In perhaps the biggest move of its kind so far, the Indian drug regulator has flagged about 500 manufacturing plants for quality-related issues. The government plans to inspect these facilities for compliance with good manufacturing practices and take action where they don't meet the standards.
The move is part of a drive to weed out supplies of substandard drugs in the market, a senior official in the health ministry told ET.
The government has begun inspection of 200-250 facilities in the first leg on a risk priority-basis, the official said, requesting not to be named. The official declined to divulge the names of the companies involved.
Under the Central Drugs Standard Control Organisation's (CDSCO) newly introduced "risk-based" inspection system, manufacturing sites found to pose maximum risk due to non-compliance issues would be inspected on priority.
The move is part of a drive to weed out supplies of substandard drugs in the market, a senior official in the health ministry told ET.
The government has begun inspection of 200-250 facilities in the first leg on a risk priority-basis, the official said, requesting not to be named. The official declined to divulge the names of the companies involved.
Under the Central Drugs Standard Control Organisation's (CDSCO) newly introduced "risk-based" inspection system, manufacturing sites found to pose maximum risk due to non-compliance issues would be inspected on priority.
"This kind of inspection had never been taken up in India before. We are planning to cleanse the system completely," the official said.
"We are checking for practices like hygiene and qualification of the personnel (at the plant) and whether they (the drug makers) are adopting shortcuts in procedures they have to follow when internally testing their products," the official said, adding that the government will analyse and take action on lapses found only after it completes inspections at all the manufacturing sites.
"We are checking for practices like hygiene and qualification of the personnel (at the plant) and whether they (the drug makers) are adopting shortcuts in procedures they have to follow when internally testing their products," the official said, adding that the government will analyse and take action on lapses found only after it completes inspections at all the manufacturing sites.
The government expects the latest action and punitive follow up measures to cut the deficiencies associated with the quality of drugs in India by 80-90%. While the ministry's main aim is to point out problems that companies should fix in their manufacturing processes, government representatives had also earlier told ET of actions like suspension of manufacturing licences where major faults were detected.
The regulator will prioritise the sites for inspections based on the number of products that failed quality tests over the past seven years. Another criterion will be the complaints it received from state and foreign drug regulators.
These facilities have made at least five medicinal products that failed quality tests, with one even having made as many as 70, said another senior health ministry official who also didn't wish to be named.
These facilities have made at least five medicinal products that failed quality tests, with one even having made as many as 70, said another senior health ministry official who also didn't wish to be named.
State authorities will investigate and take the required action against companies flagged with substandard drugs, while the Centre's inspection team will check whether the facilities comply with the country's good manufacturing practices.
CDSCO has currently sent out seven teams to check compliance of facilities in Andhra Pradesh, Telangana, Uttar Pradesh, Punjab, Gujarat and Assam. The teams, which include a lab expert to check the drug testing equipment at these sites, are inspecting facilities of 20 companies, sources said.
CDSCO has currently sent out seven teams to check compliance of facilities in Andhra Pradesh, Telangana, Uttar Pradesh, Punjab, Gujarat and Assam. The teams, which include a lab expert to check the drug testing equipment at these sites, are inspecting facilities of 20 companies, sources said.
The objective of this inspection is to see whether the companies have a system in place that meets all the technical requirements to ensure the consistency and quality of the product," the health ministry official said.
So far, 19 teams have been trained to conduct these risk-based inspections, the official said, adding that more teams were being trained for the same.
So far, 19 teams have been trained to conduct these risk-based inspections, the official said, adding that more teams were being trained for the same.
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