THE country’s drug pricing body, National Pharmaceutical Pricing
Authority (NPPA), has recommended action against three companies for
allegedly changing the composition of some medicines while retaining
their old brand names, which helped it dodge price controls.
NPPA has asked the drug quality regulator Drug Controller General of India (DCGI) to take action against Sun Pharma, Franco Indian and Emcure Pharma for allegedly misguiding consumers with their actions, said an NPPA official requesting anonymity.
According to another NPPA official, the pricing authority has also issued notices to these companies, asking them to explain the change in the price controlled composition and the price hike.
As punishment, the DCGI can ask these companies to withdraw the drugs in question from the market immediately. The drug regulator, whose approval is a must for companies to launch any new composition into the market or to change a previously approved combination, confirmed that it had received NPPA’s letter and said it was examining the cases. “We will make our stand clear in our next meeting with NPPA,” said DCGI Surinder Singh.
NPPA officials said its investigations had revealed that the three companies have replaced price-controlled bulk drugs with ones outside price control without changing the brand names of the medicines.
“We have written to the DCGI asking to take appropriate action against such violations. It is not just mis-branding, but companies also tried to dodge price control by altering the composition of brands,” the first NPPA official said, adding that the companies also increased the prices of those drugs manifold.
According to NPPA officials, Sun Pharma has replaced price controlled bulk drug pseudoephedrine with phenylepherine in its anti-cold medicine brand Cetrizet D.
Sun Pharma defended its action saying that pseudoephedrine, used earlier in the drug, had the potential for abuse because of its stimulant effects and was being replaced by drugmakers the world over.
A company spokesman said pseudoephedrine “has the potential to cause addiction” when used as a stimulant, because of its enhancing effects on sexual pleasure, alertness and ability to concentrate. “As a result, pseudoephedrine has largely been phased out globally and replaced by alternative decongestants,” he said in an emailed reply while denying the price hike.
As for Franco Indian, NPPA said it had replaced two price-controlled ingredients—ciprofloxacin and tinidazole—in its brand Brakke, used to treat diarrohea, with ofloxacin and ornidazole. Officials at Franco Indian were not available for comment despite several calls to their offices.
Emcure Pharma has also replaced norfloxacin and metronidazole with ofloxacin and ornidazole in Normet, also used for diarrohea, NPPA alleged. The company confirmed receiving a letter from NPPA, but did not have a comment at the time of going to press.
Replaced pseudoephedrine with phenylepherine in its anti-cold tablet Cetrizet D
Increased price from Rs 8 (for a strip of 10) to Rs 28
Replaced ciprofloxacin and tinidazole with ofloxacin & ornidazole in Brakke
Increased price from Rs 14 (for a 30 ml bottle) to Rs 35
Replaced norfloxacin and metronidazole with ofloxacin and ornidazole in anti-diarrohea tab Normet
Increased price from Rs 20 (for a strip of 10) to Rs 80
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