Wockhardt under lens for tweaking dosage of essential medicine
New Delhi: Wockhardt Ltd is under the scanner for allegedly tweaking the dosage of an essential medicine to sell it at a higher price.
The National Pharmaceuticals Pricing Authority (NPPA) is considering a proposal to refer the matter to a government agency dealing with economic offences, two people aware of the matter said. The drugs in question are methyldopa 250mg and methyldopa 500mg and are used for the treatment of high blood pressure. They are currently under price control. The matter came to the regulator’s attention following complaints Wockhardt stopped supplying the 250mg dosage drug that came under price control and has instead introduced a different dosage so that it can sell it at a higher price.
The maximum price of methyldopa 250mg was fixed at Rs2.48 per tablet in 2015. The 500 mg version of the drug also came under price control a year later in 2016 and was priced at Rs16 per tablet. Wockhardt sells methyldopa 500mg under the brand name Alphadopa.
While Wockhardt has denied selling methyldopa 250mg, NPPA is skeptical. On investigation, the regulator found 17.1 million strips of methyldopa 250mg worth Rs31.49 crore was sold between January 2012 and December 2017. “This indicates the drug has been withdrawn from market,” NPPA said, adding that “some evidence” available with NPPA show Wockhardt was the manufacturer of methyldopa 250mg. The Authority was of the view that this kind of “total denial by M/s Wockhardt Ltd gives rise to strong suspicions,” stated the minutes of NPPA’s February meeting.
At a meeting on 23 April, it has now been decided to refer the matter “to an appropriate agency of the government of India dealing with economic offences,” said the minutes of the meeting. Mint has reviewed the minutes.
NPPA has also constituted a three-member panel comprising its adviser, director pricing and joint director to enquire the matter into detail and conduct a preliminary inquiry into the claims of the company.
“While the committee set up by the NPPA has to submit the enquiry report at the earliest, keeping in view the gravity of the case, it will be referred to the central economic intelligence bureau, department of revenue,” one of the persons cited above said, requesting anonymity.
An email sent to Wockhardt did not elicit response.
According to NPPA, if Wockhardt 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,” stated the minutes of NPPA’s meeting.