The US FDA has put an import ban on Wockhardt 's injectible facility in Waluj . Apart from an import ban on the Waluj facility, the UK drug regulator has issued a restricted GMP certificate to Wockhardt's plants in Chikalthana and Kadaiya.
The anti-dumping duty on Chinese Paracetamol would benefit the Indian pharma industry but it could also result in 5-10 percent price increase, says Khorakiwala, in an interview to CNBC-TV18.
"Chinese tendency has been that when they dump, they get manufacturers out of the system and then they raise the prices significantly," he adds
Paracetamol is a very important anti-fever and painkiller, which has a large domestic production. India consumes about 10,000 tonnes of the drug in one year, he adds.
According to him the anti dumping duty is for active pharmaceutical ingredients (API), the bulk drug of Paracetamol.
Below is the verbatim transcript of his interview on CNBC-TV18
Q: Government has decided to impose anti-dumping duty on Chinese paracetamol. What is your reaction on that? How much of a fillip would it actually add to the Indian paracetamol market?
A: Paracetamol is a very important anti-fever and painkiller and there is a large domestic production too. There has been a dumping by China on this product, so I think it is appropriate for government what they did to protect the Indian industry from an unrealistic pricing.
India consumes about 10,000 tonnes of paracetamol a year and it is one of the main products. Chinese tendency has been that when they dump, they get manufacturers out of the system and then they raise the prices significantly.
So, this decision will certainly protect the Indian manufacturers and also ensure the availability of paracetamol. However it will also have an impact on the increase of the prices by about 5-10 percent.
Q: How much of the market share is actually shared by Chinese paracetamol at this point?
A: They have been supplying fairly significant amount of it. I am not familiar with the market share but they also supply the intermediate. Indian companies over the years have started using the Chinese intermediate because they are much cheaper than to make it themselves.
Q: Would it fall under the new pricing policy?
A: Yes the product containing paracetamol would fall under the new pricing policy.
Q: The market is also looking for some responses from you on what has been happening on regulatory front with your company, especially with plants at Waluj and Chikalthana. If you could give your investors an assurance on by when some of these issues will be resolved.
A: I can only say that we are taking appropriate measures internally by restructuring the organisation and having the expert inputs through consultants.
We believe that once we are done with it we would invite FDA to revisit us and hope that they would visit us hopefully in early 2014 and then we will need to see their response.
Q: What is the current status at the Chikalthana unit?
A: As of now we have not heard anything from FDA, but at the same time we have taken very active action in all compliances in Chikalthana. We are now manufacturing under the consultant oversight and we are keeping FDA informed of the progress we are making on a regular basis.
Q: Is this anti dumping duty on paracetamol is it for all drugs that contain paracetamol or is it just a standard sale of the drug?
A: My understanding is that the anti dumping duty is for active pharmaceutical ingredients (API), the bulk drug of Paracetamol. And as far as the price control issue is concerned it is only Paracetamol and not all product containing Paracetamol.
Q: So there will be far big increase of prices across drugs if it is the intermediate or API right?
A: No, it is API at the moment and it will have impact on Paracetamol and not a combination with Paracetamol.
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