Why has the Centre banned 156 cocktail drugs? Which are they?

The Centre has banned 156 cocktail medicines, many of which might be easily found at home.

The list includes medicines for fever, cold, allergies, pain, hair growth, skin care, multivitamins, antiparasitics, and more.

Authorities believe the banned medicines are “likely to involve risk to human beings.”

Let’s take a closer look.

The ban on cocktail medicines

Fixed-dose combinations (FDCs) are medicines that combine more than one drug in a single pill and are also referred to as “cocktail” medicines.

According to a gazette notification issued by the Union Health Ministry on August 12, the government has banned “Aceclofenac 50 mg + Paracetamol 125 mg tablet,” one of the popular combinations used as pain-relieving medicines manufactured by top pharma companies.

The list also includes a combination of “Levocetirizine + Phenylephrine” to treat runny nose, sneezing, and other symptoms of allergic rhinitis or seasonal hay fever, as well as “Paracetamol + Pentazocine” to relieve pain, as per News18.

It consists of numerous formulations including levocetirizine, an antihistamine that blocks the body’s histamine production.

Other banned medicines include Mefenamic Acid Paracetamol Injection, Cetirizine HCI Paracetamol Phenylephrine HCI, Paracetamol Chlorpheniramine Maleate Phenyl Propanolamine and Camylofin Dihydrochloride 25 mg Paracetamol 300 mg.

The list bans magnesium chloride, which is used in the treatment of nutritional deficiencies, and multi-enzyme complexes that contain about 12–15 enzymes and 20 formulations containing naphazoline, a decongestant commonly used in eye drops, as per The Print.

The Centre has also banned the combination of Paracetamol, Tramadol, Taurine and Caffeine. Tramadol is an opioid-based pain killer.

The list also includes certain products which have already been discontinued by many drug makers.

Leading pharmaceutical businesses, including Cipla, Torrent, Sun Pharma, IPCA Labs, and Lupin have all seen some of their medicines affected by the ban.

The reason

“The Central Government is satisfied that the use of the Fixed Dose Combination drug is likely to involve risks to human beings, whereas safer alternatives to the said drug are available,” the notification said.

It said that the matter was examined by an expert committee appointed by the Centre, which considered these FDCs “irrational.”

It further stated that the apex panel of the Drugs Technical Advisory Board (DTAB) also examined these FDCs and recommended that “there is no therapeutic justification for the ingredients contained in these FDCs.”

“The FDC may involve risks to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under Section 26A of the Drugs and Cosmetics Act 1940,” the notification read.

“In view of the 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,” it added.

Following the DTAB’s recommendations, the notification said that “the Central government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture, sale and distribution for human use of the said drug in the country.”

Public health experts have repeatedly pressed the Central Drugs Standard Control Organisation (CDSCO), the health regulatory body and the ministry of health, to remove cocktail medications from the Indian market, as per The Print.

These “cocktail” medications are intended to make it easier for patients who must take more than one medication to comply with long-term treatment regimens or when the combination shows proven advantages over single-compound medications. However, it was only recently that they came under scrutiny.

Not the first time

Irrational FDCs began to appear on the Indian market in the 1980s, according to The Print, which cited experts on drug safety, but the issue was not brought to light until 2012, when a parliamentary standing committee published a critical report.

The committee noted that certain state licencing agencies had authorised the manufacture of multiple FDCs without first obtaining approval from the CDSCO. This led to an excess of medication formulations that had not been thoroughly examined for safety and efficacy, endangering patients. Notably, only CDSCO is authorised to grant marketing permits for new drugs under the Drugs and Cosmetics Act of India.

The CDSCO requested a list of FDCs that had been authorised by the state drug authorities in response to the 2012 parliamentary report, and 6,320 applications were submitted.

As a result, a commission headed by senior pharmacologist CK Kokate was established to investigate the scientific basis of FDCs. In 2016, the health ministry banned 344 FDCs based on the panel’s first recommendations.

However, some drug companies contested this in the Supreme Court, and the court’s ruling led to the formation of another DTAB subcommittee, led by Dr Nilima Kshirsagar. The panel supported the Kokate committee’s conclusions, and the Centre ultimately banned the 344 FDCs in 2018.

The decision had impacted over 2,700 branded drugs, the report said.

Drugmakers’ response

Although businesses continue to analyse the prohibition, an official response from the sector is anticipated.

Experts in the field informed News18 that several FDCs on the list received little attention because they were licenced before 1988.

Additionally, because the procedure has not been carried out transparently, they think that other lawsuits will probably be brought.

“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 told the channel.

While applauding the recent action, Chinu Srinivasa, co-convenor of the All India Drug Action Network (AIDAN), a patient rights organisation, also drew attention to the decision’s lack of transparency.

“The government should put out the basis and recommendations of the expert panel based on which the decision has been made and also tell us whether the views by the companies have been heard,” he told The Print.

With inputs from PTI