The union health ministry had recently banned 156 fixed-dose combination (FDC) drugs, including antibiotics, and painkillers, citing lack of acceptable safety, efficacy, and therapeutic justification. S Srinivasan, co-convenor of All India Drug Action Network, explains how these drugs entered the market and the reason behind the ban, in an interview with Sinduja Jane.
Edited excerpts:
What are FDCs or cocktail drugs?
FDCs are fixed-dose combinations of more than one active drug in a medicine. It is taken by patients in the form of tablets, capsules, liquids, injections, ointments, etc. There are 384 drugs in the National List of Essential Medicines (NLEM) 2022. In the minimum list of medicines that are considered essential for healthcare, only 22 are FDCs, which are considered scientific and rational drugs along with a few other FDCs not listed in NLEM. The Kokate Committee examined the rationality of about 6,200 FDCs in India before recommending the ban on the first tranche of 344 FDCs in March 2016.
The number of irrational and unscientific FDCs are aplenty. How did these drugs enter the Indian market?
Many of these drugs entered the pharmaceutical market in the early 70s, 80s, and 90s—when the pharmaceutical market was booming in India and a kind of irrational exuberance prevailed in the industry. These FDCs were given manufacturing licenses by the state licensing authorities (SLAs) without marketing approval by the Central Drugs Standard Control Organisation (CDSCO). The 59th Report of the Parliamentary Standing Committee for the Ministry of Health and Family Welfare on the ‘Functioning of the Central Drugs Standard Control Organisation’ in 2012 first alerted the country about the market being flooded with such FDCs whose safety, efficacy, and therapeutic justification were not examined.
It pointed out how they entered the market without approval by CDSCO. FDCs entered the market by directly getting a manufacturing license from the state drugs control authorities. The three member committee formed in 2012 also faulted the regulatory system in India.
Do these contribute to the public health challenges like antimicrobial resistance?
When patients take two or three drugs when they require only one, they end up consuming more medicines than necessary. Any allopathic medicine will have some side effects if consumed repeatedly. For pain, paracetamol is enough; you do not need the anti-inflammatory Ibuprofen too. The combination of paracetamol and Ibuprofen will have these two medicines in a single medicine, so patients end up taking both. This is definitely a problem. Similarly, when you take two antibiotics at a time when only one is necessary, you end up taking an unnecessary antibiotic, thus increasing chances of antimicrobial resistance.
If there are over 6,000 FDCs, why is the government banning only a few at a time? Why not ban all FDCs at one go?
The figure 6,000 is the number of FDCs examined by the Kokate Committee in a particular context—namely, prevalence of FDCs that were manufactured by irregular issues of manufacturing license without marketing approval from CDSCO and DCGI. Since this process was sidestepped and state licensing authorities issued licences without much demurral, we have this phenomenon of unapproved, unexamined FDCs, many of which also happen to be irrational and unscientific.
So the government gave a second chance to FDC manufacturers?
Yes. The government, through the Kokate committee, gave a second chance, rather a long rope to these FDC manufacturers to produce data to justify the rationality of their mostly dubious FDCs prevalent in the market. The government could have simply banned the FDCs because they did not follow the process for acquiring manufacturing licenses.
And how did the courts come into the process?
The entire process took even more time, adding to further prolongation because of the immediate appeal in high courts and the Supreme Court by the affected FDC manufacturers—they appealed that the ban order be quashed, as the manufacturers claimed they did not agree or ‘understand’ the logic adopted by the experts for recommending the bans. There were other issues also - the expert committee felt that they needed more data on those FDCs where irrationality, or rationality, was not clear cut (The Kokate Committee—it must be mentioned—also declared a few FDCs to be rational). It is not yet over. Out of these 156 FDCs, some of the affected companies have already gone to courts, appealing for deferment of ban and/or quashing of the FDC ban order per se.
Why combination drugs?
Sometimes—a few times—two or more drugs are better because of synergistic action on the disease. Like ORS (oral rehydration salt), trimethoprim and sulfamethoxazole (Bactrim), magnesium trisilicate and aluminium hydroxide (antacid), and so on. These are rational FDCs and also ensure better patient compliance than if taken singly. Some anti-TB drugs are combined like this for better compliance. Most of the other FDCs in the Indian market are not scientific and cause more problems because one or more of the FDC constituents are not necessary.
Are FDCs available abroad?
Yes, even in the better regulated countries in the west, but only rational FDCs by and large.
What’s the impact of banning these drugs?
You eat less poison and minimise drug/antibiotic resistance.
What role can doctors play in prescribing the right medicine?
Educating the patient about why most FDCs are not advisable and why it increases the cost, sticking to nationally agreed standard treatment guidelines. Medical associations can tell pharma companies not to manufacture irrational FDCs, and demand the government to ban them.