are used as a treatment for TB led to kidney and liver failure, said pharmacologist Dr Sharmila Anand.
Though the final order is awaited, officials say that the state authorities have been already informed of the decision and the ban implementation will be made anytime soon. However, members of the Tamil Nadu Chemists’ and Druggists’ Association are worried about disposing the current stock of the medicines.
“There will be some 6,000-7,000 products of the mentioned 344 combinations and it will be a difficult situation for us if the ban of the drugs is immediately brought into effect. Therefore,
we request the state authorities to give a notice time to either sell the drugs for a specific period of time or sort them out and return it back to the manufacturers,” said S Ramachandran, president of Tamil Nadu Chemists’ and Druggists’ Association.
“We would need two months to sell the present stock and at least one month top return it back to the manufacturers,” he said.
