Ranbaxy hires consultants as part of consent decree with USFDA

The USFDA had banned 30 generic drugs produced by Ranbaxy at its Paonta Sahib and Batamandi, both in Himachal Pradesh and Dewas in Madhya Pradesh facilities, citing gross violation of approved manufacturing norms

Tokyo: Pharmaceutical company Ranbaxy Laboratories Ltd Friday said it has hired two US-based consultants to advise it on remedial work to be done at its manufacturing units in India as part of a consent decree signed with the US Food and Drug Administration (USFDA) to revoke ban imposed by the US health regulator.

The company said it expects the consultation process to be completed before the quarter ending June this year, following which it can get ahead with the residual work.

"We have engaged two consultants from US. These consultants will come and visit our plants. After they have seen, they will tell us if there is and what is the residual work that we need to do..." Ranbaxy CEO & Managing Director Arun Sawhney told PTI.

Asked how long the process will take, he said: "...all of this is going to happen before quarter ending June."

On the overall time that is expected to take for the ban to be lifted, Sawhney said: "The time is governed by certain steps we will have to take in the consent decree. One of the things to estimate how early we can get back into business is to make an assessment of how long will it take us to do some of those measures."

The company had signed a consent decree with the US FDA in December last year, which was then filed with the US District Court of Maryland in January this year.

Under the decree, the company had committed to further strengthen procedures and policies to ensure data integrity and to comply with current good manufacturing practices in order to lift ban imposed on its plants in India by the USFDA.

Ranbaxy's facilities at Paonta Sahib and Batamandi (both in Himachal Pradesh) along with Dewas (in Madhya Pradesh) have been on FDA import alert since 2008.

The USFDA had banned 30 generic drugs produced by Ranbaxy at these three units, citing gross violation of approved manufacturing norms.

Ranbaxy had also closed its Gloversville facility in New York in July last year.

According to the USFDA, the consent decree also prevents Ranbaxy from manufacturing drugs for introduction to the US market and for the President's Emergency Plan for AIDS Relief (PEPFAR) Programme at the Paonta Sahib, Batamandi, Dewas and Gloversville facilities until drugs can be manufactured at such facilities in compliance with US manufacturing quality standards.


Camlin Fine Sciences FY net profit up to Rs10.14 crore

For the full year Camlin Fine Sciences' net sales rose to Rs251.75 crore from Rs161.62 crore last year

Mumbai: Camlin Fine Sciences Ltd (CFSL), world's largest integrated manufacturer of food antioxidants, on Friday said its full year net profit increased to Rs10.14 crore from Rs6.66 crore in a year ago, reports PTI.

The company's net sales also increased to Rs251.75 crore in FY12 as against Rs161.62 crore in FY11, a company statement said.

CFSL said it has posted profit before tax of Rs16.44 crore, EBIDTA of Rs39.13 crore and its sales/income from operations have grown by 56.3% in FY12.

The company's net sales increased to Rs74.1 crore in fourth qurter of FY12 as against Rs51.98 crore same period last year. However, the net profit declined to Rs1.27 crore in the quarter ended March 2012 as against Rs2.73 crore in the corresponding period last year.

The year under review for food antioxidants TBHQ and BHA was a challenging one due to the pricing volatility of key raw material hydroquinone, the release said.

The company has registered a high growth in extremely volatile market situation and increased its market share of food antioxidants in FY12. This was possible by the focused approach on the stability of supplies and prices to the customers. The backward integration due to acquisition of an Italian company Borregaard Italia S.p.A. helped the company to ensure competitive pricing of key raw material, it said.

The company's future plans include building upon its core strength in the food segment by expanding its products and to emerge as a leading food ingredient and solution providing company to food industry in the coming years.

CFSL is also in the process of setting up additional distillation facility for enhancing its capacity of its existing and new products. The facility is expected to be commissioned in the first half of the financial year 2012-13.

The company is also developing new ingredients in the areas of bakery, confectionery, dairy and beverages industry, the release added.


Air India: Ajit Singh meets striking pilots to end impasse

Singh indicated that the process to revoke sack orders of 101 pilots would begin as and when they resume duty

New Delhi: In a bid to end the stalemate, Indian Civil Aviation Minister Ajit Singh on Friday met striking pilots from Air India for the first time and told them that there would be no victimisation if they resumed duty immediately and that their grievances would be considered, reports PTI.

For the first time in 18 days since the strike began, five pilots of the Indian Pilots' Guild (IPG), spearheading the stir, called on Singh at the Ministry's headquarters here and held a 90-minute-long meeting with him. Air India CMD Rohit Nandan was asked to join the meeting at the fag end.

"We reiterated the stand of the government that it is an illegal strike. It has caused untold miseries to passengers. Air India has lost much and therefore they should come back to work immediately," Singh told reporters after the meeting.

Asked whether the pilots were willing to return to work, he said, "That you have to ask them."

Singh said that he had stated in Parliament that "we won't be vindictive. We understand their problems also. Lot of young people are there ..... They are also worried, we also realise that we want them back. But it is for them to decide."

He said that the pilots began their agitation without serving a notice and "reported sick when they were not".

The Minister is understood to have told the pilots that the ailing airline had suffered a great deal not only in terms of financial losses but also on its image and the people's confidence in it.

Sources said Singh indicated that the process to revoke sack orders of pilots would begin as and when they resume duty. A total of 101 pilots owing allegiance to IPG have so far been sacked by the airline management.

After the meeting, IPG sources said they would be meeting Friday evening to take stock of the discussions five of their members had with the Minister and decide on the future course of action.

In a letter to Singh, IPG General Secretary Erjahn Kapadia had sought an appointment with the Minister, saying they wanted to present their case before him.

However, the Minister said, "Some pilots wanted to meet me. So I met them," making it clear that the IPG was now a derecognised body.

He said Air India was already implementing a contingency business plan in accordance with the situation that it is facing now in the wake of the agitation by the pilots.

The strike has so far caused an estimated loss of over Rs250 crore to Air India, which has been operating curtailed international operations. The national carrier has announced the contingency plan would remain effective till 30 June.

Under the interim schedule, Air India will operate 38 international flights per day instead of 45 that it operates under normal conditions.

While most flights affected are those to Europe and North America where a curtailed operation is on, the destinations not covered under this schedule are Hong Kong, Osaka, Seoul and Toronto.

All flights to the UAE, Oman, Bahrain, Kuwait, Singapore, Thailand and SAARC countries are being operated as per normal schedule.

Domestic operations of Air India are also carrying on normally and there has been no disruption on this front due to the present agitation, officials said.




5 years ago

For once the stand of the Govt on AI strike will yield results. The IPG has rightly been derecognized. All its Office bearers who have instigated the strike and have been sacked ,should not be taken back. The High Court order on contempt gives AI a good legal backing against striking office bearers and it should not buckle under pressure to take them back. Other members of the IPG may be taken back if they were passive followers and not active strikers. Post strike AI must work with unions on implementing Dharmadhikari report on HR and take all towards integration , though merger itself was foolhardy on Praful Patel's part.

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