The central government has banned 156 cocktail drugs — many of which you might have at home. The list of these banned products includes those used for hair growth, skincare, and pain relief, or as multivitamins, antiparasitics, antiallergics, and more.
Fixed-dose combinations (FDCs) are medicines that combine more than one drug in a single pill and are also referred to as “cocktail” medicines.
Although the drugmakers have not yet announced the financial impact of the ban, leading pharma companies such as Cipla, Torrent, Sun Pharma, IPCA Labs, and Lupin have all had some of their products affected by the prohibition.
According to the gazette notification issued by the government announcing the ban of these 156 fixed-dose combination (FDC) drugs, the central government is satisfied that the use of the drug FDC is likely to involve “risk to human beings whereas safer alternatives to the said drug are available”.
The notification said that the matter was examined by an expert committee appointed by the Centre, which deemed these FDCs “irrational”.
The notification clarified that the apex panel Drugs Technical Advisory Board (DTAB) also examined these combinations and recommended that “there is no therapeutic justification for the ingredients “contained in these FDCs.
“Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940,” the notification said while declaring the ban on drug combinations listed individually. “In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”.
Following the advice of DTAB, the notification said that “the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country…”
On the list
While the industry is still analysing the impact of the ban, the list includes certain products which were already discontinued by many drugmakers. For instance, the combination of the antibiotic azithromycin with adapalene which is used to treat acne.
The list bans “Aceclofenac 50mg + Paracetamol 125mg tablet”. This is one of the popular combinations of pain-relieving medicines manufactured by top pharma companies.
The list also includes “Paracetamol+Pentazocine” which is used for pain relief and a combination of “Levocetirizine + Phenylephrine” which is used to treat runny nose, sneezing, or other symptoms caused by seasonal hay fever or allergic rhinitis. It includes many other combinations involving Levocetirizine which is an antihistamine that works by preventing the effects of histamine produced by the body.
The list bans magnesium chloride which is used in the treatment of nutritional deficiencies.
It also prohibits the combination of paracetamol, tramadol, taurine, and caffeine, in which tramadol is an opioid-based painkiller.
Drugmakers yet to respond, may go to court
An official comment from the industry is awaited as companies are still analysing the ban. Industry veterans told News18 that the list includes several FDCs which were licensed before 1988 and kept out of the list of consideration. They also believe that several litigations are likely to be raised as the process has not been done transparently.
“Also, we are quite surprised that when these meetings with DTAB took place. We are still analysing and we believe that many pharma companies may drag the government into court cases,” said an industry insider.
Why fixed-dose combinations are banned
On several occasions, public health experts have nudged the health ministry and the health regulatory agency, Central Drugs Standard Control Organisation (CDSCO), to filter out cocktail drugs from the Indian market. The idea behind these cocktail medicines is to ease compliance for those required to take multiple medicines as part of long-term treatment or when the combination is proven to have a clear benefit over single-compound drugs.
However, these drugs have been under the scanner because a lax regulatory framework allowed several unscientific combinations to flood the market. There are also fears that this may increase drug resistance in people.
In 2016, the ministry started a drive to filter out irrational drug combinations from the Indian pharmaceutical industry by banning around 350 FDCs, which impacted over 2,700 branded drugs.