15 Licenses canceled & 76 firms asked to stop manufacturing.
Source: The Wire
New Delhi: India’s drug regulator has ordered 76 of 237 pharmaceutical companies it has inspected to stop manufacturing for poor standards, according to Economic Times.
These poor manufacturing standards were discovered during risk-based inspections that have been carried out since December, people aware of the matter told ET
The newspaper cited data from the Central Drugs Standard Control Organisation (CDSCO), saying that out of the 237 manufacturing units that have been inspected so far, 179 have been issued show cause notices.
Licences of 15 firms have been cancelled, it added.
Over 15% of the total samples drawn from these manufacturing units have been declared to be not of standard quality. And therefore, 35 units have been sent warning letters for discrepancies.
The drug regulator is currently conducting Phase IV of these inspections, during which 51 pharma firms have been inspected, according to ET.
According to News18, the common observations in the latest round of inspection were about “issues of data integrity”.
It also found a “lack of a dedicated section for potent products” apart from a “lack of vendor qualification”, “lack of SOPs or failure to follow SOPs” and “lack of freedom to the technical staff”, the news outlet reported.
Overall, in previous inspections, the common observations have been “food supplements manufactured in the same premises”, the report said.
This information was based on a presentation made by Chandrashekhar Ranga, deputy drugs controller of CDSCO.
Citing the presentation, News18 reported that one of the outcomes of risk-based inspections was that “regulators came to know the ground reality”.
According to ET, these inspections were carried out by the CDSCO along with state drug inspectors after cough syrups manufactured in India were linked to the deaths of more than 60 children in Gambia. This incident sparked serious concerns over the quality of Indian drugs.
At least 299 firms, including 72 private testing laboratories, were inspected during the four phases of the risk-based inspections, the newspaper reported.
These labs are required to comply with good laboratory practices.
Since July, 72 public testing labs have been audited. Of them, 39 were sent show cause notices, nine were issued orders to stop testing, and five were sent warning letters, a senior government official told ET.
Overall, a total of 218 firms have been sent show cause notices, 76 (33%) were issued stop manufacturing orders, 15 firms faced cancellation of licences and 40 were issued warning letters, people in the know told ET.
According to the News18 report, the inspection sites were selected based on six parameters – a national survey conducted by the National Institute of Biologics (NIB), reports from the labs under CDSCO, reports from state labs, reports from international regulatory agencies, information gathered through intelligence and all 130 oxytocin injection manufacturers.
As per Ranga’s presentation, the risk-based inspections conducted in 2016 and 2022-2023 showed that there are 423 sites with two or more failures, 319 sites with three or more failures and spurious, and 100 sites with five or more failures and spurious.
