New Delhi:

A particular batch of Metronidazole 400 mg and Paracetamol 500 mg tablets made by Hindustan Antibiotic Limited and Karnataka Antibiotic and Pharmaceuticals Limited, respectively have been found to be “not of standard quality” during testing, the government told Rajya Sabha on Tuesday.

As informed by the Department of Pharmaceuticals, both Hindustan Antibiotic Limited and Karnataka Antibiotic and Pharmaceuticals Limited have withdrawn/replaced the requisite ‘Not of Standard Quality’ (NSQ) stocks to the consignee with fresh stocks, Union Minister of State for Health Anupriya Patel said in a written reply.

A list of such drugs along with their details, which are declared not of standard quality/spurious/misbranded/adulterated by the Central Drugs Testing Laboratories is regularly uploaded and available on the website of Central Drugs Standard Control Organization (CDSCO) under the heading of drug alert.

“As informed by the Department of Pharmaceuticals, Tablet Metronidazole 400 mg (Batch No. HMAA04) manufactured by Hindustan Antibiotic Limited (HAL) and Tablet Paracetamol 500 mg (Batch No. 2508323) manufactured by Karnataka Antibiotic and Pharmaceuticals Limited (KAPL) have been found to be ‘Not of Standard Quality’ (NSQ) during testing.

“As informed by the Department of Pharmaceuticals, both HAL and KAPL have withdrawn/replaced the requisite NSQ stocks to the consignee’s with fresh stocks,” Patel said.

As per the Drugs Rules, 1945, all manufacturers are required to comply with the conditions of the license including the good manufacturing practices (GMP) as prescribed under the Schedule M of the Drugs Rules, 1945.

Further, the Central government has amended the Drugs Rules 1945 dated 28.12.2023 to revise the schedule M related to good manufacturing practices and requirements of premises, plant and equipment for pharmaceutical products.

In the cases concerning the quality or safety of drugs as and when reported, actions are taken by the licensing authorities concerned under the provisions of the Drugs and Cosmetics Act, 1940, and its rules, including prosecution in the appropriate court of law.

As a part of surveillance and monitoring activities, the drug inspectors draw drug samples from the supply chain at regular frequency for quality checks. In case the sample is found to be NSQ/spurious/adulterated/misbranded, actions are initiated as per provisions of the Drugs and Cosmetics Act, 1940, and the rules thereunder.

“Manufacture of spurious/adulterated/Not of Standard Quality drugs etc. is a punishable offence under the provisions of Drugs and Cosmetics Act, 1940, and concerned licensing authorities are empowered to take action in such cases,” Patel said.

Use of any spurious/adulterated/not of standard quality drugs etc. is detrimental and may cause adverse effects on the patient’s health, she said.

Isolated complaints regarding such drugs as and when received are investigated along with the licensing authorities concerned for taking action as per the provisions of the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945, the minister added.

(Except for the headline, this story has not been edited by NDTV staff and is published from a syndicated feed.)

The Central Drugs Standard Control Organisation (CDSCO) has raised concerns over the quality of 51 drug samples, including popular medications like paracetamol, pantoprazole and various antibiotics used to treat bacterial infections.

In a report released on June 20, CDSCO, India’s drugs regulatory body, said 22 of these substandard drugs were manufactured in Himachal Pradesh. The other samples were collected from Jaipur, Hyderabad, Waghodia, Vadodara, Andhra Pradesh and Indore. 

Full list of drugs that failed quality tests:

1. Cyra Tablets, Rabeprazole Sodium Tablets IP
2. Rabedin tablet Tablets, Rabeprazole Sodium GastroResistant Tablets IP
3. Moxtas Distab 250 Tablets, Amoxycillin trihydrate dispersible tablets IP
4. Tolcenta-P Tablets, Tolperisone Hydrochloride and Paracetamol tablets
5. Nagris Pakeezah Art Henna 
6. Oxifer-XT Tablets, Ferrous ascorbate elemental iron, Folic acid and Zinc sulphate Tablets
7. Levolets- M Kid Syrups, Montelukast Sodium & Levocetirizine Dihydrochloride syrup 
8. Meazon Plus injection Parentaral Preparations, Mecobalamine, Folic acid & Niacianamideinj 1 ml
9. Xeronac-SP Tablets, Aceclofenac, Paracetamol and Serratiopeptidas e Tablets
10. Pedxim-200 Tablets, Cefpodoximepro xetil Tablets 200 mg
11.  DofloxOZT Tablets, Ofloxacin&Ornid azole Tablets 
12. Disinfectants, Surgical Spirit BP 
13. Sif Alben Suspension, Albendazole Oral Suspension 2.5% w/v (Vet)
14. Terbutaline Sulfate,Bromhexin e Hydrochloride with Guaiphenesin Syrup
15. Metoprolol Succinate Extended Release Tablets IP
16. Cuftin Cough Linctus 
17. CefuroximeAxetil Tablets IP 
18. LevosalbutamolSul phate,AmbroxolHC L,Guaiphenesin Syrup
19. Acetylsalicylic Acid Tablets 75 mg
20. LactuloseSolution U.S.P.
21. Terbutaline Sulphate, Bromhexine Hydrochloride, Guaiphenesinand Menthol Syrup
22. Prednisolone Tablets IP10mg
23. Mecobalamin, AlphaLipoicAcid, Pyridoxine Hydrochlorideand Folic Acid Soft Gelatin Capsules
24. Telmisartan Andamlodipine Tablets IP 
25. Cefoperazone& Sulbactam for Injection 
26. Cefotaxime InjectionIP500mg
27. Dexamethasone SodiumPhosphate Injection I.P
28. Amoxycillin&Potas sium Clavulanate InjectionIP1.2gm
29. Telmisartan and Metoprolol Succinate (Extended Release) Tablets
30. Pantoprazole Tablets IP.
31. Ambroxol HCl, Levosalbutamoland Guaiphenesin Syrup 
32. Dexamethasone Sodium Phosphate Injection I.P. (8mg/2ml)
33. Dexamethasone Sodiumphosphate Injection IP 
34. Paracetamol 500 mg. Tablets
35. Ofloxacin Ornidazole Tablets IP 
36. Vildagliptinand Metformin Hydrochloride Tablets IP 50mg/1000mg
37. Amoxycillin and Potassium Clavulanate Tablets I.P.
38. Clonazepam TabletsI.P.0.5mg
39. Metronidazole Extended Release Tablets USP 600 MG
40. Diclofenac Sodium and Paracetamol Tablets IP 
41. Atropine Sulphate Injection IP 
42. Montelukast Sodium and Levocetirizine Hydrochloride Tablets
43. Fluconazole Tablets IP (150 mg)
44. Ceftriaxone Injection IP 
45. Ramipril and Hydrochlorthiazide Tablets IP
46. Glipizideand Metformin Tablets IP
47. Ceftriaxone for InjectionI.P.1gm
48. Gentamicin Sulphate Injection I.P. 2ml 
49. Calcium 500 mg with Vitamin D3250 IU Tablets IP
50. Cefixime and Ofloxacin Tablets
51. Ceftriaxone Injection IP 

The drug regulator has issued notices to the pharmaceutical companies manufacturing these medicines, news agency PTI reported. The failed samples will also be recalled from the market.

The list of 51 drugs that failed the quality test is significantly smaller compared to last year’s 120. These samples, manufactured in Himachal Pradesh, had also failed quality tests.