Update: The Supreme Court has reserved the ban on Saridon and two other drugs after the pharma companies approached the apex court claiming that they have been manufacturing the drug since the 1980s.
The Ministry of Health and Family Welfare (MHFW), on September 12, 2018, banned the manufacture, sale and distribution of 328 Fixed Dose Combinations (FDCs) drugs. Six more FCD medicines are currently put on certain restrictions.
“With regard to six FDCs, the Board recommended that their manufacture, sale and distribution be restricted, subject to certain conditions based on their therapeutic justification,” said an official of the MHFW.
A total of 6,000 brands will be affected by the ban, which has been imposed with immediate effect, including popular brands like Saridon.
Let’s look at what led to the ban on these “unsafe” drugs.
The battle for banning the medicines had started two years ago, on March 10, 2016, when the Central Drugs Standard Control Organisation (CDSCO) had sent a notification, issuing a ban of manufacture, sale and distribution of a total of 349 FDCs (344 were banned initially and five more added to the list later). These included a combination of medicines like Aceclofenac+ Paracetamol+ Rabeprazole, Nimesulide + Cetirizine + Caffeine, and Paracetamol + Cetirizine + Caffeine.
But the manufacturers of these drugs had challenged the ban in a number of High Courts as well as the Supreme Court.
The apex court then directed the Drugs Technical Advisory Board (DTAB) to examine the claims. This led to the DTAB concluding that “there is no therapeutic justification for the ingredients contained in 328 FDCs and that these FDCs may involve risk to human beings” and recommended imposing a ban on them. This recommendation came under Section 26A of the Drugs and Cosmetics Act, 1940.
On September 7, 2018, the MHFW followed the recommendation and banned the human use of 328 such FDCs “in public interest”.
These drugs include popular brands like Saridon (painkiller), Panderm (skin cream), Gluconorm PG (combination diabetes drug), Lupidiclox (antibiotic) and Taxim AZ (antibacterial).
The All India Drug Action Network, supporting the ban, said in a statement, “The banned FDCs account for about Rs 2,500 crore and represent only the tip of the iceberg. In our estimate, the market or unsafe, problematic FDCs in India is at least one-fourth of the total pharma market which is valued at Rs 1.3 trillion.”
However, another set of popular medicines, like Corex (cough syrup) and D Cold Total (mild analgesic), which were banned by the government in 2016 have escaped the prohibition this time. Fifteen such FDCs out of the total 344 have escaped the ban since they are claimed to be manufactured before September 21, 1988. The Supreme Court has said that the Ministry needs to initiate a re-investigation to impose a ban on them.
(Edited by Shruti Singhal)