Wockhardt Pharma's reply "unsatisfactory", say dist drug authorities
The district drug authorities have found "unsatisfactory" the reply of Wockhardt Pharmaceuticals in response to a notice issued against it after 13 lakh Spasmo Proxyvon Plus capsules were seized from its local dealer on January 30.Updated: Mar 18, 2014 23:01 IST
The district drug authorities have found "unsatisfactory" the reply of Wockhardt Pharmaceuticals in response to a notice issued against it after 13 lakh Spasmo Proxyvon Plus capsules were seized from its local dealer on January 30.
The authorities claim that the company has not sent any proof of approval of Drug Controller General of India (DCGI) for making capsules with three salts viz. tramadol, paracetamol and dicyclomine.
The company has submitted the copies of approval of Himachal Pradesh Drug Control Authority to the district drug authorities along with its reply, but failed to send letter by the DCGI.
The drug authorities said the company's reply regarding packaging and colour of Spasmo Proxyvon Plus
capsules which were similar to the packaging of Spasmo Proxyvon, which was banned by the central government, was also incomplete as per the Drugs and Cosmetics Act, 1940.
The authorities said the company had made no efforts to give a concrete reply and they would again approach the state authorities to take up the issue.
Officials in the drug department said whenever any new drug is invented it needs to be approved by the DCGI.
The same drug was approved by the Himachal state drug controller in violation of instructions of the DCGI, they maintained.
The state drug controlling authorities had also shot a letter to the DCGI to ban this capsule and even claimed that they would not allow the sale of this capsule which has become a habit-forming drug in Punjab.
Drug inspector Navdeep Singh said he would write to the state drug authorities about the company's reply and it was up to them to take further action.
Assistant state drug controller Bhag Singh said, "We are yet to get any communication from the DCGI about the letter regarding Spasmo Proxyvon Plus capsules."
A team of drug department had seized 13 lakh Spasmo Proxyvon Plus capsules from Sehgal Medical Agencies in Jawahar Nagar.
The investigation thereafter had found that the capsules were being freely supplied in many districts despite the fact that the DCGI had not approved them for supply.
The central government had banned production and sale of painkiller Dextropropoxyphene and its formulations on May 23, 2013 over concerns about its consumption.
After the ban, Wockhardt started using tramadol, paracetamol and dicyclomine in under new name Spasmo Proxyvon Plus.
First Published: Mar 18, 2014 22:56 IST