NOTICE ISSUED TO PHARMACEUTICAL COMPANIES
Face2News/Shimla
In the investigation of Central Drugs Standard Control Organization and State Drug Regulators, samples of 186 drugs made in the country including 45 drugs made in Himachal Pradesh have been reportedly failed. The drugs whose samples failed include those for the treatment of acidity, fever, stomach ulcers, heart disease, inflammation, arthritis and high BP.
In the drug alert issued in June, samples of 33 drug companies of Solan district, 9 of Sirmaur and 3 of Una district have been failed. These include drugs for killing stomach worms, injection for relieving heartburn, drugs for curing infection during fever, injection given during gastric and drugs for killing bacteria.
(SUBHEAD)Two samples of a Baddi company have failed simultaneously. These include Telmisartan, a vaccine for high blood pressure. The failed samples of three drugs of Dutch formulation company of Kala Amb include Ofloxacin for infection and Azithromycin for chest infection. 4 samples of Paradox Pharmaceuticals of Nalagarh have failed. Two samples of Azithromycin, one of Amoxicillin and one of Gastric did not meet the quality standards. The painkiller Brufin and Iron syrup of Medipol Pharmaceuticals of Baddi are included. State Drug Controller Manish Kapoor has issued notices to the companies and directed them to recall the stock.
The medicines whose samples have failed include Ofloxacin tablets and several consignments of antibiotics like Amoxicillin and Potassium Clavulanate. Apart from these, medicines like Vitamin Supplements, Aceclofenac Paracetamol Tablets, Folic Acid Syrup, Cefixime Powder, Rumiheal.D, Itraconazole, Ofloxacin, Ornidazole, Clobetasol Propionate Cream also did not meet the quality standards.
Many injection samples and cough syrups have also failed in the investigation. Serious manufacturing defects such as lack of assay content, incorrect labeling, improper PA levels and failure in disintegration test have been found.
State Drug Controller Manish Kapoor said that all the Pharma company whose drug samples have failed in the drug alert have been issued notices and instructions have been given to remove the related drug products from the market. Along with this, the units whose names are repeatedly appearing in these monthly lists will be inspected risk-based and the deficiencies will be identified.
