Keep record of drug invoices: FDA to chemists
After the death of the man, his wife had written to the FDA to institute an inquiry, following which the regulator recalled all the injections (500 mg /10 ml) manufactured by Emcure Pharmaceuticals Ltd, from across the country
Mumbai A year after the death of a 55-year-old man of suspected adverse drug reaction after he was injected with Orofer FCM (ferric carboxymaltose), an iron supplement given to patients to increase haemoglobin, at Saifee Hospital, in Charni Road, the Food and Drugs Administration (FDA) has been unable to pin down the source in the supply chain of the drug. In the face of this, last week FDA-Maharashtra made it mandatory for all retail and wholesale dealers in the state to maintain records of invoices of the drugs purchased from outside the state.
After the death of the man, his wife had written to the FDA to institute an inquiry, following which the regulator recalled all the injections (500 mg /10 ml) manufactured by Emcure Pharmaceuticals Ltd, from across the country. “After the incident, during our investigation, we found that the chain of purchasing the drug ended somewhere in Delhi or Uttar Pradesh but we could not establish who actually produced the duplicate material,” said Bhushan Patil, joint commissioner (Drugs).
On the back of this, Patil said while the body regularly inspects the license and manufacturing facilities of the state manufacturers, after the Saifee Hospital incident, it felt the urgency to check on the drugs coming from outside Maharashtra.
“Chemists buy from authorised distributors and stockists, and are aware of the margin of discount and fixed earning. However, it was observed that people producing spurious raw materials or drugs were from outside the state. They offered huge discounts to entice the chemists,” he said. Dr Patil said since FDA-Maharashtra did not have control on the facilities outside the state, they decided to put a system in place to keep tabs on the entry of such drugs in the state.
At the time of the death in Saifee Hospital, there was conversation around spurious drugs doing the rounds in the market.
“We have decided to create a portal for all out-of-state purchases. Drug sellers or chemists have to send invoices of the purchases from outside the state or even abroad. In case we need to recall the product, we will have all the details available at the click of a button,” he said.
Patil added that the district and divisional office of FDA will keep a record of the supply chain and punitive action will be taken if irregularities are found.
While request to create a portal has been put forward to the Medical Education and Drugs Department, of the state government, Patil said, as a temporary measure drug sellers have been asked to maintain physical records. “All the officers have created an email id on which the drug sellers of their area will send the details. The circular to this effect was issued on October 16. It will act as a deterrent, as chemists and manufacturers will be cautious about our close watch. Their invoices will be scrutinised daily,” said Patil.
An FDA officer said while the police is still investigating the Emcure case, FDA’s investigation hit a roadblock as they could not find the third party who was involved in producing the spurious injection. “We could not find out how it came to the market,” said the officer.
