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90 Unapproved Drug Samples Found, Including Paracetamol; Regulator Cracks Down

The Drug Controller General of India has identified 90 samples of Fixed Dose Combination drugs as unapproved, including common medicines like Paracetamol and multivitamins. The regulator has written to state authorities, stating these unapproved drugs fall under the 'New Drug' category and their sale violates the 2019 rules. It has directed states to initiate investigations and regulatory action against the responsible manufacturers and marketers. The matter has been flagged as a top priority for public health, with states required to submit an action taken report.

Key Points: 90 Unapproved Drug Samples Found, Regulator Orders Action

  • 90 FDC drug samples found unapproved
  • Includes Paracetamol and multivitamins
  • Regulator directs states to investigate
  • Violates New Drugs and Clinical Trial Rules
  • Action taken report demanded
2 min read

90 FDC drug samples, including Paracetamol and multivitamins, found unapproved; regulator asks states to take action

India's drug regulator finds 90 unapproved FDC drug samples, including Paracetamol and multivitamins, and directs states to investigate manufacturers.

"The presence of unapproved drugs in the supply chain is a matter of serious concern - Drug Regulator Letter"

By Shalini Bhardwaj, New Delhi, March 23

The Drug Controller General of India has launched a nationwide crackdown on unapproved Fixed Dose Combination. The drug regulator has requested to examine the 90 FDCs in the generic name, whether approval is granted by the state or UT drug controllers, according to a letter accessed by.

These drugs include Multi vitamins, folic acids, syrups, Paracetamol, Clotrimazole and Betamethasone Cream, Diclofenac Potassium and Dicyclomine Hydrochloride Tablets, etc.

According to the letter, "The SUGAM lab testing data for the year 2025, a large number of drug samples (FDCs) are detected as unapproved and fall under the category of 'New Drug'. No new drug shall be manufactured for sale unless it is approved by the Licensing Authority 'as defined in Rule 3 of New Drugs and Clinical Trial Rules, 2019, Further, as per Rule 80 of New Drugs & Clinical Trial Rules 2019, a person who intends to manufacture new drug in the form of API or Pharmaceuticals formulation, as the case may be, for sale or distribution, shall make an application for grant of permission to the Central Licensing Authority in Form CT-21 along with a fee as specified in Sixth Schedule."

"The presence of unapproved drugs in the supply chain is a matter of serious concern, posing potential risks to public health and safety. It also indicates non- compliance with the provisions of the Drugs and Cosmetics Act, 1940, and rules made thereunder," the letter read.

"Accordingly, please initiate appropriate investigation and regulatory action against the concerned manufacturers, marketers, and other stakeholders, as deemed fit. Kindly ensure strict monitoring and enforcement to prevent manufacture, sale, and distribution of such unapproved drugs," the letter states, on appropriate action against the sale and distribution of unapproved drugs.

Considering the matter in public interest drug regulator has mentioned it as a serious concern, "In case the manufacturer has submitted the New Drug permission, which is mandatory as per Rule 83 of NDCT Rules, 2019, before grant of manufacturing licence, please provide a copy of the same. You are further requested to submit an action taken report (ATR) to this office at the earliest. This matter may be accorded top priority in the interest of public health."

- ANI

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Reader Comments

R
Rohit P
Finally some action! The pharmacy next to my house always pushes some unknown multivitamin brands. Now I know why. Hope the states actually follow through and don't just file the letter.
A
Aditya G
While the crackdown is necessary, I hope it doesn't create a shortage of essential medicines. The system needs to be proactive, not just reactive. Why were these allowed to be manufactured and sold in the first place? The licensing process itself seems flawed.
S
Sarah B
As an expat living here, this is very concerning. We rely on local pharmacies for everyday remedies. There needs to be more transparency so consumers can check if their medicine is approved.
K
Karthik V
This is the tip of the iceberg. The entire supply chain from manufacturer to local chemist needs auditing. Naming and shaming the companies involved would be a good start. Jai Hind!
M
Meera T
My mother was prescribed one of these combination tablets last month. Feeling worried now. The letter says "potential risks" but what are the actual dangers? The article should explain that more.

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