Methyldopa : Wockhardt under NPPA lens over essential BP medicine price
New Delhi: More trouble seems mounting for Wockhardt after the National Pharmaceutical Pricing Authority (NPPA) began an investigation against the company for stopping the supply of blood pressure treatment medicines which are under price control and launching a different dosage on higher retail price.
Medical Dialogues team had recently reported that the company is already under the CDSCO scanner for allegedly manufacturing and marketing FDC drugs for various ailments like diabetes and fungal infections without prior approval.
Read also: Selling Unapproved FDC drugs: Wockhardt, two others under CDSCO scanner
Now as per a recent report in Economic Times, NPPA has called for investigation against the company on methyldopa 250 mg and methyldopa 500mg that are for the treatment of high blood pressure and currently, both the drugs are under price control.
It is reported that in February 2015, NPPA received a complaint against Wockhardt that the firm had stopped distributing methyldopa 250 mg, as per the minutes of the authority's latest meeting on February 26 and the firm had instead launched methyldopa 500 mg at a "much higher" retail price.
In 2015, the maximum price of Methyldopa 250 mg had been limited to Rs 2.48 per tablet whereas its 500 mg version was priced around 545% higher at Rs 16 per tablet. The firm markets methyldopa 500 mg under the brand name Alphadopa.
NPPA stated that Wockhardt had denied ever marketing methyldopa 250 mg.
"Some evidences available with NPPA show that M/s Wockhardt Ltd was the manufacturer of methyldopa 250 mg," stated the minutes of NPPA's meeting.
According to the daily, the regulator had stated that 1.71 crore strips of methyldopa 250 mg worth Rs 31.49 crore was sold in the market between January 2012 and December 2017. From 2013-2017, the number of strips of methyldopa 250 mg sold in the market plummeted to 32,445 strips from nearly 50 lakh strips.
This "clearly" indicates that the drug has been withdrawn from the market, according to NPPA.
"The Authority was of the view that this kind of total denial by M/s Wockhardt Ltd gives rise to strong suspicions. It was decided that the matter needs to be enquired into in detail and the matter needs to be referred to an appropriate agency of the government of India dealing with such economic offences," stated the minutes.
In March 2016, NPPA slashed the price of Alphadopa (500mg) by over 70% when it fixed the medicine's retail price at Rs 4.46 per tablet. After the drug came under the National List of Essential Medicines (NLEM), its price dropped to Rs 4.33 a tablet report ET.
According to the minutes reviewed by ET, Wockhardt has challenged the price that NPPA has fixed for Alphadopa (500 mg) and if the company is found not to be an existing manufacturer of methyldopa 250 mg, the price fixation of methyldopa 500 mg may be re-examined "once it is proved in an expert investigation."