Combination Drugs

Govt restricts 2-compound fixed drug combinations for children under 4

In a significant step to safeguard the health and safety of young children, the government has imposed restrictions on the manufacture, sale and distribution of all fixed dose combinations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride, mandating a clear warning that these medicines shall not be used in children below four years of age. Earlier, vide a notification dated April 15, 2025, the government had restricted certain fixed dose combinations (FDCs) containing the two chemical compounds, subject to the same age-specific warning. The latest notification extends this requirement to all formulations containing these two ingredients. The decision followed recommendations by an expert committee and the Drugs Technical Advisory Board (DTAB). The government noted that the use of such combinations may pose risks to children below four years of age and that safer alternatives are available. Manufacturers have been directed to clearly display the warning "Fixed Do

India's psychotropic drug market flooded with unapproved FDCs: Study

Over 60 per cent of the fixed-dose combination (FDC) drugs used for treating mental health disorders in India are 'unapproved' and lack proven therapeutic value, the study found

DTAB to review 19 fixed-dose combinations drugs, codeine formulations today

CDSCO aims to phase out these combinations and codeine-based drugs in a phased manner

Medicines costing less than Rs 5 per dose may be taken out of price control

If this goes through, drugmakers will have the liberty to raise the prices of these drugs by up to 10 per cent every year

1,600 combination drugs under govt lens, may face ban over safety issues

Of the 1,600 FDC drugs that are under watch now, around 600 are learnt to be vitamins

Letters: Drug regulation

I fully agree with the points raised in "Knee-jerk reaction" (March 18). It is a well-known fact that combination drugs have been in the market for quite some time now, and that people have been using them extensively and benefitting from them greatly, too. How come the government woke up now on the issue, when these medicines have proven to be effective in their fields? Has any test been carried out to prove that these are harmful? If yes, why were such tests not done before permission was given to companies to manufacture the drugs in question?While I appreciate the government's eagerness to protect the common man from the ill-effects of extensive use of non-prescription medicines (over-the-counter drugs), I wonder why there is no regulation in place to check the veracity of the claims made by the manufacturers before they carry out commercial production. In my opinion, all over-the-counter medicines should be banned and all pharmaceutical products should be sold only on prescription