Drug contamination crisis: Indian pharma industry faces regulatory crackdown | Check list of substandard drugs here

Source: CNBC TV18

The Indian drug regulator, CDSCO, found contamination in drugs from Fourrts India and Norris Medicines, including the cough syrup COLD OUT. This adds to India’s recent struggles with drug contamination, including fatal incidents abroad. The government is cracking down on pharmaceutical companies to safeguard India’s global reputation for drug quality.

The Indian drug regulatory authority, Central Drugs Standard Control Organisation (CDSCO) released a report in August revealing contamination of drugs produced by two pharmaceutical companies: Fourrts India and Norris Medicines. The drugs were found to contain diethylene and/or ethylene glycol.

Specifically, the cough syrup COLD OUT, produced by Chennai-based Fourrts, was confirmed to be contaminated by the World Health Organization (WHO) in a sample obtained from Iraq in August. Subsequent testing by the Indian drug regulator affirmed this contamination. One batch of COLD OUT was found to be tainted with diethylene and ethylene glycol, while another batch tested positive for ethylene glycol.

Moreover, additional drugs contaminated with ethylene glycol were identified, including two cough syrups manufactured by Norris Medicines: Trimax Expectorant and Sylpro Plus Syrup. Consequently, the government has taken action by sealing the manufacturing units of Norris Medicines.

The Indian pharmaceutical industry has faced increased scrutiny since the previous year due to a series of incidents related to drug contamination involving DEG and EG. These include cases like Maiden Pharma’s cough syrups being allegedly associated with the deaths of over 65 children in Gambia, and Marion Biotech’s cough syrup being linked to the alleged deaths of 18 children in Uzbekistan.

The WHO also issued an alert concerning a cough syrup produced by Punjab-based QP Pharmachem and marketed by Haryana-based Trillium Pharma. While Maiden Pharma faced accusations, the Indian government denied them.

In response to the alarming number of incidents, the government has intensified its crackdown. Actions taken range from cancelling licenses of 18 pharmaceutical companies allegedly producing counterfeit drugs to implementing mandatory testing of cough syrups at government labs before exportation.

As many as 48 drugs were declared substandard in August 2023, as per the latest notification. These included drugs manufactured by Aan Pharma Private Limited, Medisky Pharmaceuticals, Globela Pharma Pvt. Ltd and Norris Medicines Limited.

Here’s a list of drugs which were recently declared as “Not of Standard Quality”:

• MOL-PCB Syrup (Paracetamol, Bromhexine Hydrobromide Chlorpheniramine Maleate, Phenylephrine Hydrochloride, Menthol Syrup) – 60 ml
• Nifedipine Sustain Release Tablets I.P. 20 mg
• DICLOGLOBE 50 (Diclofenac Sodium Tablets I.P. 50 mg)
• Trimax Expectorant (Terbutaline Sulphate with BromhexineHCl and Guaiphenesin),
• Frusemide Injection IP (2ml)
• Refined Glycerin CP Grade
• Sterile Noradrenaline Concentrate IP (2mg /1ml)
• CyproheptadineHCl with Tricholine Citrate Syrup (Sylpro Plus Syrup)
• Sibolone (Tibolone Tablets IP)
• Methylprednisolone Sodium Succinate for Injection USP 40mg
• Misoprostol Tablets I.P. 200 mcg
• Cefotaxime for Injection IP 500 mg
• Bacillus Clausii Spores Suspension (EbaniproSuspension) (Absorbable Surgical Suture U.S.P (synthetic) 70 cm), (Monofilament Poliglecaprone 25) (STERGIC)
• Erythromycin Stearate Tablets IP 250 mg
• Selamer-400 Tablets (Sevelamer Carbonate Tablets 400 mg)
• Telmisartan and Chlorthalidone Tablets
• AMTAS PRP (Amlodipine and Perindopril Tablets)
• Esylate (Etamsylate Injection 250 mg)
• Montelukast Sodium and Levocetirizine Hydrochloride Tablets IP (Montzer-C)
• Nicomode-2 (Nicoumalone Tablets IP 2 mg)
• Erythromycin Stearate Tablets (Enthrocin-500)
• Cefoperazone & Sulbactam for injection
• Doxycycline and Lactic Acid Bacillus Capsules (DOXORIA-L)
• 5 Amoxycillin Capsules IP 500 MG (AMOXYCILLIN 500)
• Ciprofloxacin Hydrochloride Tablets IP 500 mg
• Ofloxacin & Metronidazole Benzoate Suspension (VIVFLOX-MZ Suspension) (For Paediatric USE ONLY)
• Metronidazole & Ofloxacin Suspension (nor-metrogyl Suspension)
• Ibuprofen and Paracetamol Dispersible Tablets (Ibucon Plus Kid)
• Calamine, Zinc Oxide, Aloe vera & Light Liquid Paraffin (Calmin Lotion)
• Lorazepam Tablets I.P. 2 mg
• Calcium and Vitamin D3 Tablets I.P.
• Levocetirizine and Amrboxol Syrup (C & C Syrup)
• Povidone-Iodine Ointment USP 5% w/w
• Cefpodoxime Proxetil for Oral Suspension IP
• Diclofenac Prolonged Release Tablets IP 100 mg
• Aspirin Gastro-resistant and Atorvastatin Capsules IP (75mg/10mg)
• Mupirocin Ointment IP (MUPIJAI OINTMENT)
• The auto disable syringe (KOJAK SELINGE)
• Rabeprazole Gastroresistant Tablets IP (RABALKEM-20)
• Paracetamol 120 mg + Chlorpheniramine Maleate 2 mg/ 5ml syrup (COLD OUT)
• Paracetamol 120 mg + Chlorpheniramine Maleate 2 mg/ 5 ml syrup (COLD OUT)
• Paracetamol 120 mg + Chlorpheniramine Maleate 2 mg/ 5 ml syrup (COLD OUT)
• CALCIUM ACETATE TABLETS USP 667 mg., (Lanum)
• GENTAMYCIN INJECTION I.P. (GENTAVIK 2ml.)
• Pantoprazole Gastro Resistant Tablets I.P. (PAVE -40)
• COMPOUND SODIUM LACTATE INJECTION I.P.

Experts emphasise the necessity of taking steps to ensure standardised quality across therapies, preserving India’s reputation as the “pharmacy of the world” and mitigating long-term damage to its image.