Substandard medicines, insufficient training, lack of quality culture, data integrity and more – an internal assessment of Indian pharmaceutical companies has exposed significant lapses during inspections across India.
According to a presentation by Chandrashekhar Ranga, Deputy Drugs Controller, CDSCO, at a session organised by All India Drugs Control Officers’ Confederation (AIDCOC), one of the outcomes of risk-based inspections in 2022-23 was “regulators came to know the ground reality”.
The live webinar session was organised on the topic of ‘Risk Based Inspections in India – An Overview’ on November 18, where Ranga was the speaker. The presentation, accessed by News18, said that the “ultimate objective” of these inspections was to “improve the quality of drugs produced in the country”.
The presentation, under the section on outcomes of Risk-Based Inspections 2022-23, mentions “high NSQ rate”, which means a high rate of non-standard quality products.
It also said the procedure helped in the “convergence of thoughts of the central and state regulators” along with “sensitisation of the manufacturers through outreach programs” and “stress on digitisation”.
The presentation mentioned that the complaints highlighted by Gambia were one of the triggers behind the country-wide launch of inspections.
The Ministry of Health and Family Welfare via its drug regulatory wing, Central Drugs Standard Control Organisation (CDSCO), has been conducting inspections at certain shortlisted companies. These are called risk-based inspections and were triggered after the World Health Organization and several other countries, including Gambia, Uzbekistan, Marshall Islands and Micronesia and the US, raised doubts over the quality of Indian medicines.
The ministry shortlisted ‘risky manufacturing sites’ to conduct inspections in three phases, starting December 2022.
How India Identified the Sites Posing a High Risk
The 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.
Ranga’s presentation shows that overall, in risk-based inspections conducted in 2016 and 2022-2023, 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.
Observations in the Latest Round of Inspections
The latest risk-based inspection was done in four phases with more than 300 inspections. However, the common observations in the latest round of inspection, as per the presentation, 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”.
Overall, in previous inspections, the common observations have been “food supplements manufactured in the same premises”.
“Lack of facilities for the licensed products” and “lack of measures to prevent cross-contamination” have also been noted along with a lack of consistent batch size and lack of research and development, poor product understanding during formulation.
Other critical points noted include “water system not validated”, “raw materials and finished goods not tested”, “poor microbiology lab facilities” and “analytical method not validated”.
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