Do you know that we are consuming fake medicines? Yes the latest report from the Journal Of Pharmaceutical Policy and Practice (JOPPP) it was found that the majority of antibiotics available in the market are either unapproved or banned which means they are treated as fake medicines. So check out this article to find out what are fake medicines available in the market.
FDC Antibiotics:
Fixed Dose Combinations (FDCs) contain two or more pharmaceutical ingredients with a fixed ratio in a single drug.
Medicines that are sold with permission from a central regulatory body can be treated as original medicine. Even though medicines are licensed the company should get approval from a central regulatory body to sell them in the market but that is not happening which is a concern. This issue was found by collecting data from sources like the Ministry Of Health, the National List Of Essential Medicines(NLEM), court judgments, and along with sales data from 2008 to 2020. This data revealed that 70% of antibiotic medicines through “Fixed dose combinations(FDC)” are unapproved or banned in the country.
FDC Antibiotics Formulation:
Formulation mainly depends upon usage and effectiveness. We can see certain medications in the market for multiple uses through a single drug, for this kind of medicines the central regulatory body approves only certain formulations so that it does not show negative symptoms but the pharma companies sell different formulations in a single drug for high effectiveness through heavy dosage leading to high pricing for profits which is not recommended and are not approved by the central regulatory body. The regulatory enforcement team took necessary actions in 2007 and 2013 but the impact was shallow resulting in many unapproved and banned medications in the market.
FDC Valuation:
The unapproved medicines’ side effects are unknown until and unless sent for approval. The central has raised in power for approval where the FDCs have significantly become low but in 2019 the central power over approval got less due to other regulations in the pharma industry which led to an increase of unapproved and banned FDC sales and market share.
The market share of unapproved or banned medicines in the category of antibiotics is 70% with a sale of 15% in the market whereas the approved market share was 30% with a sale of around 60% in the market in 2020. So the centre has conducted a meeting with documentation to take necessary steps over the unapproved or banned FDC which otherwise would lead to an increase in its share in the market which might affect the health of Indian citizens.
Challenges of Central Committees:
Over the years the central regulatory body with other committees and boards related to drug control has faced many backlashes. The pharma companies have never been transparent over the drug combinations even though the center tried to achieve the safety of people and tried different formulations that might harm people’s health while some companies got approval from courts which were unapproved or banned which led to loss of central regulatory body power of approval for FDC.
Conclusion:
After the latest report, the center is aiming to regain its power for approval and periodic reviews of approved drugs. It has also stated for explanation from the government why it removed the state for approval which is a prerequisite and necessary for all new drugs for safety and effectiveness over people and calls for more transparent coordination between centre and states
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