By Elton Gomes
Correction: D’Cold Total has not been banned, although reports suggested it was on the draft ban list. The story has been updated to reflect this news.
Painkiller Saridon and Panderm skin cream have been included among 328 fixed-dose combination (FDC) drugs banned by the government to stop their “irrational use”. The government order will place an immediate ban on the manufacture, marketing, and sale of several common cough syrups, painkillers, and cold and flu drugs. Indias drug advisory body, the Drug Technical Advisory Board (DTAB) said that the drugs must be banned as there is no therapeutic justification for their ingredients.
Why has the ban been imposed?
An FDC drug is known to contain two or more active ingredients in a fixed dosage ratio. For example, an FDC in the banned list is called “naproxen plus paracetamol”, which means that it’s not the single drug but a combination of the two that has been considered unnecessary for consumption.
The health ministry said that the ingredients do not add to the benefits that people can get from taking them. The ministry imposed the ban after the DTAB said in a report that taking any of the 328 FDCs could put a persons health at risk.
Which drugs are included in the ban?
The initial draft ban was expected to cover popular cough syrups, painkillers and medicines like Phensedyl, Saridon, and DCold Total, according to the Economic Times. Two people knowledgeable of the matter said that painkillers, antibiotics, antiseptics for treatment of mouth and throat conditions, and anti-diabetic drugs have not been included in the ban, though there are caveats, Hindustan Times reported.
How will firms be impacted?
Deepnath Roychowdhury, President of the Indian Drug Manufacturers Association, said that the government order is bound to have an impact on the market estimated to be around Rs 16 billion a year for such drugs. Roychowdhury said that the order will be respected, Reuters reported.
A majority of Indian firms seem to have discontinued their FDCs or have little stock left with them, Dilip Shah from the Indian Pharmaceutical Alliance told NDTV.
What happened previously?
The expert panel appointed to probe the effectiveness of 349 banned FDCs complied with the December 2017 judgement of the Supreme Court and submitted its report to the Drug Technical Advisory Board (DTAB) on July 25. After terming the drugs irrational, the panel cited safety issues and a lack of therapeutic justification, recommended continuing the ban.
In its previous report submitted in January 2015, the expert panel led by Chandrakant Kokate, vice-chancellor of KLE University, Karnataka, said that these FDCs are irrational. Kokate said that the drugs posed health risks and he was in favour of banning them, thus urging some firms and pharma groups to challenge the governments notification banning FDCs.
In December 2017, the Supreme Court referred the matter to DTAB so that it could conduct a fresh review on whether these drugs should continue to be sold. The Supreme Court suggested DTAB decide whether the manufacture and sale of the drugs should be regulated, restricted, or explicitly banned. DTAB then had to submit its report and recommendations to the government within six months.
Thereafter, an expert panel was formed under the chairmanship of Nilima Kshirsagar, professor-head of clinical pharmacology, G.S. Medical College and KEM Hospital, Mumbai, to assess the efficacy and therapeutic justification of these drugs.
Elton Gomes is a staff writer at Qrius
Correction: D’Cold Total has not been banned, although reports suggested it was on the draft ban list. The story has been updated to reflect this news.