CDSCO – Artifex.News https://artifexnews.net Stay Connected. Stay Informed. Wed, 26 Jun 2024 13:20:31 +0000 en-US hourly 1 https://wordpress.org/?v=6.6.1 https://artifexnews.net/wp-content/uploads/2023/08/cropped-Artifex-Round-32x32.png CDSCO – Artifex.News https://artifexnews.net 32 32 Paracetamol, 50 Other Drug Samples Fail Quality Test. See Full List https://artifexnews.net/paracetamol-50-other-drug-samples-fail-quality-test-see-full-list-5975029rand29/ Wed, 26 Jun 2024 13:20:31 +0000 https://artifexnews.net/paracetamol-50-other-drug-samples-fail-quality-test-see-full-list-5975029rand29/ Read More “Paracetamol, 50 Other Drug Samples Fail Quality Test. See Full List” »

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22 of these substandard drugs were manufactured in Himachal Pradesh (representational)

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.



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How is India streamlining the pharma sector? | Explained https://artifexnews.net/article68165988-ece/ Sat, 11 May 2024 22:54:00 +0000 https://artifexnews.net/article68165988-ece/ Read More “How is India streamlining the pharma sector? | Explained” »

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India ranks third worldwide as a producer of drugs and pharmaceuticals by volume, exporting to around 200 countries/territories. 
| Photo Credit: Getty Images/iStockphoto

The story so far: India’s drug regulator, the Central Drugs Standard Control Organisation (CDSCO), has withdrawn powers delegated to State licensing authorities to issue NOCs (no objection certificates) for manufacture of unapproved, banned or new drugs for export purposes. This latest announcement covering drugs for export comes at a time when India has been under scrutiny for allegations of supplying substandard drugs causing health concerns in several countries. The CDSCO is now the sole authority for issuing manufacturing licences for drugs meant for export.

What is India’s role in the pharma market?

India ranks third worldwide as a producer of drugs and pharmaceuticals by volume, exporting to around 200 countries/territories. The Indian pharmaceutical industry supplies 62% of the global demand for vaccines and is a leading supplier of DPT (diphtheria, pertussis and tetanus), BCG (Bacillus Calmette-Guérin, used primarily against tuberculosis), and measles vaccines. At least 70% of WHO’s vaccines (as per the essential immunisation schedule) are sourced from India, the Centre had noted in a submission in Parliament.

What will be the impact?

India is a key player in the international generic medicine market and any change in policy has a direct impact on manufacturers and importers, say industry insiders. The centralising of the licensing authority is significant, they point out, because according to a study conducted by the Department of Pharmaceuticals, India needs to get ready to take advantage of drug sales worth $251 billion going off-patent this coming decade.

The study notes: “In the years between 2022 and 2030, the pharmaceutical sector in India will undergo landmark changes as several drugs are expected to go off-patent and provide an opportunity for the entry of generic products. Expiry of patents is very promising for the Indian generic drug market as it is expected to expand and grow further with inclusion of these new drugs. With ongoing developments, India has started focusing on self-reliance at a large scale. Hence, it is imperative to identify these drugs beforehand, draft and implement strategies which help in their timely entry into the market by promoting generic drug manufacturing.”

What are the challenges?

India is dealing with several challenges, including tackling intellectual property rights, lack of research and development etc. The study points out that understanding the political, economic, sociocultural, technological, environmental, and legal factors is vital for assessing the opportunities and challenges in the pharmaceutical market in India. “The industry must adapt to changes in these external factors, navigate regulatory requirements, leverage technology advancements, and align their strategies with the evolving needs of the pharmaceutical industry to succeed in the global market,” it noted. Speaking about the change, Raheel Shah, business development director, BDR Pharmaceuticals, says the move is welcome as the centralisation of NOCs will formalise the Indian pharma industry. “This will result in the efficiency of the overall process along with bolstering pharma exports to key international markets. It will help to bring uniformity in protocols, achieve the target of reaching $450 billion by 2047,” he adds.

What about the quality of manufacturing?

