The Narendra Modi government is planning a big move to start surprise inspections of the manufacturing units of pharmaceutical firms whose drugs have failed quality audits more than twice in the past year, News18.com has learnt.
The office of union health minister Mansukh Mandaviya, according to the government sources privy to the development, has instructed the Drugs Controller General of India (DCGI) to “make India free of spurious and poor quality medicines.”
The health ministry has informed the drug regulator, VG Somani, to form a task force for inspecting the units across states.
“Now, India has recovered from the bout of Covid-19 and with excellent coverage of vaccination, we believe India is safe. It’s time to take up other projects such as cleaning of spurious and low-quality products from the Indian pharmaceuticals industry,” a top government source told News18.com. “The initiative has been taken by the health minister and he has instructed the DCGI to hunt for pharmaceutical companies whose drugs are regularly failing the quality audits.”
The government conducts regular checking of drugs to determine if they are of standard quality or not-of-standard quality (NSQ). The list of these drugs is updated on the website of the country’s apex drug regulation body, Central Drugs Standard Control Organisation (CDSCO).
For instance, in January, 1,227 samples were tested, and 27 drugs were declared NSQ.
“Roughly, 2 per cent of the total samples collected failed the audit – which requires immediate attention,” the officer said.
These products failed the testing due to several reasons including dissolution, disintegration and uniformity of content of chemicals used.
The trend has been highlighted in the report released by the United States Trade Representative (USTR) in 2019 which had claimed that almost 20 per cent of all pharmaceutical goods sold in the Indian market are counterfeit or spurious.
This was perceived to be a damning claim, considering the expanding pharmaceutical industry of India along with its decades-old reputation of being the “pharmacy to the world”.
What is the plan?
According to the top government official, the DCGI office is likely to constitute a task force as suggested by the minister.
“The minister’s office had directed the DCGI to target all pharma manufacturers who are habitually producing under-quality drugs. The government’s new objective is to make India free of spurious medicines,” said the official.
The task force, which will be formed under the DCGI, will discharge several duties, including conducting raids on manufacturing sites, checking the stipulated production norms along with collecting samples from the sites.
“If these samples fail to clear the checks, the manufacturer will be penalised heavily,” the official said.
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