NEW DELHI: Country's top drug advisory board has backed the health ministry's decision to ban 343 fixed dose combinations, some of which were commonly used drugs used in treatment of cold and cough. However, it has recommended lifting the ban from 6 other products and instead allow them with certain restriction for specific indications or quantities.

The report, prepared by a sub-committee of the Drugs Technical Advisory Board (DTAB), recommended that 343 FDCs be banned and six others are either restricted or regulated for specific indications or quantities, a senior official said. “The DTAB has accepted the recommendations made in the report and will send it to the health ministry in a few days,” he said.

Once the suggestions are approved by the ministry, it will notify a fresh order.

However, it is not clear which six drugs have managed to come out of the scanner.

In March 2016, the Centre had banned several fixed dose combination drugs, including some popular cough syrups based on codeine , saying they involve health “risk” and safer alternatives were available.

A fixed dose combination or FDC is one that contains two or more drugs combined in a fixed ratio of doses and available in a single dosage form.

Though approval by the Central drug regulator — drugs controller general of India — is mandatory for FDCs, many unapproved formulations were thriving with a weak monitoring mechanism at state level. The main aim of the Centre’s ban was to eliminate such medicines.

Hundreds of pharma companies moved the Delhi high court against the move, following which the court lifted the ban on the manufacture and sale of these medicines later that year.

The government approached the Supreme Court against the HC order. In December 2017, the apex court said DTAB should have a view on the matter. DTAB subsequently decided to set up a sub-committee under Nilima Kshirsagar to decide the same.

Now, on July 25 DTAB examined the recommendations of the Nilima Kshirsagar committee and approved the same.

A study published in 2015 in journal PLOS Medicine pointed that over 12% of nonsteroidal anti-inflammatory drugs (NSAID) FDCs sales volume contain drugs that have either been withdrawn from the market or have had their use restricted.

