The Maharashtra Food and Drug Administration (FDA), as a part of its routine random inspections of drugs marketed in the state, has found 20 not-of-standard drugs in April.
The FDA will also be taking action against Jaywin Remedies Pvt Ltd for misbranding their product RDA Gold tablets. Under Drugs & Cosmetics Act (D&C Act), address of the manufacturer on the label of sample is mandatory. However according to FDA sources, the pack of RDA Gold tablets do not mention address in prescribed manner and therefore considered as misbranded.
Well known drug manufacturers like Norris Medicines Ltd for Onvin-4/Ondansetron tablets IP, Bonsai Pharma for Orlin Suspension, Karnatak Antibiotics & Pharmaceutical Ltd for Slow Diclofenac tablets BP 100 mg, Akums Drugs & Pharmaceutical Ltd. for amoxycillin and potassium clavunate oral suspension and Hiral Labs Ltd. for Hizyme-B-a powerful digestive concentrate also figure in the list.
Out of 20 such drug samples, six were from Himachal Pradesh, five from Uttaranchal, three from Gujarat, one each from Maharashtra, Daman, Delhi, Karnataka and Uttar Pradesh.
Products of companies such as ARBRO Pharmaceuticals Ltd {Brufamol (ibuprofen and paracetamol tablets)}, Nirma Ltd (Healthcare Division) (Nircaine ADR injection), Norris Medicines Ltd (Onvin-4/Ondanestron tablets IP), Arion Healthcare {Ondiozet (ondanestron oral solution IP)}, Medisys Biotech Pvt Ltd. {Rubber-20 (rabeprazole sodium tablets)}, Vadenere Laboratories (V-Setron Syrup) do not comply with the IP requirements.
Companies in the substandard list during the month include: Aristo Pharmaceutical from Daman, Arbro Pharmaceutical from Delhi, Nibin Pharmaceutical, Norris Medicines and Nirma Ltd from Gujarat, Arion Healthcare, Bonsai Pharma, Digital Vision, Medisys Biotech Pvt Ltd. and Preet Remedies Pvt Ltd. from Himachal Pradesh, Karnataka Antibiotics & Pharmaceutical Ltd. from Karnataka, Vadenere Laboratories from Maharashtra, Cotec Healthcare Pvt Ltd from Uttar Pradesh, Akums Drugs & Pharmaceutical Ltd., Fizark Healthcare, Hiral Labs Ltd, PRO Laboratories (P) Ltd and Suraksha Pharma Pvt Ltd from Uttaranchal.