The Centre has banned the manufacture, sale or distribution of 328 Fixed Dose Combination (FDCs) drugs—drugs containing two or more active pharmaceutical ingredients in a fixed dosage ratio— through a notification dated September 7. It has also restricted the manufacture, sale or distribution of six FDCs, subject to certain conditions.
The ban is expected to affect thousands of drugs in the market, including popular brands such as Saridon (painkiller, combination of paracetamol, propyphenazone and caffeine), Panderm skin cream, and Corex cough syrup.
Welcoming the ban, experts said these combinations were “unnecessary, irrational and harmful”. “These are not part of any textbook of medicine or pharmacology. The situation existed because there are anomalies in the system of drug approvals in the country. This ban serves as a small correction,” said Anurag Bhargava, professor of medicine at Yenepoya Medical College, Mangaluru. Bhargava, who is also a part of the All India Drug Action Network (that had petitioned the Supreme Court against the quashing of the ban by the Delhi High Court) said the drugs were present in the market only because of a lax regulatory system.
Bhargava said about 50 per cent of the drugs market in India consisted of combination drugs, and the 328 that were banned represented the “tip of the iceberg”. In the list of now banned drugs there are several antibiotic combinations that were unjustified. This meant that those who did not need one component in their treatment ended up having it because of the combination. “At a time when antibiotic resistance is increasing, such irrational combination only contribute to it,” he said.
Bhargava points to several other drugs, particularly the case of analgesics (painkillers), where the combinations are of up to three painkillers. “Now, if a person needs only paracetamol for treating pain, they end up having the combination with ibuprofen, which is unnecessary. This can cause side effects (of ibuprofen) such as stomach bleeding in elderly patients,” he said.
Other examples include combinations that contain nimesulide (that has not been approved for use in several countries owing to its toxic effects on the liver), and combinations containing Serratiopeptidase (painkiller), that has been recalled by the Japanese company Takeda due to its efficacy.
If the safety and efficacy of such combination drugs has not been proven, why are they being manufactured and sold? Bhargava said the answer lay in the fact that a combination drug allowed companies to evade the government’s price control mechanism. While the molecule paracetamol might be under price control, when in combination with another drug, that was not the case. Fixed dose combinations were used to treat malaria, AIDS and TB, but pharmaceutical companies continue to manufacture them for simple ailments such as headaches, vomiting, and common infections.
In a statement on the Centre’s ban, the All India Drug Action Network said rationality (for drug combinations) needs to be demonstrated by safety, efficacy and therapeutic justification. “None of the FDCs meet the criteria of a rational and safe FDC. The people of India have been made the consumers of unsafe medicines for too long and this is one step towards rectifying the grave situation of a pharma market brimming with innumerable irrational FDCs,” the statement read.
The FDCs under scrutiny account for approximately Rs 2,500 crore in sales. “In our estimation, the market of unsafe, problematic FDCs in India is at least one fourth of the total pharma market valued at Rs. 1.3 trillion,” according to AIDAN.
“The task that remains is combating the continued prevalence of a very large number of FDCs of doubtful scientific validity which have somehow slipped through the net and been approved wrongly by the Central government. Review of all such FDCs in the market is required in the interest of patient safety,” AIDAN said in its statement.
