India Bans 156 Combination Drugs Due to Health Risks
In a significant move to safeguard public health, the Indian government has banned 156 fixed-dose combination (FDC) drugs that were widely used to treat conditions such as fever, cold, allergies, and pain. The decision follows concerns raised by the Drugs Technical Advisory Board (DTAB) and an expert committee, which found these combinations to be “irrational” and likely to involve risk to human health.
The banned drugs include commonly used combinations like Aceclofenac 50mg + Paracetamol 125mg tablet, Mefenamic Acid + Paracetamol Injection, and Cetirizine HCl + Paracetamol + Phenylephrine HCl. The government issued the ban under Section 26A of the Drugs and Cosmetics Act, 1940, which empowers it to prohibit the manufacture, sale, and distribution of drugs considered harmful.
This decision was prompted by the findings that these FDCs lacked therapeutic justification and posed significant risks. The DTAB emphasized that no regulation or restriction could make these drugs safe for patients, leading to their complete prohibition.
The move marks the latest in a series of steps by the Indian government to regulate the pharmaceutical industry and ensure the safety of medications available to the public. The ban is expected to have a wide-reaching impact, as several of the banned combinations were already discontinued by many drug manufacturers following similar concerns raised in the past.
This decision follows a similar ban in 2016 when 344 drug combinations were prohibited, many of which were also found to be irrational. The government’s proactive stance in monitoring and banning unsafe drugs underscores its commitment to public health and safety.
As the ban takes effect, healthcare providers and patients are advised to seek safer alternatives for treating common ailments. The government assures that sufficient alternatives are available in the market that do not pose the same risks.
For those affected by this ban, it is recommended to consult with healthcare professionals to understand the best and safest treatment options moving forward.
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