New Delhi: The Central Drugs Standard Control Organization (CDSCO) has identified as many as 131 spurious and substandard quality drugs manufactured by different pharmaceutical companies across the country in March. The drug regulator has also ordered for immediate withdrawal of such drugs from the market.
“The central drugs laboratories have identified 70 drug samples to be not of standard quality (NSQ) and state drugs testing laboratories have identified 61 drugs samples as not of standard quality. Identification of drug samples as NSQ is done based on the failure of the drug sample in one or the other specified quality parameters,” an official said.
According to the official, the failure is specific to the drug products of the batch tested by the government laboratory and it does not warrant any concerns on the other drug products available in the market.
Further, in March 2025, one drug sample from the State of West Bengal was identified as a spurious drug, which was manufactured by an unauthorised manufacturer using a brand name owned by another company, the matter is under investigation and action will be taken as per Act & Rules.
“This action of identifying NSQ and Spurious medicines is taken on a regular basis in collaboration with state regulators to ensure that these drugs are identified and removed from the market,” the official added.
Some of the drugs which were declared as not of standard quality include Calcium & Vitamin D3 Tablets IP with batch number PGT246 72 manufactured by Affy Parenterals based in Solan district oh Himachal Pradesh, Zinc Sulphate 20mg Dispersible Tablets IP with batch number T-15192 and manufactured by Karnal Pharmaceuticals Pvt Ltd of Dehradun in Uttarakhand, RABISAP tablets Rabeprazole Gastro Resistant Tablets IP 20 mg with batch number AST 24524 and manufactured by AASSK Pharmaceuticals Pvt Ltd from Chennai in Tamil Nadu etc.
Ironically, the drug regulator has also recently instructed to immediately stop the manufacture, sale, and distribution of 35 unapproved fixed-dose combination (FDC) drugs, which include painkillers, nutritional supplements, and anti-diabetic medications.
An order in this regard has been issued to the drug regulators across all states and Union Territories. The copy of the order which is in possession of ETV Bharat, warned of potential adverse drug reactions and drug interactions due to the lack of scientific validation.
“It has come to the notice of this directorate that certain FDC drugs have been licensed for manufacture, sale, and distribution without prior evaluation of safety and efficacy,” Dr Rajeev Raghuvanshi, Drugs Controller General of India (DCGI), said.
He has also asked the drug regulators to review their processes for granting approvals to FDCs and ensure strict adherence to the Drugs and Cosmetics Act, 1940, and the New Drugs and Clinical Trials (NDCT) Rules, 2019.
The drug regulator banned the use of chlorpheniramine maleate + phenylephrine hydrochloride for below four years of age because of the risk to children.
Some of the state regulators to review their processes for granting approvals to FDCs and ensure strict adherence to the Drugs and Cosmetics Act, 1940, and the New Drugs and Clinical Trials (NDCT) Rules, 2019
Some of the unapproved fixed-dose combination drugs include Mirabegron 25mg (ER tablet) + Solifenacin Succinate 5mg (film-coated tablet), Nefopam Hydrochloride 30mg + Paracetamol 325mg tablets, Metformin Hydrochloride IP 500mg + Glimepiride IP 3mg + Dapagliflozin Propanediol Monohydrate IP eq. to Dapagliflozin 10mg (film-coated bilayered tablets) among others.
Read more:
