Substantiate allegations against Ranbaxy, says Supreme Court

Experts say allegations against the generic pharma company motivated by vested interests

By Kundan Pandey
Published: Wednesday 12 June 2013

In the aftermath of the US case against Indian pharma Ranbaxy Laboratories Ltd, a public interest petition demanding the company’s Indian manufacturing units be sealed was filed in the Supreme Court last week. On Monday, the Supreme Court asked the petitioner to substantiate his claim that the company is manufacturing and selling adulterated medicines. The next hearing on the petition is scheduled for tomorrow.

Advocate M L Sharma had filed the public interest litigation (PIL) after the US subsidiary of the company was asked to pay $ 500 million to settle charges by the US government of selling adulterated drugs manufactured in India. The drugs were manufactured at Ranbaxy’s plants in India at Paonta Sahib in Himachal Pradesh and Dewas in Madhya Pradesh. The company, which is India’s largest generic drug manufacturer, is also alleged to have given false data to the US health authorities.

With the media attention following the US case and the demands of the Indian Medical Association for an investigation, the office of the Drug Controller General of India (DGCI) began an inquiry into the quality of drugs produced and sold by Ranbaxy in India. The DGCI is to submit a report within a month.

Damaging accusations

Meanwhile, the government has defended the Indian pharmaceutical industry . “There are reasons to believe that vested interests are raking up isolated issues reported regarding technical deficiencies on manufacturing and GMP (good manufacturing practices),” said a statement by the Union Ministry of Commerce and Industry.

Experts too allege that vested interests are behind the accusations against Ranbaxy. Such allegations also put the Indian generic drug industry at risk. Indian generic drugs provide cheap treatment options to billions of people around the world.

Doubts about the quality of Ranbaxy’s drugs have resulted in several hospitals suspending their use for a few days. This was revoked after the press release from the commerce ministry. Kailash Gupta, president of All India Chemist and Distributors Federation, says negative publicity has had some impact on sales. If patients are literate and follow the media, they hesitate to buy the medicine. It would be tough to put a figure to the decrease in sales of Ranbaxy drugs, he adds.

Ranbaxy’s drugs have been doubted before. In 2004, the World Health Organization (WHO) had removed three Ranbaxy manufactured drugs from its list of generic AIDS medicines recommended for use in developing countries when they did not meet its standard of quality. The drugs were reinstated in the list in 2005 after company tests proved their equivalence to the patented variants. After the US settlement, in a press release on May 13, WHO stated, “At present, there is no evidence any of the Ranbaxy products currently included in the WHO list of prequalified medicinal products are of unacceptable quality.”

The official spokesperson of Apollo Pharmacy, drug retailer in India, said, "We have been working closely with Ranbaxy over the past week to verify all necessary certifications of their drugs. A cautionary advisory was issued based on concerns raised by the medical oversight committee. The matter is in the process of being resolved as Ranbaxy continues to provide the necessary paperwork."

S Srinivasan, managing trustee of LOCOST, a Vadodara-based non-profit drug manufacturing unit, expresses hope that the incident will affect the Indian pharma industry positively by ensuring that the quality of drugs manufactured become a priority.

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