PUNE: After ‘Calximax- 500’ was confiscated in Mumbai last week, the question of original and duplicate medicines again came into limelight. Chemists and officials from Food and Drug Administration (FDA) discussed with Sakal Times about the how the drugs are standardised.
Explaining what type of drugs are fake, RP Chaudhari, Assistant Commissioner of zone -1 in FDA said that fake drugs are either substandard, i.e. with inaccurate composition or are duplicate, which means they are ineffective.
“Drugs that bring a good profit margin or are expensive can be an easy target for duplication as they make more money. Same goes for branded drugs which don’t need more marketing. These medicines can be sub-standard or duplicate,” said Chaudhari.
He further added that that the medicines are tested according to various standards.
“The drugs are tested according to their composition. If a medicine with prescribed composition does not fit into the standard, then we recall the batch,”Chaudhari said.
“Another way of testing the medicine is to see when the medicines start giving the results. Every medicine should show the result in some given time. If the medicine takes more time, then there is a problem with it,” added Chaudhari.
He further clarified that the medicine samples are taken from chemists and are then sent for testing.
“If the test result for medicines are not up to the mark, these medicines are traced to the company. If the chain of supply does not reach the manufacturer then, there is a problem,” Chaudhari said.
Speaking on the issue, city-based pharmacist Ketan Patil said that the environment in which the medicines are manufactured also defines their effectiveness.
“The hygiene standard of some manufacturers is also an important aspect though which the effectiveness of the medicine is defined. Sometimes, the hygiene level of two drugs is not the same and hence their effectiveness varies,” said Patil.
SUBSTANDARD OR DUPLICATE MEDICINES
1. Why duplicate?
- Expensive medicines fetch large profit margin
- Duplicates of branded medicines do not need marketing
2. Red flags
- If a medicine does not give results.
- The drug fails in composition tests
- Supply chain of the drug does not reach the manufacturer on checking.
FAKE DRUGS & RISK TO LIVES
Duplicate medicines and drugs were confiscated in Mumbai by the police and FDA recently. Sakal Times in its three-part series highlights issues like consumer awareness and role of FDA