Health Ministry asks DCGI to rid India of shoddy drugs, prescribes raids on errant pharmaceutical companies
Narendra Modi’s government plans to launch surprise inspections of manufacturing units of pharmaceutical companies whose drugs have failed quality audits more than twice in the past year, News18.com has learned.
The office of Union Health Minister Mansukh Mandaviya, according to government sources familiar with the development, has instructed the Comptroller General of Medicines of India (DCGI) to “liberate India from falsified and bad medicines quality”.
The Ministry of Health has informed the drug regulator, VG Somani, to form a task force to inspect units in all states.
“Now India has recovered from the Covid-19 episode and with excellent vaccination coverage, we believe India is safe. It is time to undertake other projects such as cleaning up the bogus and shoddy products from the Indian pharmaceutical industry,” a senior government source told News18.com. “The initiative was taken by the Minister of Health and he instructed the DCGI to drive out the labs companies whose drugs regularly fail quality audits.”
The government carries out regular checks on medicines to determine whether they are of standard quality or non-standard quality (NSQ). The list of these drugs is updated on the website of the national drug regulatory body, Central Drugs Standard Control Organization (CDSCO).
For example, in January, 1,227 samples were tested and 27 drugs were declared NSQ.
“Roughly 2% of the total samples collected failed the audit – requiring immediate attention,” the officer said.
These products failed tests for several reasons, including dissolution, disintegration, and uniformity in the content of the chemicals used.
The trend was highlighted in the report released by the United States Trade Representative (USTR) in 2019, which claimed that nearly 20% of all pharmaceuticals sold in the Indian market were counterfeit or fake.
This was seen as a damning assertion, given India’s expanding pharmaceutical industry and its decades-old reputation as the “pharmacy of the world”.
What is the plan?
According to the senior government official, the DCGI office is likely to set up a working group as suggested by the minister.
“The minister’s office had ordered DCGI to target all pharmaceutical manufacturers who usually produce substandard drugs. The new goal of the government is to make India free from fake medicines,” the official said.
The task force, which will be formed under the DCGI, will carry out several tasks including conducting raids on manufacturing sites, verifying stipulated production standards as well as collecting samples from the sites.
“If these samples fail to pass the checks, the manufacturer will be heavily penalized,” the official said.
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