New Delhi: The Central Drugs Standard Control Organisation has launched an investigation into how a suspended anti-diabetic oral insulin drug has been on sale in the Capital, prompted by Mint’s findings.
It is now in the process of “freezing” Oral Recosulin at all retail pharmacies. This means that the pharmacy cannot dispose or sell the stock till further orders from the regulator. The drug is marketed in India by Mumbai-based Shreya Life Sciences Pvt. Ltd.
India’s drugs regulator had halted marketing approval and the import licence for Oral Recosulin in March 2009 following a Mint report in March that revealed the drug, manufactured by Canada-based Generex Biotechnology Corp., had been approved for sales in India without local human clinical trials, as mandated by The Drug and Cosmetics Act.
On Monday, 11 months after its sale was suspended by the Drug Controller General of India (DCGI), Mint was able to purchase Oral Recosulin from a local pharmacy in Delhi for Rs2,389.
The batch number of the drug, which has an import date of 25 April 2008 and expires in July 2010, is 8ER0702. Mint informed DCGI of this.
Calls and emails to both Shreya and Generex remained unanswered at press time. However, a Shreya executive told Mint on condition of anonymity that DCGI had “categorically told us that not a single vial of the drug should be available in the market. DCGI granted us permission to conduct phase III human clinical trials, which we are doing already.”
In August 2009, Mint had reported that DCGI had asked Shreya to conduct the mandatory phase III trials. The trials were needed before marketing approval because under Indian law, it falls under the category of a “new drug” because it is administered by inhalation as opposed to the widely used method of injection. At the time it got marketing approval in India in late 2007, Oral Recosulin (known as Oral-Lyn in other countries), was being sold only in one other country —Ecuador.
“Generex has been in talks with the health ministry for revoking the marketing suspension, but we wrote to them 10 days ago that their Indian agent Shreya Life Sciences has applied for a clinical trial, so how can they ask for an approval before that is complete?” said DCGI Surinder Singh. “We will investigate this matter and find out how this drug is still being sold.”
A December 2009 Generex press release referred to the drug being on sale in the country. “The company’s flagship product, oral insulin (Generex Oral-lyn(TM)), which is available for sale in India, Lebanon, Algeria, and Ecuador for the treatment of subjects with Type 1 and Type 2 diabetes, is in phase III clinical trials at several sites around the world,” it said.
Mint found that other pharmacies too had stocks of the drug readily available for sale.
“We had got 16 packs of the product though none of them have been sold. However, even in this period we have not received any communication from the company to either recall the drug or stop its sale,” said Jai Kumar, who looks after the Apollo Pharmacy chain in Delhi. The stock available with them bears the same batch number as the product purchased by Mint.
Prior to the suspension of its import licence, Generex had obtained marketing and import permission for 10 million packs of the drug.
In April, Ram Shelat, director (domestic business) at Shreya Life Sciences had said in an email response to Mint that “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.”