Karnataka drugs control department has issued 193 show cause notices to sales outlets for violations of Drugs & Cosmetics Act between September 1 and 31 October, 2009. During the period, 93 pharmacy trade licenses had been suspended and 36 sales licenses were cancelled. The reasons for issue of show cause notices are for not possessing a trade license, no issue of sales bills and for storing date expired drugs along with regular medicines.
The Department issued show cause notices to seven manufacturing units for violations. These include the units not adhering to Schedule M norms like lack of record maintenance in batch production of drugs.
The department also issued 315 fresh licenses for sales units during the period. One manufacturing license was issued between September and October 2009.
The state licensing authority also filed three prosecution cases in Court. In the same period, three cases were disposed and all three were convicted. There were also 11 complaints from the public.
In the Drug Test Lab, a total of 224 samples were analyzed, of which six samples were declared not-of-standard quality and investigations are being carried out. These are Pantocent by Precision Pharma in Chanalon, Hexpan by Kreszent Pharma in Puducherry, Subocet Syrup by Kanak Pharma in Panipet, and Bromex by Bonsai Pharma in Himachal Pradesh.
In addition, the government analyst of the drugs test lab has said that 8 drugs are not-of-standard quality. The drugs are Lomofex tablets manufactured by Cortex Labs in Hyderabad. Esafen which contains diclofenac sodium and paracetamol manufactured by Fizikem Life Sciences at Baddi in Himachal Pradesh. Paracetamol Tablets manufactured by Paris Dakner in Chennai. Alcid Suspension which is an antacid and anti flatulent manufactured by Torque Pharma in Dappar. Dicyclomine and Enalapril Maleate tablets by Embiotic Labs in Bangalore, Ofloxacon Tablets by Madhav Biotech in Solan in Himachal Pradesh. Atropine injections by Martin and Brown Pharmaceuticals in Hissar and Don tablets which contains paracetamol, diclofenac and potassium, magnesium trisilicate manufactured by East African Overseas, Deharadun. All healthcare providers and the public have been cautioned to refrain from prescribing or purchasing these drugs.
The state has 23,038 sales premises, 172 blood banks, 31 blood storage centres, 235 drug manufacturing units and 92 cosmetic units.
Sub standard drugs are those with manufacturing defects like chipping of the tablet, labelling deficiency or suffering from deterioration because of storage condition and not labelled on the medicines.
Every month surprise inspections are being carried out by the Department to ascertain the quality of drugs being circulated in the market. By and large Karnataka companies have adhered to good manufacturing practices, but at times during transit there are damages. When the units are intimated about the detection of substandard medicines, they need to withdraw them from the shelves of the pharmacy outlets immediately, said Dr BR Jagashetty, Karnataka Drugs Controller.