An article in the British Medical Journal titled, ‘Indian government cracks down on 18 drug companies for poor quality manufacturing’, noted that the Indian government had cancelled the licences of over 10 pharmaceutical companies as part of a crackdown on poor quality manufacturing. The action last March came after an inspection of 76 drug firms across 20 States. “The government is also understood to have given notices to a further 26 companies for not complying with good manufacturing processes. The Indian pharmaceutical industry has an estimated 10,500 companies, with drug exports having more than doubled in the past decade. But the industry has faced a series of scandals of late, including a World Health Organization investigation into four contaminated cough syrups that caused acute kidney injuries and were linked to the deaths of 66 children in the Republic of the Gambia last year,” it added.

In what seems like an effort to keep a strict watch, the latest order by CDSCO states that pharmaceutical companies will have to get their NOCs from the zonal offices of CDSCO online before applying for manufacturing licences from their respective State/UT drug regulators. The Drugs Controller General of India, Rajeev Singh Raghuvanshi, said the decision was taken to facilitate the application process. In 2018, the CDSCO had permitted State and UTs’ drug licensing authorities to grant permissions to export some specific drugs. As per the new order, local regulators will have to hand over the details of all the approvals they have given from August 2018 to May 2024 to CDSCO.

Are drugs manufactured in India safe? | In Focus podcast

The centralisation of powers hasn’t come as an overnight development, says an industry expert. The Central government’s advisory group on drugs had earlier this year noted that getting NOCs from local drug regulators for pharmaceutical products is a tedious process, leading to delays. Says Harish K. Jain, president, Federation of Pharma Entrepreneurs: “We don’t anticipate any major impact as far as costing or delays with this latest move. Export of goods is on the Union List. Also, the central authority was always the Central government; the power to hand out licences for export of drugs was delegated to States a few years ago.”



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Drugs regulator issues alert after pharma firm Abbott India recalls antacid syrup Digene Gel https://artifexnews.net/article67277325-ece/ Wed, 06 Sep 2023 14:40:11 +0000 https://artifexnews.net/article67277325-ece/ Read More “Drugs regulator issues alert after pharma firm Abbott India recalls antacid syrup Digene Gel” »

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Abbott India informed drug controller Central Drugs Standard Control Organisation of the voluntary recall of Digene Gell and stopped production of all variants of the product manufactured at their Goa facility. Photo: digeneindia.com

The Central Drugs Standard Control Organisation (CDSCO) has alerted healthcare professionals, consumers, patients, wholesalers, distributors, and regulatory authorities about the voluntary recall of Abbott India’s popular antacid syrup Digene Gel, manufactured at its Goa facility.

The public notice issued by the apex drug controller on its website said: “The impugned product may be unsafe and its use may result in adverse reaction.”

The Drugs Controller General of India (DCGI), who heads the CDSCO, also advised the doctors and healthcare professionals to carefully prescribe and educate their patients to discontinue the use and to report any adverse drug reactions arising due to consumption of Digene Gel.

“Healthcare professionals should promptly report any suspicious cases of adverse events linked to this product,” the DCGI stated in the letter.

The drug controller’s notice said the company initially withdrew one batch of its product available in mint flavour and four batches in orange flavour after receiving a complaint about a product that was white, had bitter taste and pungent smell early August. Within a week the company recalled all batches of its Digene syrup sold in mint, orange, and mixed-fruit flavours manufactured at its Goa facility.

CDSCO said it was reported on August 9 that one bottle of Digene Gel Mint Flavour used by customers was of regular taste (sweet) and light pink colour whereas another bottle of the same batch was of white colour with bitter taste and pungent odour as per the complaint.

Abbott India Limited informed the drug controller of the voluntary product recall and voluntarily stopped production of all variants of Digene Gel manufactured at their Goa facility.

CDSCO also urged distributors and users to discontinue the use of Digene Gel manufactured at the Goa facility while stating that there is no need to panic.

The drug is known to relieve acidity and its symptoms such as heartburn, stomach discomfort, abdominal pain and gas. It can be prescribed for gastritis (inflammation of the stomach lining) and acid reflux (a condition where stomach acid flows back to the food pipe). It uses basic compounds like magnesium hydroxide to neutralise the stomach acid.

Abbott spokesperson on Wednesday noted that the company had voluntarily recalled the antacid medicine manufactured at Goa site due to isolated customer complaints on taste and odour. 

“There have been no reports of patient health concerns. Other forms of Digene, such as tablets and stick packs are not impacted and Digene Gel manufactured at our other production site is not affected and continues to be available in sufficient quantities to meet current demand. The other production site is in Baddi,” the spokesperson added.



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