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The Union Ministry of Health has finally banned over 300 fixed-dose combinations (FDCs), which are two or more drugs combined in specific ratios. They have been ordered off the market as more than one set of experts — appointed by the government to study them — found that they had no therapeutic rationale to exist and could actually be risky to consume.
While FDCs per se are not bad, this ban is about the ones that lack scientific evidence to prove safety and efficacy. The growth of such 'irrational' FDCs in India is the outcome of a weak regulatory system unable to deal with the ill-effects of business opportunism.
The situation was in the making for years. A decade of multiple attempts by the central office of the Drugs Controller General of India (DCGI) to weed out irrational FDCs were either blocked by industry players in court or ignored by state drug regulators who share oversight of the drug industry with the Centre and approved several of these FDCs. An outmoded law and the central regulator's tardy and inconsistent approach did not help matters. Let me take these one at a time.
First, states liberally approved FDCs with scant evidence. A drug that is to be launched in the country for the first time secures the DCGI approval after providing the required safety and efficacy data. This first drug becomes a "reference" product and subsequent manufacturers of the drug have to demonstrate equivalence to this reference product for the DCGI approval.
However, once a drug has been on the market for four years, a company wanting to make such a product need only secure a manufacturing licence from a state food and drug administration. The states read this to mean that if each of the constituent drugs of an FDC had been approved by the DCGI, their combination was not "new". As a result, a plethora of FDCs, unsupported by sufficient evidence but licensed by states, flooded the Indian market. By the time the DCGI took note, the problem had gotten out of hand. When it tried reining the states in, it was initially rebuffed. Its demand for data found little traction.
Second, the law did not keep pace. Even as the market was seeing more of these launches, a framework to guide the approval of FDCs was absent. For instance, as scientific publication The Lancet reported in 2015, the DCGI had approved 41 combinations of the diabetes drug metformin with other drugs without publishing the justification for these approvals.
Third, pharma companies were known to use FDCs for business reasons. Initially, they were a means to escape price control (adding an ingredient to skirt price control norms) and later, a tool to differentiate in a market overrun with me-too drugs. For instance, by the late nineties it was clear that since India was a signatory to the intellectual property treaty of the World Trade Organization, India's companies could no longer make patented drugs by a different process after 2005.
The homegrown industry went overboard launching every pre-2005 drug it could find in order to beef up for the drought that would eventually come. In such a crowded market, FDCs helped gain doctor interest. The MNCs followed to beat them at their own game. And since there was no robust post-market surveillance/pharmacovigilance system in place, any adverse effects were probably never caught. So high were the stakes that in 2007, the DCGI had to suspend plans to ban hundreds of FDCs as the industry sued and obtained a stay.
This is not to state that companies didn't launch rational FDCs for patient benefit. They did. But even those that were being called into question in the scientific community and by the central regulator continued to be sold in India. Repeated calls for data to let them stay on market fell on deaf ears. Finally, in 2016, when the government ordered a sweeping ban on 344 FDCs after commissioning a study by experts, the industry objected in court on grounds of procedure. But when it came to data, they were unable to convince a different expert panel, this one directed to be set up by the Supreme Court, thus leading to the current ban.
Now, India does have a FDC-specific procedure, though only since 2011. States are being pressured to act. Earlier this year, Uttarakhand banned FDCs not approved by the Centre after joint raids on factories showed the extent of the problem. The industry has also begun phasing out such FDCs though the extent is not known.
No doubt, in the case of the 300-plus FDCs under review, the office of the DCGI has prevailed, but in the most inefficient way possible. It has let the problem get out of hand, then fought the industry in more than one court, constituted two different committees to weigh in on the issue and culminated with a relatively small, but valuable, number of drugs from its 2016 list still awaiting further study. In the interim, it has drawn global criticism for its lax attitude towards safety.
And the problem isn't over. It continues to pressure states to withdraw FDCs that it hasn't approved. The threat of lawsuits still looms; at the time of writing, a pharma company had reportedly petitioned the Delhi High Court against the ban on one of its brands. Given the lack of a rigorous track-and-trace system, it is also going to be challenging to ensure that the ban is enforced.
The lesson, therefore, to be learnt from the FDC fiasco is this: India needs a strengthened, co-ordinated drug regulatory system, a proactive regulator with teeth, an updated and robust law, and an industry that is made to feel the consequences of crossing it.