5 Indian Drug Companies Eager for US Entry After Clean Inspections

5 Indian Drug Companies Eager for US Entry After Clean Inspections

July 5th, 2011 // 12:26 pm @

FDA has inspected the manufacturing plants of at least half-a-dozen Indian drugmakers, raising hopes that these companies will be able to export medicines to the world’s largest drug market, reports Khomba Singh from New Delhi. Several industry executives said teams of inspectors from the US Food and Drug Administration (FDA) did not find any major deficiency during their inspection of facilities of Ranbaxy Laboratories , Orchid Chemicals, Emcure Pharma, Nectar LifeSciences and Ind Swift Laboratories. But this could not be officially confirmed from the FDA.

The US drug regulator has inspected manufacturing plants of at least half a dozen Indian drugmakers in the last few weeks, raising hopes among some of these companies that they will shortly be able to export medicines to the world’s largest drug market.

Several industry executives said teams of inspectors of the US Food and Drugs Administration (FDA) did not find any major deficiency during inspection of facilities of Ranbaxy Laboratories, Orchid Chemicals & Pharmaceuticals , Emcure Pharma, Nectar Lifesciences and Ind Swift Laboratories over the course of the last four weeks. But this could not be officially confirmed from FDA, which did not respond to an e-mail query sent last Thursday.

While in the case of Ranbaxy and Nectar, a go-ahead from the FDA will mean that they can begin exporting to the US from their units, in the case of other companies, an FDA approval will allow them to continue exporting. FDA conducts audit to ensure that Indian drugmakers meet US drug manufacturing norms so that the medicines made at these facilities are safe for American citizens, before they are allowed to be sold in the US market.

Senior industry executives said this was the first time that FDA had inspected so many manufacturing units in India during such a short span of time. “The US government may be trying to expedite approval of generic drugs to reduce healthcare cost, which is a welcome move,” D G Shah, secretary-general of Indian Pharmaceutical Alliance , an association of big Indian drugmakers said.

An estimated $30-40 billion worth of drugs, including top-selling drugs like Lipitor ( Pfizer )), Nexium (Astra Zeneca) and Plavix ( Bristol Myers Squibb), will lose patent protect protection in the next 1-2 years. This means generic firms can launch their versions at one-tenth of the price of the original brand, if they have FDA approval. For the US consumer, sale of more generic drugs will result in greater competition and therefore, lower prices. Ranbaxy Laboratories, the country’s largest drugmaker, stands to benefit the most from a favourable report from the FDA.

The US constitutes a fourth of Ranbaxy’s total sales and a nod from the FDA will permit the Gurgaon-based firm to sell new drugs in the US from its Indian plants, nearly three years after FDA banned and halted marketing approval of new drugs from its two main plants for data fabrication. Two FDA officials spent about two weeks examining the drugmaker’s new manufacturing facility at Mohali, Punjab and it is learnt that they have not pointed out any major flaw during the examination. A Ranbaxy spokesperson declined comment.

FDA officials carried out separate four-day inspections at the active pharmaceutical ingredient (API) plants of two Chandigarh-based firms, Nectar Lifesciences and Ind Swift, at their Dera Bassi plants. Nectar can begin exporting APIs to the US once it gets a formal approval from the American regulator. For Ind Swift, which already exports to the US, this was a re-inspection which concluded about a week back, said the company’s managing director NR Munjal. The Nectar Lifesciences spokesman declined comment.

Chennai-based Orchid Chemicals said late last month that its cephalosporin API manufacturing facility in Alathur, Chennai has cleared a recent FDA inspection allowing it to continue supply of niche APIs to developed markets. For Pune-based Emcure, this was the third reinspection of its API plant in Kurkumbh, near Pune.

FDA officials also audited the facility of a Mumbai-based drugmaker’s plant in Naroda, near Ahmedabad. Local industry executives said Indian firms are better prepared for scrutiny as top drugmakers such as Ranbaxy, Dr Reddy’s, Sun Pharma and Aurobindo have been penalised by FDA in the last two years.

While some executives were of the view that the FDA teams followed a more ‘collaborative approach’, others said the officials from the regulator stuck to their guidelines and did not show any leniency. According to the Pharmaceutical Exports Council of India, US accounts for about a quarter of the country’s .`50,000-crore drug market. Despite increased pressure on margins, the US market remains highly profitable and a key growth driver for many Indian companies.

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