Source:fiercepharma

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Context

Novo Nordisk, a company that makes popular diabetes and weight-loss drugs like Ozempic and Wegovy, is asking the FDA to stop compounding pharmacies from making copycat versions of its drug ingredient, semaglutide.

Details

Novo says semaglutide is too complex for these pharmacies to safely copy, and it wants to protect patients by ensuring they only get the original, FDA-approved versions.

Compounding pharmacies create medications when there's a shortage, and many Americans have turned to them for cheaper versions of Novo's and Eli Lilly's drugs, especially since shortages began in 2022. However, the compounding industry argues that Novo is mainly trying to protect its profits, especially since it waited a long time to raise these safety concerns.

What Are Compounded Drugs?

Compounded drugs are specially prepared medications created by pharmacists based on a doctor's prescription to meet an individual’s specific needs. This is common when a patient requires a particular dose, form (like a liquid instead of a pill) or ingredient adjustments.

Compounding is useful for patients who may have allergies to certain ingredients in commercial drugs or require unique dosages that aren't available in pre-made medications.

In India, compounded medications are typically found in hospitals or pharmacies with specialized capabilities.

Though not as widely regulated as manufactured drugs, compounded drugs must still meet quality standards under the Drugs and Cosmetics Act, 1940. However, ensuring quality in compounded drugs is a growing concern due to limited oversight.

If a child can’t swallow pills a pharmacist might make a liquid version of the drug.

What Are Generic Drugs?

Generic drugs are medications that have the same active ingredients, strength, and dosage form as brand-name drugs but they are produced and sold under their chemical name once the brand’s patent expires. They provide the same therapeutic benefits but usually cost less.

Generic drugs are widely prescribed for chronic conditions like hypertension and diabetes where long-term medication adherence is critical. They offer an affordable alternative to brand-name drugs.

India is a global leader in the production of generic drugs supplying nearly 20% of the world’s generics. The government has actively promoted generics to improve healthcare affordability.

Programs like the Pradhan Mantri Bhartiya JanaushadhiPariyojana aim to provide quality generics at lower costs to the public​.

Paracetamol is a generic drug which can be found under brand names like Crocin or Calpol.

Sources:

fiercepharma