The Central Drugs Standard Control Organisation or CDSCO, India’s drug regulator, has identified over 50 medicines as “Not of Standard Quality (NSQ) Alert” in its latest monthly report. More than 50 drugs, including those used to treat fever, diabetes, hypertension, vitamins, calcium D3 supplements, bacterial infections, and acid reflux, failed quality tests undertaken by India’s drugs regulatory authority.
CDSCO has released two lists of pharmaceuticals that did not pass quality checks: one “Not of Standard Quality” naming 48 popular drugs and another with answers from pharmaceutical companies whose products failed to meet the safety standards. Companies producing negatively rated pharmaceuticals include Hetero Drugs, Alkem Laboratories, Hindustan Antibiotics Limited (HAL), Karnataka Antibiotics & Pharmaceuticals Ltd, Meg Lifesciences, and Pure & Cure Healthcare. In addition, Hindustan Antibiotic Limited (HAL) manufactured the anti-stomach infection medicine Metronidazole, which did not meet the quality criteria.
A drug-testing facility in Kolkata identified Alkem Health Science’s antibiotics Clavam 625 and Pan D below required standards. The lab found Hetero’s Cepodem XP 50 Dry Suspension, commonly administered to children with serious bacterial infections, to be unsatisfactory. Karnataka Antibiotics & Pharmaceuticals Ltd’s paracetamol tablets were also found to have quality concerns. The government has scrutinised many leading pharmaceutical corporations, including Sun Pharma, Glenmark Pharmaceuticals, and Macleods Pharmaceuticals.
According to the CDSCO report, Sun Pharma’s Pantocid, Pulmosil (Sildenafil Injection) and Ursocol (batch number GTE1350A) are adulterated products. “The actual manufacturer (as per label claim) has informed that the impugned batch of the product has not been manufacturer by them and that it is a spurious drug. The product is purported to be spurious, however, the same is subjected to the outcome of investigation,” the drug regulator has said. The list also includes Glenmark Pharmaceuticals’ Telma H medications (batch number 18230080) and Macleods Pharmaceuticals’ Deflazacort Tablets (batch number GDB23041A).
“State Drugs Licensing Authorities of Andhra Pradesh, Arunachal Pradesh, Assam, Bihar, Chhattisgarh, Goa, Gujarat, Haryana, Himachal Pradesh, Manipur, Rajasthan, Meghalaya, Mizoram, Nagaland, Odisha, Punjab, Sikkim, Tamil Nadu, Pondicherry, Telangana, Delhi, Uttarakhand, West Bengal, Andaman & Nicobar, Dadar and Nagar Haveli; Daman and Diu, Lakshadweep have not submitted any data in respect of the Not of Standard Quality (NSQ) Alert,” the CDSCO said.
Several drugs, including Pantomed -40 (batch number GTEO230C), Cefixime (batch number CADA-02), and Pantoprazole Inj. BP 40 mg (batch number D0726/24-25), have been flagged. Bhaskara Vilasam Vaidyasala’s Haridrakhandam failed the ‘pH’ test as per API (Ayurvedic Pharmacopoeia of India). Yogaraja Guggulu of the same firm also failed the quality test. In addition, pharmaceutical firms like M/s.Gnosis Pharmaceuticals, Digital Vision 176, Nestor Pharma, Alexa Pharma, Bala Herbals, Steadfast Medishield, and Aglomed Ltd., have failed to meet safety standards.
Shelcal, Paracetamol, Amoxicillin, Levocetirizine, Adrenaline injection and more commonly used drugs were found “Not of Standard Quality” in the CDSCO report
A batch of Amoxicillin and Potassium Clavulanate tablets IP (Clavam 625) manufactured by Alkem Health Science, a leading pharmaceutical company, also failed to meet standards.
The tested batches included Calcium And Vitamin D3 Tablets IP Shelcal 500 (Shelcal) by Pure & Cure Healthcare Pvt. Ltd, Vitamin B Complex with Vitamin C Softgels by Asoj Soft Caps Pvt. Ltd, Pantoprazole Gastro-Resistant and Domperidone Prolonged-Release Capsules IP (Pan-D) by Alkem Health Science, Paracetamol Tablets IP 500 mg by Karnataka Antibiotics and Pharmaceuticals Ltd, and Nimesulide, Phenylephrine Hydrochloride & Levocetirizine Dihydrochloride Tablets (Nunim Cold) by Unispeed Pharmaceuticals, Adrenaline Injection I.P. Sterile 1 ml manufactured by Alves Healthcare, Diclofenac Sodium IP manufactured by Sara Exports were among those drugs which failed to meet the prescribed standards.
The CDSCO also released the State “Not of Standard Quality” alert list for the month of August 2024. It mentions medicines Paziva -40 which failed the test ‘Dissolution’ as per IP. The same NSQ result was found with Pantomed -40. Cefixime Oral Suspension IP (Dry Syrup) failed the test ‘Assay’ and ‘water’ as per IP. In the medicine Moxymed CV, the content of Amoxycillin and Clavulanic acid is not within the limits of schedule ‘V’ of Drugs and Cosmetics Act & Rules. The CDSCO listed 11 substandard medicines in the state list.
Moreover, the drugs regulatory body stated that State Drugs Licensing Authorities of Andhra Pradesh, Arunachal Pradesh, Assam, Bihar, Chhattisgarh, Goa, Gujarat, Haryana, Himachal Pradesh, Manipur, Rajasthan, Meghalaya, Mizoram, Nagaland, Odisha, Punjab, Sikkim, Tamil Nadu, Pondicherry, Telangana, Delhi, Uttarakhand, West Bengal, Andaman & Nicobar, Dadar and Nagar Haveli; Daman and Diu, Lakshadweep have not submitted any data in respect of the Not of Standard Quality (NSQ) Alert for the Month of August, 2024.
