FDA Inspection In several Indian Manufacturing Plants: A Boost in Exports Expected!!

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.


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.
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. 


Several other plants which were inspected are listed below:

COMPANY	PRODUCT	LOCATION
Ranbaxy	Finished dosage	Mohali
Nectar Lifesciences	API	Chandigarh
Ind Swift	API	Chandigarh
Orchid Chemicals	API	Chennai
Emcure Pharma	API	Pune
Mumbai based Firm	API	Ahmedabad

 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.


(Source: Economic Times)

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