Government Analysis: India-wide Pharma Firm Inspections Revealed Serious Failures in Drug Manufacturing
A comprehensive internal review of pharmaceutical businesses in India has shown notable shortcomings during inspections throughout the country, including substandard drugs, inadequate training, a deficiency in quality culture, and data integrity, among other issues.
During an All India Drugs Control Officers’ Confederation (AIDCOC) conference, Chandrashekhar Ranga, Deputy Drugs Controller, CDSCO, gave a presentation. One of the results of risk-based inspections in 2022–2023 was that “regulators came to know the ground reality.”
On November 18, a live webinar with Ranga as the speaker was held on the subject of “Risk Based Inspections in India – An Overview.” The “ultimate objective” of these inspections, according to the presentation that News18 was able to see, was to “improve the quality of drugs produced in the country.”
“High NSQ rate” refers to a high percentage of non-standard quality items, and it is mentioned in the presentation under the section on the results of Risk-Based Inspections 2022–2023.
Along with “sensitization of the manufacturers through outreach programs” and “stress on digitisation,” it also said that the approach assisted in the “convergence of thoughts of the central and state regulators.”
The presentation said that one of the factors leading to the nationwide start of inspections was the issues brought to light by Gambia.
Inspections of a few chosen firms have been carried out by the Ministry of Health and Family Welfare via the Central Drugs Standard Control Organization (CDSCO), its drug regulating arm. These are known as risk-based inspections, and they were initiated in response to concerns expressed by the US, the World Health Organization, the Gambia, Uzbekistan, Marshall Islands, Micronesia, and the US on the quality of Indian pharmaceuticals.
The “risky manufacturing sites” that the ministry nominated will be inspected in three stages beginning in December 2022.
WAYS INDIA DETECTED THE HIGHLY RISKY SITES
Six criteria were used to select the sites: information obtained through intelligence, reports from state labs, reports from international regulatory agencies, a national survey carried out by the National Institute of Biologics (NIB), reports from labs under CDSCO, reports from state labs, and information obtained from all 130 oxytocin injection manufacturers.
According to Ranga’s presentation, there were 423 locations with two or more failures, 319 sites with three or more spurious failures, and 100 sites with five or more spurious failures overall in risk-based inspections carried out in 2016 and 2022–2023.
Observations from the most recent inspection round
More than 300 inspections were performed throughout the four stages of the most recent risk-based examination. Nonetheless, the presentation said that “issues of data integrity” were the frequent observed in the most recent round of examination.
In addition to “lack of vendor qualification” and “lack of SOPs or failure to follow SOPs,” it also discovered a “lack of a dedicated section for potent products.”
as well as “lack of technical staff freedom.”
Generally, “food supplements manufactured in the same premises” has been noted often during prior inspections.
Along with a lack of uniform batch size, research and development, and inadequate product knowledge during formulation, other issues have been observed, such as “lack of facilities for the licensed products” and “lack of measures to prevent cross-contamination.”
The following other important problems are highlighted: “poor microbiology lab facilities,” “water system not validated,” “raw materials and finished goods not tested,” and “analytical method not validated.”
