The Union government has banned 14 fixed-dose combination (FDC) drugs in India on the recommendation of an expert committee which said there is "no therapeutic justification" for these medicines and that they may involve "risk" to people.
The expert committee constituted by the Government of India furnished its report on April 1 last year.
“Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of these FDC under section 26A of the Drugs and Cosmetics Act, 1940,” the gazette notification by the Health Ministry said.
FDCs are drugs which contain one or more active drug ingredients and are used for a particular disease indication.
The committee in its report stated that any kind of regulation or restriction to allow for any use in patients is not justifiable.
“Therefore, only prohibition under section 26A is recommended,” the notification read.
Welcome move
Chinu Srinivasan of All India Drug Action Network welcomed the government's action on FDCs saying they deserved to be banned in the country.
“It is a correct move by the government. There are two expert committees (Kokate and Dr Nilima Kshirsagar) who recommended the FDCs be banned in the country. There are so many other combinations which need strict examination,” he added.
When asked about the over-the-counter availability of these FDC drugs in India, Srinivasan pointed out that the OTC drugs aren’t specified in the country.
One of the key FDCs banned by the government includes Nimesulide+Paracetamol which is often used to relieve pain in conditions such as toothache, ear pain, joint pain, headache and menstrual cramps. It is also used for fever.
Another banned FDC is Amoxicillin+ Bromhexine which is often prescribed for lower respiratory tract infections.
The list of banned FDCs also includes chlorpheniramine maleate and codeine which are used to treat cough, runny nose, and sneezing caused by allergies or the common cold.
Similarly, the banned combination of bromhexine, dextromethorphan and ammonium chloride is often used to treat dry cough.
FDCs banned by DCGI
In December last year, while replying to a question by AAP Punjab MP Harbhajan Singh, the government said 36 cases of unapproved FDCs licensed by the state regulators were reported from 2020 till date.
“A few cases of grant of manufacturing licence of new drugs, including fixed-dose combinations (FDCs), by some of the state licensing authorities (SLAs) without the due approval of the Drugs Controller General of India came to the notice of the government. Thirty-six cases of unapproved FDCs licensed by the SLA, considered as new drugs, have been reported from 2020 till date," Minister of State for Health Bharati Pravin Pawar told Rajya Sabha.
"During the Drug Consultative Committee meetings, State Drugs Controllers have also been requested to ensure that new drugs and FDCs are not permitted without the approval of the DCGI,” the minister had said.
The approval of the banned FDCs was given by Uttarakhand (10), Himachal Pradesh (9), Sikkim (5), Gujarat (4), Maharashtra (2), Karnataka (2), Uttar Pradesh (2), Telangana (1) and Daman and Diu (1).
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