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No major violations at Ranbaxy’s Mohali plant: India’s drug regulator

The regulator says it found no violations under the Drugs and Cosmetics Act at the firm’s Mohali plant
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First Published: Thu, Sep 19 2013. 08 07 PM IST
The US Food and Drug Administration (USFDA), announcing its import alert or ban, said that Ranbaxy had failed to properly investigate its observations on various violations at the Mohali plant, including the presence of a black fibre, suspected to be hair, in a tablet manufactured there. Photo: Pradeep Gaur/Mint
The US Food and Drug Administration (USFDA), announcing its import alert or ban, said that Ranbaxy had failed to properly investigate its observations on various violations at the Mohali plant, including the presence of a black fibre, suspected to be hair, in a tablet manufactured there. Photo: Pradeep Gaur/Mint
Updated: Fri, Sep 20 2013. 12 08 AM IST
New Delhi: India’s drug regulator on Thursday said it found no major discrepancies at Ranbaxy Laboratories Ltd’s manufacturing plant in Mohali, after the US drug regulator earlier this week banned imports from the facility citing irregularities.
“We had carried out inspections of products and services in the concerned manufacturing units of Ranbaxy, and have found no major discrepancies. Hence there are no violations by the company under the Drugs and Cosmetics Act and Ranbaxy operations will continue in India as usual,” said G.N. Singh, India’s Drugs Controller General of India (DGCI).
Ranbaxy declined to comment.
The US Food and Drug Administration (FDA), announcing its import alert or ban on Friday, said that Ranbaxy had failed to properly investigate its observations on various violations at the Mohali plant, including the presence of a black fibre, suspected to be hair, in a tablet manufactured there.
In September and December 2012, FDA inspections had identified significant violations of its current good manufacturing practices (CGMP) at the Mohali facility, including failure to adequately investigate manufacturing problems and to establish adequate procedures to ensure manufacturing quality, according to a press release issued by the FDA on Monday.
“The regulations of the Drugs and Cosmetics Act are not competent, as compared to the meticulous norms laid down by the FDA. Several reports have come out saying that the current regulations are poor, but the recommendations have been completely ignored. It seems that the drug companies are arm twisting the drug controller,” said Gopal Dabade, convenor of Mumbai-based NGO All India Drug Action Network.
The Mohali factory, which is yet to start full-fledged manufacturing and exports to the US market, is the company’s third plant to have come under the US regulator’s import alert or import ban after its plants located at Dewas in Madhya Pradesh, and Paonta Sahib in Himachal Pradesh.
In May, Ranbaxy pleaded guilty to charges brought by the US’s department of justice related to the manufacture and distribution of some adulterated drugs made at these factories and agreed to pay $500 million as penalty.
Ranbaxy also signed a consent decree with the FDA that it would comply with the quality manufacturing norms as suggested by the regulator within five years.
“The pharma industry suffers from a credibility deficit. The problems do not lie in regulations which are critical to the industry, but the challenge is to enforce the regulations in a manner that does not affect growth,” said D.S. Kalha, secretary, department of pharmaceuticals.
Both Singh and Kalha spoke on the sidelines of a conference on accountable health at the PHD Chamber of Commerce in New Delhi.
Ranbaxy shares rose nearly 5% to Rs.350.50 on BSE on a day the Sensex index gained 3.43% to end at 20,646.64 points.
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First Published: Thu, Sep 19 2013. 08 07 PM IST
More Topics: Ranbaxy | Mohali plant | DCGI | FDA | Pharma |