AFTER FINDING batches of Combiflam to be “substandard” on March 10 this year, the Central Drugs Standard Control Organisation (CDSCO) has asked all its sub-offices to keep “strong vigil” on the “movement” of this drug. It has also asked them to take “necessary action” if any such movement is reported. “You are hereby requested to instruct your inspectorate staff under your jurisdiction to keep strong vigil on the movement of subject drug in your state. If any movement of such drug is reported, necessary action may kindly be taken in the matter, and required information may be forwarded directly to this office at the earliest,” K Bangarurajan, Deputy Drugs Controller (India), West Zone, CDSCO, said in the letter dated March 16.
The letter was sent to CDSCO zonal and sub-zonal offices, as well as state licensing authorities under the west zone — Chhattisgarh, Goa, Daman & Diu, Gujarat, Madhya Pradesh and Maharashtra. In India, drug regulation is done by state licensing authorities as well as CDSCO.
According to a senior official from Goa’s state licensing authority, it is not clear what “necessary action” has to be taken if any “movement” of this drug is observed.
On March 10, Combiflam batch number A151195, manufactured in October 2015, failed CDSCO’s disintegration test. The test checks if the time taken by the tablet to completely disintegrate in the blood stream is within the prescribed limit or not.
According to QuintilesIMS, a technology-driven healthcare service provider, the annual sales of Combiflam adds up to Rs 169.2 crore. Combiflam, which has been in India for more than 25 years, is the leader of the molecule category Ibuprofen + Paracetamol, with approximately 50 per cent market share.
In total, CDSCO has issued an alert for 60 medicines, including Combiflam, which failed different quality tests in March. Currently, India does not have any regulations in the legal framework that allow recall of substandard batches.
The spokesperson of Sanofi India, which manufactures and sells Combiflam, told The Indian Express: “We have already addressed the issue of disintegration. We are working closely with CDSCO and have taken necessary action as required. Furthermore, we have not received any information or notification from CDSCO, as reported by you.”
The company did not clarify whether the affected batches of Combiflam were withdrawn after the March 10 test results. Last year too, CDSCO had found Combiflam to be substandard three times — in February, April and June — for failing the disintegration test. The company had then recalled the affected batches from the market.
Although India does not have a drug recall system in place, CDSCO and some state drug regulators have developed their own standard operating procedure (SOP). According to this SOP, they usually issue a notice asking the company to recall the substandard drug batch from the market.
“Once a recall notice has been issued, the manufacturer is asked to provide a complete chain of custody for every batch. This means records of when the batch left the manufacturer, who bought it, when it was shipped, who did the wholesaler distribute it to, and which retail pharmacies received that particular batch. This information is provided by the manufacturer to the regulator. The regulator then tracks each SKU (stock keeping unit) within the suspect batch and removes it from the market. Once collected, the stock of the failed batch is fully accounted for and then destroyed,” said Dinesh Thakur, a public health activist and chairman of Medassure Global Compliance Corporation.
Asked if it is usual procedure to monitor the movement of a drug which has been found to be substandard, Thakur said: “I dont have access to internal SOPs (standard operating procedures) from CDSCO and therefore, I am not sure what they mean by ‘strong vigil’. What I find interesting is that they seem to be interested in monitoring this particular drug. I wonder why? Is it because they want to recall all the batches which were found to be substandard or because they fear that somehow the manufacturer will try and get the stock out to the pharmacist. Without direct knowledge of their modus operandi, I am afraid I cannot comment.”