E-Paper
FDA orders to stop sale and manufacturing of 14 drugs in Pune district
The Union health ministry banned these 14 FDCs earlier this month, citing there is ‘no therapeutic basis’ for these drugs and that they may pose a ‘danger’ to humans
The Food and Drug Administration (FDA) has notified the Chemist Association Pune District (CAPD) and allopathic medication makers in the Pune district that 14 fixed-dose combination drugs (FDC) will no longer be manufactured, sold, or distributed. The Union health ministry banned these 14 FDCs earlier this month, citing there is ‘no therapeutic basis’ for these drugs and that they may pose a ‘danger’ to humans.
Following the central government’s notification issued on June 3, the FDA issued a letter dated June 6 to CAPD and Allopathic Drug Manufacturers in the Pune region (Pune, Solapur, Sangli, Satara, and Kolhapur) in this regard.
Dinesh Khivensara, assistant commissioner of FDA, Pune region, informed that these medicines will not be sold in the country.
“These medicines were used to treat coughs, colds, and respiratory infections, and the majority of them are available over the counter. Both the sales and manufacturing have been asked to be stopped immediately. We will undertake surprise inspections to find if the drugs are still in circulation and sold. If the order is not followed, action will be taken under the Drug and Cosmetic Act of 1940,” he said.
An FDC contains two or more active ingredients in a fixed dose ratio. The decision was made in response to the expert committee’s and the Drugs Technical Advisory Board’s recommendations. The expert committee said that there is ‘no therapeutic justification’ for these FDCs and involve risk to human beings.
The banned FDCs are part of 344 fixed-dose combinations prohibited for sale by the Union Health Ministry in 2016. However, the government order was challenged by 15 manufacturers in court.
Vivek Tapkir, vice president, CAPD, said, the sale of these banned drugs has been stopped by all chemists.
“Some of us have received notification from a few manufacturers to return the banned drug. Few of these prohibited medications are in high demand, particularly codeine cough syrup. We have currently set aside the existing supply of these prohibited pharmaceuticals and labelled them as not for sale. We have asked our association members to return the stock of these drugs to the distributors.
Dr Sanjay Patil, chairman, Hospital Board of India (HBI), Pune chapter, said, if the doctors and hospitals don’t get the supply of the banned drugs, they will automatically stop prescribing them.
“As this FDC includes drugs used for common cold and fever there is a need to create awareness among the doctors. Doctors must exercise caution while writing prescriptions. We will conduct an awareness session for the banned drugs among the doctors. It is always good to be aware of the banned drugs,” he said.
