Samples of 32 drugs produced in state found substandard by regulator
In an alarming development, 13 injection samples manufactured by various drug firms of Baddi and Sirmaur figure among 32 drugs declared substandard in the monthly alert issued by the national drugs regulator last week.
Since a majority of the injection samples were found to contain particulate matter, it has put a question mark on their manufacturing standard as contamination is categorised as a grossly substandard defect. Presence of particulate matter in an injection represents a potentially life-threatening health hazard as injections can lead to several adverse effects, point out health experts.
According to the guidelines of the Central Drugs Standard Control Organisation, they constitute category B, not of standard quality drugs as they comprise serious quality defects due to negligence or non-compliance with Good Manufacturing Practices (GMPs). They have significantly low active ingredient content, disintegration/dissolution failures and contamination, hitting the efficacy of a drug.
More than two or more drug samples pertain to four to five firms which are found to figure in this list month after month. A large number of drugs, including injections, which have failed to adhere to quality standards, pertain to firms of Paonta Sahib in Sirmaur district.
These injections are used to treat common ailments. They comprise Ceftriaxone and Salbactam injection manufactured by two different firms. These are used in the treatment of bacterial infection.
Dexamethasone Sodium Phosphate injection, which is used to treat a variety of conditions, including inflammation, allergic reactions and certain autoimmune disease, was found lacking in assay which would hit its efficacy.
Nuropat injection is used to treat vitamin deficiencies, particularly those related to nerve function. Two batches of Rabeprazole Sodium injection, used to reduce stomach acid production, were manufactured by a Nalagarh-based firm. Calcium Gluconate injection is used significantly for hypocalcemia, cardiac arrest and cardiotoxicity. Iron Sucrose injection is used to treat anemia, Amoxycillin & Potassium Clavulanate injection for bacterial infection while Gentamicin Sulphate injection is used for serious bacterial infections.
Four batches of Vitamin D granule sachets manufactured by two different firms of Baddi were found lacking in the requisite assay content, thus reducing the effectiveness.
Multiple drug samples of the same firm have also been listed in the alert, thus bringing the manufacturing levels of the firm under the scanner. Two batches of Omeprazole injections and an eye drop manufactured by the same Paonta Sahib based firm figure in the alert list.
Povidone-Iodine ointment, a popular cure for skin infections and burns, Telmisartan tablets, used for treating blood pressure, Albendazole Tablets, used for de-worming, and Exphenicol eye ointment have been listed in the monthly alert setting raising concern as they are popularly used in every household.
State Drugs Controller Manish Kapoor, when asked, said they were doing risk based inspections of firms which repeatedly figure in the alert. All batches, which have been listed in the alert, would be immediately withdrawn from the market and the erring firms would be issued notices to explain the reasons for their drugs found lacking in quality parameters.
Himachal Tribune