New Delhi: Shreya Life Sciences Pvt. Ltd has put on hold its imports of Canada-based Generex Biotechnology Corp.’s anti-diabetes drug Oral Recosulin and stopped sales of the drug in the country after being told by the drugs regulator, Drugs Controller General of India (DCGI).
The company’s decision comes even as DCGI has decided to refer the matter to the health ministry for a more detailed investigation.
Oral Recosulin was approved for marketing in India without undergoing any local human clinical trials, as mandated by the Drug and Cosmetics Act of India.
“Based on DCGI’s letter, we have stopped sales and dispatches of the product. We have not placed any further order to Generex for import,” said Ram Shelat, director (domestic business) at Shreya Life Sciences.
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An investigation by Mint, reported on 26 March, had disclosed that the drug Oral Recosulin, an inhaled form of insulin, was approved for marketing without mandatory human clinical trials. It was also found that the drug, which falls under the category of “new drug”, since it is administered through inhalation as opposed to the widely used injectable insulin, was being sold only in one other country at the time it got marketing approval in late 2007.
Meanwhile, DCGI has said that the matter will be referred to the health ministry.
“We are investigating how the marketing approval and import licence were granted to Generex Biotechnology and then later transferred to Shreya Life Sciences. What was the basis on which the approval was given to the company? Until the investigation is complete and a decision is taken, the product cannot be sold,” said DCGI Surinder Singh. He added that the investigation could last up to a month.
Generex Biotechnology’s representative office in Mumbai was given marketing approval for its drug Oral-lyn in October 2007 by the then DCGI, M. Venkateswarlu. The approval was for the treatment of insulin-dependent diabetes mellitus. The same approval also required that the company conduct a post marketing surveillance (PMS) study and submit annual reports. However, Indian law requires that a new drug first undergo a phase II or phase III clinical trial before being approved for PMS.
This marketing approval and import permission was later transferred to Generex’s licensee Shreya Life Sciences in April 2008 by DCGI Singh, who is now investigating the basis on which the initial approval was awarded.
“We have also made arrangement not to proceed with the PMS study. As required by DCGI, relevant data on status is being compiled,” said Shelat. He added that the company believes the “permission granted to Generex and transfer to Shreya Life are in accordance with drug law of the country”.
According to a Generex press release dated 25 March 2008, it received a purchase order for 210,000 canisters of Oral-lyn (sold as Oral Recosulin in India) from Shreya Life Sciences. The marketing and import permission obtained by Generex was for 10 million packs of the drug.
In an email communication immediately after Mint published the first story, Generex, said, “The article is based on false premise.” The mail went on to say that the approval granted in India “was based on years of research and clinical studies involving hundreds of patients from all parts of the world, including specific diabetic patients in India”.
However, when Shreya and Generex were asked, prior to publishing the story, both companies had said that there were no trials undertaken here and they were now conducting a PMS study.
The mail from Generex further added that the “Indian government properly saw that Recosulin is something that is now urgently needed and DCGI’s approval reflects the government’s concern for the public’s health”. Citing several misstatements in the article, Generex had offered to clarify matters to Mint.
However, Generex declined to follow up and maintained that all future queries should be directed to its India licensee, Shreya Life Sciences.