Regulatory & Safety

Indian Courts asked to revoke Ranbaxy's manufacturing license

17-Mar-2014
Last updated on 29-Mar-2014 at 18:37 GMT2014-03-29T18:37:01Z - By Gareth MacDonald+
India asked to pull Ranbaxy license over quality problems
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The Indian Supreme Court has been asked to cancel Ranbaxy’s manufacturing license in the wake of quality problems that earned the firm a US import ban.

Late last week Indian media outlets (Business Standard, Live Mint) reported that the Court had notified the drugmaker of the request, which was submitted by activist lawyer Manohar Lal Sharma in a Public Interest Litigation (PIL) filing.

The reports suggest that Sharma has accused Ranbaxy of making sub-standard drugs – citing the current US import ban – and asked the courts to revoke the firm’s license and initiate an investigation of its activities.

According to The Hindu Chief Justice Sathasivam – who has been tasked with reviewing the PIL - decided not to order Ranbaxy to halt production immediately pending a full review of the firm’s operations.

The Supreme Court has yet to publish full details of the PIL and did not respond to in-Pharmatechnologist.com’s request for confirmation.

In an emailed statement Ranbaxy told us it “has not yet received any notice to file reply from the Hon’ble Supreme Court of India. If the company receives a notice, it will respond appropriately to the observations.

Ranbaxy is compliant with all the requirements under Indian Law and maintains that all the drugs sold by the company in the Indian market are safe and effective.”

History

The PIL is not the first to be filed against Ranbaxy by Sharma. Last year he asked the Court to revoke the drugmaker’s manufacturing license citing its problems with the US Food and Drug Administration (FDA).

According to a report by the Business Standard the 2013 appeal was rejected by the Court, which said told Sharma his “entire argument is based on proceedings in the US. We have no jurisdiction over it.

Show us material that things are happening in India and it adversely affects right to life of people here.”

Related topics: Regulatory & Safety, QA/QC, APIs (active pharmaceutical ingredients)