Even as eight days have lapsed since the Central Drugs Standard Control Organisation sent an alert to the state’s regulatory authorities to monitor the movement of the controversial Avastin drug, there has been no action from the Madhya Pradesh government in this direction. Neither has it directed a state charitable hospital that administered the drug on patients in December to stop its usage.
Avastin is a Roche-manufactured drug whose sale has been put on hold in Gujarat and Telangana after reports of partial loss of eyesight from Gujarat.
HT had earlier reported that even though doctors around the globe use Avastin to treat vision loss, it has not been approved by the US Food and Drug Administration for the purpose. The company too does not claim to sell the drug for this specific purpose.
On January 24, HT reported that 32 patients, who had in December been administered the drug at Sadguru Netra Chikitsalaya in Chitrakoot, were complaining of pain and swelling in their eyes.
The Chikitsalaya has now ceased its usage on its own accord and has sent vials for culture-testing to an Indore-based lab.
Sadguru Netra Chikitsalaya administrator, Dr Elesh Jain told HT that they had sent vials of two batches of Avastin — one used and the other unused — for culture test after 18 patients showed an adverse reaction to in December.
“The tests from the Indore-based lab have come negative. The stain test we conducted here at the hospital on Avastin had also been negative. But we have still stopped using it. On January 21, the drugs controller (general) India had sent an alert notice to all states to stop the usage of Avastin in ophthalmology and monitor its movement and usage in the state,” he said.
The January 21 alert-notice issued by drugs controller general (India) Dr GN Singh said that according to media reports, “The drug Avastin (Bevacizumab Injection)… manufactured and marketed by Roche Product (India) Pvt Ltd, have been used in the treatment of eye ailments through intra-vitreal route and this has led to loss of vision in certain patients at CH Nagri Eye Hospital, Ahmadabad, Gujarat.”
The notice adds that the ‘drug is not approved in the country for intra-vitreal use for ophthalmology purposes. In view to safeguard the public health and as a precautionary measure, all concerned are hereby directed that the drug is not used in ophthalmology and the State/UT Regulatory authorities may alert their inspectorate staff to monitor the movement of the said drug and its use in ophthalmology’.
When HT asked Pramod Shukla, joint controller, food and drugs administration, if the MP government had instructed its inspectorate staff to monitor the movement and usage of the drug, he said that the directions had not been given yet, but that they would be issued by Friday evening.
“We are directing our officials to check the movement and usage of Avastin in eye clinics and eye hospitals across the state and ensure it is not used for ophthalmological purposes,” he said.