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

Aug. 23, 2024, 8:28 a.m.

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The government has prohibited the sale of 156 over-the-counter medications, many of which are commonly available.

The list encompasses medications for fever, colds, allergies, pain, hair growth, skincare, multivitamins, antiparasitics, and more.

Authorities believe the prohibited medications are “likely to pose a danger to human health.”

Let’s take a closer look.

The ban on cocktail medicines

Fixed-dose combinations (FDCs) are medications that combine multiple drugs in a single tablet and are also known as “cocktail” medicines.

The government has prohibited the sale of “Aceclofenac 50 mg + Paracetamol 125 mg tablets,” a widely used pain reliever produced by leading pharmaceutical companies, according to a notice published by the Union Health Ministry on August 12.

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 prohibited medications 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 of banned substances includes magnesium chloride, commonly used to address nutritional deficiencies. Multi-enzyme complexes containing 12-15 enzymes have also been banned, along with 20 formulations containing naphazoline, a decongestant commonly found in eye drops.

The ban also includes a combination of Paracetamol, Tramadol, Taurine, and Caffeine. Tramadol is a pain reliever that belongs to the opioid class.

The list also contains products that have already been discontinued by several drug manufacturers.

Major pharmaceutical companies such as Cipla, Torrent, Sun Pharma, IPCA Labs, and Lupin have had some of their products included in the ban.

The reason

The government has determined that the use of this particular fixed-dose combination drug poses risks to human health, especially considering the availability of safer alternatives.

An expert committee established by the central government reviewed the drug combination and deemed it “irrational.”

The notification further stated that the apex panel of the Drugs Technical Advisory Board (DTAB) also reviewed these FDCs and concluded that “there is no therapeutic rationale for the ingredients contained in these FDCs.”

The government has decided to ban the manufacture, sale, and distribution of a specific drug, citing potential risks to human health. This decision was made under Section 26A of the Drugs and Cosmetics Act of 1940, which allows for such action in the interest of public well-being.

“Considering the above, any form of regulation or restriction to allow their use in patients is not justified. Therefore, only prohibition under Section 26A is recommended,” the notification added.

Following the DTAB's recommendations, the notification stated that “the Central government believes it is essential and in the public interest to prohibit the manufacture, sale, and distribution for human use of the aforementioned drugs in the country.”

Public health experts have consistently urged the Central Drugs Standard Control Organisation (CDSCO), the health regulatory body and the Ministry of Health, to remove these cocktail medications from the Indian market, as reported by 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.

Advertisement Not the first time

Fixed-dose combinations (FDCs) containing irrational ingredients began appearing on the Indian market in the 1980s, according to The Print, citing experts in drug safety. However, the issue did not gain widespread attention until 2012 when a parliamentary standing committee released a critical report exposing the problem.

The committee observed that some state licensing authorities had permitted the production of multiple FDCs without prior approval from the CDSCO. This led to an excessive number of medication formulations that lacked thorough safety and efficacy evaluations, putting patients at risk. Notably, only CDSCO is authorized to grant marketing permits for new drugs under India's Drugs and Cosmetics Act.

Advertisement In response to the 2012 parliamentary report, the CDSCO sought a list of FDCs that had received authorization from state drug authorities, resulting in 6,320 applications being 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 ruling impacted over 2,700 branded medicines, according to the report.

Drugmakers’ response

While companies are examining the ban, a formal response from the industry is expected.

Industry experts informed News18 that several FDCs on the list received little scrutiny because they were licensed prior to 1988.

Furthermore, due to the lack of transparency in the procedure, they anticipate additional legal challenges.

“We are surprised by the timing of these meetings with DTAB. We are still evaluating the situation, and we believe that numerous pharmaceutical companies may challenge the government's decision in court,” 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 disclose the expert panel's recommendations and rationale behind this decision. It should also clarify if the companies' perspectives were considered,” he said to The Print.

With inputs from PTI