All That You Wanted To Know About The 328 Banned Drugs And The Reasons Behind It

Most of us have suffered from headaches, coughs and cold. Instead of consulting a doctor we just go out popping a handful of over-the-counter medications without even reading the label and its ingredients. Even parents do that to help their kids feel better. But shockingly, these easily available medications are not as safe as you would like to think. Disrupted sleep, addiction, and toxicity are few of the symptoms that come along with it. Addiction to these drugs can prove fatal at times.


Two years ago, the Ministry of Health and Family Welfare (MHFW) aware of the ill-effects of these medicines started taking steps towards banning them. Finally, on March 10, 2016, Central Drugs Standard Control Organization (CDSCO) had sent a notification, issuing a ban on manufacture, sale and distribution of a total of 349 FDCs (344 were banned initially and five more added to the list later), which had the combination of medicines like Aceclofenac+ Paracetamol+ Rabeprazole, Nimesulide + Cetirizine + Caffeine, and Paracetamol + Cetirizine + Caffeine.

The manufacturers of these drugs decided to contest the ban in High Courts as well as the Supreme Court. In December 2017, the Drugs Technical Advisory Board (DTAB) was then asked to examine the claims made by the drug companies and submit its report and recommendations to the government within six months. An expert panel was then formed under the chairmanship of Nilima Kshirsagar, professor-head clinical pharmacology, G.S. Medical College and KEM Hospital, Mumbai.


On 25th July, DTAB submitted a report stating that “there is no therapeutic justification for the ingredients contained in 328 FDCs and that these FDCs may involve risk to human beings.” The expert panel also found that many FDCs were formulated without due diligence, with dosing mismatches that could result in toxicity, thus recommended imposing a ban on them. This recommendation came under Section 26A of the Drugs and Cosmetics Act, 1940.

The Ministry of health, finally on September 12, 2018, banned the manufacture, sale and distribution of 328 Fixed Dose Combinations (FDCs) drugs, which they deemed "irrational" and "unsafe" for human use, thereby bringing an end to the 2 year long legal battle between the manufacturers and the health ministry. Along with that, the ministry has also restricted the manufacture, sale or distribution of six other FDCs, subject to certain conditions based on their healing justifications.

The health ministry’s ban on FDCs which included painkillers, anti-diabetic, respiratory and gastro-intestinal medicines, will affect 6,000 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.”

Even the Indian Drug Manufacturers’ Association (IDMA) welcomed the decision, Deepnath Roy Chowdhury (president) said, “The FDC issue has gone through the legal process and the Honourable Supreme Court has given its verdict. As responsible citizens of India we respect the verdict. IDMA is a responsible body and has never advocated irrational FDCs but we do believe in the advantages of patient convenience & compliance that FDCs provide”.


It wouldn't be wrong if one says that the most dangerous drugs that there are available right now are the drugs that are legal - over-the-counter medication. It's never too late to rethink your options.

Picture Source : Business Medical Dialogues; News Dog Today;


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