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S C Sehgal Chariman and Managing Director, Ozone Group of Companies
FDI in pharma retail Against all odds…
How can chemists integrate better with pharma companies?
ACG Pampac, Talegaon (Pune) Providing innovative packaging solutions
Intas plans to raise ` 1,000 crore by IPO Ahmedabad-based drug manufacturer, Intas Pharma has decided to raise around ` 1000 crore through its Initial Public Offer (IPO) plan. The company receives around 40 per cent of its sales from overseas and its gross revenues cross around ` 3,000 crore. Meanwhile bankers value this company to be more than ` 5,000 crore. The promoters currently hold around 85 per cent and Chrys Capital holds a stake of 15 per cent in Intas. Chrys Capital is a Private Equity (PE) firm, which had invested ` 300 crore last year before Intas had planned to hit the markets.
Glenmark recalls three drugs According to US FDA, Glenmark Pharmaceuticals subsidiary, Glenmark Generics, is recalling multiple lots of its three drugs from US market due to ‘odd smell’. A notification issued by US FDA said that the drug major has initiated voluntary recall of its Gabapentin tablets 600 mg, 500-count bottle and 800 mg, 500-count bottle; Pravastatin Sodium tablets 40 mg, 90-count bottle; and Topiramate tablets 200 mg, 60-count bottles from the US market following the identification of the problem. The recall was initiated under Class-III which FDA defined as ‘a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.’
US FDA imposes ‘import alert’ on Wockhardt Wockhardt is next in line to face the ire of US FDA. It imposed a ban on a plant operated by the generic drug maker at Aurangabad, Mahrashtra. In April, Wockhardt said that the FDA had carried out an inspection at its injectables plant in Aurangabad in Maharashtra, and had issued form 483s to the company. A form 483 is issued when inspectors see conditions that they believe may violate US rules, according to the FDA. An FDA import ban can be costly. The Wockhardt management, however, said it should be able to restore most of that ($ 100 million impact on revenues) within six to nine months by shifting production elsewhere. “That is a worst-case scenario,” said Habil Khorakiwala, Chairman, Wochkardt. The news has sent the price of the company shares to a 7-month low.
How will the Ranbaxy case affect Indian drug makers? Reputation built over the years does not take too long to destroy. With Ranbaxy recently pleading guilty, and agreeing to pay a whooping $ 500 million fine, as a part of drug safety settlement, the Indian pharma industry is abuzz with the impact that this case may have on the industry. The optimistic part of the industry believes that such cases do not badly deter the ‘Indian’ image as they are ‘one-odd’ cases occuring rarely. While the pessimists of the industry are holding their guns and believe that $ 500 million is a ‘kind’ fine for the impact that this will have on the Indian generics industry. Post the recent happenings, Arun Sawhney, CEO & Managing Director, Ranbaxy, stated that, “Ranbaxy is a different company today. The steps we have taken over the recent years reflect the wide-ranging efforts of the current board and management to address certain
conduct of the past and ensure that Ranbaxy moves forward with integrity and professionalism in everything we do. We are fully committed to upholding the high standards that patients, prescribers and all other stakeholders expect.” Time will only tell so as to how far will these steps and statements help in salvaging the industry and company image? MNCs have been attracted towards the Indian pharma market post the introduction of product patents in 2005, 100 per cent FDI in pharma in 2006 and the country’s strong growth prospects for generics and biosimilars. However, recent spate of issues in the form of Glivec disapproval, approval of Zita and Zita-met and other approvals of compulsory licences might make these companies wary of Indian laws and Indian companies.
The recent case has questions looming over the credibility of quality of Indian generics firms, the authority of independent auditing firms, the corporate integrity of Indian firms and it will be interesting to see how China takes advantage of the current situation and increases the lead it already has over the Indian generics market. Will the number of FDA-approved plants in India be affected in the long run? Will Japanese and other MNCs shy away from buying Indian firms? Will FDA get more stringent on granting approvals to Indian firms? There are many questions arising with this case. It will be worth noticing how well the Indian drug and policy makers move amid this scenario, because when they move global to do business their business practices will be under a big scanner. Parita Dholakia
DISSO INDIA begins with a focus on quality Every pharmaceutical product has to pass through dissolution testing process. This testing helps in classification of the product’s traits. The growing market demands for improved and better testing processes. Society for Pharmaceutical Dissolution Science (SPDS) has organised its 1st Annual International Symposium Conference, Disso India 2013 on May 3rd and 4th at The Lalit, Mumbai. The event is focussed on introduction of new technology, innovation and various issues faced related to ‘dissolution.’ Dissolution is vital as it is the predictable test for the effect of medicine in human body. This test is called in vitro test as it simulates the action of medicine in the body and is performed on a machine called dissolution tester. Before getting released in the market, 70 per cent of the global pharmaceutical medicines produced undergo dissolution testing. Vinod P Shah, Pharmaceutical Consultant, said, “No drug can pass without dissolution test. With the increasing variations of products
Delegates at the inauguration ceremony of the DISSO-2013
the types of processes is also increasing. In coming years, we are going to have dissolution testing for ointments.” Supporting the context, Dr L Ramaswamy, Managing Director, Sotax, said, “This was the first time that we arranged this conference. We are hoping for more such events and provide maximum information to the people from the industry.” Disso India 2013 event witnessed eminent professionals from the pharmaceutical industry. Disso India is being attended by the professionals from R&D, QA and QC as well as the Academia. As many as 300 delegates
registered and participated in the event, which is the first mega event focussing on dissolution. The event was organised under the Chairmanship of Dr Vinay G Nayak, President-Technical, Alembic Pharmaceuticals Ltd. Dr L Ramaswamy, Managing Director of Sotax India Pvt Ltd is the Organising Secretary of this event and the General Secretary of SPDS. The Scientific sessions were programmed and executed under the chairmanship of Dr Mangal Nagarsenker, HOD & Professor - Pharmaceutics, Bombay College of Pharmacy, Mumbai. Anubhav Sharma
Adaptive signs biomarker discovery collaboration agreement with Bristol-Myers Squibb Adaptive Biotechnologies recently announced that it has entered into a collaboration agreement with BristolMyers Squibb (BMS) for the discovery of immunological biomarkers in oncology. Under the collaboration, Adaptive will use its proprietary immune profiling assay, immunoSEQ, to identify potential biomarkers that may inform about drug response. The immunoSEQ assay uses high
throughput next-generation sequencing to characterise the repertoire of T and B cell receptors. Application of this technology is being explored in cells of cancer patients, to assess the impact of treatments on the immune system and evaluated as a tool to identify patient populations who might be more likely to respond to targeted therapies based on their immune status.
“We are delighted to collaborate with BMS to help uncover immunological biomarkers of response to cancer agents,” said Chad Robins, CEO and Founder, Adaptive Biotechnologies. “Collaborating with BMS is a real win for companies like ours that are committed to deepening the understanding of the interaction between the host immune system and the cancer cells themselves.”