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Cadila receives tentative nod for Topiramate tablets

MUMBAI: Cadila Healthcare on Wednesday said it has received tentative” USFDA approval for Topiramate tablets, an anti-epileptic drug in multiple strengths. In a communique to the Bombay Stock Exchange, the company said it has received the USFDA approval for Topiramate tablets in the strengths of 25 mg, 50 mg, 100 mg and 200 mg. It is scheduled to be launched in September 2008 upon patent expiry, it added. The group has 24 approvals since the commencement of filing process in financial year 2003-04. Currently, the group markets 10 generics through its subsidiary Zydus Pharmaceuticals (USA) Inc.

Small pharma cos’ staff reap big dividend

EMPLOYEES of smaller pharmaceutical and biotech companies are no more children of a lesser God. As business booms and the big dozen in India’s drug-makers look to touch the skies, they are swooping on the smaller companies for trained manpower.

Much to their delight, employees of the smaller companies are now being equally lured by the biggies and pampered by their existing small firms. Even middle management and executives are being offered profit shares, stakes in companies, high incentives and even sponsorship for children’s education. In the small and medium-sized companies, salaries have gone up by 20% in the last one year or so, say experts.

Ranbaxy SRI, part of India’s biggest pharma company, Ranbaxy Labs, is carrying out major expansion and will hire a large number of employees soon. The company’s HR head Niraj Goel knows that he will have to create alternate models of hiring to tide over the manpower crunch in the industry. “For industry neutral talent like IT, HR is easy. For medical specific talent, we look at smaller companies apart from hiring from rival firms,” he says. Such is the attraction of large corporate houses that several executives at smaller pharma firms are now willing to join them at a marginal salary hike or even for the same salary. “Needless to say, much akin to what happened in the IT industry, smaller companies in the pharma and healthcare sectors are also doling out various incentives to their managers to retain them,” says recruitment firm Elixir Web Solutions MD Vipul Prakash.

Adds Himanshu Baid, MD, Polymed, a medical device manufacturer, “Big pharma companies are setting up manufacturing units in states enjoying tax holidays. Employees in small companies are getting offers which are 50-60% bigger than their current salaries to shift to these locations. When we heard the alarms bells ringing, we also started offering flexible salaries with high incentives and perks. For our senior executive, we plan to provide stock options, which will be given to them after they stay in the company for a certain period of time.”

An growing number of contract manufactures are also going in for a hiring drive and senior-level managers, executives and employees of small domestic pharma companies are much in demand. What has compounded the matter for these small companies is that pharma and healthcare being a specialized sector, they cannot hire from other sectors.

Adds Achal Khanna country head of Kelly Services India, “Small pharma and healthcare companies have realized that they need to give their employees benefits. Employees are getting global exposure and companies are even sponsoring their kids’ higher studies.” She added that as a last resort, small companies have to get fresh graduates or people from other sectors and train them.

Stricter safety norm may hold up copycat drugs

Panel Calls for Clear Timeframe for Allowing Generics

LONG before Pfizer decided to introduce its famed Viagra in India, nearly a dozen me-too pills had flooded the market here. Later, reports surfaced that the blue pill that helped millions to rise to the occasion, may have had a role in a small number of them losing eyesight. Of course, a drug is approved only when its benefits far outweigh the risks involved. But this practice of Indian pharmaceutical companies flooding the local market with copycat versions of MNC drugs immediately after they hit the international market may be restricted soon.

The Satwant Reddy panel on drug data exclusivity has recommended that there should be clarity on how long India should wait and watch a global brand before Indian companies seeking to sell that product here can be given any waiver in the approval requirements. The existing law merely says ’several years.’ Any relaxation on generation of clinical data should be granted only after the expiry of a more clearly specified time, the report recommends.

Unlike in the US, India does not have strong laws for seeking compensation from a drug maker for injuries due to a drug’s side effects. The issue is crucial as Indian companies do not prove their copy’s safety and efficacy directly. Instead, they show limited research data to prove that their copy is similar to the drug that is approved by a sophisticated foreign drug regulator and that their copy is available in the blood stream at similar levels.

Accepting the judgement of a more equipped regulator is fine. But sometimes, drugs meant to treat minor ailments may report serious life threatening side effects later on, leading to its recall in other countries. Some rare side effects surface only when a drug is used by a large section of the population for many years. Regulators find it difficult to wait that long before giving the benefits of that drug to a large section of the needy population. In the absence of clarity on how long India should wait before approving a copy, the instinct and the judgement of the drug controller general counts.

University of Sydney dean and a panellist of 12 international clinical studies, professor Andrew JS Coats told ET during a recent visit that drug control departments the world over should make approval criteria more stringent in the case of life style drugs, and relax or maintain status quo on drugs for life threatening diseases. More clinical studies could be demanded for drugs meant for symptomatic relief as a better informed approval decision would justify the time delay. However, for drugs treating life threatening diseases, the emphasis could be to make the therapeutic benefit available to patients at the earliest as per the present norms.

“It is a scientific dilemma between protecting consumers from side effects unknown at the time of approval while at the same time not closing the doors on a new drug’s therapeutic benefits. This becomes difficult as there is no 100% validated method to predict the safety of a drug. As more data emerge from mass consumption, unknown chemical aspects of a drug also emerge,” former Drugs Controller General of India Ashwini Kumar told ET. The government is likely to take the panel’s suggestion seriously.

Lupin gets USFDA approval for Cefadroxil capsules
Mumbai: Augmenting Lupin’s cephalosporin portfolio in the $8.7 billion broad spectrum antibiotic market in the US, the drug maker Thursday said it has received USFDA nod for it’s abbreviated new drug application (ANDA) for antibiotic Cefadroxil capsules (500 mg). The company’s Cefadroxil capsules are the AB-rated generic equivalent of Warner Chilcott (erstwhile) Duricef capsules and the drug is a broad spectrum antibiotic used to treat bacterial infections, Lupin informed the BSE. With this approval, Lupin now has 23 AND as approved by the US Food & Drug Administration, it added.