Earlier in August, the Ministry of Health and Family Welfare (MoHFW) issued a ban on 156 fixed-dose combination drugs (FDC), citing safety concerns. These included antibiotics, vitamins, anti-pyrectics, and blood pressure medications. Despite the ban, these banned drugs continue to be sold, prescribed, and purchased. Fixed-dose combination drugs contain two or more active pharmaceutical ingredients in a single dose and are used to treat a particular concern. While FDCs are beneficial in treating certain afflictions when used in the right combination, they can be lethal in cases where clinical trials have not established adequate safety.
In India, the Central Drugs Standard Control Organisation (CDSCO), under the MoHFW, is responsible for regulating the safety, efficacy, and quality of all drugs, cosmetics, and medical devices. CDSCO is governed by the Drugs and Cosmetics Act of 1940. The Act regulates the sale, manufacturing, and distribution of pharmaceuticals. The government holds the right to ban drugs on evidence of adverse effects, lack of therapeutic efficacy, potential for misuse, and even unethical marketing practices.
Banned drugs sale up
The continued sale of banned drugs reflects poorly on the inability of authorities to eliminate these drugs from the market. A report of the department-related parliamentary committee in 2012 revealed that CDSCO operates under-resourced both in terms of funds and functionaries. It was also observed that state licensing authorities had issued manufacturing licenses for various FDCs without clearance from the CDSCO. Another reason banned drugs continue to be sold is that pharma companies often contest the government order, and a stay order is issued. Furthermore, the process of recalling drugs in India is extremely lengthy, and hence, pharmacies and hospitals continue to stock the banned drugs. The absence of penalties or incentives to hospitals or pharmacies for compliance with the directive also leads to poor outcomes when it comes to bans.
Low consumer awareness
In a country like India, where consumer awareness is fairly low, the availability and consumption of banned drugs can be lethal to public health. The continued use of banned medicines raises alarms, especially when it is an antibiotic formulation or a drug for pediatric consumption.
For instance, the combination of Ofloxacin and Ornidazole injection and suspension was banned in 2018. The combination medication in tablet form continues to be sold and even prescribed. Ofloxacin is an antibiotic, and Ornidazole is an antiprotozoal drug. Therefore, the use of the drug in non-bacterial infections could cause drug resistance. This, in turn, leads to difficulty in treating other bacterial infections, such as urinary tract infections and tuberculosis, whose treatments are now riddled with concerns of drug resistance. Moreover, following the ban, the sales of the Ofloxacin and Ornidazole combination tablet increased by 6% in 2019, and in fact, it is the most sold antimicrobial in India. The ban increased the sale of medication that met the same specifications as banned products. Thus, loopholes in regulatory structure allow companies to bypass the regulation with ease.
Patients at risk
The sale of irrational FDCs puts patients at risk of antimicrobial resistance (AMR) and other adverse reactions. In 2019, India had 297,000 deaths attributable to AMR and 1,042,500 deaths associated with AMR. A Lancet study reported that nearly 10.4 lakh sepsis deaths in India in 2019 were associated with AMR. Lancet predicts that AMR will continue to accelerate rapidly in the coming years, with more than 39 million people across the world dying from antibiotic-resistant infections in the next 25 years.
Another drug, Nimesulide, a non-steroidal anti-inflammatory drug (NSAID), was banned for use in children under 12 years old in 2011 due to reports of adverse effects on the liver. The drug continues to be sold and prescribed in several over-the-counter formulations, especially in rural hinterlands.
Thus, the continued existence of such formulations despite orders to withdraw them puts uninformed and poor consumers at grave risk. Populations residing in remote regions often lack information about such bans; even doctors and pharmacists in such areas are not updated about such information.
More burden
The continued use of banned drugs often results in further health complications and poor health outcomes. This, in turn, leads to more treatments, tests, and hospital visits, leading to increased healthcare costs. Given that most of the healthcare expenses in India are borne out-of-pocket, the entire process places an immense financial burden on individuals. Prolonged hospital stays and additional treatments also place a burden on the already constrained healthcare machinery in the country.
The free availability of banned drugs represents a growing public health crisis that needs to be tackled on a priority basis. On the one hand, regulatory oversight needs to be strengthened with stricter enforcement of the ban and incorporating penalties for non-compliance; on the other hand, it is important to raise public awareness of banned medication and irrational use of antibiotics.
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